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LMC Forum - A Forum of Leadership Management in Cardiovascular Medicine

The Leadership & Management Forum aspires to assemble senior executives of the cardiovascular community who are occupied either in the academic field or in the National Schools of Public Health, directors of cardiovascular clinics and labs, decision makers in public and private health care sectors, as well as executives in the Insurance, Pharma and Medtech Industry. The Forum offers an unparalleled opportunity to exchange ideas and share best practices amongst high-level specialists, from a variety of institutional settings and professional experiences in a three-day meeting dedicated to reinforce the perspective of cardiovascular medicine.

 

Top News

Apr 25, 2016

Lipoprotein insulin resistance measurement predicts future diabetes risk
In healthy adults, a lipoprotein insulin resistance measurement can predict future risk for type 2 diabetes, according to a secondary analysis of the JUPITER trial which published in JAMA Cardiology. In this analysis, the authors analyzed data from 11,918 adults without diabetes at baseline who participated in the JUPITER trial, a worldwide, randomized, placebo-controlled trial conducted in 26 countries (4,334 women; mean age, 66 years) taking place between December 2003 and August 2008. Men aged at least 50 years and women aged at least 60 years had baseline LDL levels less than 130 mg/dL, high-sensitivity C-reactive protein levels at least 2 mg/L and triglyceride levels less than 500 mg/dL. Patients were randomly assigned 20 mg daily rosuvastatin or placebo. Researchers measured size and concentration of lipids, apolipoproteins and lipoproteins at baseline and 12 months after randomization (n = 9,180). The LPIR score was calculated as a weighted combination of size and concentrations of LDL, VLDL and HDL particles. A prespecified secondary aim of the study was to assess the effect of rosuvastatin on type 2 diabetes; 370 participants (212 from rosuvastatin arm) developed type 2 diabetes during a median 2-year follow-up. Researchers found that rosuvastatin lowered the levels of LDL particles (–39.6%; 95% CI, –49.4 to –24.6), VLDL particles (–19.6%; 95% CI, –40.6 to 10.3) and VLDL triglycerides (–15.2%; 95% CI, –35.9 to 11.3), and shifted the lipoprotein subclass distribution toward smaller LDL size (–1.5%; 95% CI, –3.7 to 0.5), larger VLDL size (2.8%; 95% CI, –5.8 to 12.7) and lower LPIR score (–3.2%; 95% CI, –20.6 to 16.9). In multivariate analyses, HR for type 2 diabetes per standard deviation of LPIR score in the placebo arm was 1.99 (95% CI, 1.64-2.42) vs. 2.06 in the rosuvastatin arm (95% CI, 1.74-2.43).

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Prolonged DAPT confers ischemic benefit in patients with MI
In analyses of the DAPT study, researchers determined that prolonged dual antiplatelet therapy after stenting offers ischemic benefit in patients with prior or index MI, and the DAPT Score improves prediction of benefit from prolonged dual antiplatelet therapy. In the DAPT study, all patients (n = 11,648) were treated with aspirin plus clopidogrel or prasugrel for 12 months after stenting, then randomly assigned to aspirin plus continued thienopyridine therapy or placebo for 12 to 30 months after stenting. In this subanalysis it was compared the 21.1% of participants in the DAPT study who had prior MI (n = 2,456; median time before stenting, 891 days) with the 30.7% of participants who had index MI (n = 3,576). It was assessed whether the DAPT Score predicted benefit or harm with prolonged DAPT therapy. A DAPT Score of 2 or more indicates potential benefit from DAPT longer than 1 year, whereas a DAPT Score of less than 2 indicates potential harm from it. Rates of late MI were higher in those with any MI compared with those with no MI (3.8% vs. 2.4%; P = .01), but prolonged DAPT was associated with reduction of late MI regardless of MI history (HR for any MI = 0.46; P < .001; HR for no MI = 0.6; P = .003). Participants from the DAPT study with a DAPT Score of at least 2 had less MI or stent thrombosis on continued DAPT vs. aspirin and placebo regardless of prior MI status (any MI, 2.7% vs. 6%; P < .001; no MI, 2.6% vs. 5.2%; P = .002). In that population, rates of late bleeding did not differ by assignment to prolonged DAPT or aspirin plus placebo (any MI, 1.5% vs. 1.1%; P = .24; no MI, 2.2% vs. 2%; P = .68). However, among participants with a DAPT Score of less than 2, regardless of MI history, prolonged DAPT was associated with increased risk for bleeding (any MI, 3.2% vs. 1.2%; P = .01; no MI, 2.9% vs. 1.6%; P = .004) but no significant difference in late MI or stent thrombosis (any MI, 2.1% vs. 3.2%; P = .17; no MI, 1.5% vs. 2%; P = .21).

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Healthy diet may reduce hypertension risk in women with gestational diabetes
Women with gestational diabetes were 20% less likely to develop hypertension later in life if they maintained a healthy diet, researchers reported in Hypertension. The authors analyzed data from 3.818 women with a history of gestational diabetes. All were participants of the Nurses’ Health Study II between 1989 and 2011. The mean age at onset of gestational diabetes was 32 years. During a median follow-up of 18.5 years, 1,069 women developed hypertension. After adjustment for potential confounders including BMI, the researchers observed an inverse association between the three dietary patterns — the alternative Healthy Eating Index-2010 (AHEI-2010), the Mediterranean diet and the Dietary Approaches to Stop Hypertension (DASH) — and risk for hypertension. When comparing the highest quartiles of diet scores to the lowest, the HR for hypertension was 0.76 (95% CI, 0.61-0.94) for the AHEI-2010, 0.7 (95% CI, 0.56-0.88) for the Mediterranean diet and 0.72 (95% CI, 0.58-0.9) for the DASH diet. The researchers also observed that lower weight gain also seemed a factor in the reduced risk for hypertension, but a healthy diet regardless of weight gain or weight loss still had a positive effect on BP.

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Apr 18, 2016

FDA Pulls Approval of Niacin, Fibrate in Combo with Statins
Citing a lack of cardiovascular benefit, the FDA is taking the unusual step of withdrawing approvals it had previously given for their combined use with statins to treat high cholesterol. The decision affects niacin extended-release and fenofibric acid. The drug was first approved by the FDA in 1997 and later indicated in combination with simvastatin or lovastatin for the treatment of primary hyperlipidemia and mixed dyslipidemia when monotherapy with any of the three drugs was inadequate. Based on several large cardiovascular outcome trials including AIM-HIGH, ACCORD, and HPS2-THRIVE, the FDA decided that "scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL-cholesterol levels in statin-treated patients results in a reduction in the risk of cardiovascular events. The same reasoning was cited for pulling its approval of niacin extended-release/lovastati n and niacin extended-release/simvastatin. Both drugs were voluntary pulled from the shelves at the end of 2015 by the manufacturers.

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EACPR Cancels EuroPRevent Conference in Istanbul Due to Safety Concerns
Because of worries about the safety of attendees, the European Association for Cardiovascular Prevention and Rehabilitation (EACPR) has announced the cancellation of its EuroPRevent 2016 conference, which was scheduled to begin May 5 in Istanbul. This is the first time in the history of EACPR/ESC congresses that the Committee have had to make such an important, impactful decision. ESC is also looking into ways that the research chosen to be presented at EuroPRevent 2016 can instead be presented at other events, such as at the ESC annual meeting.

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Sex Matters in the Diagnostic Performance of Coronary Artery Disease Testing (PROMISE trial)
The relative prognostic value of coronary computed-tomography angiography (CTA) and stress testing varies by sex in patients with suspected coronary artery disease, according to a new analysis of the PROMISE trial which published in the Journal of the American College of Cardiology. In the overall PROMISE trial, there were no significant differences between anatomic CTA and stress-testing strategies in clinical events (3.3% vs 3.0%) or between sexes in the 10.003 patients. What that analysis didn't do, however, was to evaluate how likely a positive CTA or stress test is in women or men and, if the test were positive, what kind of outcomes they could expect. To tackle this, multivariable analyses were performed using data from 8966 (90%) PROMISE patients with interpretable results. In women, a positive CTA was less likely than a positive stress test (adjusted odds ratio [OR] 0.67; P<0.001), and a positive CTA is more predictive of clinical outcomes (adjusted hazard ratios [HR] 5.86 CTA, HR 2.27 stress test; P=0.028). In men, a positive CTA is more likely than a positive stress test (adjusted OR 1.23; P=0.019), and positive results were similarly predictive for both tests (adjusted HR 2.80 CTA, HR 4.42 stress test; P=0.168).

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Apr 13, 2016

Next-generation TAVR system linked to higher pacemaker implantation rate than previous designs
The rate of permanent pacemaker implantation is higher after transcatheter aortic valve replacement with a next-generation balloon-expandable compared with a previous generation of the balloon-expandable valve according to a study published in JACC: Cardiovascular Interventions.. However, researchers suggested that the increased need for permanent pacemaker implantation may be associated with the implantation height of the valve. The Sapien 3 group had a significant decrease in paravalvular regurgitation compared with the Sapien XT group. Although 2.8% of the patients in the Sapien XT group had moderate paravalvular regurgitation, none of the patients in the XT group had moderate or severe paravalvular regurgitation, the researchers wrote. The onset of any type of new atrioventricular conduction abnormalities was higher in the Sapien 3 group vs. the Sapien XT group (29% vs. 28.9%; P = .022). Moreover, the Sapien 3 group had a higher permanent pacemaker implantation rate compared with the Sapien XT group (19.1% vs. 12.2%; P = .049). Patients in the Sapien 3 group who required a permanent pacemaker had a lower mean implantation height vs. those who did not (aortic/ventricular stent extension: 67%/33% vs. 72%/28%; P = .032). Multivariate logistic regression analysis, which included presence of pre-existing right bundle branch block, implantation height, valve sizing, age and sex, revealed that only implantation height was independently predictive of the need for permanent pacemaker implantation (OR = 0.95; 95% CI, 0.91-0.99).

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PCI with DES appears safe for patients on dialysis
In patients with end-stage renal disease who are on dialysis, PCI with drug-eluting stents appears to be safe and yields lower rates of death, MI and repeat revascularization compared with bare-metal stents, researchers reported in the Journal of the American College of Cardiology. Researchers evaluated 36.117 patients on dialysis from the United States Renal Data System (USRDS). Eligible participants were aged at least 18 years and underwent PCI with DES from April 2003 to 2010. At 1-year follow-up after index PCI, the researchers evaluated all-cause death, death or MI, and death, MI or repeat revascularization. The researchers also analyzed these outcomes based on age, sex, race, dialysis modality and presumed cause of ESRD. At 1 year, there were 38 cases of death from any cause, 55 cases of death or MI and 71 cases of death, MI or repeat revascularization. Compared with patients who received BMS, those who received DES had lower unadjusted rates of death, death or MI, and death, MI or repeat revascularization. In a propensity score-matched cohort, DES was correlated with an 18% lower mortality risk compared with BMS, a 16% lower risk for death or MI and a 13% lower risk for death, MI or repeat revascularization.

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Morning home BP strongly predicts CAD, stroke events (HONEST study)
BP taken at home in the morning is a strong predictor for future CAD and stroke events, according to new data from the HONEST study published in JACC. They studied 21,591 patients treated for hypertension (mean age, 64.9 years) who at 1 week, 4 weeks, 16 weeks, 6 months, 12 months, 18 months and 24 months had home BP measured twice in the morning and twice at bedtime on two different days. The outcomes of interest were stroke and CAD events. Mean follow-up was 2.02 years.The authors reported that during the study period, there were 127 stroke events (2.92/1,000 patient-years) and 121 CAD events (2.78/1,000 patient-years). They found that stroke incidence was higher in patients with morning home systolic BP of at least 145 mm Hg compared with those with morning home systolic BP less than 125 mm Hg, and in patients with clinic systolic BP of at least 150 mm Hg compared with those with clinic systolic BP less than 130 mm Hg. Compared with people who had morning home systolic BP less than 125 mm Hg, those with morning home systolic BP of at least 155 mm Hg had a sixfold elevated risk for stroke (HR = 6.01; 95% CI, 2.85-12.68), Kario, from the division of cardiology, department of medicine, Jichi Medical University School of Medicine, Tochigi, Japan, and colleagues wrote. They found similar results for clinic systolic BP of at least 160 mm Hg vs. clinic systolic BP less than 130 mm Hg (HR = 5.82; 95% CI, 3.17-10.67), and determined that morning home systolic BP predicted stroke events with about the same accuracy as clinic systolic BP. For CAD events, incidence was higher in those with morning home systolic BP of at least 145 mm Hg vs. those with morning home systolic BP less than 125 mm Hg, and in those with clinic systolic BP of at least 160 mm Hg vs. those with clinic systolic BP less than 130 mm Hg, according to the researchers. Compared with those with morning systolic BP less than 125 mm Hg, those with levels of at least 155 mm Hg had more than a sixfold elevated risk for CAD events (HR = 6.24; 95% CI, 2.82-13.84), whereas the relationship between clinic systolic BP and CAD events was less strong (HR for 160 mm Hg vs. < 125 mm Hg = 3.51; 95% CI, 1.71-7.2).

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Apr 4, 2016

Gene transfer therapy appears to benefit patients with heart failure
A gene transfer therapy improved left ventricular function in patients with HF with reduced ejection fraction, according to the results of a phase 2 clinical trial published in JAMA Cardiology. The researchers randomly assigned 56 patients with HF and an ejection fraction of 40% or less (mean age, 63 years; mean EF, 30%) to one to five doses of inactivated adenovirus vector encoding human adenylyl cyclase type 6 or placebo. Before randomization, patients underwent exercise testing, measurement of LVEF by echocardiography and recording of LV pressure development (+dP/dt) and decline (–dP/dt) via cardiac catheterization. At 4 weeks, they received exercise testing, LVEF measurement and measurement of +dP/dt and –dP/dt, and at 12 weeks, they received exercise testing and LVEF measurement again. The primary endpoints were exercise duration and EF at 4 weeks and 12 weeks and +dP/dt and –dP/dt at 4 weeks. The gene transfer therapy and placebo groups had no difference in exercise duration (P at 4 weeks = .27; P at 12 weeks = .47.

At 4 weeks, compared with those assigned placebo, those assigned four or five doses of the gene transfer therapy had increased EF (+6 EF units; standard error, 1.7; P < .004), but the same was not true at 12 weeks (+3 EF units; standard error, 2.4; P = .16), according to the researchers, who noted that those assigned placebo had no increase in EF at either time point. In participants with non-ischemic HF, the gene transfer therapy increased LVEF compared with placebo (P = .024).

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Statins Lower CV Events in Intermediate-CHD-Risk Patients (HOPE-3 study)
Cholesterol-lowering therapy alone and with blood-pressure (BP)–lowering treatment may prevent CV events in patients considered at "intermediate risk" for CHD—but BP lowering alone doesn't do the trick unless BP was high to begin with, suggests primary results from the randomized Heart Outcomes Prevention Evaluation-3 (HOPE-3) trial which announced at the American College of Cardiology (ACC) 2016 Scientific Sessions and simultaneously published in the New England Journal of Medicine.

In HOPE-3's first arm, those who received BP-lowering treatment consisting of candesartan 16 mg/day and hydrochlorothiazide 12.5 mg/day did not have significantly fewer occurrences of a composite of CV-related death, nonfatal MI, or nonfatal stroke (the first co-primary outcome) a mean of 5.6 years later compared with those who received placebo (4.1% vs 4.4%, respectively). The second co–primary outcome, which added heart failure, cardiac arrest, or revascularization to the composite, was also not significantly different between the groups (4.9% vs 5.2%). However, prespecified subgroup analysis, which divided baseline systolic BP into thirds, showed that the participants with upper-third measurements (>143.5 mm Hg) receiving candesartan/hydrochlorothiazide did meet the co–primary outcomes.

In the second arm, the participants who were randomized to rosuvastatin 10 mg/day also met both primary outcomes vs placebo (P=0.002 and P< 0.001 for both group comparisons, respectively) and had a 24% lower risk for CV events.

The trial\'s third arm[3] assessed patients randomized to rosuvastatin plus candesartan/hydrochlorothiazide vs rosuvastatin plus placebo vs candesartan/hydrochlorothiazide plus placebo vs two placebos. The findings showed that those who received both of the treatment drugs together had significantly lower rates of the first primary outcome vs the double-placebo group (3.6% vs 5.0%, respectively, P=0.005), as well as the second primary outcome (4.3% vs 5.9%, P=0.003).

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CVD, CHD event risk may lower with BP, LDL, HbA1c control in diabetes
Adults with diabetes do not commonly have optimal measurements for blood pressure, LDL and HbA1c; however, optimal values would lower the risk for coronary heart disease and cardiovascular disease, a new study published in Diabetes Care.

The authors evaluated data from the Atherosclerosis Risk in Communities study, Multi-Ethnic Study of Atherosclerosis and the Jackson Heart Study on 2,018 adults aged 28 to 86 years with diabetes but without known CVD. Researchers sought to determine whether being at targets for BP, HbA1c and LDL cholesterol together are linked to lower risks for CVD events. Of the participants, 41.8% were at target levels for BP, 32.1% for LDL and 41.9% for HbA1c; 7% of participants were at target levels for all three. The risk for CVD and CHD events was 17% lower for participants with BP at target levels. Participants at LDL target levels had a 33% lower risk for CVD events and 41% lower risk for CHD events. There was a 37% lower risk for CVD events and 36% lower risk for CHD events among participants with HbA1c at target levels. Risks were reduced by 36% for CVD events with one risk factor controlled, 52% with two controlled and 62% with three controlled. Risks were reduced by 41% for CHD with one risk factor controlled, 56% with two controlled and 60% with three controlled.

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Mar 28, 2016

Chemical renal denervation may be feasible approach to resistant hypertension
In patients with severe hypertension, the use of chemical renal denervation with alcohol appears to be a safe and feasible alternative to energy-based renal denervation, according to recent findings from a study published in JACC Cardiov. Interv. In the first-in-human, single-center, prospective feasibility study, researchers evaluated 18 patients aged 18 to 75 years with refractory hypertension despite a stable regimen of at least three antihypertensive medications and a suitable renal artery anatomy. These patients underwent chemical renal sympathetic denervation using a novel three-needle delivery device . This procedure involved the bilateral infusion of microdoses (0.3 mL per renal artery) of dehydrated alcohol into the adventitial space of 37 arteries. The researchers conducted clinical and laboratory evaluations in the hospital and at 1, 3 and 6 months after procedure. Procedural success, defined as successful infusion of the neurolytic agent without serious procedural adverse events, was achieved in 100% of patients and arteries. No cases of perforation, dissection or significant spasm were observed on visual assessment. No device- or intervention-related complications or adverse events were seen. There was one death 9 weeks after procedure owing to a mechanical small bowel obstruction. Although this was treated surgically, the patient developed peritonitis 5 days later, followed by septic shock and organ failure. This event was adjudicated to be unrelated to the device or procedure. In angiographic data of 32 treated vessels in 16 participants accessible for 6-month follow-up, there was no evidence of renal artery stenosis, aneurysms, thrombi, pseudoaneurysms or dissections, and no significant change from baseline angiography in any vessel. At the 6-month follow-up, the researchers observed a mean decrease in office BP of 24 ± 22 mm Hg (systolic) and 12 ± 9 mmHg (diastolic).

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Circulating PCSK9 predicts risk for CVD events
Serum PCSK9 concentration may be a predictor of future CVD events, even after adjusting for traditional CVD risk factors, including LDL cholesterol, researchers reported in Circulation. All the 4232 participants underwent initial baseline blood sampling including measurement of serum PCSK9 using enzyme-linked immunosorbent assay. The primary endpoint of the study was incident CVD events including MI, unstable angina, sudden cardiac arrest and CHD, and stroke mortality. The secondary endpoint was a composite of MI, stroke and CHD mortality. The researchers adjusted for the following covariates: diabetes, BMI, physical inactivity, smoking, hypertension and hypercholesterolemia. Overall, 485 CVD events (304 men and 181 women) occurred during 490,438 person-years at risk. The overall median concentration of PCSK9 was 94.3 ng/mL, but the mean value for women was higher than for men (108.9 ng/mL vs. 80.5 ng/mL). All participants were divided into quartiles based on increasing PCSK9 concentration. Those in quartiles 3 and 4 were predominantly female, diabetic or prediabetic, overweight, smokers and not physically active. In general, statin use was low across all quartiles, but those in quartiles 3 and 4 were more likely to be users. The correlation coefficient between serum PCSK9 and LDL was 0.18 (P < .0001), and between triglycerides and serum PCSK9, it was 0.12 (P < .001). It was also observed a significant association between serum PCSK9 and CVD events, even after adjusting for other CVD risk factors, including elevated LDL (HR = 1.15; 95% CI, 1.05-1.26). In addition, the risk for CVD gradually increased across the quartiles, with the highest risk correlating with greater concentration of PCSK9. For quartile 4, the HR was 1.48 (95% CI, 1.12-1.95; P = .0063 for trend).

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Conservative bifurcation stenting strategy yields favorable 3-year outcomes
In patients with a large coronary bifurcation lesion undergoing provisional bifurcation stenting, a conservative strategy appears to yield better 3-year clinical outcomes compared with an aggressive strategy, according to recent findings from a study published in JACC Cardiov. Interv. In the prospective, randomized, nonblinded, single-center trial, researchers evaluated 258 patients with stable CAD or non-ST-segment elevation ACS and a de novo coronary bifurcation lesion who underwent PCI with a drug-eluting stent. Patients were stratified by presence or absence of a left main bifurcation lesion and randomly allocated 1:1 to a conservative (n = 128) or aggressive (n = 130) intervention strategy for provisional side branch intervention after stenting of the main vessel. The researchers found that between randomization and 3-year follow-up, the conservative approach correlated with a lower incidence of TVF (11.7% vs. 20.8%; P = .049). Although there were no significant between-group differences in TVF at 1 year (9.4% conservative vs. 9.2% aggressive; P = .97), a landmark analysis between 1 year and 3 years revealed fewer TVF events in patients on the conservative regimen (2.6% vs. 12.7%; P = .004). During the 3-year follow-up, there was a lower incidence of the composite of cardiac death or MI in the conservative group vs. the aggressive group (0.8% vs. 6.2%; P = .036), with lower rates of TVR. At 3 years, TLR was similar between the two groups. However, a landmark analysis of TLR at 1 year after randomization found lower rates of 3-year TLR. There were two cases (0.8%) of stent thrombosis, both of which occurred among patients in the aggressive group, despite the use of dual antiplatelet therapy.

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Mar 21, 2016

Gene Variant of HDL May Increase CHD Risk
A rare gene mutation in some individuals with elevated HDL cholesterol, may actually increase the risk of CHD development, new research published in Science suggests. When assessing more than 300 participants with very high HDL-C levels (mean 106.8 mg/dL), investigators found that only one person carried two copies of the gene variant known as P376L, which impairs function of the scavenger receptor BI (SR-BI)—the major receptor for HDL. Four others had single copies of the variant. In further analysis of 1282 additional people, the P376L mutation was again rare and significantly associated with high HDL-C (P=0.005)—findings that were echoed when the investigators examined genetics records for another 300,000 individuals and when they conducted a meta-analysis of 16 population-based genotyping studies. The meta-analysis also showed that P376L carriers had a 79% higher risk of CHD vs noncarriers. They then assessed data from the Global Lipid Genetics Consortium for more than 300,000 people and again found that the variant was very rare (minor allele frequency [MAF] -0.0003). It was also significantly associated with high HDL-C—but not with LDL-C or triglycerides. Finally, the researchers conducted their 16-study meta-analysis, which examined patients with CHD (total cases 49,846) and their healthy peers (total 88,149). The odds ratio for CHD was 1.79 for those who carried the P376L variant compared with noncarriers (P=0.02).

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Familial hypercholesterolemia twice as common as previously believed
According to the Dutch Lipid Clinic criteria, one in 250 Americans are affected by familial hypercholesterolemia, researchers reported in Circulation. Previous research conducted outside of the United States in less diverse populations suggested that the prevalence of FH was one in 500 adults. For the study, were assessed data from 36,949 adults (aged 20 years or older) from the 1999-2012 National Health and Nutrition Examination Survey using Dutch Lipid Clinic criteria, which included LDL, as well as personal and family history of early atherosclerotic CVD, and then extrapolated to 210 million U.S. adults. The researchers estimated that 834,500 U.S. adults may have FH. No differences were observed between men and women. In a secondary analysis, the researchers estimated prevalence for adolescents aged 12 to 19 years using only LDL data from 13,343 adolescents and found that one in 237 American adolescents may have FH, a rate similar to the adults.

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Warfarin increases intracranial bleeding risk in older adults with AF
Patients with atrial fibrillation aged at least 75 years assigned warfarin had higher rates of intracranial bleeding than seen in clinical trial populations, according to findings published in JAMA Cardiology. In this retrospective cohort study of 31,951 veterans aged 75 years or older (mean age, 81.1 years; 98.1% men; 82.5% with hypertension; 42.6% with CAD; 33.8% with diabetes) with AF who were newly referred for warfarin therapy to VA anticoagulation clinics between 2002 and 2012. The primary outcome was hospitalization for traumatic intracranial bleeding. Secondary outcomes included hospitalization for any intracranial bleeding or ischemic stroke. Median follow-up was 2.97 years. The incidence rate for hospitalization due to traumatic intracranial bleeding was 4.8/1.000 person-years. They also found that the incidence rate of hospitalization for any intracranial bleeding was 14.58/1,000 person-years; for ischemic stroke, the rate was 13.44/1,000 person-years. When they adjusted for confounders, the following variables remained significant predictors: dementia (HR = 1.76; 95% CI, 1.26-2.46), anemia (HR = 1.23; 95% CI, 1-1.52), depression (HR = 1.3; 95% CI, 1.05-1.61), use of an anticonvulsant (HR = 1.35; 95% CI, 1.04-1.75) and labile INR (HR = 1.33; 95% CI, 1.04-1.72).

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Mar 15, 2016

New risk score outperforms existing score for prediction of stroke in patients with AF
A novel biomarker-based risk score outperformed the most popular risk score for predicting stroke in patients with atrial fibrillation, according to new findings published in Eur. Heart Journal. The researchers developed the ABC (age, biomarkers, clinical history) stroke risk score, which consists of four variables: age, NT-proBNP, high-sensitivity cardiac troponin I or T, and prior stroke or transient ischemic attack. They developed it in a cohort of 14,701 patients from the ARISTOTLE trial for whom biomarker information was available and who were followed for a median of 1.9 years. There were 391 cases of stroke or systemic embolism during 27,929 person-years of follow-up. In that population, those four variables were the strongest predictors of stroke, and other clinical variables and biomarkers did not add sufficient information to the score. In internal validation, the ABC-stroke score had a C-statistic of 0.68 for stroke or systemic embolism vs. 0.62 for the CHA2DS2-VASc score (P < .001). The researchers then externally validated the score in 1,400 people with AF or atrial flutter from the STABILITY trial. During 4,751 person-years of follow-up that included 48 stroke events, the ABC-stroke score had a C-statistic of 0.66 vs. 0.58 for the CHA2DS2-VASc score (P < .001), according to the researchers.

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Lifestyle changes led to improved cholesterol for high CV risk patients
From 1994 to 2014, adults at high risk for ischemic heart disease lowered their total cholesterol, driven by changes in diet and increased use of statins, according to results from the Northern Sweden MONICA study which published in Eur. Heart Journal. In the study, 4,546 women and 4,349 men aged 25 to 74 years at baseline answered surveys at five points between 1994 and 2014. At each visit, participants were tested for total cholesterol and BP, and self-reported diabetes, MI and stroke. In the overall cohort, mean total cholesterol declined from 6.2 mmol/L (95% CI, 6.1-6.2) in 1994 to 5.5 mmol/L (95% CI, 5.4-5.5) in 2014. The decline occurred in both sexes and in all age groups (P < .001 for all) and did not differ by sex, but it was more pronounced in older participants (women aged 65-74 years, 1.1 mmol/L; 95% CI, 0.9-1.3; men aged 65-74 years, 1 mmol/L; 95% CI, 0.8-1.2) than in younger ones (women aged 25-34 years, 0.5 mmol/L; 95% CI, 0.4-0.7; men aged 25-34 years, 0.6 mmol/L; 95% CI, 0.3-0.8; P for year-by-age group interaction < .001). In 1994, those with prior CVD, diabetes or hypertension had cholesterol levels similar to or higher than the general population, but in 2014, the high-risk group had lower cholesterol levels compared with the general population, the researchers wrote, noting that cholesterol levels declined faster in those with CVD than in those without it (P < .001). Lipid-lowering drugs were used by 1.4% (95% CI, 0.8-1.9) of the cohort in 1994 but by 14.3% (95% CI, 12.6-16.1) in 2014. It is estimated that lipid-lowering drugs accounted for approximately 31% of the decline in cholesterol levels in the overall cohort, and approximately 44% of the decline in the group aged 65 to 74 years.

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AF appears to worsen outcomes in patients with MI
In a new study published in Heart, atrial fibrillation, regardless of type, was associated with increased risk for death, reinfarction and ischemic stroke in patients with MI. Researchers analyzed 155,071 survivors of MI between 2000 and 2009 from Swedish registries to determine whether the different types of AF had any effect on death and CV outcomes in this population. The outcomes of interest were a composite of all-cause mortality, MI and ischemic stroke, and individual components of that composite. Follow-up was 90 days. They found that 15.5% of the cohort had AF (new-onset AF with sinus rhythm at discharge, 3.7%; new-onset AF with AF at discharge, 3.9%; paroxysmal AF, 4.9%; chronic AF, 3%). Those with AF had an event rate of the composite outcome of 90.9 per 100 person-years vs. 45.2 per 100 person-years in those without AF (HR = 1.28; 95% CI, 1.19-1.37). There were no differences in the composite outcome between the subtypes of AF, Compared with no AF, presence of AF was associated with elevated risk for mortality (HR = 1.59; 95% CI, 1.41-1.8), reinfarction (HR = 1.14; 95% CI, 1.05-1.24) and ischemic stroke (HR = 2.29; 95% CI, 1.92-2.74). AF conferred higher risk for the composite outcome regardless of whether a patient had STEMI (HR = 1.34; 95% CI, 1.21-1.48) or non-STEMI (HR = 1.24; 95% CI, 1.13-1.36; P for interaction =0 .23).

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Mar 7, 2016

Score devised to predict outcomes in asymptomatic patients with aortic stenosis
A novel clinical score using factors related to midwall myocardial fibrosis predicted poor outcomes in patients with asymptomatic aortic stenosis, according to findings published in the European Heart Journal.
The score could be used to identify patients who are high risk despite lack of symptoms and could benefit from early valve replacement. The score — which includes age, sex, log-transformed high-sensitivity plasma cardiac troponin I concentration, log-transformed peak aortic velocity and ECG strain — showed good discrimination (C-statistic = 0.85; 95% CI, 0.78-0.91; P < .001) and calibration (Hosmer–Lemeshow test = 7.3; P = .5), according to the researchers. The researchers tested the score’s prognostic value in an internal cohort (n = 127; median follow-up, 10.3 years; interquartile range, 5.7-11.2) and an external cohort (n = 289; median follow-up, 2.6 years; interquartile range, 1.6-4.5) of patients with asymptomatic aortic stenosis. The primary outcome was a composite of CV death, HF and new angina/dyspnea/syncope, all of which could be related to aortic stenosis. In both cohorts, the patients were classified as low risk (probability score < 7%), intermediate risk (probability score 7% to 57%) or high risk (probability score > 57%). Event rates were much higher in the high-risk group than in the low-risk group (internal cohort: 23.9 events/100 patient-years vs. 2.1 events/100 patient-years; log rank P < 0.001; external cohort: 31.6 events/100 patient-years vs. 4.6 events/100 patient-years; log rank P < 0.001).

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Prior PCI a risk factor for bleeding, MACCE in patients undergoing noncardiac surgery
Prior implantation of a coronary stent was identified as an independent risk factor for perioperative bleeding and MACCE in patients undergoing noncardiac surgery when the time between stenting and surgery is less than 1 year. Moreover, the use of bare-metal stents does not appear to decrease risk for these events vs. drug-eluting stents, researchers wrote in the Journal of the American College of Cardiology. There were included 24,313 noncardiac surgery cases Of those, 4.6% of patients had previously implanted coronary stents. According to the results, stented patients had a 3.7% rate of 30-day MACCE (death, MI, cardiac arrest or stroke) vs. 1.5% in those without stents (P < .001). The researchers observed a strong relationship between risk for MACCE and time from stent implantation to noncardiac surgery, suggesting a significantly increased risk within the first year of stent implantation (adjusted OR = 2.59; 95% CI, 1.36-4.94). This risk was attenuated after 1 year (adjusted OR = 0.89; 95% CI, 0.59-1.35). Similar findings were observed for bleeding risk, suggesting increased risk in the first year after stent implantation (adjusted OR = 3.34; 95% CI, 1.55-3.21), but not after the first year (adjusted OR = 1.07; 95% CI, 0.89-1.28). In a subgroup analysis based on stent type, the researchers found increased risk for MACCE in patients who had noncardiac surgery 6 to 12 months after implantation of BMS (adjusted OR = 4.21; 95% CI, 1.49-11.91). The same association was not found with DES (adjusted OR = 1.03; 95% CI, 0.22-4.78). Bleeding risk was only increased in the first year after stent implantation, regardless of stent type. Results persisted after excluding patients with non-overlapping propensity scores.

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TAVR Survival Superior in Women vs Men (PARTNER subanalysis)
Women are more likely than men to be alive 1 year after transcatheter aortic-valve replacement (TAVR), despite more vascular complications and major bleeding at 30 days, according to a secondary analysis of PARTNER data which published online in Annals of Internal Medicine. The study represents the largest analysis of sex-specific outcomes in patients with severe aortic stenosis (AS) undergoing TAVR, with 1220 women and 1339 men (mean age 84.9 years and 84.1 years) from 25 sites. At 30 days, women and men had similar all-cause mortality (6.5% vs 5.9%; P=0.52) and cardiac mortality (4.8% vs 3.9%; P=0.23). Vascular complications occurred in 17.3% of women vs 10% of men (P < 0.001) and major bleeding in 10.5% vs 7.7%, respectively (P=0.012). At 1 year, women had significantly lower unadjusted all-cause mortality than men (19% vs 25.9%; hazard ratio 0.72; P< 0.001) and fewer rehospitalizations (15.8% vs 18.9%; HR 0.82; P=0.043). In multivariable analysis, female sex was independently associated with lower 1-year mortality (HR 0.72; P< 0.001), after adjustment for presence of diabetes, oxygen-dependent chronic obstructive pulmonary disease (COPD), higher Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score, major arrhythmia, renal disease, and liver disease.

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Feb 29, 2016

Aggressive antihypertensive treatment may cause harm in people with diabetes
People with diabetes and systolic blood pressure levels less than 140 mm Hg have an increased risk for death from cardiovascular causes when they are assigned antihypertensive drugs, according to a study published in BMJ. Researchers found a reduction in all-cause mortality when before-treatment systolic BP levels were higher than 140 mm Hg and when BP reached 130 mm Hg to 140 mm Hg with treatment. There was a small increased risk for all-cause mortality when baseline systolic BP was less than 140 mm Hg; however, this was not significant. There was a reduction in CV mortality when baseline systolic BP was higher than 150 mm Hg; however, the risk was increased by 15% when baseline systolic BP was less than 140 mm Hg (RR = 1.15; 95% CI, 1-1.32).

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Women less likely than men to receive optimal care for CAD
Among patients with CAD aged 65 years or older, women were less likely to receive optimal care than men, which may account for much of women’s increased risk for mortality after CAD treatment, according to results from a study published in Circ. Cardiov. Oual. Outcome. The researchers analyzed 49,358 patients aged 65 years or older admitted to a U.S. hospital with CAD between 2003 and 2009 and included in the Get With the Guidelines–Coronary Artery Disease registry and linked to Medicare inpatient data. investigated disparities in 3-year mortality by sex, race/ethnicity and geographic region, with optimal quality of care as a mediator. During the 3-year follow-up period, 32.7% of patients died, including 35.6% of women, 30.8% of men, 38.5% of blacks, 38.3% of Asians, 32.3% of whites and 29.8% of Hispanics. Compared with men, women were more likely to have hypertension and HF when admitted to the hospital (P < .0001) and were less likely to be given lipid-lowering therapies and receive in-hospital procedures (P < .0001), both of which contributed to them being less likely to receive optimal care at hospital discharge (OR = 0.92; 95% CI, 0.88-0.95). Overall, the unadjusted 1.2-fold increase in 3-year mortality held by women over men was attenuated when adjusted for demographic and medical characteristics (OR = 0.99; 95% CI, 0.95-1.03), but Bhatt and colleagues found that women who received suboptimal care had higher odds of mortality than men (OR = 1.25; 95% CI, 1-1.55). The same was not true for women who received optimal care (OR = 0.97; 95% CI, 0.93-1.01). They determined that approximately 69% of the sex disparity associated with 3-year all-cause mortality in this population could be reduced if all women received optimal care (P = .001). The sex disparity in mortality occurred in patients younger than 80 years, but not in those aged 80 years or older (P for interaction = .004).

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Aspirin Before CABG Does Not Increase Bleeding Risk
Patients who are taking aspirin prior to undergoing CABG are not at increased risk for bleeding during the procedure according to a new study published in NEJM. The findings are from the aspirin portion of the multicountry Aspirin and Tranexamic Acid for Coronary Artery Surgery (ATACAS) 2x2 factorial trial. In this cohort of 2100 participants, there were no significant differences in risk for mortality, thrombotic complications, or major bleeding between those randomly assigned to 100 mg of aspirin the day of surgery and those randomized to placebo. The primary outcome, a composite of death and/or thrombotic complications within 30 days' postsurgery, occurred in 19.3% of those receiving aspirin preoperatively and in 20.4% of those receiving placebo. In addition, reoperation for hemorrhage occurred in 1.8% vs 2.1%, respectively; and cardiac tamponade occurred in 1.1% vs 0.4%. In the study, 1047 of the patients (83.3% men; age 66.5 years) were randomly assigned to receive enteric-coated aspirin and 1053 (81.5% men; age 66.2 years) were randomized to matching placebo. These tablets were then given between 1 and 2 hours before surgery. The relative risk (RR) for death or thrombotic events within 30 days for those receiving aspirin vs those receiving placebo was 0.94 (95% CI 0.8–1.1). "Thrombotic events" were defined as nonfatal MI, stroke, renal failure, pulmonary embolism, or bowel infarction. When renal failure was excluded from the composite outcome, the primary end point occurred in 16.4% vs 18.3% of the aspirin and placebo groups, respectively (RR 0.90; 95% CI, 0.8–1.1).

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Feb 22, 2016

Enlarged left atrial diameter confers higher risk for CV death in women with AF
Women with atrial fibrillation are more likely to have enlarged left atrial diameter, and patients with atrial fibrillation and enlarged left atrial diameter, particularly women, are at increased risk for CV death according to a post-hoc analysis of the AFFIRM trial, in which analyzed 2,615 patients with AF and available data on left atrial dimension. The researchers found that 1,751 patients (67%; mean age, 71 years; 41.5% women) had an enlarged left atrial diameter compared with 864 patients (33%; mean age, 70 years; 37.2% women) who had normal left atrial diameter. Enlarged left atrial diameter was more common in women (P = .032). They determined that BMI (OR = 1.05; 95% CI, 1.02-1.07), left ventricular mass (OR = 1.01; 95% CI, 1-1.01), female sex (OR = 1.73; 95% CI, 1.32-2.28) and mitral valve insufficiency (OR = 3.04; 95% CI, 2.1-4.39) all were associated with enlargement of the left atrial. Further analysis indicated that women with AF and left atrial enlargement had increased risk for CV death (P = .011), increase in left atrial diameter was associated with CV death (P < .001) and left atrial diameter was an independent predictor for CV death in women with AF (HR = 2.28; 95% CI, 1.33-3.9).

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Ticagrelor shows better results than clopidogrel in patients with low risk ACS undergoing PCI
In low-risk patients with ACS who undergo ad hoc PCI, a loading dose of ticagrelor was associated with greater effects on platelet inhibition and lower high on-treatment platelet reactivity compared with a loading dose of clopidogrel. Researchers for the prospective, open-label, randomized, parallel-group, phase 4 study evaluated 100 troponin-negative ACS patients undergoing ad hoc PCI at 15 U.S. sites between July 2012 and June 2014. All patients were receiving aspirin therapy but had never received a P2Y12 inhibitor. The primary endpoint was platelet reactivity 2 hours after the ticagrelor or clopidogrel loading dose, quantified as PRU level using the VerifyNow assay. Patients who received ticagrelor had significantly lower PRU levels at 2 hours after the loading dose compared with those who received clopidogrel (98.4 vs. 257; P < .001); the treatment difference was 159.1 (95% CI, 194.7-123.5). In all randomly assigned patients with PRU measurements available at this time point, similar results were seen. The researchers also reported an overall lower level of platelet reactivity across the study’s time intervals in patients who received ticagrelor vs. clopidogrel (P < .001). PRU level analysis at the different time points demonstrated a nonsignificant decrease in platelet reactivity at 0.5 hours with ticagrelor vs. clopidogrel, with significant differences between the groups emerging at the end-of-PCI assessment (ticagrelor, mean 0.6 ± 0.4 hours from loading dose; clopidogrel, mean 0.6 ± 0.3 hours from loading dose). Significant differences continued up to 8 hours from the loading dose (P < .001), according to the results. In an exploratory analysis, the researchers found that fewer patients in the ticagrelor group had high on-treatment platelet reactivity at the end of PCI (P = .03), at 2 hours (P < .001) and at 8 hours (P < .001) after loading dose vs. those treated with clopidogrel. Moreover, at 8 hours, 53.3% of patients in the clopidogrel group continued to have high on-treatment platelet reactivity vs. 2.4% of patients in the ticagrelor group.

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European Commission Approves Late Post-MI Ticagrelor at 60 mg
The European Commission (EC) has followed the recommendation last year from its Committee for Medicinal Products for Human Use (CHMP) for an additional indication for the oral platelet inhibitor ticagrelor in the treatment of post-MI patients in the European Union. The new marketing authorization from the EC is for a dose of 60 mg. The FDA approved ticagrelor for patients with a history of MI at this 60-mg dose last September. The EC had previously approved the drug at 90 mg for treating atherothrombotic events. All indications are for patients who experienced an MI at least 1 year previously and who are at increased risk for subsequent events. The new approval is based on results from the 21,000-patient strong PEGASUS TIMI-54 study, which showed that those who received ticagrelor plus low-dose aspirin had a 15% lower risk of MI, CV death, or stroke vs those receiving matching placebo plus aspirin.

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Feb 17, 2016

Efficacy, safety outcomes in ROCKET AF unaffected by device malfunction
The malfunction of the whole-blood, point-of-care device used in the ROCKET AF trial did not affect efficacy and safety outcomes of the study, according to analyses published in a letter to the editor in The Journal of New England Medicine. The original findings of ROCKET AF demonstrated that rivaroxaban was noninferior to warfarin for the prevention of stroke and systemic embolism in patients with atrial fibrillation. However, an FDA recall of the whole-blood, point-of-care device used in the study, called into question the accuracy of these data, according to the authors. The recall correction notice stated that the INRatio monitor system may provide lower INR results than an automated, plasma-based laboratory INR in patients with certain specific medical conditions, including abnormal hematocrit levels, conditions associated with raised fibrinogen levels and bleeding or bruising. The researchers conducted a series of post-hoc analyses of the ROCKET AF data to explore whether the malfunctioning device led to lower INR values and high doses of warfarin and bleeding. The researchers categorized trial participants based on whether they had any of the recall conditions, and then compared efficacy and safety outcomes of patients who received rivaroxaban with those who received warfarin within each of those subgroups. According to the findings, 63% of the total safety population (n = 14,236) had no recall condition. Patients without recall conditions were younger and more likely to have a history of stroke. Patients with recall conditions were more likely to have diabetes and to have been treated with a vitamin K antagonist before the start of the trial. The efficacy and safety outcomes in the subgroup of patients with no recall conditions were consistent with those of the overall population: noninferiority of rivaroxaban vs. warfarin for preventing stroke and systemic embolism, with similar rates of overall bleeding and lower rates of fatal and intracranial bleeding among patients treated with rivaroxaban, although higher rate of gastrointestinal bleeding, according to the authors.

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Digoxin for Heart Failure Fell Sharply in a Decade, May Be Given More Selectively
Prescriptions for digoxin to patients discharged with reduced ejection-fraction (EF) heart failure fell by two-thirds over the 10 years ending in 2014, independent of age, sex, and history of atrial fibrillation (AF), in a look at about 250,000 patients in the Get With the Guidelines–Heart Failure (GWTG-HF) registry. Use of digoxin in preserved-EF heart failure was much less common but fell over the 10 years to a similar degree. Throughout the decade, digoxin use was significantly associated with use of an implantable defibrillator (ICD) or pacemaker, lower ejection fraction, AF, chronic obstructive pulmonary disease, diabetes, and normal renal function. These findings are published in JACC: Heart Failure. Digoxin was less likely to be prescribed to patients who were older, smoked, or had renal dysfunction, hypertension, ischemic heart disease, or anemia. At the 398 hospitals represented in the GWTG-HF analysis, digoxin prescriptions for reduced-EF heart failure fell from 33.1% of patients discharged in 2005 to 10.7% in 2014 (P<0.0001). The corresponding drop for patients with preserved-EF heart failure was from 16.0% to 5.7% (P<0.0001).

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Better Exercise Capacity Can Lessen Mortality From a First MI (FIT Project)
Patients with greater exercise capacity are at the lowest risk for early death associated with a first acute MI, suggests a retrospective analysis based on the longitudinal Henry Ford Exercise Testing Project (the FIT Project) cohort. The analysis, published in Mayo Clinic Proceedings, included a subset of the overall study cohort consisting of 2086 patients without a history of MI. At baseline, all patients underwent "routine, clinically referred, symptom-limited maximal treadmill stress testing following the standard Bruce protocol," according to the report. Exercise capacity was categorized on the basis of peak metabolic equivalents (METs) achieved during a graded treadmill test of less than 6 METs; 6 to 9 METs; 10 to 11 METs; and 12 or more METs. Early mortality was defined as all-cause mortality within 28, 90, or 365 days of the first acute MI, and the mean time from the exercise test to the MI was 6.1 years. Overall, 10.6% of the cohort had died 28 days after their MI, as had 15.7% of the group by 90 days and 24.5% of the group at 365 days post-MI. However, the proportion of patients who experienced early mortality at all three time points steadily decreased as exercise capacity increased. When investigators analyzed exercise capacity as a continuous variable, "each additional 1-MET increment in exercise capacity was associated with an 8% to 10% reduction in risk in early mortality after a first MI.

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Feb 8, 2016

Insertable cardiac monitor superior for AF detection at 3 years (CRYSTAL AF)
Consistent with 6-month and 1-year results, an insertable cardiac monitor was superior to routine care at detecting atrial fibrillation in patients with cryptogenic stroke at 3 years, according to new data from the CRYSTAL AF study which published in Circulation Arrhythmia and Electrophysiology. They assigned 441 patients with cryptogenic stroke (mean age, 61 years; 63% men) to the insertable cardiac monitor or conventional monitoring. At 3 years, AF was detected in 30% of patients assigned the insertable cardiac monitor vs. 3% of those assigned routine care (HR = 8.8; 95% CI, 3.5-22.2), an even wider gap than was seen at 6 months (8.9% vs. 1.4%) and 1 year (12.4% vs. 2%). Oral anticoagulation was prescribed in 94.7% of those in the insertable cardiac monitor arm detected with AF at 6 months, 96.6% in those detected at 1 year and 90.5% of those detected at 3 years. Of those assigned the insertable cardiac monitor, median time to detection of AF was 8.4 months, 81% had asymptomatic first AF episodes and 94.9% had at least 1 day in which AF lasted longer than 6 minutes. At 36 months, recurrent stroke or transient ischemic attack occurred in 20 patients assigned the insertable cardiac monitor and 24 assigned routine care, although the study was not powered to detect differences in that outcome. Five patients (2.4%) had the insertable cardiac monitor removed because of infection or pocket erosion.

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Hospitalization for heart failure may predict VTE risk
Heart failure may serve as an independent risk factor for venous thromboembolism among hospitalized patients, according to the results of a systematic review and meta-analysis published in Lancet Haematol. The authors searched several medical databases for studies that examined VTE risk in hospitalized patients with heart failure. They identified 8,673 studies published between January 1955 and March 2015. They included 71 studies ― 68 full-length articles and three meeting abstracts ― in their final analysis. Rates of VTE varied considerably in hospitalized patients with heart failure in different settings. Overall, the median symptomatic VTE rate was 2.48% (interquartile range [IQR], 0.84-5.61), with rates of 3.73% (IQR, 1.05-7.31) among patients who did not receive thromboprophylaxis and 1.47% (IQR, 0.64-3.54) among those who did. Hospitalized patients with heart failure had an overall RR of 1.51 (95% CI, 1.36-1.68; I2 = 96.1%). Egger’s test results did not indicate evidence of publication bias. Study limitations included the inability to study the severity of heart failure due to lack of data, as well as the small number of studies (n = 6) that focused on acute heart failure. Further, the researchers were unable to account for many potential confounding factors.

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Early Invasive ACS Strategy Best in octogenarian patients
Octogenarian patients presenting with non-ST-segment-elevation MI (NSTEMI) or unstable angina showed significant reductions in a composite clinical end point when managed with an early, relatively invasive strategy rather than by solely medical management in an analysis from the open-label, randomized After Eighty Study. The invasive strategy also did not increase the risk of bleeding complications. The analysis was published online in the Lancet. The trialists enrolled clinically stable patients 80 years of age and older, with NSTEMI or unstable angina with or without ST-segment depression on electrocardiography and whose troponin T or I levels were either normal or raised. A total of 457 patients 80 years of age or older were assigned to an invasive strategy that included early coronary angiography with immediate assessment for PCI, CABG surgery, or optimal medical treatment or to a conservative strategy consisting of optimal medications alone. Dual antiplatelet therapy consisting of aspirin and clopidogrel was used in both groups, which included 229 patients (mean age 84.7 years) in the invasive group and 228 (mean age 84.9 years) in the conservative group. In the invasive group, 47% of patients underwent PCI while 3% underwent CABG. It is noteworthy that patients were admitted to hospitals without PCI facilities so they did not undergo angiography for a mean of 3 days following admission. During a median follow-up of 1.53 years, 40.6% of patients in the invasive group reached the primary composite end point of MI, the need for urgent revascularization, stroke, or death compared with 61.4% of patients in the conservative group, for a >50% reduction in the risk of reaching the primary outcome in favor of the invasive strategy (P=0.0001). Reductions in MI and urgent revascularization accounted for most of the benefit.

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Feb 1, 2016

High pulse pressure associated with adverse CV outcomes
High pulse pressure confers elevated risk for adverse CV outcomes and enables refinement of prognostication beyond mean arterial pressure, according to new data from the REACH registry. Researchers assessed whether pulse pressure, defined as the difference between systolic BP and diastolic BP, had any effect on CV outcomes in a broad international population. They analyzed 45,087 participants from the REACH registry (mean age, 68 years; 35% women) with clinical atherothrombotic disease or risk factors for it. They assessed the effect of pulse pressure on the following outcomes: CV death, nonfatal MI, nonfatal stroke, all MI, all stroke, CV hospitalization and CV death/MI/stroke/hospitalization. Participants were stratified into four quartiles based on pulse pressure and followed for 4 years. In a univariate analysis, the higher the quartile of pulse pressure, the worse the results for all outcomes (P < .05 for all). After adjustment for age, sex, current smoking status, hypercholesterolemia, diabetes, use of aspirin, use of statins, use of BP medications and mean arterial pressure, the highest quartile of pulse pressure was associated with increased risk for the following outcomes compared with the lowest quartile: nonfatal MI (HR = 1.3; 95% CI, 1.1-1.5); all MI (HR = 1.1; 95% CI, 1-1.3); nonfatal stroke (HR = 1.2; 95% CI, 1-1.3); CV hospitalization (HR = 1.1; 95% CI, 1.1-1.2); and CV death/MI/stroke/hospitalization (HR = 1.1; 95% CI, 1-1.1). Elevated pulse pressure was not associated with increased risk for CV death (HR = 0.8; 95% CI, 0.7-0.9) or all stroke (HR = 1.1; 95% CI, 0.9-1.2), the researchers found. After adjustment for mean arterial pressure to determine whether pulse pressure adds clinically useful information, the researchers found that the relationship between high pulse pressure and adverse events remained for nonfatal MI, all MI, CV hospitalization and CV death/MI/stroke/hospitalization (P < .01 for all).

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One-stage PCI superior to multistage PCI in multivessel non-STEMI (SMILE study)
Complete one-stage PCI appears to be a superior strategy compared with multistage PCI for the treatment of patients with multivessel non-STEMI, yielding significantly lower rates of MACCE, according to results of the SMILE trial. In the two-center, unmasked, randomized clinical trial, researchers evaluated 542 consecutive non-STEMI patients slated to undergo an early invasive revascularization procedure (PCI within 24 hours) between September 2011 and August 2013. Participants were aged at least 18 years, diagnosed with non-STEMI, presented with multivessel disease, had a glomerular filtration rate greater than 60 mL/min and planned early invasive treatment. Participants were randomly assigned 1:1 to one-stage PCI (n = 264) or multistage PCI (n = 263). The second-stage procedure in multistage PCI was performed between 3 and 7 days of the original procedure. The study’s primary endpoint was the occurrence of MACCE, defined as cardiac death, death, reinfarction, rehospitalization due to unstable angina, repeat coronary revascularization, target vessel revascularization and stroke, at 1 year. Kaplan-Meier curves revealed that the primary endpoint was lower in the one-stage PCI group (P = .004). Compared with the one-stage group, there was significantly higher occurrence of the 1-year primary endpoint in the multistage group (one-stage PCI: n = 36 [13.63%] vs. multistage PCI: n = 61 [23.19%]; HR = 0.549; 95% CI, 0.363-0.828). Additionally, there was a significantly higher 1-year rate of TVR in the multistage PCI group vs. the one-stage PCI group (one-stage PCI: n = 22 [8.33%] vs. multistage PCI: n = 40 [15.2%]; HR = 0.522; 95% CI, 0.31-0.878). No significant differences between the groups were seen when the analysis was confined to the two main components of the primary outcome, cardiac death (one-stage PCI: n = 9 [3.41%] vs. multistage PCI: n = 14 [5.32%]; HR = 0.624; 95% CI, 0.27-1.441) and MI (one-stage PCI: n = 7 [2.65%] vs. multistage PCI: n = 10 [3.8%]; HR = 0.678; 95% CI, 0.156-2.657).

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Regular caffeine consumption unlikely to lead to changes in heart rhythm
In a new study, regular consumption of caffeinated products including coffee, tea and chocolate was not associated with premature atrial and ventricular contractions. Researchers evaluated 1,388 participants from the NHLBI Cardiovascular Health Study, a prospective, community-based cohort study, to evaluate the relationship between dietary patterns and premature cardiac contractions such as premature atrial contractions (PAC) and premature ventricular contractions (PVC). All participants underwent dietary assessment and 24-hour Holter monitoring. Chronic caffeine consumption was defined as average frequency of consumption during the past 12 months. According to the findings, more than 60% of participants consumed one or more daily servings of coffee, tea or chocolate. However, the researchers reported no difference in the number of PACs/hour, PVCs/hour, or supraventricular tachycardia or ventricular tachycardia runs. After adjusting for other variables, the combined intake of coffee, tea and chocolate as a continuous measure did not increase premature cardiac contractions. Instead, it was associated with 0.48% fewer PACs/hour (95% CI, –4.6 to 3.64) and 2.87% fewer PVCs/hour (95% CI, –8.18 to 2.43) per 1-serving/week increase in consumption. Adjusted analyses indicated an association between coffee consumption one to four times/week and tea consumption five to 10 times/year with an increase in ventricular tachycardia runs, although no significant trends were revealed.

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Jan 25, 2016

AF may worsen mortality outcomes in patients undergoing TAVR
The presence of atrial fibrillation at discharge after transcatheter aortic valve replacement is associated with increased risk for mortality, according to new data from the PARTNER study published online in Cir. Cardiov. Int. Researchers analyzed 1,879 patients from PARTNER who were assigned to and underwent TAVR with a balloon-expandable system (and had baseline and discharge ECGs. Among the study population, 1,262 patients had sinus rhythm at baseline and at discharge, 113 had sinus rhythm at baseline and AF at discharge, 470 had AF at baseline and at discharge. Those with sinus rhythm at baseline and AF at discharge had the highest rate of 30-day mortality at 14.2% compared with 3.6% for those with AF at baseline and discharge and 2.6% for those with sinus rhythm at baseline and discharge (adjusted HR vs. sinus rhythm at baseline and discharge = 3.41; P = .0002). The researchers observed a similar trend in CV mortality, but there was no difference between the groups in rehospitalization, stroke/transient ischemic attack, major bleeding or major vascular events.
At 1 year, the group with sinus rhythm at baseline and AF at discharge had a mortality rate of 35.7% vs. 29.9% for AF at baseline and discharge and 15.8% for sinus rhythm at baseline and discharge (adjusted HR vs. sinus rhythm at baseline and discharge = 2.14; P < .0001; P for trend < .0001). The researchers observed a similar trend in CV mortality and rehospitalization but found no differences in stroke/TIA, major bleeding or major vascular events. The authors determined that presence of AF at baseline or discharge was an independent predictor for mortality at 1 year (adjusted HR for sinus rhythm/AF group = 2.14; adjusted HF for continuous AF group = 1.88; P for both vs. continuous sinus rhythm group < .0001).
Among those with AF at discharge, the 1-year mortality rate was lower in patients with lower ventricular response, defined as less than 90 bpm (HR = 0.74; P = .04).

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Higher BMI related to lower mortality in patients with AF
An analysis of patients from the ORBIT-AF registry has revealed an “obesity paradox” in patients with prevalent atrial fibrillation. Researchers found that patients from the registry with higher BMI had lower risk for mortality, independent of other risk factors, although patients with higher BMI tended to be younger than patients with lower BMI. Investigators stratified the 9,606 patients (42% women) enrolled in the registry from June 2010 to August 2011 into five BMI categories: normal weight, overweight, class I obese, class II obese and class III obese. Seventy-eight percent of patients were overweight or obese.
They assessed the association between BMI and clinical outcomes, including mortality, during a median 2 years of follow-up. Those with higher BMI also were more likely to be using anticoagulation and rhythm control strategies than those with lower BMI.
According to the researchers, all-cause mortality rates during follow-up declined in a near-linear fashion with increasing BMI (normal-weight group, 8.28/100 patient-years; class III obese group, 3.81/100 patient-years). When they performed multivariable adjustment, higher BMI was associated with lower risk for mortality and the lowest-risk group was class I obese (HR vs. normal weight = 0.65; 95% CI, 0.54-0.78). They found that the hazard of mortality was 7% lower for every BMI increase of 5 kg/m2 (HR = 0.93; 95% CI, 0.89-0.98).
BMI was not associated with other clinical outcomes such as new-onset HF, progression of AF, first CV hospitalization and first bleeding hospitalization. Higher BMI was associated with lower risk for stroke, transient ischemic attack or noncentral nervous system embolism in an unadjusted analysis (HR for class III obese vs. normal weight = 0.38; 95% CI, 0.23-0.63), but the association disappeared after adjustment for other risk factors.

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Bradycardia does not increase risk for incident CVD, mortality
A heart rate of less than 50 bpm was not associated with greater risk for incident CVD or mortality, but patients with bradycardia assigned heart rate-modifying drugs may have a higher risk for mortality, researchers reported in JAMA Internal Medicine.
The retrospective analysis included 6,733 adults aged 45 to 84 years who participated in the MESA study. All patients were free of clinical CVD at baseline (2000-2002) and were followed for development of CVD or death. Patients were categorized by heart rate and assignment to heart rate-modifying medications. The mean heart rate for the 5,831 patients not assigned a heart rate-modifying drug was 63 bpm; 5.3% had a heart rate lower than 50 bpm; and 30.3% a heart rate of 50 bpm to 59 bpm. The mean heart rate for the 902 patients assigned heart rate-modifying drugs was 60 bpm; 11.2% had a heart rate of less than 50 bpm; and 39.1% a heart rate of 50 bpm to 59 bpm. The primary outcomes were CVD events and all-cause mortality. During more than 10 years of follow-up, 633 CVD events and 697 deaths (160 CVD-related) were reported. For patients not assigned heart rate-modifying medications, the mortality risk remained the same for those with a heart rate less than 50 bpm (HR = 0.71; 95% CI, 0.41-1.09), but increased among those with a heart rate greater than 80 bpm (HR = 1.49; 95% CI, 1.08-2.05). Results also indicated an association between heart rate-modifying drugs and a higher mortality risk in participants with both a heart rate less than 50 bpm (HR = 2.42; 95% CI, 1.39-4.2) and a heart rate greater than 80 bpm (HR = 3.55; 95% CI, 1.65-7.65).

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Jan 18, 2016

Rarely or never consuming breakfast increases risk for stroke
Frequency of breakfast intake was inversely associated with increased risk for stroke but not increased risk for CHD, according to a study published in Stroke. Researchers investigated whether omission of breakfast correlated to increased risk for stroke and CHD in a Japanese population. They analyzed 82,722 participants (52% women) aged 45 to 74 years from the Japan Public Health Center-based Prospective Study with no history of CVD or cancer from 1995 to 2010, stratifying them by frequency of breakfast consumption: zero to two times per week, three to four times per week, five to six times per week or seven times per week.
During 1,050,030 person-years of follow-up, they identified 3,772 strokes and 870 cases of CHD. Of the strokes, 1,051 were cerebral hemorrhages, 417 were subarachnoid hemorrhages and 2,286 were cerebral infarctions.
After adjustment for age, sex, diet factors, lifestyle factors and health center, compared with those who ate breakfast seven times per week, those who ate breakfast zero to two times per week had increased risk for any stroke (HR = 1.18; 95% CI, 1.04-1.34).
They also found those who ate breakfast zero to two times per week had increased risk for total CVD (HR = 1.14; 95% CI, 1.01-1.27) and cerebral hemorrhage (HR = 1.36; 95% CI, 1.1-1.7) compared with those who ate breakfast every day, but that was not the case for CHD (HR = 0.96; 95% CI, 0.73-1.25), subarachnoid hemorrhage (HR = 1.1; 95% CI, 0.76-1.6) or cerebral infarction (HR = 1.1; 95% CI, 0.92-1.3).
Those who ate breakfast three or four times per week or five or six times per week had no increased risk for any outcome compared with those who ate breakfast every day.

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Wider Eligibility for Heart Transplantation in New Guidelines
The 2016 International Society for Heart Lung Transplantation (ISHLT) listing criteria for heart transplantation updates the criteria issued in 2006, adds recommendations for patients who were previously deemed ineligible, and even touches on marijuana use. The new guidelines, , were published online in the Journal of Heart and Lung Transplantation.
The upper age and weight cutoffs have been relaxed. "Carefully selected patients >70 years of age may be considered for cardiac transplantation," according to the guidelines. "
The report recommends that patients lose enough weight to have a body-mass index (BMI) below 35 (as opposed to below 30) before they are listed for a heart transplant. Nevertheless, "the average person gains anywhere from 12 to 30 pounds in the first year after transplantation," so adverse effects such as sleep apnea, arthritis, or infections are magnified in obese patients.
Listing for a heart transplant should not be based solely on heart-failure survival scores, since these scores have inherent limitations, the report warns.

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Safety, efficacy of sodium restriction in patients with HF questioned in new study
Sodium restriction may increase the risk for death or HF hospitalization in symptomatic patients with HF, according to new data from the HART trial which published in JACC heart Failure Journal.
Sodium intake data were available for 833 (145 sodium restricted, 688 sodium unrestricted) of the 902 NYHA class II/III HF patients enrolled in the trial. Of these 833 patients, 260 were propensity matched into sodium-restricted (< 2,500 mg/day; n = 130) and sodium-unrestricted ( 2,500 mg/day; n = 130) groups.
The primary outcome measured was a composite of death or HF hospitalization. Secondary outcomes included cardiac death and HF hospitalization. Median follow-up was 36 months (interquartile range, 27-36).
In the propensity-matched cohort overall, 89 events of death or HF hospitalization (adjusted HR = 1.72; 95% CI, 1.12-2.65) were reported, according to Doukky and colleagues. Sodium restriction was associated with a 42.3% risk for death or HF hospitalization compared with a 26.2% risk for the sodium-unrestricted group (adjusted HR = 1.72; 95% CI, 1.12-2.65). The rate of HF hospitalization was 32.3% in the sodium-restricted group vs. 20% in the unrestricted group (adjusted HR = 1.68; 95% CI, 1.02-2.75). According to subgroup analyses, sodium restriction was associated with increased risk for death or HF hospitalization in patients not assigned ACE inhibitors or angiotensin receptor blockers (HR = 5.78; 95% CI, 1.93-17.27).

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Jan 11, 2016

Permanent AF may lead to cognitive impairment in patients with HF
The presence of permanent atrial fibrillation may increase the risk for cognitive impairment in patients with HF, according to study results published in The American Journal of Cardiology. Researchers assessed the relationship between permanent AF and cognitive impairment in 881 patients with stable HF (mean age, 73 ± 11 years). Cognitive function was measured by both the Mini-Mental State Examination test (n = 876) and the Pfeiffer short portable mental status questionnaire (n = 848). Of those enrolled, 33.5% had cognitive impairment, with 5.1% considered severe or moderate. The researchers found no significant difference between patients with preserved ejection fraction and reduced ejection fraction. Cognitive impairment was more prevalent in patients with permanent AF than in those patients without permanent AF (42.8% vs. 31%; P = .002). Patients with permanent AF also experienced higher rates of moderate or severe cognitive impairment (8.3% vs. 4.5%; P = .039). Through multivariate analysis, the researchers established that permanent AF was independently associated with cognitive impairment in patients with HF (OR = 1.54; 95% CI, 1.05-2.28). Patients with cognitive impairment also were more likely to be older women with higher rates of diabetes, previous stroke, chronic kidney disease and a NYHA HF class of III to IV.

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Immediate intervention better than delayed in patients with non-STEMI (RIDDLE-NSTEMI)
In patients with non-STEMI, an immediate invasive strategy reduced risk for death or new MI compared with a delayed invasive strategy, according to RIDDLE-NSTEMI study which published in JACC Interv. Journal. Researchers conducted a randomized controlled trial of 323 patients with non-STEMI at a single center to determine a difference in outcomes for immediate intervention vs. delayed intervention; previous research was inconsistent. Patients were assigned immediate intervention, in which they were transferred for angiography as soon as possible, less than 2 hours after randomization; or delayed intervention, in which they were transferred for angiography 2 to 72 hours after randomization, unless they had chest pain, recurrent ischemia or otherwise became clinically unstable while waiting. The primary endpoint was death or new MI at 30 days. Median time from randomization to angiography was 1.4 hours in the immediate-intervention group (n = 162) and 61 hours in the delayed-intervention group (n = 161). At 30 days, the rate of death or new MI was 4.3% in the immediate-intervention group and 13% in the delayed-intervention group (HR = 0.32; 95% CI, 0.13-0.74). The curves for the primary outcome remained separated at 1 year (immediate, 6.8%; delayed, 18.8%; HR = 0.34; 95% CI, 0.17-0.67). The researchers also found that the rate of death, new MI or recurrent ischemia was lower in the immediate-intervention group at 30 days (6.8% vs. 26.7%; P < .001) and 1 year (15.4% vs. 33.1%; P < .001).

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Heart-Rate Range Could Be a Prognostic Marker in Heart Failure
Ambulatory heart-rate (HR) range as captured on 24-hour Holter monitoring predicts all-cause mortality in patients with chronic heart failure and left-ventricular systolic dysfunction, according to a prospective, observational cohort study published in Heart Journal. After adjustment for other potential confounders in 791 such patients, each one-beat increment in ambulatory HR range was associated with a 0.9% reduction in risk of death from any cause. Their findings were validated in a cohort of 408 patients with chronic heart failure with either preserved or reduced LVEF. Over a mean 4.1-year follow-up of the original cohort of 791 patients, 268 patients died, including 95 from progressive heart failure. The observed 0.9% reduction in all-cause mortality risk per beat-per-minute increment in HR range was adjusted for patient characteristics including beta-blocker dosing. In addition, HR range was associated with a significant risk of heart-failure–related hospitalizations (P=0.009) but not with risk of nonelective hospitalization. The validation cohort of 408 patients, taken from the UK-HEART study population, also had chronic HF with either reduced or preserved LVEF but was more heterogeneous than the study cohort, with significant differences in age, use of beta-blockers, ejection fraction, comorbidities, and arrhythmia burden. After a mean follow-up of 3 years, 144 patients in the validation cohort had died, including 59 from progressive heart failure. In multivariate analysis, ambulatory HR range remained significantly associated with all-cause mortality (P<0.001) despite the population being more diverse than the original cohort. The ambulatory HR range also fell progressively with rising NYHA functional class (P<0.001). Ambulatory HR range also correlated significantly with the standard deviation of normal-to-normal intervals (SDNN) (P<0.001), which, as the authors explain, is a well-established marker of beat-to-beat cycle-length variation.

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Jan 4, 2016

Patients with MI, PCI on triple therapy show excess risk for bleeding
Compared with dual antiplatelet therapy only, patients treated with dual antiplatelet therapy plus an oral anticoagulant had elevated risk for bleeding after PCI treatment for acute MI, according to new data from the TRANSLATE-ACS study published in JACC Cardiov. Interv. Among patients on triple therapy, those assigned prasugrel had more self-reported bleeding than those assigned clopidogrel.

The researchers compared 6-month adjusted risks for bleeding as assessed by the Bleeding Academic Research Consortium (BARC), and whether bleeding was associated with rehospitalization. The 11,756 patients were stratified into four groups: those discharged on aspirin, clopidogrel and an oral anticoagulant (4.5%); those on aspirin, prasugrel and an oral anticoagulant (0.8%); those on aspirin and clopidogrel (66%); and those on aspirin and prasugrel (29%).

The researchers found that triple therapy was associated with greater frequency of BARC-defined bleeding at 6 months compared with DAPT. Compared with patients on aspirin and clopidogrel, those on aspirin, clopidogrel and an oral anticoagulant had a higher rate of bleeding (28.7% vs. 19.7%; adjusted incidence rate ratio [IRR] = 1.68; 95% CI, 1.29-2.18). Similarly, compared with those on aspirin and prasugrel, those on aspirin, prasugrel and an oral anticoagulant were more likely to bleed (38.5% vs. 26.7%; adjusted IRR = 1.88; 95% CI, 1.1-3.2). Among those on triple therapy, those assigned prasugrel were more likely to bleed than those assigned clopidogrel (39% vs. 24.4%; adjusted IRR = 2.37; 95% CI, 1.36-4.15), according to the researchers. For bleeding that required rehospitalization, triple therapy with clopidogrel conferred an increased risk compared with DAPT with clopidogrel (OR = 3.13; 95% CI, 1.97-4.96), and triple therapy with prasugrel conferred an increased risk compared with DAPT with prasugrel (OR = 4.91; 95% CI, 1.36-17.7), but there was no difference in odds of bleeding between triple therapy with prasugrel and triple therapy with clopidogrel (OR = 0.62; 95% CI, 0.2-1.93). For patient-reported bleeding, triple therapy with clopidogrel conferred an increased risk compared with DAPT with clopidogrel (OR = 1.4; 95% CI, 1.03-1.91), and triple therapy with prasugrel conferred an increased risk compared with triple therapy with clopidogrel (OR = 3.19; 95% CI, 1.52-6.66) but there was no difference in odds of bleeding between triple therapy with prasugrel and DAPT with prasugrel (OR = 1.56; 95% CI, 0.85-2.86).

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Novel antiplatelet agent shows promise in first-in-human study
Use of PZ-128, a cell-penetrating pepducin therapy, successfully demonstrated inhibition of platelet aggregation in a first-in-human study. According to the study background, PZ-128 targets protease-activated receptor-1 (PAR1), a platelet-activating receptor, similar to the mechanism of action of vorapaxar. However, vorapaxar is a slow-acting agent and is not approved for use in cardiac procedures, while PZ-128 is fast-acting and could potentially be used to prevent ischemic complications in patients undergoing PCI.

For the NHLBI-funded study, researchers administered PZ-128 to 32 patients with CAD or multiple risk factors for CAD (mean age, 57 years; 59% men; 50% white); one patient was not dosed because of an adverse event. Safety, antiplatelet efficacy and pharmacokinetics were assessed at baseline, 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 7 days and 10 days. found that higher the dose of PZ-128 administered, the better PZ-128 blocked platelet aggregation. At 30 minutes to 6 hours, the researchers observed 20% to 40% platelet inhibition with a dose of 0.3 mg/kg, 40% to 60% platelet inhibition with a dose of 0.5 mg/kg and more than 80% to 100% platelet inhibition with a dose of 1 to 2 mg/kg. Patients who received aspirin in addition to a 0.5-mg/kg or 1-mg/kg dose of PZ-128 had 65% to 100% platelet inhibition at 30 minutes to 2 hours and 95% to 100% platelet inhibition by 6 hours. In addition, the effects of platelet inhibition with a PZ-128 dose of 0.5 mg/kg were reversible, with 50% recovery at 24 hours, and the drug was not detectable in urine.

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Cardiovascular Risk Increased With Early- vs Late-Onset Diabetes
The risk of developing nonfatal cardiovascular disease (CVD) is almost twice as high in patients who develop type 2 diabetes before the age of 40 compared with those who develop later-onset disease, although the risk is attenuated when adjusted for disease duration, according a large cross-sectional survey which published online in The Lancet Diabetes Endocrinology.

A total of 630 hospitals participated in the study, including 12 primary care hospitals, 132 secondary care hospitals, and 486 tertiary care hospitals. Overall, 222,773 patients were included in the analysis. The mean age of the cohort was 58.3 years and the mean duration of diabetes was 5.6 years. The mean age of patients who had early-onset diabetes was 34 years compared with 55 years for those who developed diabetes later in life. After adjustment for age and sex, early-onset type 2 diabetes was associated with a 1.91 times greater risk of nonfatal CVD events (coronary heart disease and stroke) compared with late-onset disease. The risk was attenuated at an odds ratio (OR) of 1.13 when adjusted for duration of disease, the authors add, but additional adjustment for other factors only slightly attenuated effect sizes.

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Dec 14, 2015

Overweight and obesity increase risk for sudden cardiac death in women
Overweight and obesity conferred elevated risk for sudden cardiac death in women throughout adulthood, according to 32-year results from the Nurses’ Health Study which published online in JACC Elevtrophysiology. The association was especially prominent in those with severe obesity and when overweight or obesity was present in early adulthood, according to the researchers. The authors analyzed 72,484 women free from chronic disease at baseline between 1980 and 2012. At baseline, they assessed height, weight and weight at age 18 years as remembered for each participant. Every 2 years, weight was reassessed. The primary outcome was sudden cardiac death, which occurred in 445 women during the study period. After adjustment for confounders, higher BMI updated biennially was associated with greater risk for sudden cardiac death (P for linear trend < .001). Compared with BMI 21 kg/m2 to 22.9 kg/m2, BMI 25 kg/m2 to 29.9 kg/m2 was associated with a 46% increased risk for sudden cardiac death (RR = 1.46; 95% CI, 1.05-2.04), as was BMI 30 kg/m2 to 34.9 kg/m2 (RR = 1.46; 95% CI, 1-2.13), whereas BMI of at least 35 kg/m2 was associated with a more than twofold increased risk (RR = 2.18; 95% CI, 1.44-3.28), according to the researchers. In women with BMI of at least 35 kg/m2, the elevated risk remained after adjustment for development of CHD during the study period and other mediators (RR = 1.72; 95% CI, 1.13-2.6), they wrote, noting that the risk was attenuated in the BMI 25 kg/m2 to 29.9 kg/m2 and 30 kg/m2 to 34.9 kg/m2 groups after those adjustments. Elevated BMI at baseline was associated with greater risk for sudden cardiac death (P for trend < .001; P for quadratic trend = .27), and the trend was not affected by current BMI.

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More Clots in Bioresorbable vs Metal Stents in 1-Year
A meta-analysis of six trials comparing 1-year outcomes in patients randomized to receive PCI with an everolimus-eluting bioresorbable vascular-scaffold stent (Absorb, Abbott Vascular) or an everolimus-eluting conventional metal stent revealed that the "disappearing" stent conferred a twofold greater risk of stent thrombosis and greater late lumen loss, although the rates of repeat revascularization were similar with both strategies. The meta-analysis, published in the Lancet and analyzed data from 6 trials. At a median follow-up of 1 year, a similar percentage of patients in the bioresorbable-stent group (3%) and in the metal-stent group (3.3%) had target lesion revascularization. However, significantly more patients in the bioresorbable-stent group (1.3%) than in the metal-stent group (0.5%) had definite or probable stent thrombosis. The highest risk of stent thrombosis in the bioresorbable stent group occurred within 1 to 30 days after implantation (odds ratio 3.11; 95% CI 1.24–7.82; P=0.02). Similarly, more patients who received the bioresorbable stent had an MI during follow-up (5.2%) compared with patients who received a metal stent (3.5%), but this difference was not significant. A total of 30 patients (1%) died, with similar numbers in both patient groups, but this outcome varied widely in the six trials. Last, angiographic data for 1265 (96%) of the lesions at a median of 10.5 months showed that lesions treated with the bioresorbable stents had significantly greater in-device and in-segment late lumen loss.

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Optimistic ACS Patients Less Likely to Be Readmitted
Holding onto hope after a hospitalization for MI or unstable angina may improve both behavioral and clinical outcomes, new research published online in Circulation: Cardiovascular Quality and Outcomes suggests. The observational Gratitude Research in Acute Coronary Events (GRACE) study showed that participants who had high scores on a measure of optimism 2 weeks after experiencing an ACS had significantly greater accelerometer-measured physical activity (P=0.02) and fewer cardiac readmissions (P=0.006) 6 months later vs those with lower levels of optimism. Although the investigators had hypothesized that having strong feelings of gratitude would also affect physical activity and readmissions, these associations were not statistically significant. Also, there were no significant associations between optimism or gratitude and prognostic biomarkers of inflammation or mortality risk, such as IL-6 and N- terminal pro-B-type natriuretic peptide (NT-proBNP).

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Dec 7, 2015

PPI increased high platelet reactivity in patients with DES (ADAPT-DES study)
Concomitant administration of proton pump inhibitors and dual antiplatelet therapy yielded increased rates of high platelet reactivity in patients undergoing PCI with drug-eluting stents, according to results from the ADAPT-DES registry. The researchers evaluated data from 8,582 patients who underwent coronary intervention at 11 sites throughout the United States and Germany. The cohort included 2,697 patients who were on proton pump inhibitors (PPI) at the time of intervention, and 2,162 who received a prescription for a PPI upon discharge from the hospital. All patients were treated with antiplatelet therapy, including 1 year or more of clopidogrel and aspirin for an indefinite period after PCI. The primary endpoint was definite or probable stent thrombosis, with other evaluated endpoints including all-cause mortality, MI and clinically relevant bleeding. Patients had high platelet reactivity, defined as more than 208 P2Y12 reactivity units, in 48.5% of cases in the PPI group and 40.8% of those who did not receive PPI (P < .0001). Results from adjusted analyses indicated an independent association between PPI use and high platelet reactivity (OR = 1.38; 95% CI, 1.25-1.52). No significant association was observed between PPI use and increased risk for stent thrombosis, either in-hospital or at 2 years post-discharge. Results from propensity-matched multivariate analysis at 2-year follow-up indicated an independent association between PPI use and increased risk for MACE, defined as cardiac death, MI, or ischemia-driven target lesion revascularization, (HR = 1.21; 95% CI, 1.04-1.42). The researchers also observed a borderline significant association between PPI use and clinically driven target vessel revascularization (HR = 1.27; 95% CI, 1.09-1.49), along with a strong trend toward increased mortality risk in the PPI group (HR = 1.28; 95% CI, 1-1.63). However, 2-year clinically relevant bleeding outside the hospital setting was not increased in the PPI group (HR = 1.03; 95% CI, 0.84-1.26).

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Nearly half of Americans who need cholesterol treatment not taking medication
Despite more than one-third of Americans qualifying for cholesterol treatment under recent national guidelines, nearly half are not taking medication, according to a recent report published in Morbidity and Mortality Weekly Report. CDC researchers also found that women were more likely than men, and blacks and Mexican Americans were less likely than whites to be taking cholesterol-lowering medications. Results showed that 36.7% of U.S. adults aged at least 21 years were on or eligible for cholesterol treatment. Among that group, 55.5% were taking cholesterol medication and 46.6% had made lifestyle changes to lower cholesterol. Mercado and colleagues reported that 37.1% of the eligible group had made lifestyle changes in addition to taking medication and 35.5% had done neither. Data analysis also demonstrated differences between men (40.8%) and women (32%; P .001) who were eligible for or already on medication as well as between Mexican Americans (24.2%), whites (38.4%) and blacks (39.5%; P < .001). Within these groups, results showed differences in adults who were taking medications; 52.9% of men vs. 58.6% of women (P = .01) and 58% of whites vs. 47.1% of Mexican Americans vs. 46% of blacks (P < .001). Additionally, researchers noted that 88% of adults taking medication to lower their cholesterol were taking statins.

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High Levels of Fitness in Young Adulthood Lowers CVD, Mortality Risk (CARDIA study)
Level of cardiorespiratory fitness (CRF) at an early age may predict long-term cardiac outcomes, new research suggests. New analysis from the Coronary Artery Risk Development in Young Adults (CARDIA) study showed that participants who had higher treadmill exercise testing scores at baseline, when they were between the ages of 18 and 30 years, had significantly lower LV mass index and better"global longitudinal strain" 25 years later (P=0.02 and P<0.001, respectively). In addition, each additional minute of baseline exercise test duration was associated with a 15% lower hazard of death and a 12% lower hazard of CVD. On the other hand, each 1 minute of exercise reduction at the 7-year follow-up was linked to 20% increased hazard of CVD and 21% increased hazard of all-cause mortality. There were no significant associations found between fitness levels and coronary artery calcification (CAC). CARDIA was a prospective study that included 5115 young adults enrolled at four US sites. For the current analysis, the researchers examined data on 4872 of the participants (51.3% black; mean age 24.8 years) who completed a treadmill test at baseline between March 1985 and June 1986. In secondary analysis, they also examined the 2472 participants who underwent a second treadmill test 7 years later. Other measurements included CAC scores through computed tomography at 15-, 20-, and 25-year follow-ups and LV mass at the 5- and 25-year follow-ups. At the latter point, global longitudinal strain was also assessed. At the final follow-up, there were 193 CVD events (4%). There were also 273 deaths (5.6%); however, 200 of these were non-CV-related. After full adjustments, the hazard ratio (HR) for all-cause mortality was 0.85 for each minute of exercise duration that was increased at baseline (95% CI 0.80–0.91, P<0.001), and the HR for CVD was 0.88 (95% CI 0.81–0.96, P=0.002).

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Nov 30, 2015

No Clinical Gain Seen for Thrombectomy With PCI in NSTEMI patients
The routine addition of aspiration thrombectomy before PCI does not improve clinical outcomes at 12 months in patients with non-ST-elevation myocardial infarction (NSTEMI), according to a randomized trial published 9 in the European Heart Journal: Acute Cardiovascular Care. The results of the Thrombus Aspiration in Thrombus-Containing Culprit Lesions in NSTEMI (TATORT-NSTEMI) trial complement a number of other trials suggesting that thrombectomy at primary PCI does not improve STEMI outcomes. And they follow shorter-term results from TATORT-NSTEMI showing that aspiration thrombectomy does not decrease microvascular obstruction in patients with NSTEMI and detectable thrombus compared with PCI alone. The open-label TATORT-NSTEMI trial took place at eight high-volume clinical sites in Germany. Researchers randomized 440 high-risk NSTEMI patients with thrombus-associated lesions to aspiration thrombectomy before PCI (n=221) or standard PCI alone (n=219). Overall, 11% (n=48) of patients experienced the 12-month primary end point of major adverse cardiac events (MACE), defined as all-cause death, MI, target vessel revascularization, and new congestive heart failure, with similar rates between groups at 12 months. They included 8.7% of the thrombectomy group vs 13.4% of the standard PCI group (relative risk [RR] 0.63, 95% CI 0.35-1.12; P=0.11), with no significant differences in any of the MACE end point components. Further analyses showed similar rates of MACE across subgroups analyzed by age, gender, diabetes, Global Registry of Acute Coronary Events (GRACE) score, Thrombolysis in Myocardial Infarction (TIMI) thrombus grade, TIMI flow before PCI, direct stenting, and treatment with glycoprotein IIb/IIIa inhibitors (all P>0.05).

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Premenstrual syndrome may confer elevated risk for hypertension
Women with moderate-to-severe premenstrual syndrome had a 40% increased risk for hypertension later in life compared with women with few or no menstrual symptoms in a recent study published in Am. J. Epidemiology. The researchers analyzed participants from the Nurses’ Health Study II, comparing 1,257 women with clinically significant PMS to 2,463 age-matched controls with few menstrual symptoms. They followed the women for 6 to 20 years until 2011. The primary outcome was incident hypertension. During the study period, 342 women with PMS developed hypertension, as did 541 controls. After adjusting for age, smoking, BMI and other hypertension risk factors, they found that women with PMS had elevated risk for development of hypertension (HR = 1.4; 95% CI, 1.2-1.6) compared with controls. The association was most pronounced among women who developed hypertension at an age younger than 40 years (HR = 3.3; 95% CI, 1.7-6.5; P for interaction = .0002). The following symptoms of PMS were associated with elevated risk for incident hypertension: nausea (HR = 1.7; 95% CI, 1-2.9), insomnia (HR = 1.6; 95% CI, 1.3-2.1), backache (HR = 1.5; 95% CI, 1.2-1.8), tendency to cry easily (HR = 1.5; 95% CI, 1.2-1.8), swelling of extremities (HR = 1.5; 95% CI, 1.1-1.9) and hot flashes (HR = 1.4; 95% CI, 1-2.2). Taking oral contraceptives or antidepressants did not affect the risk, but it was attenuated in women taking high amounts of thiamine (HR = 1.1; 95% CI, 0.9-1.4) and riboflavin (P = .03).

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Higher Resting Heart Rate Linked to Higher Mortality
A higher resting heart rate is associated with a higher risk for all-cause and cardiovascular mortality, even in those without traditional risk factors for cardiovascular disease, according to a meta-analysis published online in CMAJ. Results from this meta-analysis suggest the risk of all-cause and cardiovascular mortality increased by 9% and 8% for every 10 beats/min increment of resting heart rate. The risk of all-cause mortality increased significantly with increasing resting heart rate in a linear relation, but a significantly increased risk of cardiovascular mortality was observed at 90 beats/min...consistent with the traditionally defined tachycardia threshold of 90 or 100 beats/min for prevention of cardiovascular disease. The data set included more than 1.2 million patients and 78,349 all-cause deaths from 40 studies. Data specific to cardiovascular mortality included 848,320 patients and 25,800 deaths from 29 studies. Duration of follow-up across the studies ranged from 3 to 40 years. The authors found that those with a resting heart rate of 60 to 80 bpm were 12% more likely to die from any cause and 8% more likely to die from cardiovascular causes compared with those with a resting heart rate of 45 bpm (RR, 1.12 [95% CI, 1.07 - 1.17], and RR, 1.08 [95% CI, 0.99 - 1.17], respectively). The risk became 45% greater for all-cause mortality and 33% greater for cardiovascular mortality among patients with a resting heart rate greater than 80 bpm (RR, 1.45 [95% CI, 1.34 - 1.57], and RR, 1.33 [95% CI, 1.19 - 1.47], respectively).

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2015: Τρία φάρμακα για το καρδιαγγειακό αναμένεται να έχουν τεράστια εμπορική επιτυχία

Οι δύο αναστολείς PCSK9, το evolocumab και το alirocumab, καθώς και ο διπλός αναστολέας υποδοχέων νεπριλυσίνης και αγγειοτενσίνης, το LCZ696, αποτελούν τα νέα φάρμακα του καρδιαγγειακού συστήματος που λαμβάνουν έγκριση μέσα στο 2015 και πρόκειται να σημειώσουν μεγάλη εμπορική επιτυχία, με τζίρο που αναμένεται να φτάσει τα 10 δις $ έως το 2019. Τα μονοκλωνικά αντισώματα έναντι της προπρωτεΐνης της κονβερτάσης subtilisin/kexin 9 μειώνουν τα επίπεδα της LDL χοληστερόλης και έχουν δείξει κλινικά οφέλη από τη μείωση των καρδιαγγειακών συμβαμάτων. Το alirocumab, που αναμένεται να κυκλοφορήσει με το εμπορικό όνομα Praluent (Sanofi/ Regeneron Pharmaceuticals) πρόκειται να κάνει τζίρο 4.4 δις $ έως το 2019, ενώ και το evolocumab (Amgen) αναμένεται να εγκριθεί και να αγγίξει τα 1.9 δις $ σε πωλήσεις έως το 2019. Ο διπλός αναστολέας υποδοχέων νεπριλυσίνης και αγγειοτενσίνης που κυκλοφόρησε με το όνομα Entresto (Novartis) και έχει καταδείξει σημαντικό όφελος επιβίωσης σε ασθενείς με χρόνια καρδιακή ανεπάρκεια αναμένεται να φτάσει τα 3.7 δις $ σε πωλήσεις έως το 2019.

Nov 23, 2015

COURAGE Finds No Late Benefit From Routine Early Stenting in Stable CAD
In an extended follow-up, no late benefit in survival emerged between COURAGE trial participants with stable CAD who received PCI as an initial strategy plus optimal medical therapy and those who received optimal medical therapy alone, a new analysis published online in NEJM indicates. The findings from a follow-up averaging about 12 years are consistent with the primary results. As originally reported, COURAGE found no significant differences between patients who received initial PCI and those who did not with respect to the composite primary end point of death from any cause or nonfatal MI or in any of the other cardiac end points during a median follow-up of 4.6 years. The new extended survival analysis was done to examine whether or not a potential long-term survival benefit from initial PCI might emerge after many more years of follow-up. Posttrial survival information was available for 1211 patients, or 53% of the original study population, for a median follow-up of 11.9 years. Long-term mortality was virtually identical in patients treated with initial PCI vs initally only medical therapy: 25% vs 24%. In multivariate analysis, the hazard ratio (HR) for initial PCI vs no initial PCI was 1.03 (95% CI 0.83–1.21; P=0.76)..

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Strokes after cardioversion more frequent in patients with AF not on anticoagulation
A prespecified analysis of the FibStroke study showed cardioversion plays a key role in strokes among patients with paroxysmal or persistent atrial fibrillation, according to results published in the International Journal of Cardiology. FibStroke included patients with AF who experienced an ischemic stroke or intracranial bleed, identified between 2003 and 2012 through a discharge registry of four hospitals in Finland. Overall, 3,677 patients had 3,252 strokes and 956 TIAs; however, the analysis concentrated on 1,644 events in patients who had paroxysmal or persistent AF at the time of stroke or TIA. The investigators found cardioversion preceded 78 strokes and 22 TIAs. Further, in patients with paroxysmal or persistent AF, 6.4% of strokes occurred after cardioversion. Of the cardioversions precipitating an ischemic event, 77 were acute and 23 were elective. Every 16th stroke of patients with paroxysmal or persistent AF is preceded by a cardioversion of AF, the researchers wrote. A majority of strokes occur in patients not using HYPERLINK "http://www.healio.com/cardiology/arrhythmia-disorders/news/online/%7B771f10df-0638-4d80-8f70-a6c6bbddfa30%7D/oral-anticoagulation-recommended-for-patients-with-af-one-additional-stroke-risk-factor" oral anticoagulation before cardioversion of acute AF and typically 2 to 3 days after successful cardioversion.

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Miniature leadless pacemaker meets safety, efficacy goals at 6 months
A miniaturized leadless transcatheter pacing system met 6-month safety performance goals and efficacy endpoints, according to findings presented at the American Heart Association Scientific Sessions and simultaneously published online in NEJM. Researchers implanted the transcatheter intracardiac pacemaker in 725 patients (mean age, 76 years; 59% men) with guideline-based indications for ventricular pacing and began the present analysis when 300 patients reached 6-month follow-up. The primary safety endpoint was freedom from major complications related to the system or the procedure. The primary efficacy endpoint was percentage of patients with low and stable pacing capture thresholds, defined as up to 2 V at a pulse width of 0.24 ms and an increase of up to 1.5 V from baseline. The researchers evaluated the endpoints based on historical performance goals of 83% for the safety parameters and 80% for the efficacy parameters. They also performed a post-hoc analysis comparing major complication rates to those observed in a cohort of 2,667 patients from six studies implanted with transvenous pacemakers. According to results presented, the implantation success rate was 99.2%, with only six patients unable to receive a successfully implanted device. The Kaplan-Meier estimate of the rate of the primary safety endpoint was 96% (95% CI, 93.9-97.3; P < .001 compared with safety performance goal), and the rate of the primary efficacy endpoint was 98.3% (95% CI, 96.1-99.5; P < .001 compared with efficacy performance goal). Reynolds reported that 25 patients experienced 28 major complications, including one death from metabolic acidosis, but the risk was much lower than that of the transvenous pacemaker control cohort (HR = 0.49; 95% CI, 0.33-0.75). Propensity matching to a subset of the control group did not change the results (HR = 0.46; 95% CI, 0.28-0.74).

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Nov 16, 2015

Rivaroxaban antidote met all endpoints in phase 3 ANNEXA-R study
Andexanet alfa, a novel agent for reversal of Factor Xa-inhibitor anticoagulation, successfully reversed the effects of rivaroxaban in elderly individuals, according to data presented at the American Heart Association Scientific Sessions. In a simultaneous published in the New England Journal of Medicine, the ANNEXA-R investigators reported that andexanet alfa was also successful for reversal of the effects of apixaban in elderly individuals. In ANNEXA-R, 39 healthy elderly volunteers were randomly assigned on a 2:1 basis to receive andexanet alfa or placebo after taking rivaroxaban for 4 days. All received a bolus followed by an infusion of the study drug after last dose of rivaroxaban. No safety issues in any of the ANNEXA-R participants, including serious adverse events, reactions to the infusion and thrombotic events were reported. Mean percent change in anti-Factor Xa activity in those receiving andexanet alfa was 97% after the infusion (P < .0001 vs. placebo). Secondary endpoints of percent change in anti-Factor Xa activity after the bolus (95%; P < 0.0001 vs. placebo), occurrence of at least 80% Factor Xa reduction (andexanet alfa group, 100%; placebo group, 0%; P < 0.0001), mean change in free rivaroxaban concentration (reduced by 23.4 ng/mL in the andexanet alfa arm vs. 4.2 ng/mL in the placebo arm; P < 0.0001), change in thrombin generation (fully restored in 96% of the andexanet alfa arm vs. 7% of the placebo arm; P < .0001) and occurrence of thrombin generation above lower limit of derived normal range (P < .0001 vs. placebo) were all met.

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No survival benefit with PCI at 15 years reported in COURAGE trial
Extended follow-up data out to 15 years show no survival benefit with an initial strategy of PCI plus optimal medical therapy compared with optimal medical therapy alone among patients in the COURAGE trial. In the main COURAGE trial, results of which were published in 2007, there was no significant difference in the rate of survival during a median follow-up of 4.6 years among 2,287 patients with stable ischemic heart disease at 50 centers randomly assigned PCI plus medical therapy or medical therapy alone. The new analysis included 53% (n = 1,211) of the original COURAGE population followed for up to 15 years. Median follow-up duration for the extended follow-up cohort was 11.9 years (range, 0-15). Twenty-five percent (n = 561) of the overall COURAGE population died over the course of the study: 180 during the original trial period and 381 during extended follow-up. Of those deaths, 25% occurred in the PCI group and 24% in the medical therapy group (unadjusted HR for PCI = 0.98; 95% CI, 0.83-1.15; P = .77). Among the patients with extended follow-up, 41% of those in the PCI group and 42% in the medical therapy group died (unadjusted HR = 0.95; 95% CI, 0.79-1.13; P = .53). Cox regression analysis yielded an HR for death from any cause in the PCI group vs. medical therapy group of 1.03 (95% CI, 0.83-1.21; P =0.76). The researchers noted that data from the original COURAGE trial suggested that a late survival benefit with PCI may have emerged during extended follow-up, as survival curves indicated a separation at 5 years in favor of PCI (HR for death = 0.87; 95% CI, 0.65-1.13). However, the current data indicate no late trend to suggest a survival advantage. Several limitations of the new analysis were discussed in the NEJM paper, such as: survival data were only available for 53% of the COURAGE population, which included only a small number of non-VA trial participants and no Canadian participants; the endpoint of death from any cause allowed for no distinction as to whether deaths were cardiac- or noncardiac-related; and older device technologies and pharmacologic treatments were used, as the main trial randomized patients from 1999 to 2004.

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SPRINT: Aggressive BP target confers lower risk for death, CV events
A systolic BP target of less than 120 mm Hg was associated with lower rates of death and CV events compared with a target of less than 140 mm Hg, according to results from the SPRINT trial. In the SPRINT trial randomly assigned 9,361 people with systolic BP ≥ 130 mm Hg and high CV risk but no diabetes to an intensive treatment regimen with target systolic BP < 120 mm Hg or a standard treatment regimen with target systolic BP < 140 mm Hg. The primary outcome was a composite of MI, other ACS, stroke, HF and death from CV causes. Another outcome of interest was all-cause mortality. At 1 year, mean systolic BP was 121.4 mm Hg in the intensive-treatment group and 136.2 mm Hg in the standard-treatment group. During the study period, the intensive-treatment group was prescribed an average of 2.8 hypertensive medications compared with 1.8 for the standard-treatment group. All prescribed medications were guideline-directed therapies commonly used for BP reduction. SPRINT was stopped after a median follow-up of 3.26 years because the researchers observed a much lower rate of the primary outcome in the intensive-treatment group: 1.65% per year vs. 2.19% per year; HR = 0.75; 95% CI, 0.64-0.89. The curves began to separate at 1 year and widened over time. In addition, all-cause mortality was lower in the intensive-treatment group than in the standard-treatment group (HR = 0.73; 95% CI, 0.6-0.9). According to the researchers, the curves for mortality separated at 2 years, and death from CV causes was 43% lower in the intensive-treatment group (HR = 0.57; 95% CI, 0.38-0.85). The number needed to treat to prevent one primary outcome event was 61. The number needed to treat to prevent one death was 90 and to prevent one CV death was 172. The results were consistent across all subgroups. Treating death as a competing risk in a Fine-Gray model did not change the results for the primary outcome (HR = 0.76; 95% CI, 0.64-0.9).

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SPRINT: Aggressive BP target confers lower risk for death, CV events
A systolic BP target of less than 120 mm Hg was associated with lower rates of death and CV events compared with a target of less than 140 mm Hg, according to results from the SPRINT trial. In the SPRINT trial randomly assigned 9,361 people with systolic BP ≥ 130 mm Hg and high CV risk but no diabetes to an intensive treatment regimen with target systolic BP < 120 mm Hg or a standard treatment regimen with target systolic BP < 140 mm Hg. The primary outcome was a composite of MI, other ACS, stroke, HF and death from CV causes. Another outcome of interest was all-cause mortality. At 1 year, mean systolic BP was 121.4 mm Hg in the intensive-treatment group and 136.2 mm Hg in the standard-treatment group. During the study period, the intensive-treatment group was prescribed an average of 2.8 hypertensive medications compared with 1.8 for the standard-treatment group. All prescribed medications were guideline-directed therapies commonly used for BP reduction. SPRINT was stopped after a median follow-up of 3.26 years because the researchers observed a much lower rate of the primary outcome in the intensive-treatment group: 1.65% per year vs. 2.19% per year; HR = 0.75; 95% CI, 0.64-0.89. The curves began to separate at 1 year and widened over time. In addition, all-cause mortality was lower in the intensive-treatment group than in the standard-treatment group (HR = 0.73; 95% CI, 0.6-0.9). According to the researchers, the curves for mortality separated at 2 years, and death from CV causes was 43% lower in the intensive-treatment group (HR = 0.57; 95% CI, 0.38-0.85). The number needed to treat to prevent one primary outcome event was 61. The number needed to treat to prevent one death was 90 and to prevent one CV death was 172. The results were consistent across all subgroups. Treating death as a competing risk in a Fine-Gray model did not change the results for the primary outcome (HR = 0.76; 95% CI, 0.64-0.9).

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Nov 2, 2015

457 Hospitals Pay United States More Than $250 Million to Resolve False Claims Act Allegations Related to Implantation of Cardiac Devices
More than 450 hospitals in 43 states have agreed to pay more than $250 million to settle claims they placed implantable cardioverter defibrillators (ICDs) in Medicare patients who did not meet coverage requirements, according to an announcement from the US Department of Justice. The settlement stems from allegations that hospitals violated the Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) by failing to observe a waiting before implanting the ICD in patients who recently had an MI or underwent coronary revascularization. The 40-day post-MI and 90-day post-CABG/angioplasty waiting periods are intended to allow sufficient time for cardiac recovery following the clinical event and/or procedure, allowing physicians to determine whether an ICD is truly needed. The Department of Justice alleged that between 2003 and 2010, physicians from 457 US hospitals implanted ICDs in patients without adhering to the 40-day and 90-day waiting periods, thereby violating the Medicare NCD.

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FDA advisory committee members explain approval of PCSK9 inhibitors
Three members of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee explained their decision to approve two proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors (alirocumab and evolocumab) in the New England Journal of Medicine . They explained that alirocumab lowered low-density lipoprotein (LDL) cholesterol by 39% to 62% compared with placebo, while evolocumab decreased LDL cholesterol by 47% to 56% compared with placebo. Meanwhile, approximately 37% of patients receiving evolocumab and 24% of patients receiving alirocumab had LDL cholesterol levels below 25 mg per deciliter on two consecutive measurements. The injectable medications are intended for adults with primary hypercholesterolemia, mixed dyslipidemia and those unable to take statins. Patients with homozygous familial hypercholesterolemia were also included in the evolocumab studies. The committee did not receive efficacy data on cardiovascular outcomes, although preliminary adverse events with evolocumab were encouraging. The FDA advisory committee approved alirocumab by a 13 to 3 vote and approved evolocumab by an 11 to 4 vote.

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Dabigatran Use, Effectiveness Differs Between Women and Men with Atrial Fibrillation
Sex differences exist in effectiveness, dose use, and safety for the novel oral anticoagulant (NOAC) dabigatran for patients with atrial fibrillation (AF), suggests new research published in Circulation: Cardiovascular Quality and Outcomes. A population-based cohort study of more than 63.000 Canadian patients with AF showed that women had a higher risk of stroke at baseline and a lower bleeding risk vs men. Although the male dabigatran users had a significantly lower risk of bleeding vs the men who used warfarin, based on propensity scoring (P for interaction=0.008), this dabigatran-vs-warfarin association was not significant in the women. The women who used dabigatran at 150 mg twice daily did have a trend toward lower stroke risk vs the women who used warfarin (HR 0.79, 95% CI 0.56–1.04). However, 65% of the female dabigatran users filled their prescriptions at a lower dose (110 mg twice daily). For this study, the investigators examined administrative data on 63,110 patients (50.4% women) from Quebec who had been discharged from hospitalization for AF or a major comorbid diagnosis between 1999 and 2013. They found 15,918 users of dabigatran at doses of either 150 or 110 mg twice daily and matched them at a 1:3 ratio with warfarin users (n=47,192). The mean follow-up was 1.3 years.

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Oct 27, 2015

Post hoc analysis of ACCORD: Insulin Dose Not Linked to CV Death
Insulin dose did not play a role in the greater cardiovascular mortality seen among high-risk type 2 diabetes patients randomized to intensive glycemic control in the Action to Control Cardiovascular Risk in Diabetes (ACCORD), a newly published post hoc analysis published online in Diabetes Care, suggests. In the 7 years since ACCORD was stopped early and the startling results published, investigators have struggled to explain the counterintuitive result. Proposed contributing factors include hypoglycemia, rate of HbA1c reduction, weight gain, or insulin dose. Of 10.163 ACCORD patients with follow-up data, there were 328 total cardiovascular deaths. As previously reported at ADA, in univariate analysis, several baseline characteristics were associated with increased cardiovascular mortality during the study, including older age, male sex, longer diabetes duration, history of cardiovascular disease, heart failure, diabetes-related complications, insulin use prior to the study, higher HbA1c, serum creatinine, and urine albumin/creatinine ratio. As expected by design, more of the intensive-treatment group used insulin during the study (79% vs 62%), and their average insulin dose was higher than in the standard control group (0.41 vs 0.30 units/kg body weight, P < .001). Prior to adjustment for confounders, every one-unit increase in insulin dose was associated with a significant increased risk for cardiovascular death, with a hazard ratio of 1.83 for total (basal plus bolus) insulin. However, that association disappeared after adjustment for age, history of cardiovascular disease, heart failure, amputation, education, use of angiotensin-receptor blockers, peripheral neuropathy, QT index, baseline HbA1c, HDL cholesterol, serum creatinine, urinary albumin/creatinine ratio, integrated health plan, and certified diabetes educator on staff at randomization (hazard ratio, 1.21).

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AF associated with elevated risk for dementia regardless of stroke
Adults with atrial fibrillation had a higher risk for dementia than those without atrial fibrillation, regardless of whether they had experienced a stroke, according to the results of a prospective, population-based study published in JAMA Neurology. They assessed the relationship between incident and prevalent AF and incident dementia between 1989 and 2010 in 6.,514 participants from the Rotterdam Study aged at least 55 years at baseline. They also analyzed whether duration of AF was a factor in onset of dementia. The primary outcome was incident dementia, defined according to criteria from Diagnostic and Statistical Manual of Mental Disorders, third edition (DSM-III) and the National Institute of Neurological and Communicative Disorders and Stroke – Alzheimer’s Disease and Related Disorders Association. There were 81,483 person-years of follow-up. The authors found that 4.9% of participants had prevalent AF at baseline and 15.3% developed incident dementia during the study period. Prevalent AF conferred a higher risk for dementia (adjusted HR = 1.33; 95% CI, 1.02-1.73). Among the 6.196 participants without prevalent AF at baseline, 11.7% developed incident AF and 15% developed incident dementia during 79,003 person-years of follow-up. In participants younger than 67 years, incident AF was associated with increased risk for dementia (adjusted HR = 1.81; 95% CI, 1.11-2.94), but that was not the case for those aged at least 67 years (adjusted HR = 1.12; 95% CI, 0.85-1.46; P for interaction = .02). The authors also stratified patients with AF by duration of exposure to AF, and observed an association between elevated dementia risk and duration of exposure among those younger than 67 years, (HR for stratum with longest exposure = 3.3; 95% CI, 1.16-9.38; P for trend = .003), but not those aged at least 67 years (HR for stratum with longest exposure = 0.25; 95% CI, 0.04-1.86; P for trend = .94).

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Updated guideline endorses treating nonculprit lesions in some patients with STEMI
An update to the American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions guideline on primary PCI for patients with STEMI states that nonculprit lesions can be treated in some cases. The update also includes a recommendation against performing aspiration thrombectomy during primary PCI. The guideline now gives a class IIb recommendation, instead of a class III (harm) recommendation, to stenting nonculprit lesions in patients with STEMI who are hemodynamically stable. They cited data from the PRAMI, CvLPRIT, DANAMI-3–PRIMULTI and PRAGUE-13 trials, all of which indicated that patients with MI and multivessel disease who had nonculprit lesions treated had similar or better outcomes compared with those who had only the culprit lesion treated. The panel also updated its recommendation on aspiration thrombectomy before PCI for patients with STEMI. It had previously received a class IIa recommendation as reasonable before primary PCI. However, the INFUSE-AMI, TASTE and TOTAL trials showed no benefit from the strategy, and results from TOTAL indicated an increased risk for stroke among patients who underwent aspiration thrombectomy before PCI. The panel changed the recommendation for routine aspiration thrombectomy to class III (no benefit), calling it “not useful,” and the recommendation for selective and bailout aspiration thrombectomy to class IIb, calling its usefulness “not well established.

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Updated guideline endorses treating nonculprit lesions in some patients with STEMI
An update to the American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions guideline on primary PCI for patients with STEMI states that nonculprit lesions can be treated in some cases. The update also includes a recommendation against performing aspiration thrombectomy during primary PCI. The guideline now gives a class IIb recommendation, instead of a class III (harm) recommendation, to stenting nonculprit lesions in patients with STEMI who are hemodynamically stable. They cited data from the PRAMI, CvLPRIT, DANAMI-3–PRIMULTI and PRAGUE-13 trials, all of which indicated that patients with MI and multivessel disease who had nonculprit lesions treated had similar or better outcomes compared with those who had only the culprit lesion treated. The panel also updated its recommendation on aspiration thrombectomy before PCI for patients with STEMI. It had previously received a class IIa recommendation as reasonable before primary PCI. However, the INFUSE-AMI, TASTE and TOTAL trials showed no benefit from the strategy, and results from TOTAL indicated an increased risk for stroke among patients who underwent aspiration thrombectomy before PCI. The panel changed the recommendation for routine aspiration thrombectomy to class III (no benefit), calling it “not useful,” and the recommendation for selective and bailout aspiration thrombectomy to class IIb, calling its usefulness “not well established.

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Oct 20, 2015

FDA Approves idarucizumab to Reverse Anticoagulant dabigatran
The US Food and Drug Administration (FDA) has granted accelerated approval to idarucizumab to rapidly reverse the blood-thinning effects of the anticoagulant dabigatran. The FDA approved dabigatran in 2010 to prevent stroke and systemic blood clots in patients with atrial fibrillation, as well as for the treatment and prevention of deep venous thrombosis and pulmonary embolism. This is the first reversal agent approved specifically for dabigatran and works by binding to the drug compound to neutralize its effect. It is administered via intravenous injection. According to the FDA, the safety and effectiveness of idarucizumab were studied in three trials involving a total of 283 healthy volunteers taking dabigatran. In volunteers given idarucizumab, there was an immediate reduction in the amount of dabigatran in participants' blood, which was measured as unbound dabigatran plasma concentration that lasted for at least 24 hours. In this study, the most common adverse effect of idarucizumab was headache. Another trial included 123 patients taking dabigatran who received idarucizumab because of uncontrolled bleeding or because they required emergency surgery. In this ongoing trial, on the basis of laboratory testing, the anticoagulant effect of dabigatran was fully reversed in 89% of patients within 4 hours of receiving idarucizumab. In this trial, the most common adverse effects were hypokalemia, confusion, constipation, fever, and pneumonia. The idarucizumab labeling recommends that patients resume their anticoagulant therapy as soon as medically appropriate, as determined by their healthcare provider.

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COPD increases mortality among individuals with atrial fibrillation
A diagnosis of COPD independently increased risk for cardiovascular and non-cardiovascular mortality among patients with atrial fibrillation, according to study results. COPD is associated with poor outcomes among patients with cardiovascular disease; however, prior research has not established whether COPD influences the risks for stroke or mortality among those with atrial fibrillation, according to study background. evaluated data from 18,134 participants in the ARISTOTLE trial, which compared the effects of apixaban and warfarin on the risk for systemic embolism or stroke. All participants had atrial fibrillation and available pulmonary disease history. They used Cox proportional hazards models to assess the associations between comorbid COPD and risks for stroke, systemic embolism or mortality. They adjusted for treatment allocation, as well as smoking history and other risk factors. Researchers identified COPD in 1.950 (10.7%) members of the cohort. Multivariable adjustment showed COPD was not associated with risk for systemic embolism or stroke (adjusted HR = 0.85; 95% CI, 0.6-1.21). However, COPD did appear associated with greater risk for all-cause mortality (adjusted HR = 1.6; 95% CI, 1.36-1.88), as well as both cardiovascular and non-cardiovascular mortality. The benefit of apixaban compared with warfarin on systemic embolism or stroke appeared consistent among patients with COPD (HR = 0.92; 95% CI, 0.52-1.63) and without COPD (HR = 0.78; 95% CI, 0.65-0.95).

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Psoriasis severity linked to vascular inflammation beyond CV risk factors
Severity of psoriasis appears to be associated with vascular inflammation independent of risk factors for vascular disease, according to recent findings. In a prospective observational study, researchers evaluated 60 patients with psoriasis (median age, 47.5 years; 28 men and 32 women) and 20 matched controls (median age, 41 years; 13 men and seven women). The researchers measured psoriasis severity using the psoriasis area severity index (PASI), and measured vascular inflammation using average aortic target-to-background ratio employing 18F-fluorodeoxyglucose PET/CT. Both patients and controls were at low overall risk for CVD according to Framingham risk scores (median for psoriasis group, 3; median for controls, 1). The researchers observed mild-to-moderate skin disease severity in the patients with psoriasis (median PASI score, 5.4). Unadjusted linear regression models revealed an association between increasing PASI score vascular inflammation (beta = 0.41; P = .001). This correlation largely persisted after adjustment for age and sex (beta = 0.39; P = .002) and Framingham risk score (beta = 0.39; P = .001). Patients with psoriasis had higher absolute neutrophil counts (psoriasis, mean 3.7 ± 1.2 vs. controls, mean 2.9 ± 1.2; P = .02), the researchers wrote. Immunophenotyping confirmed an increase in neutrophil frequencies in circulating whole blood among patients compared with controls (patients, mean 65.2 ± 11.9 vs. controls, mean 56.3 ± 13.8; P < .01). Patients with psoriasis also had elevated serum levels of S100A8/A9 protein (745.1 ± 53.3 vs. 195.4 ± 157.8 ng/mL; P < .01) and neutrophil elastase-1 (43 ± 2.4 vs. 30.8 ± 6.7 ng/mL; P < .001). Researchers also observed an association between S100A8/A9 protein and psoriasis skin disease severity (beta = 0.53; P = .02), as well as between S100A8/A9 and vascular inflammation after adjustment for Framingham risk score (beta = 0.48; P = .02).

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Oct 12, 2015

Beta-blockers at Noncardiac Surgery Up CV Risk in Lower-Risk Cohort
Continued use of beta-blockers for hypertension during noncardiac surgery can raise the risk of major adverse cardiac events (MACE) and all-cause mortality within 30 days in a relatively low-risk population, suggests new research that is in line with earlier studies that generally included higher-risk patients. A Danish cohort of more than 55,000 low-risk hypertension patients which published online in JAMA Internal Medicine, showed that those who were taking a beta-blocker plus another type of antihypertensive medication before noncardiac surgery had significantly increased 30-day postoperative risk of MACE and all-cause mortality compared with those who took non–beta-blocker antihypertensive drugs. In the analysis, the authors evaluated Danish health records for 55,320 hypertension patients without cardiac, renal, and liver disease who underwent noncardiac surgery between 2005 and 2011. A beta-blocker was part of the two-drug regime for 14,644 of these patients. Other antihypertensives used by the participants included renin-angiotensin system (RAS) inhibitors, thiazides, and calcium antagonists. The primary outcomes were 30-day all-cause mortality and incidence of MACE, which was defined as a combination of CV death, nonfatal ischemic stroke, and nonfatal MI. In the patients who included a beta-blocker in their treatment, 1.32% had MACE 30-day postsurgery vs 0.84% of the non–beta-blocker group (P <0.001). When researchers examined the MACE components individually, CV death was also significantly higher in the beta-blocker–treated group (0.90% vs 0.45%, respectively, P<0.001.). All-cause mortality was 1.93% vs 1.32% in the beta-blocker vs non–beta-blocker groups, respectively (P<0.001). In addition, all treatment combinations that included a beta-blocker had significantly increased risk of both MACE and all-cause mortality compared with the reference treatment of RAS and thiazides.

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New-onset diabetes risk rises with BP
Elevated BP may be a risk factor for new-onset type 2 diabetes, and the association appears strongest in those who are younger and have a lower BMI, according to an analysis of 4.1 million adults in the United Kingdom which published in JACC. Using validated linked electronic health records, the authors analyzed a cohort of 4.132.138 adults aged 30 to 90 years (55.9% women) in the U.K. Clinical Practice Research database who had BP measurements taken from January 1990 to January 2013, were registered at a general practice for 1 year, and had no pre-existing CVD and diabetes. The researchers examined BP levels, BMI, total cholesterol, HDL and smoking status within 2 years of baseline systolic BP and diastolic BP measurement. The primary outcome was diagnosis of type 2 diabetes or insulin/antidiabetic therapy prescription. Overall, a 20-mm Hg higher systolic BP (HR = 1.58; 95% CI, 1.56-1.59) and 10-mm Hg higher diastolic BP (HR = 1.52; 95% CI, 1.51-1.54) were associated with greater risk for new-onset diabetes. A 20-mm Hg higher systolic BP was associated with a greater increase in risk for diabetes in adults with a BMI up to 25 kg/m2 (HR = 1.89; 95% CI, 1.84-1.94) compared with a BMI greater than 35 kg/m2 (HR = 1.19; 95% CI, 1.16-1.22; P for interaction < .0001). A 10-mm Hg higher diastolic BP was associated with a greater increased risk for diabetes in adults with a BMI less than 20 kg/m2 (HR = 1.73; 95% CI, 1.68-1.78) compared with a BMI greater than 35 kg/m2 (HR = 1.19; 95% CI, 1.16-1.22; P for interaction < .0001). Researchers also performed a meta-analysis of 30 observational studies (n = 285,664; 17,388 with diabetes), and found that a 20-mm Hg higher systolic BP was associated with a 77% higher risk of new-onset diabetes (RR = 1.77; 95% CI, 1.53-2.05).

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New guideline from AHA focuses on management of adults with supraventricular tachycardia
The American College of Cardiology, American Heart Association and Heart Rhythm Society have released a guideline on best practices for management of adults with supraventricular tachycardia. The guideline covers all forms of supraventricular tachycardia (SVT) except atrial fibrillation, which has its own guideline. The guideline includes decision trees on how to make a specific diagnosis of adults presenting with narrow QRS tachycardia, as well as how to treat and manage the following conditions: regular SVT of unknown mechanism, suspected acute focal atrial tachycardia, atrioventricular nodal reentrant tachycardia, orthodromic atrioventricular reentrant tachycardia, atrial flutter, junctional tachycardia and SVT in adults with congenital heart disease. According to the document, for ongoing management of patients with SVT, electrophysiological study with the option of ablation is useful and patients should be taught how to do vagal maneuvers. For those with symptomatic SVT without ventricular pre-excitation during sinus rhythm, the following medications are recommended: oral beta-blockers, diltiazem and verapamil. For certain patients with symptomatic SVT, flecainide, propafenone, sotalol, dofetilide, oral amiodarone or oral digoxin may be appropriate. For patients with inappropriate sinus tachycardia, doctors should look for and treat reversible causes, and ivabradine, beta-blockers or a combination may be appropriate. Patients with hemodynamically unstable focal atrial tachycardia should undergo synchronized cardioversion, whereas those with hemodynamically stable focal atrial tachycardia can be treated with IV beta-blockers, diltiazem or verapamil in acute settings and adenosine, IV amiodarone or ibutilide in nonacute settings, according to the document. The panel noted that catheter ablation is a recommended alternative to medical therapy in these patients. In patients with atrial flutter, oral dofetilide or IV ibutilide is strongly recommended for acute cardioversion. However, patients who are hemodynamically unstable and unresponsive to medication should have synchronized cardioversion. Patients with adult congenital heart disease and SVT who are hemodynamically unstable should undergo synchronized cardioversion.

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Oct 05, 2015

Severe Obesity Ups Cardiometabolic Risk in the Young
Severe obesity in children and young adults is associated with a high prevalence of abnormal levels of cardiometabolic risk factors, and the overall risk increases with greater levels of obesity, new research published in NEJM shows. Investigators analyzed 8579 overweight or obese children and young adults between the ages of 3 and 19 years who were included in the US National Health and Nutrition Examination Survey 1999–2012. Weight categories according to age and sex-specific body mass index (BMI) percentiles used in the study were defined as overweight (≥85th to < 95th percentile); class I obesity (≥95th percentile to < 120% of the 95th percentile); class II obesity (≥120% to < 140% of the 95th percentile or a BMI ≥35 kg/m2, whichever was lower); and class III obesity (≥140% of the 95th percentile or a BMI≥40 kg/m2, whichever was lower). Among the 8579 children and young adults with a BMI at the 85th percentile or higher, 46.9% were overweight while 36.4% had class I obesity; 11.9% had class II obesity, and 4.8% had class III obesity, investigators report. In multivariable analysis controlling for age, race or ethnic group, and sex, the risk of low HDL-cholesterol levels, high systolic and diastolic blood pressure, high triglycerides, and high HbA1c levels were all greater among children and young adults with class III obesity compared with those with class I obesity.

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ESC guidelines poor at identifying patients with hypertrophic cardiomyopathy needing ICD
Guidelines from the European Society of Cardiology do a poor job of identifying patients with hypertrophic cardiomyopathy who are at high risk for sudden death and require an implantable cardioverter defibrillator, according to an analysis in the American Journal of Cardiology. The authors applied the formula in the ESC guidelines used to determine which patients with hypertrophic cardiomyopathy should receive an ICD due to high risk for sudden cardiac death to 1,629 consecutive case records at two centers from October 1992 to May 2014. All patients were aged 16 years or older at first evaluation, and total follow-up was 13,274 patient-years. In that population, there were 35 HYPERLINK "http://www.healio.com/search?q=sudden%20death&requiredfields=specialty:Cardiology" \t "_blank" sudden death events; 23 patients died and 12 were resuscitated, Maron and colleagues reported. Mean age at sudden death event was 43 years. Of those patients, only 11% qualified as high risk for sudden death under the ESC formula, having a score greater than 6% per 5 years, the guideline’s threshold for recommendation of an ICD, according to the researchers. In addition, 60% of patients with a sudden death event had a score low enough (less than 4% per 5 years) to justify a recommendation that an ICD not be implanted, they wrote. The researchers also identified 46 patients who had an ICD and received an appropriate intervention from their device for ventricular fibrillation or ventricular tachycardia. Of these, 26% had a score high enough to recommend an ICD and 59% had a score low enough to justify a recommendation that an ICD not be implanted. Furthermore, there were 414 patients who had an ICD but did not require an intervention from their device. Among these patients, 62% had a score low enough to justify a recommendation that an ICD not be implanted, according to the researchers. Overall, 5% of patients had a sudden death event or appropriate ICD discharge, but only 20% of those patients would have been classified as high risk for sudden death using the ESC criteria.

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Multiarterial CABG improves long-term outcomes
Compared with PCI using bare-metal stents or drug-eluting stents, multiarterial CABG was associated with improved long-term survival and reintervention-free survival according a study published in JACC. Researchers studied longer-term outcomes of CABG vs. PCI in 8,402 patients with multivessel disease who had procedures at Mount Sinai Beth Israel Medical Center in New York from 1994 to 2011. Of those, 2,381 underwent PCI with DES (mean age, 66 years), 2,289 underwent single arterial CABG (mean age, 69 years), 2,207 underwent PCI with BMS (mean age, 66 years) and 1,525 underwent multiarterial CABG (mean age, 58 years). Patients who underwent PCI with BMS had poorer survival outcomes from the time of procedure until 7 years of follow-up compared with single-artery CABG (P = .015). Through 9 years of follow-up, the survival rate for BMS PCI was 76.3% compared with 86.9% for multiarterial CABG (P < .001). Patients who underwent PCI with DES had a similar rate of survival as patients who underwent single-artery CABG; however, single-artery CABG was associated with a modest survival benefit over DES PCI during the first 3 years of follow-up (P = .615). Through 9 years of follow-up, the survival rate for DES PCI was 82.8% compared with 89.8% with for multiarterial CABG (P < .001). The risk for reintervention was increased among all patients who underwent PCI compared with CABG (P < .001).

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Sep 28, 2015

EMA Recommends Approval of Idarucizumab (Praxbind), a Dabigatran-Specific Antidote
The European Medicines Agency (EMA) has recommended the approval of idarucizumab , a specific antidote to reverse the anticoagulant effect of the direct oral thrombin inhibitor dabigatran. The recommendation for approval follows an accelerated assessment from the Committee for Medicinal Products for Human Use (CHMP). Based on its review, the CHMP recommends use of the dabigatran-specific antidote in dabigatran-treated patients who need to undergo emergency surgery or when life-threatening or uncontrolled bleeding occurs. The antidote will be available as 2.5g/50 mL solution for injection/infusion. Idarucizumab, is a specific reversal agent for dabigatran (ATC code: V03AB). It is a humanised monoclonal antibody fragment that binds to dabigatran and its metabolites with very high affinity and neutralises their anticoagulant effect. It is used when rapid reversal of dabigatran effect is required. The benefits with the antidote are its ability to reverse the anticoagulant effect of dabigatran within 5 minutes of administration, that its action lasts long enough to allow clinical emergency management of patients if needed and that it does not interfere with routine treatment in case of bleeding or urgent surgery. Mild symptoms suggestive of hypersensitivity have been reported but a causal relationship to idarucizumab could not be established. The full indication is: “A specific reversal agent for dabigatran and is indicated in adult patients treated with dabigatran etexilate when rapid reversal of its anticoagulant effects is required: For emergency surgery/urgent procedures In life-threatening or uncontrolled bleeding.” It is proposed that the drug will be restricted to hospital use only.

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High lean body mass predicts AF in postmenopausal women
Greater lean body mass was an independent predictor of atrial fibrillation in postmenopausal women, according to new data from the Women’s Health Initiative. Elevated BMI is known to be a risk factor for AF, but little research had been done on the association between elevated lean body mass and AF, according to the researchers. They evaluated 11,393 participants from the Women’s Health Initiative study of postmenopausal women aged 50 to 79 years. All participants underwent dual-energy X-ray absorptiometry to assess lean body mass, and the researchers documented incident AF via hospitalization records and Medicare diagnostic codes. After excluding some participants because of prevalent AF or incomplete data, they analyzed 8,832 participants (mean age, 63.3 years; 77.3% white). Mean follow-up was 11.6 years, during which 1,035 cases of incident AF were documented. After adjusting for covariates, the authors found that all measures of lean body mass independently predicted AF onset. These included: total lean body mass (HR = 1.24 per 5 kg increase; 95% CI, 1.14-1.34); central lean body mass (HR = 1.51 per 5 kg increase; 95% CI, 1.31-1.74); and peripheral lean body mass (HR = 1.39 per 5 kg increase; 95% CI, 1.19-1.63). When adjusted for total fat mass, total lean body mass remained an independent predictor of AF (HR = 1.22 per 5 kg increase; 95% CI, 1.13-1.31). Compared with those in the lowest tertile of total lean body mass, those in the highest tertile were more likely to be younger and black (P < .001 for both), according to the researchers. They also found that those in the highest tertile were more likely than those in the lowest tertile to have AF risk factors such as hypertension (P < .001), diabetes (P < .001), CAD (P = .029), HF (P = .007), peripheral artery disease (P = .036) and smoking (P < .001).

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Long-term anticoagulation after radiofrequency ablation of atrial flutter may benefit some patients
After successful radiofrequency ablation of typical atrial flutter, patients remain at an increased risk for developing atrial fibrillation and stroke, according to findings published in the International Journal of Cardiology. The authors studied 393 patients (mean age, 64.4 ± 11.2 years) with typical atrial flutter (116 with history of AF) who underwent successful radiofrequency ablation. After the procedure, 230 patients (58.5%) continued on oral anticoagulation therapy. The investigators looked for incidence of, and risk factors for, new-onset AF and ischemic stroke to determine which patients might benefit from long-term anticoagulation. Minimum follow-up was 1 year (interquartile range, 5.1-9.1 years). Overall, 215 patients (54.7%) developed AF after radiofrequency ablation. Of those, 130 patients had new-onset AF (33.1%). The strongest predictor of AF was prior AF (HR = 2.18, 95% CI, 1.66-2.88). Based on univariate analysis, new-onset AF predictors included: diabetes (HR = 1.49; 95% CI, 1.01-2.22); chronic obstructive pulmonary disease (HR = 1.72; 95% CI, 1.17-2.51); left atrial enlargement, defined as diameter of at least 40 mm (HR = 2.61; 95% CI, 1.64–4.13); and CHA2DS2-VASc score (HR = 1.14; 95% CI, 1.04-1.3). However, multivariate analysis showed the only predictor for new-onset AF was left atrial enlargement (HR = 2.65, 95% CI 1.67-4.2). Overall, 22 (5.6%) patients developed ischemic stroke after radiofrequency ablation, for an incidence rate of 8.4 strokes per 1,000 person-years. Of those patients, 15 (68.2%) had previous AF. Among patients with stroke, CHA2DS2-VASc score also showed good predictive capability (HR = 1.49; 95% CI 1.12-1.98). At the time of procedure, 17 patients (77.3%) had a score of at least 2 points, four patients (18.2%) had a score of 1 point, and one patient had a score of 0.

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Sep 21, 2015

FDA Approves First ICD Designed to Be MRI Compatible
The US Food and Drug Administration (FDA) has approved the first implantable cardioverter defibrillator (ICD) that was designed to be used safely in patients who undergo MRI. The device is a single- or dual-chamber ICD modified with changes to the firmware and hardware to make it compatible with an MRI scan. The FDA approval is based on data from the Evera MRI Study, a trial that included 275 patients implanted with the MRI-compatible ICD and randomized to a series of full-body MRI scans—including scans of the chest, thoracic spine, cervical spine, and head—or to the control arm. The results of the study were presented at the Heart Rhythm Society 2015 Scientific Sessions.

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New data demonstrate sustained reversal of anticoagulant effect of Factor Xa inhibitor rivaroxaban
The second part of phase 3 ANNEXATM-R (Andexanet alfa a novel antidote to the anticoagulant effects of FXa inhibitors–rivaroxaban) study achieved all primary and secondary endpoints with high statistical significance. Andexanet alfa, a US Food and Drug Administration (FDA)-designated breakthrough therapy, is a recombinant protein specifically designed to reverse the anticoagulant activity of Factor Xa inhibitors. Andexanet alfa as a universal reversal agent for patients anticoagulated with an oral or injectable Factor Xa inhibitor who suffer a major bleeding episode or require emergency surgery. Full data from this part of the study have been accepted for presentation during a late breaking clinical trial session at the American Heart Association’s (AHA) Scientific Sessions 2015 (7–11 November, Orlando, Florida). The ANNEXA-R study evaluated the safety and efficacy of andexanet alfa in reversing the anticoagulant effect of the Factor Xa inhibitor rivaroxaban, as measured by anti-Factor Xa activity, in older healthy volunteers. Part one of the study demonstrated rapid reversal with a bolus infusion, and part two of the study now shows the ability of andexanet alfa to sustain that reversal. Topline data from part two show that andexanet alfa, which was administered as an intravenous bolus followed by a continuous two-hour infusion, produced rapid reversal of the anticoagulant effect of rivaroxaban and sustained it for the duration of the infusion. In the study, andexanet alfa was well tolerated, with no serious adverse events, thrombotic events, or antibodies to Factor X or Xa reported.

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High resting heart rate linked to poor functional status in older adults
Higher resting heart rate and lower heart rate variability appear to be linked to poorer functional status in older adults, regardless of CV risk factors and comorbidities, according to recent findings of PROSPER study which published in CMAJ. Researchers evaluated data on 5,042 patients enrolled in PROSPER, a randomized controlled trial assessing pravastatin in a cohort of adults aged 70 to 82 years (mean age, 75.3 years) with vascular disease or associated risk factors. The researchers measured participants’ resting heart rates and heart rate variations from a 10-second, 12-lead ECG recorded the morning of the initial study visit. They calculated the standard deviation of normal-to-normal RR intervals (SDNN), a commonly used index of heart rate variability. Participants’ functional status was evaluated using the Barthel Index and the Lawton Instrumental Activities of Daily Living (IADL) scale. The Barthel Index assesses the ability to perform basic daily living tasks (ADL) and the Lawton IADL evaluates more complex instrumental activities, with higher scores indicating a greater degree of independence and functional status. These questionnaires were administered at baseline, after 9, 18 and 30 months, and at the end of the study, with a mean follow-up of 3.2 years. Patients had a median resting heart rate of 65 beats/minute and a median standard deviation of normal-to-normal RR intervals of 18.6 ms. Over the course of follow-up, ADL score declined in 15.5% of patients and IADL score declined in 22.4%. Higher baseline heart rate was linked to worse ADL and IADL score, and lower SDNN was associated with worse IADL (all P values < .05). Among those in the highest heart rate tertile (71-117 beats per minute), there was a 1.79-fold higher risk for decline in ADL (95% CI, 1.45-2.22) and a 1.35-fold higher risk for decline in IADL (95% CI, 1.12-1.63). There was a 1.21-fold (95% CI, 1-1.46) higher risk for decline in ADL in the lowest SDNN tertile (range, 1.7-13.3 ms) and a 1.25-fold higher risk for decline in IADL in this tertile (95% CI, 1.05-1.48) (both P for trends < .05). These associations were independent of gender, medications, CV risk factors and comorbidities.

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Sep 14, 2015

SPRINT trial: More Intensive Blood Pressure Targets Cut Mortality and CV Events
More intensive management of high blood pressure, below a commonly recommended blood pressure target, significantly reduces rates of cardiovascular disease, and lowers risk of death in a group of adults 50 years and older with high blood pressure. This is according to the initial results of a landmark clinical trial sponsored by the National Institutes of Health called the Systolic Blood Pressure Intervention Trial (SPRINT). The intervention in this trial, which carefully adjusts the amount or type of blood pressure medication to achieve a target systolic pressure of 120 millimeters of mercury (mm Hg), reduced rates of cardiovascular events, such as heart attack and heart failure, as well as stroke, by almost a third and the risk of death by almost a quarter, as compared to the target systolic pressure of 140 mm Hg.
The study, which included hypertensive patients with one additional cardiovascular risk factor or preexisting kidney disease, was stopped earlier than the planned 2018 completion date, given the benefit of the intensive strategy, according to investigators. The SPRINT investigators did not disclose event rates or the absolute reduction in risk with any of the end points, including the primary composite end point of MI, acute coronary syndrome, stroke, heart failure, or cardiovascular disease death. During the media briefing, they said only that the reduction in the event rate was sufficiently large enough for the SPRINT data safety and monitoring board (DSMB) stop the trial early.

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Varenicline Not Linked With CVD or Psychiatric Risk in New Meta-Analysis
A new meta-analysis of smokers using different aids to help them quit found the use of varenicline did not result in any significant neuropsychiatric or cardiovascular risks compared with nicotine-replacement therapy.
In fact, compared with nicotine-replacement therapy, the use of varenicline was associated with a 20% lower risk of ischemic heart disease and a significant 34% lower risk of depression and a 44% lower risk of self-harm. The researchers report the use of varenicline was also associated with significantly lower risks of cerebral infarction, heart failure, and developing an arrhythmia. The results of the study are published in the Lancet: Respiratory Medicine.
In this latest meta-analysis, were identified 51,450 patients who received a prescription for varenicline, 106,759 for nicotine-replacement therapy, and 6557 for bupropion, another agent that is used to help people quit smoking. Nicotine-replacement therapy was used as the reference group, as it is presumed by regulatory agencies not to carry any risks, say the investigators. A follow-up period of 6 months was chosen, as this is the typical treatment duration for the drugs.

Varenicline significantly reduced the risks of multiple cardiovascular disease end points compared with nicotine-replacement therapy, the exception being peripheral vascular disease (odds ratio 0.95; 95% CI 0.73–1.23). Bupropion also reduced the risks of ischemic heart disease, cerebral infarction, arrhythmia, and depression compared with nicotine but had no effect on heart failure, peripheral vascular disease, or self-harm end points.

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ATTEMPT-CVD: Telmisartan in Hypertension Bests Non-ARBs in Biomarker Impact
Antihypertensive treatment with the angiotensin II receptor blocker (ARB) telmisartan improved the levels of two important biomarkers of cardiovascular and renal risk compared with treatment with non-ARBs, in 3-year results from the Trial of Telmisartan Prevention of Cardiovascular Disease (ATTEMPT-CVD) which published online in the European Journal of Preventive Cardiology. Specifically, the telmisartan-treated patients had a smaller increase in plasma brain natriuretic peptide (BNP) levels and a greater decrease in urinary albumin/creatinine ratio (UACR), independent of changes in blood pressure.
Moreover, baseline levels of BNP and UACR predicted cardiovascular events. Also, ARB-treated patients had fewer cardiovascular events than non–ARB-treated patients, but this was not statistically significant.
The researchers randomized 1228 patients from 168 institutions in Japan to an ARB group or non-ARB group. The patients were 40 to 80 years old and had hypertension plus at least one cardiovascular risk factor.
Patients in the ARB and non-ARB groups had similar baseline characteristics. More than half of the patients (58%) were men. The patients had a mean age of 66 and a mean blood pressure of 150/84 mm Hg. About 57% had dyslipidemia, 67% had type 2 diabetes, and 17% were current smokers. Baseline UACR and BNP levels were similar in the ARB and non-ARB groups.
The patients were followed for 3 years, and at 6, 12, 24, and 36 months, the researchers determined their levels of UACR, plasma BNP, serum high-sensitivity C-reactive protein (hs-CRP), urinary 8-hydroxy-deoxy-guanosine (8-OHdG), serum adiponectin, eGFR, and high-molecular weight adiponectin.
The primary efficacy end points were changes in UACR and plasma BNP levels from baseline. The secondary efficacy end points were changes in other biomarkers and time to a cardiovascular composite event (cerebral, coronary, cardiac, and aortic/peripheral arterial events, diabetes complications, and worsening renal function).
In the non-ARB arm, almost all patients were prescribed calcium-channel blockers; ACE inhibitors, beta-blockers, and diuretics were prescribed less often.
The primary end point was met: over time, UACR decreased more in patients in the ARB group than in patients in the non-ARB group (P<0.001), and plasma BNP increased by a smaller amount in patients in the ARB group than patients in the comparator group (P=0.044).
Patients in the ARB group also had fewer fatal and nonfatal cardiovascular composite events (cerebral, coronary, cardiac, and aortic/peripheral arterial events, diabetes complications, and worsening renal function), but this was not significant (odds ratio 0.71, 95% CI 0.45–1.12; P=0.14)

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Sep 07, 2015

FDA approves ticagrelor for long-term use after ACS event
It was announced by the manufactured company that a 60 mg twice-daily dose of its antiplatelet agent ticagrelor has been approved by the FDA for prevention of CV death, MI and stroke in patients more than 1 year after an ACS event. Ticagrelor was previously approved in a 90 mg twice-daily dose for use in patients up to 1 year after an ACS event for prevention of CV events and stent thrombosis. Approval for the expanded indication was based on the results of the PEGASUS–TIMI 54 study, according to the release. The PEGASUS-TIMI 54 results, presented at the 2015 American College of Cardiology Scientific Sessions and published in the New England Journal of Medicine, indicated that adding ticagrelor to low-dose aspirin reduced risk for CV death, MI or stroke in patients who had an ACS event at least 1 year prior.

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Risk of Death Increased by 50% in Smokers With Diabetes
Being a smoker and having diabetes increases the relative risk of total mortality and cardiovascular events by about 50%, and quitting smoking can reduce these risks, according to a new study published online in Circulation. According to background information in the article, as many as one-fifth of patients with diabetes are smokers. Studies have pointed to smoking as one of the leading risk factors for diabetes, cardiovascular disease (CVD), and total mortality in the general population. And diabetes also increases the risk of cardiovascular disease and other complications like retinopathy, nephropathy, and neuropathy. The new review is more comprehensive than past ones — for example, it includes nearly double the amount of studies and almost 10 times more participants than a former meta-analysis in 2011. The results showed a 55% increased risk of total mortality in diabetic patients who smoked (pooled adjusted RR of 1.55 in 48 studies with 1,132,700 participants and 109,966 deaths) and a 49% increased risk of cardiovascular mortality (RR, 1.49; 13 studies with 37,550 participants and 3163 deaths). Diabetic smokers also had a 44% increased risk for total cardiovascular disease (pooled RR, 1.44; 16 studies), a 51% increased risk for coronary heart disease (21 studies), a 54% increased risk for stroke (15 studies), a 43% increased risk for heart failure (four studies), and a more than twofold increased risk for peripheral artery disease (RR, 2.15; three studies).

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Calorie restriction could improve health outcomes related to aging
A 12% restriction in calories among average or slightly overweight individuals improved risk factors for age related diseases, as well as influenced blood pressure, cholesterol and insulin resistance, according to data from a recently released NIH-funded study (CALERIE study). To assess the correlation between caloric restriction (CR) and quality of life, disease risk factors and prediction of life span, the researchers conducted the 2-year Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy (CALERIE) trial. Participants (n = 218), who were between the ages of 21 and 51 years and were either normal weight or moderately overweight, were randomized into two groups. One group was asked to reduce their calorie intake by 25%, and the other group maintained their regular diet. Results demonstrated that participants in the CR group achieved an 11.7% CR during the first year, rather than the original goal of 25%. However, the CR group did maintain a 10.4% weight loss for the duration of the study. No significant changes were seen in the control group’s weight or caloric intake. Participants in the CR group saw a 4% decrease in BP and a 6% decrease in total cholesterol, according to the study. Additionally, a 47% reduction in C-reactive protein levels and a 20% reduction in T3 was seen in the CR group. The researchers noted the importance of CR being monitored by health care professionals to avoid any adverse events.

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Aug 31, 2015

FDA approves evalocumab to treat certain patients with high cholesterol
the US Food and Drug Administration (FDA) approved evolocumab for lowering LDL-cholesterol levels. Specifically, the FDA approved evolocumab for use in addition to diet and maximally tolerated statin therapy in adults with heterozygous and homozygous familial hypercholesterolemia (FH) or clinical evidence of atherosclerotic cardiovascular disease who require further LDL-cholesterol lowering. The approval follows a positive decision from the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). The advisory panel reviewed the data in early June and overwhelmingly stated that the benefits of lowering LDL cholesterol with evolocumab outweighed the potential risks. Evolocumab is the second proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor approved in the US. Last month, the agency approved alirocumab for patients with heterozygous familial hypercholesterolemia or those at high cardiovascular risk who cannot lower their LDL cholesterol with statins. The FDA recommends evolocumab for use in patients very similar to those in whom alirocumab is currently indicated. Neither drug, despite some speculation there might have been, was approved for use in statin-intolerant patients. The evolocumab approval is based on data from multiple clinical trials, including studies of patients with heterozygous and homozygous familial hypercholesterolemia, patients unable to tolerate a statin, and patients at high risk for cardiovascular events who are inadequately controlled on statin therapy.

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Atrial Fibrilation Can Raise Risk in Pregnant Women With Structural Heart Disease: Cohort Study
Atrial fibrillation (AF) and atrial flutter (AFL) are rare in pregnant women with structural heart disease—occurring in 1.3% of such women—but these arrhythmias are associated with an increased risk of maternal death and low fetal birth weight. These are the findings, , from an analysis of data from more than 1000 women who were part of the international Registry on Pregnancy and Cardiac Disease (ROPAC), and were reported in the JACC: Clinical Electrophysiology. Thus, pregnant women with structural heart disease—including those with a history of AF/AFL or beta-blocker use or who have left-sided disease such as aortic-valve disease, mitral-valve disease, or cardiomyopathies—should be closely followed throughout pregnancy and delivery. The study also suggests that these women should be routinely screened for AF/AFL during the second trimester, since the incidence of AF/AFL peaked at 23 to 26 weeks of gestation. Two of the 17 pregnant women with heart disease who developed AF/AFL (12%) died. The study also confirmed the existence of disparities between the developed and developing world. The women who died were from developing countries, where women "suffer significantly more frequently from adverse outcomes of pregnancy (maternal mortality, heart failure, and fetal demise),

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Quitting Smoking After MI Lowers Angina Risk and Ups Well-being
A year after having an MI, patients who still smoked were more likely to have angina, and they scored worse on mental- and physical-health aspects of quality of life, compared with other patients, in a new study based on data from two large multicenter registries (PREMIER and TRIUMPH) which published in Circulation: Cardiovascular Quality and Outcomes. However, patients who had quit smoking before their MI had a similar health status as patients who never smoked (who had the best health status). And patients who quit smoking after their MI had intermediate levels of chest pain and their mental-health scores were similar to those of nonsmokers. Thus, having a better quality of life after MI (in addition to the well-known benefit of a lower risk of having a repeat heart attack or dying earlier) might motivate smokers to ditch the habit.

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Aug 24, 2015

Home-based management cost-effective for elderly patients with chronic HF
Care for elderly patients with chronic HF was more cost-effective when based out of the patient’s home rather than a specialized outpatient clinic, according to results from an WHICH study which published in Int. J. Cardiology. In the study were included 280 elderly patients with chronic HF who were discharged after treatment at one of three tertiary hospitals in Australia. Researchers compared the cost-effectiveness of clinic-based intervention (n = 137) with home-based intervention (n = 143) during a median of 3.2 years of follow-up. Both intervention types included multidisciplinary care according to gold standard treatment, but home-based intervention took place primarily in the patient’s home and incorporated community-based care. The cohort had a mean age of 71 years and was 73% men. Costs for both treatment types were reported in 2013 Australian dollars. Mean total costs per group were AU$6.67 million with clinic-based intervention vs. AU$5.09 million with home-based intervention. Total costs were lower with home-based intervention, with a AU$13,100 decrease per patient compared with clinic-based care (P = .025). The researchers attributed this difference to a decrease in the length of all-cause hospital stay with home-based care (21 days vs. 32 days; P = .0006). Patients had a mean of 2.5 life-years with clinic-based intervention compared with 2.9 life-years with home-based intervention, with mean quality-adjusted life-years of 1.8 and 2, respectively. Although the difference in life-years between groups was statistically significant (0.4 years; P = .02), the difference in quality-adjusted life-years was not (0.26 additional years per person with home-based care; P = .078). Using a threshold of AU$50,000 for willingness-to-pay per quality-adjusted life-year, Maru and colleagues calculated a 96% probability that home-based intervention would be better-valued, with an incremental net monetary benefit of AU$24,342 (discounted 5% according to Australian health technology assessment guidelines). Factors associated with net monetary benefit included home-based intervention (vs. clinic-based), fewer comorbidities, shorter HF duration, fewer HF-related hospitalizations within 1 year, no hyponatremia and a greater degree of patient confidence in their self-care.

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Early surgery superior to rescue surgery for mitral regurgitation
Patients who underwent early surgery for mitral regurgitation were less likely to have postoperative mortality and heart failure compared with those who waited for rescue surgery, according to a study published in The Journal of Thoracic and Cardiovascular Surgery. There were examined 1,512 patients who underwent surgical correction of pure organic mitral regurgitation between 1990 and 2000. In this study, the mean age was 64, and 66 percent of patients were men. At baseline, 35 percent of patients had heart failure symptoms and 27 percent had atrial fibrillation. The most common cause of mitral regurgitation was degenerative (86 percent of patients), followed by rheumatic (5 percent), endocarditic (5 percent) and miscellaneous organic (3 percent). The researchers divided the patients into three groups: the first had class I triggers, the second had class II triggers and the third had severe mitral regurgitation and no other surgical triggers but underwent early surgery. After adjusting for age, the mortality risk was nearly doubled in the class I group and increased by 40 percent in the class II group compared with the early surgery group. After 15 years, the survival rates were 42 percent, 53 percent and 70 percent, respectively. The researchers also noted there was a 2.5 times increased risk for heart failure in the class I group and a 2 times increased heart failure risk in the class II group compared with the early surgery group. The combined rates of heart failure and death were 65 percent in the class I group, 55 percent in the class II group and 37 percent in the early surgery group.

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Model identifies risk factors for early hospital readmission after PCI
A prediction model developed by researchers in Boston found that anticoagulation treatment, frequency of emergency department visits before the procedure and anxiety were associated with early hospital readmission after patients underwent PCI. The model was described in Circulation: Cardiovascular Quality and Outcomes. In this model, the authors extracted unstructured and structured data from electronic health records by using a homegrown text search program. They then manually reviewed the data. They examined the following variables to determine which ones may be associated with an increased risk of short-term readmission after PCI: patient history of nonadherence, past need for medical interpreter, number of emergency department visits in the past year, a history of anticoagulation, a history of atrial fibrillation or atrial flutter, a history of homelessness, a history of end-stage liver disease, a history of malignancy or any subjective description of patient anxiety by providers. They mentioned those variables had not been used in previous PCI readmission risk models, but they had been associated with readmission for other conditions. Patients in the study had participated in the Partners PCI Readmission Project, a database of patients who were readmitted within 30 days of PCI within the Partners Healthcare system in Massachusetts. The PCIs were performed between 2007 and 2011 at Massachusetts General Hospital or Brigham and Women’s Hospital. In the model, the researchers matched readmitted to non-readmitted patients in a 1:2 ratio based on their predicted risk of 30-day readmission. They identified 888 readmitted patients and 1,776 non-readmitted patients. The predicted risk of readmission was 16.3 percent for readmitted patients and 16.2 percent for non-readmitted patients. The groups were significantly different with regards to the proportions of patients requiring a medical interpreter (7.9 percent in the readmitted group vs. 5.3 percent in the non-readmitted group), the number of emergency department visits in the past year (1.12 vs. 0.77), history of homelessness (3.2 percent vs. 1.6 percent), history of anticoagulation (33.9 percent vs. 22.1 percent), history of atrial fibrillation or atrial flutter (32.7 percent vs. 28.9 percent), history of presyncope or syncope (27.8 percent vs. 21.3 percent) and history of clinician describing the patient as anxious (69.4 percent vs. 62.4 percent). After performing a multivariable logistic regression analysis, patients were significantly more likely to be admitted if they had more emergency department visits, received anticoagulation and had a history of being described as anxious.

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July 27, 2015

FDA Approves New LDL-Lowering Agent Alirocumab
As widely expected, the US Food and Drug Administration (FDA) today approved alirocumab for lowering LDL-cholesterol (LDL-C). The indication is for patients with heterozygous familial hypercholesterolemia or those at high CV risk who cannot lower their LDL-C with statins. This is the first proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor to be approved in the US. Alirocumab received an approval recommendation from the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA in June. The drug, which is delivered via subcutaneous injection, was also recommended for approval by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. That recommendation is now on its way to the European Commission (EC), who will make the final decision on whether to grant marketing authorization throughout the European Union. The EC approved the drug's PCSK-9 competitor evolocumab earlier this week. Alirocumab was approved before the completion of its CV-outcomes trial. The primary outcome measures for ODYSSEY-Outcomes, which is scheduled to finish by December 2017, include possible first occurrence of CHD death, any non-fatal MI, fatal and nonfatal ischemic stroke, and unstable angina requiring hospitalization. Secondary measures included time to first occurrence of any CHD event, major CHD event, any CV event, and all-cause mortality.

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EMA Committee Backs Approval of PCSK9 Inhibitor Alirocumab
The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor alirocumab for individuals who cannot lower their high LDL-cholesterol levels with statins or who cannot tolerate statins. The indications earmark the drug as an adjunct to diet in patients with both heterozygous familial and non-familial hypercholesterolemia or with mixed dyslipidemia. After examining data on more than 3300 patients with alirocumab, the committee also noted that the drug's safety profile is acceptable, with few serious treatment-related adverse events or discontinuations, according to its press release. However, the effect...on cardiovascular morbidity and mortality has not yet been determined. Alirocumab is a monoclonal antibody given through biweekly subcutaneous injections. Today's thumbs-up from the CHMP will now be sent to the European Commission, who will make the final decision on whether this drug should be approved and made available within the European Union (EU).

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Prasugrel loading dose does not increase bleeding in patients with STEMI undergoing PCI
Patients with STEMI undergoing primary PCI who were pretreated with a loading dose of clopidogrel and then administered a loading dose of prasugrel did not have increased major bleeding events, according to results of the nonrandomized, observational studies COMFORTABLE and SPUM-ACS which published in JACC Interventional Journal. Researchers analyzed data on 2,023 patients with STEMI who were enrolled in the COMFORTABLE or SPUM-ACS studies between September 2009 and October 2012. Of those, 21% received concurrent administration of a clopidogrel and prasugrel loading dose, 22% received a prasugrel loading dose only and the rest received a clopidogrel loading dose only. The primary safety endpoint of the study was Bleeding Academic Research Consortium (BARC) types 3 to 5 bleeding at 30 days. This endpoint occurred in 1.9% of patients who received clopidogrel and a loading dose of prasugrel vs. 3.4% of those who received prasugrel only (adjusted HR = 0.57; 95% CI, 0.25-1.3). The concurrent loading dose and clopidogrel-only loading dose groups also had similar rates of TIMI major bleeding (1.2% vs. 1.8%, respectively), TIMI minor bleeding (0.7% vs. 1.6%), GUSTO severe bleeding (0.5% vs. 1.3%) and GUSTO moderate bleeding (0.5% vs. 0.5%) at 30 days. The researchers also assessed the HAS-BLED bleeding score and found a trend toward a lower bleeding risk among patients who received prasugrel only (P = .076). An analysis adjusted for the primary safety endpoint using the HAS-BLED score yielded consistent results for BARC types 3 to 5 bleeding at 30 days with clopidogrel and prasugrel (adjusted HR = 0.54; 95% CI, 0.23-1.27). At 1 year, the primary safety endpoint occurred in 3.9% of patients who received clopidogrel and a loading dose of prasugrel vs. 4.3% of patients who received prasugrel only (adjusted HR = 0.91; 95% CI, 0.46-1.79). The researchers observed no difference in the composite rate of cardiac mortality, MI or stroke at 30 days between the groups (HR = 0.66; 95% CI, 0.27-1.62).

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Ischemic stroke occurs more frequently than hemorrhagic stroke in PCI
Patients undergoing primary PCI are three times more likely to experience ischemic stroke than hemorrhagic stroke, according to recent findings from a study published in European Heart Journal.
The researchers noted that the prevalence of incident ischemic stroke complications among patients undergoing primary PCI increased between 2007 and 2012, while hemorrhagic stroke became less common during this period.
The study included data collected from the British Cardiovascular Intervention Society database on 426,297 patients who underwent primary PCI between 2007 and 2012. Rates of stroke complications were evaluated by the year PCI was performed. Thirty-day mortality and in-hospital MACE (defined as a composite of in-hospital mortality, MI, re-infarction and revascularization) with stroke complications served as outcome measures.
Ischemic stroke or transient ischemic attack occurred in 436 patients, or 0.1% of the cohort. Hemorrhagic stroke complications were reported in 0.03%.
In 2007, ischemic stroke or TIA complications occurred in 0.67 (95% CI, 0.47-0.87) per 1,000 patients vs. 1.14 (95% CI, 0.94-1.34) per 1,000 patients in 2012 (P = .006). Conversely, a nonlinear decrease was reported for hemorrhagic stroke rates, from 0.29 (95% CI, 0.19-0.39) in 2007 to 0.15 (95% CI, 0.05-0.25) per 1,000 patients in 2012 (P = .009).
Results of an analysis adjusting for baseline clinical and procedural demographics indicated an independent association between ischemic stroke and both key outcomes (30-day mortality, OR = 4.92; 95% CI, 3.06-7.92; in-hospital MACE, OR = 3.11; 95% CI, 1.83-5.27).
Hemorrhagic complications yielded a larger increase in risk for 30-day mortality (OR = 13.87; 95% CI, 6.37-30.21) and in-hospital MACE (OR = 13.5; 95% CI, 6.3-28.92).
No increase in transient ischemic attack rates was reported from 2007 to 2012. However, ischemic stroke rates increased from 0.33 (0.23-0.43) in 2007 to 0.75 (0.55-0.95) in 2012.

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QTc Interval Prolongations on Two ECGs Aid in SCD Risk Stratification: Rotterdam Study
A new analysis of participants in a population-based cohort study suggests at least two ECGs might be useful to stratify individuals at risk for sudden cardiac death (SCD) because of a prolongation in the heart-rate–corrected QT (QTc) interval.
While the risk of sudden death was significantly increased among individuals with a prolonged QTc interval, the risk of SCD was not significantly increased among those participants with an inconsistently prolonged QTc interval—defined as a prolongation on one ECG measurement but not in a second follow-up ECG—in a multivariable adjusted model.
The conclusions are based on findings from 3484 participants in the Rotterdam Study. Overall, the time between the first and second ECG ranged from 0.7 to 4.4 years, with a median time of 1.8 years between ECGs. Approximately 97% of individuals with a normal QTc interval on the first ECG had a second normal ECG. For the individuals with an abnormal QTc interval on the first assessment, approximately two-thirds had a normal ECG on the second assessment.
For those with a prolonged QTc interval at baseline, the risk of sudden cardiac death was significantly increased by more than twofold (hazard ratio [HR] 2.36; 95% CI 1.55–3.60].

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Personalized 3D Printing of Heart Model Aids in LAA-Closure Procedure
Australian physicians are taking advantage of 3D printing to create an exact replica of the patient's cardiac anatomy when planning left atrial appendage (LAA) closure procedures. The researchers say that 3D printing is useful when closing the LAA with the device, particularly in patients where the anatomy is complex and the interaction between the device and the appendage is difficult to quantify, even using advanced imaging methods.
In a letter to the editor in Journal of the American College of Cardiology: Cardiovascular Interventions, the researchers published data on their experience with 3D printing of the LAA in a 74-year-old man with a history of paroxysmal atrial fibrillation who was intolerant to oral anticoagulation. Using data from the CT scan, they printed a 3D model, which is made up of a rubberlike material to simulate atrial mechanical properties of the left atrium and LAA. The 21-mm, 24-mm, and 27-mm Watchman devices were placed into the 3D model, which was then reimaged with CT. With the three devices in the 3D model, they were able to analyze the anatomic deformation for each device. This helped identify the areas and extent of engagement of the device on the flexible atrial model,according to the investigators.
Interestingly, based on the TEE, the group reports the 21-mm device would have been selected but the data from CT scan of the 3D model suggested it would have been too small. Data from the 3D model/CT scan showed the 27-mm Watchman device was too large to be selected for the patient.

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July 13, 2015

Chronically elevated BP in young adulthood linked to cardiac dysfunction in middle age
Cumulative exposure to high BP from young adulthood through middle age was associated with left ventricular systolic and diastolic dysfunction later in life, according to new data from the CARDIA study which published in JACC. Using data from the CARDIA study, researchers evaluated 5,115 healthy black and white individuals. The participants were followed for 25 years, starting in early adulthood, and were evaluated with repeat measures of BP and CV risk factors. In total, 3,498 participants received 25-year evaluations in 2010 to 2011, and 3,474 had LV function measured by 2-D echocardiography and cardiac deformation by speckle-tracking echocardiography. After excluding 995 participants with incomplete BP measurements during follow-up, 2,479 participants were included in the analysis. The mean age at 25-year follow-up was 50 years. In the overall cohort, systolic BP gradually increased after age 35 years; diastolic BP and mean arterial pressure increased from baseline to about age 40 years, then plateaued; and pulse pressure decreased until age 40 years, then increased with age. Compared with white participants, black participants aged older than 25 years had higher levels of systolic BP, diastolic BP and mean arterial pressure. Elevated pulse pressure was more common in men compared with women. Overall, 135 participants had systolic or diastolic dysfunction: 70 had LV systolic dysfunction (LV ejection fraction < 50%) and 69 had diastolic dysfunction (E/e’ ratio > 15). The researchers assessed long-term exposure to BP using cumulative exposure of BP over 25 years, from early adulthood (18 to 30 years) to middle age (43 to 55 years), to represent long-term exposure to BP levels. The results indicated that cumulative exposure to high systolic and diastolic BP levels was associated with a lower longitudinal strain rate (P < .001 for both). The researchers found no correlation between cumulative BP measures and LV ejection fraction.

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FDA strengthens warning of link between NSAIDs and MI, stroke
The FDA is strengthening a label warning of increased risk for MI or stroke associated with the use of nonsteroidal anti-inflammatory drugs, according to a safety announcement. The labeling for all non-aspirin NSAIDs must be updated to reflect this change, the agency stated. The new warning follows an FDA review of safety data from observational studies, a combined analysis of clinical trials and other information on both prescription and over-the-counter NSAIDs. The new labeling for prescription NSAIDs must reflect the following information, and the FDA will request similar updates to labeling for over-the-counter, non-aspirin NSAIDs, according to the announcement: - MI and stroke risk can occur within weeks of beginning NSAID use, and may increase at higher doses and with longer duration of use. - The risk for MI or stroke appears to be similar for all NSAIDs, but there is not sufficient information to definitively indicate a higher or lower risk with one NSAID over another. - NSAID use can increase MI or stroke risk in patients regardless of whether they already have heart disease or risk factors for heart disease. However, the likelihood of MI or stroke is greatest among those with pre-existing disease or risk factors due to a higher baseline risk. Patients who received initial treatment with NSAIDs post-MI were more likely to die within 1 year than those who were not.

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FDA Approves Valsartan/Sacubitril Combination for Heart Failure
The US Food and Drug Administration (FDA) has now approved the combination tablet valsartan/sacubitril for the treatment of patients with heart failure. The combination drug, formerly known as LCZ696, is the first approved agent in the angiotensin receptor-neprilysin inhibitor (ARNI) class and exerts its effect within and beyond the renin-angiotensin system. Chemically, the agent consists of the angiotensin-receptor blocker valsartan affixed to the neprilysin inhibitor sacubitril. The US approval is based on results of the Prospective Comparison of ARNI with ACE-I to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) trial. In this study that included more than 8000 chronic-heart-failure patients, treatment with the valsartan/sacubitril combination significantly reduced cardiovascular death or heart-failure hospitalizations — the study's primary end point — by 20% compared with treatment with the ACE inhibitor enalapril alone. All-cause mortality, a secondary end point, was also significantly reduced with the ARNI when compared with enalapril.

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July 6, 2015

New AHA/ASA Guideline Recommends Endovascular Stroke Therapy
The American Heart Association/American Stroke Association (AHA/ASA) has updated its guidelines on endovascular treatment for acute ischemic stroke — strongly recommending its use in certain patients — based on the influx of new clinical trial data that have recently become available. The "2015 AHA/ASA Focused Update of the 2013 Guidelines for the Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment" was published online in Stroke Journal.

The guidelines are based on five new clinical trials reported in the past few months: MR CLEAN, ESCAPE, EXTEND-IA, SWIFT-PRIME, and REVASCAT.

According the authors the main bottom-line messages about thrombolysis are:

  • None of these new results changes the fact that patients suspected of having had a stroke need to get to a primary stroke center fast so they can be given tissue plasminogen activator (tPA). This is still the first-line therapy for acute ischemic stroke.
  • All patients who fit the criteria for endovascular therapy should be considered for this treatment in addition to receiving tPA. If patients are in the eligible group they should be taken to a comprehensive stroke center, where endovascular treatment can be performed.
  • Systems of care, such as a hub-and-spoke model, for acute ischemic stroke need to be put in place so that eligible patients can be quickly transported to the comprehensive centers for endovascular treatment.

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New Mutation Associated With Severe Obesity
A single-gene mutation that shuts down production of the carboxypeptidase-E (CPE) enzyme, and causes severe obesity and type 2 diabetes, has been identified.

The mutation affects insulin processing and appetite suppression and leads to intellectual disability and reproductive problems, according to the new research published in PLoS One.

The CPE gene encodes CPE, which is involved in the processing of a number of hormones including insulin and a range of neuropeptides, including those that regulate appetite and the reproductive system. CPE deficiency is a recessive condition, so an individual would need to inherit the altered genetic sequence from both parents to be affected. The frequency of the CPE gene defect is currently unknown, but according the authors is currently screening 1500 obese adults to see if there are other cases. Referring to the wider issue of genetic causes of obesity, she pointed out that the number of genetic forms of obesity is unknown because obese people are "simply not usually tested."

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Tight glucose control benefits cardiac surgery patients without diabetes
Postoperative morbidity in patients without diabetes undergoing cardiac surgery was reduced with perioperative initiation of intensive insulin therapy, according to recent study findings published in The Journal of Clinical Endocrinology & Metabolism. However, this effect was minimal in patients with diabetes, according to the researchers.

The researchers evaluated 2,383 patients aged 18 to 90 years undergoing cardiac surgery at an academic tertiary hospital between January 2007 and June 2012 to compare the effects of perioperative and postoperative initiation of tight glucose control on adverse events. Participants were randomly assigned to intensive insulin therapy perioperatively (n = 1,134) or postoperatively (n = 1,249). All participants were expected to receive postoperative ICU treatment for at least 2 consecutive days after the surgery. The target glucose range was 4.4 mmol/L to 6.1 mmol/L. Compared with the postoperative group, the perioperative group was significantly less likely to develop organ complications (RR = 0.68; 95% CI, 0.6-0.78).

Patients without diabetes had even more favorable effects of intraoperatively initiated tight glucose control and achieved a risk reduction of 37% for developing any postoperative complication (RR = 0.63; 95% CI, 0.54-0.74).

No difference was found for postoperative complication incidence for all complications except cardiovascular ones among patients with diabetes in both groups.

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June 29, 2015

Nebivolol, Hydrochlorothiazide Combo Improves Blood Pressure Better Than Irbesartan in the Elderly
The antihypertensive combination of nebivolol and hydrochlorothiazide shows greater reductions in 24-hour systolic blood pressure in elderly patients, compared with irbesartan plus hydrochlorothiazide, researchers reported at the 25th Scientific Meeting of the European Society of Hypertension (ESH) on Hypertension and Cardiovascular Protection. Combined drug therapies are recommended in for the treatment of isolated systolic hypertension (ISH) in helping to control blood pressure in older adults. In an effort to compare the efficacy of two anti-hypertensive combinations, the investigators randomised 124 patients with isolated systolic hypertension to treatment with nebivolol 5 mg plus hydrochlorothiazide 12.5 mg (NH, n = 62) or irbesartan 150 mg and hydrochlorothiazide 12.5 mg (IH, n = 62) once daily for 12 weeks. Patients had a median age of 69 years. Results showed a significantly greater reduction in sitting systolic blood pressure in the NH group compared with the IH group after 12 weeks (25.8 ± 1.6 vs 20.6 ± 1.7mm Hg; P < .03) as well as in heart rate (HR, 7.0 ± 1.0 vs 2.5 ± 1 b/min; P < .01). The NH group meanwhile showed a non-significantly greater decrease in diastolic and pulse blood pressure than the IH group (7.4 ± 1.0 and 18.3 ± 1.5 vs 5.0 ± 0.09 and 15.7 ± 1.7 mm Hg). The degree of reduction in 24-hour, daytime and night-time systolic blood pressure was nearly the same in both groups, but the NH group had a greater heart rate reduction at all time-points compared with the IH group (P < .001). The NH group also showed significantly greater reductions in 24-hour systolic blood pressure variability compared with the IH group when expressed as standard deviation (4.4 ± 2.7 vs 2.2 ± 5.1 mm Hg; P < .02) as well as a coefficient of variation (2.0 ± 2.6 vs 0.3 ± 3.4; P < .01)

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Edoxaban approved in the EU for Stroke Prevention in Nonvalvular Atrial Fibrillation and for the Treatment and Prevention of Recurrent DVT and PE
The European Commission (EC) has granted Marketing Authorisation for edoxaban, an oral, once-daily selective factor Xa-inhibitor, for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA) as well as for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. The EC approval is based on two phase 3 clinical trials, ENGAGE AF-TIMI 48 and Hokusai-VTE, which compared treatment with once-daily edoxaban to warfarin, a current standard of care for stroke prevention in patients with AF or for the treatment and prevention of VTE. These studies represent the largest single comparative trials of a novel oral anticoagulant in these patient populations, involving 21,105 and 8,292 patients, respectively. In the ENGAGE AF-TIMI 48 study, once-daily edoxaban showed comparable efficacy (stroke or SEs) in comparison to warfarin (1.18% vs. 1.50% per year, edoxaban 60 mg vs. warfarin respectively; hazard ratio [HR], 0.79; 97.5% confidence interval [CI], 0.63 to 0.99, p<0.001) and superior safety, significantly reducing major bleeding (2.75% vs. 3.43% per year, edoxaban 60 mg vs. warfarin respectively; HR, 0.80; 95% CI, 0.71 to 0.91, p<0.001), in a broad range of patients with NVAF. The Hokusai-VTE study demonstrated that edoxaban effectively reduces symptomatic recurrent VTE, including DVT and fatal and non-fatal PE risk across a broad range of patients (3.2% vs. 3.5% of patients, edoxaban 60 mg vs. warfarin respectively; HR, 0.89; 95% CI, 0.70 to 1.13, p<0.001). Edoxaban also showed a significant 19% risk reduction of clinically relevant bleeding in patients with VTE compared to warfarin (8.5% vs. 10.3% of patients, respectively; HR, 0.81; 95% CI, 0.71 to 0.94, p=0.004).

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Depression, anxiety increase mortality risk in patients undergoing oral anticoagulation
Among outpatients receiving long-term oral anticoagulation, elevated symptoms of depression and anxiety are associated with all-cause mortality, according to research published in the International Journal of Cardiology. Findings from a study that used a four-item Patient Health Questionnaire (PHQ-4) to assess depression and anxiety underscore the need to implement routine screening procedures and to develop and evaluate psychosocial treatment approaches, according to researchers. The patients were part of the observational thrombEVAL study in the German federal state of Rhineland-Palatinate and receiving long-term oral anticoagulation with vitamin K antagonists. At baseline, depression and anxiety symptoms were assessed with the PHQ-4, and the medical history obtained. The researchers looked for all-cause mortality during 24 months; the median follow-up period was 13.3 months. The death rate was 13.8%, with 191 patients dying. Every PHQ-4 point increase was associated with a 10% increase in mortality (HR = 1.1; 95% CI, 1.05-1.16) after adjusting for age, sex, high school graduation, partnership, smoking, obesity, frailty (Barthel index, Charlson comorbidity index) and CHA2DS2-VASc score. Mortality increased by 22% based on the depression component of the questionnaire and by 11% based on the anxiety component. Medical history of mental disorders did not predict excess mortality, nor did the intake of antidepressants, anxiolytics or hypnotics.

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June 22, 2015

Dabigatran Reversal Agent Looks Good in Real-World Clinical Testing
In the International Society for Thrombosis and Haemostasis (ISTH) 2015 Congress, investigators presented data from their preplanned interim analysis of the first 90 patients enrolled in the RE-VERSE AD trial and published online in NEJM simultaneously. This is a real-world clinical test of idarucizumab which shows that the agent safely and effectively reverses the anticoagulant effect of the direct oral thrombin inhibitor dabigatran in a group of high-risk patients undergoing emergency surgery or suffering from life-threatening bleeding. RE-VERSE AD study is an ongoing, international open-label trial with an expected enrollment of 250 to 300 patients. Study investigators are enrolling two types of dabigatran-treated patients in the clinical trial: patients who experience life-threatening or uncontrolled bleeding (group A) and patients who require an emergency surgery or procedure (group B). So far, 90% of patients have atrial fibrillation and were prescribed dabigatran for stroke/systemic embolism prophylaxis. Investigators have signed up approximately 400 sites worldwide to enroll the planned 300 patients, recognizing how uncommon it is for emergency centers to need to stop dabigatran and treat such patients. In 51 group A patients, the median maximum percentage reversal in anticoagulation measured at 4 hours was 100%. In the 39 group B patients, median maximum percentage reversal in anticoagulation was also 100%. For the group B patients, 36 underwent emergency surgery while one patient avoided surgery after the administration of idarucizumab. Two other patients had complete reversal of anticoagulation but were too unstable for surgery. In the 36 patients who underwent surgery, 33 had normal intraoperative hemostasis as reported by the surgeon onsite, two had mildly abnormal hemostasis, and one patient had moderately abnormal hemostasis.

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FDA Approves Third-Generation Sapien Transcatheter Heart Valve
The US Food and Drug Administration has approved the third-generation Sapien transcatheter heart valve for the treatment of patients with aortic stenosis. The Sapien 3, which is approved for patients who are unable to undergo aortic-valve-replacement surgery or are considered high risk for surgery, includes a design change over previous iterations in that it includes a polyethylene terephthalate outer skirt designed to minimize paravalvular leak. In the FDA announcement, the agency notes the rate of moderate or greater aortic insufficiency at 30 days is significantly reduced in patients treated with the Sapien 3 valve compared with those who received the older Sapien device.
The approval of the Sapien 3 valve was based on data from the PARTNER II S3 study, a clinical trial involving 583 patients with aortic-valve stenosis who were at high risk for aortic-valve-replacement surgery or who could not undergo the surgery due to excess risk.

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LAA closure confers CV mortality benefit vs. warfarin in AF
Findings from a meta-analysis of the PROTECT AF and PREVAIL trials which published in JACC indicated that left atrial appendage closure yielded a survival benefit compared with warfarin in patients with nonvalvular AF. The meta-analysis included 2,406 patients with 5,931 patient-years of follow-up. The mean follow-up duration was 2.69 years. Closure with the Watchman device yielded 0.15 hemorrhagic strokes per 100 patient-years vs. 0.96 per 100 patient-years with warfarin (HR = 0.22; P = .004). CV or unexplained mortality also was significantly lower in the LAA closure group (1.1 vs. 2.3 events per 100 person-years; HR = 0.48; P = .006), as was nonprocedural bleeding (6% vs. 11.3%; HR = 0.51; P = .006). Rates of all-cause mortality or systemic embolism were 1.75 per 100 person-years in the LAA closure group vs. 1.87 per 100 person-years in the warfarin group, which the researchers noted were statistically similar (HR = 1.02; 95% CI, 0.62-1.7). The researchers suggested that the improved mortality rates in the device group may be multifactorial. They noted that novel anticoagulant drugs generally confer a mortality benefit of approximately 10% to 15% compared with warfarin. Patients treated with the device experienced 1.6 ischemic strokes per 100 person-years, whereas warfarin was associated with 0.9 ischemic strokes per 100 person-years (HR = 1.95; P = .05). Analysis for the composite efficacy endpoint indicated that event rates were nonsignificantly lower in the LAA closure group (HR = 0.79; P = .22).

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Recurrent major CV events increased in patients with type 2 diabetes
The risk for major cardiovascular events in patients with coronary artery disease was increased when the patients also had type 2 diabetes, according to recent findings of a study published in Diabetes Care Journal. However, type 2 diabetes does not appear to be a major risk factor for subsequent major CV events in all patients with symptomatic vascular disease. In the study were participated 6,841 patients with clinically manifest vascular disease with type 2 diabetes (n = 1,155) and without (n = 5,686) to determine the effect of diabetes on recurrent major CV events. Participants were from the SMART cohort study.
The overall prevalence of type 2 diabetes was 22% in participants with polyvascular disease, 15% in those with peripheral arterial disease (PAD), 13% in participants with cerebrovascular disease and 11% in those with abdominal aortic aneurysm (AAA). The poorest glycemic control was found among participants with type 2 diabetes and PAD, with the highest fasting plasma glucose and HbA1c levels. Researchers found a 21% risk for 5-year recurrent vascular events in participants with polyvascular disease, followed by 20% in AAA, 9% in cerebrovascular disease and PAD, and 7% in CAD. Compared with patients with CAD without diabetes, those with CAD and diabetes had a higher risk for the combined vascular endpoint (HR = 1.67; 95% CI, 1.21-2.21). A higher risk for vascular endpoint also was found in those with cerebrovascular disease and diabetes (HR = 1.36; 95% CI, 0.9-2.07) but not for those with PAD and diabetes (HR = 1.42; 95% CI, 0.79-2.56) or polyvascular disease and diabetes (HR = 1.12; 95% CI, 0.83-1.5; P = 0.28 for interaction type 2 diabetes and location of vascular disease). Participants with diabetes and CAD had increased risk for vascular mortality (HR = 1.55; 95% CI, 1-2.41) as did those with cerebrovascular disease (HR = 1.57; 95% CI, 0.91-2.7). All-cause mortality was increased in participants with PAD and diabetes (HR = 1.64; 95% CI, 1.01-2.68), cerebrovascular disease and diabetes (HR = 1.34; 95% CI, 0.9-1.98), and CAD and diabetes (HR = 1.29; 95% CI, 0.95-1.75).

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June 16, 2015

FDA panel recommends approval of evolocumab
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted to recommend approval of evolocumab for reduction of LDL. The committee voted 15-0 that the benefits of evolocumab, a fully human monoclonal antibody PCSK9 inhibitor, outweigh the risks in patients with homozygous familial hypercholesterolemia (HoFH), and 11-4 that its benefits outweigh its risks in at least one patient population other than HoFH. The manufacturer company is seeking indications for the reduction of LDL and changes to other lipid parameters in adults with primary hyperlipidemia or mixed dyslipidemia, including statin-intolerant patients, either alone or in combination with other lipid-lowering therapies; and for the reduction of LDL and other lipid parameters in adults and adolescents aged 12 years or older with homozygous familial hypercholesterolemia, in combination with other lipid-lowering therapies. In the vote regarding patient populations aside from HoFH, most of those who voted yes cited patients with heterozygous familial hypercholesterolemia and those at high or very high risk for CV events who cannot achieve LDL targets despite maximally tolerated statin therapy as populations for whom the drug should be approved.

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Chronic Use of Proton Pump Inhibitors Increases Heart Risk
Proton pump inhibitors (PPIs) appear to have a negative effect on vascular function, thereby increasing the risk for myocardial infarction (MI) in the general population, according to a data-mining study published online in PLOS ONE. This association has not yet been demonstrated in a randomized controlled trial.
The investigators reviewed more than 16 million clinical documents on 2.9 million individuals for pharmacovigilance data. They describe their approach as a "novel analytical pipeline" and report that PPIs, but not H2 blockers, appear to be associated with an elevated risk for MI. Specifically, patients with gastroesophageal reflux disease who were exposed to PPIs had a 16% increased risk of MI (95% confidence interval, 1.09 - 1.24). The investigators also documented a twofold (hazard ratio, 2.00; 95% confidence interval, 1.07-fold to 3.78-fold; P = .031) increase in risk for cardiovascular mortality. Although the researchers acknowledge that PPI usage may be serving as a marker for a sicker population, they believe this is unlikely, given the lack of increased risk seen in patients taking H2 blockers.

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VTE rates following colorectal surgery remain stable despite increased prophylaxis
Venous thromboembolism incidence has remained low and largely unchanged following colorectal surgery despite an increase in pre- and post-surgical prevention strategies, according to a study published in JAMA Surg. The analysis included data from 16,120 consecutive patients (mean age, 61.4 years; 54.5% women) who underwent colorectal cancer surgery at 52 hospitals in Washington State between 2006 and 2011.
The use of perioperative (31.6% to 86.4%) and in-hospital (59.6% to 91.4%) VTE chemoprophylaxis significantly increased from 2006 to 2011 (P < .001 for both). Overall, 10.6% of patients were discharged following surgery on a chemoprophylaxis regimen. VTE occurred in 2.2% of patients. A higher rate of 90-day VTE occurred among patients undergoing abdominal operations compared with patients undergoing pelvic operations (2.5% vs. 1.8%; P = .001). A similar 90-day VTE rate occurred among patients undergoing surgery for cancer compared with those undergoing surgery for non-malignancies (2.1% vs. 2.3%). Results of adjusted analyses demonstrated an increased risk for 90-day VTE among older patients, patients undergoing nonelective surgery, patients with a history of VTE and patients receiving surgery for inflammatory disease (P ˂ .05 for all). Researchers observed no significant decrease in VTE incidence over time, and VTE rates remained between 1% and 3% annually.

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June 08, 2015

Silent AF after acute MI led to worse outcomes at 1 year
Patients with silent atrial fibrillation after acute MI experienced a nearly threefold increase in 1-year mortality compared with patients without atrial fibrillation, according to recent findings from a study published in Heart. The aim of the study was to evaluate 1-year prognosis and CV outcomes in a cohort of 737 patients with acute MI who were evaluated for silent AF using continuous ECG monitoring. Clinicians prospectively assessed patients with monitoring during the first 48 hours after hospital admission. They defined silent AF as asymptomatic episodes lasting a minimum of 30 seconds. The silent AF rate was 14.3%, with 4.3% developing symptomatic AF. The median age of patients with silent AF was 79 years vs. 62 years for those without AF (P < .001). Patients with silent AF also had increased rates of hypertension (71% vs. 49%; P < .001), lower smoking rates (23% vs. 37%; P < .001) and higher rates of impaired left ventricular ejection fraction (50% vs. 55%; P < .001). Patients with silent AF and symptomatic AF had similar risk factors, according to the results. However, 10% of patients with silent AF had a history of stroke compared with 25% for those with symptomatic AF. Also, a history of AF was less frequent in the silent group compared with the symptomatic group (10% vs. 38%). One-year outcomes indicated that hospitalization for HF occurred more frequently in the silent AF arm than in the arm without AF, 6.6% vs. 1.3% (P < .001), as did CV-related mortality (5.7% vs. 2%; P < .001). The overall CV mortality rate was 3.2%. Mortality risks were 5.7% for silent AF, 18.8% for symptomatic AF and 2% for no AF (P < .001).

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IMPROVE-IT published: Adding ezetimibe to simvastatin lowers LDL, improves CV outcomes
Confirming findings previously presented, adding ezetimibe to statin therapy lowered LDL levels and improved CV outcomes in patients with ACS, according to the results of the IMPROVE-IT study published in The New England Journal of Medicine. The researchers conducted a randomized, double blind trial of 18,144 patients hospitalized for ACS in the past 10 days who had LDL 50 mg/dL to 100 mg/dL if receiving lipid-lowering therapy or 50 mg/dL to 125 mg/dL if not receiving lipid-lowering therapy. Results were initially presented at the American Heart Association Scientific Sessions in November 2014. Patients were assigned 40 mg simvastatin plus 10 mg ezetimibe or 40 mg simvastatin plus placebo. The primary endpoint was a composite of CV death, nonfatal MI, unstable angina requiring rehospitalization, coronary revascularization 30 days or more after randomization and nonfatal stroke. Median follow-up was 6 years. According to the results, the median time-weighted average LDL level was 53.7 mg/dL in the simvastatin-ezetimibe group compared with 69.5 mg/dL in the simvastatin monotherapy group (P <l; .001). The event rate for the primary endpoint at 7 years was 32.7% in the simvastatin-ezetimibe group vs. 34.7% in the simvastatin monotherapy group (absolute risk difference, 2 percentage points; HR = 0.936; 95% CI, 0.89-0.99).

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Statins underused in patients with diabetes, noncoronary atherosclerosis
Statin use is lower and less aggressive among patients with diabetes and noncoronary atherosclerotic vascular disease compared with those with diabetes and CAD, according to recent findings. Researchers conducted a retrospective, observational study of electronic medical records of 3,336 adult patients with diabetes at University of Kansas Hospital and Medical Center. Patients had diabetes and CAD (n = 3,102) or diabetes without CAD but with one or more of the following noncoronary atherosclerotic vascular diseases: peripheral arterial disease, abdominal aortic aneurysm or carotid stenosis (n = 234). Patients with diabetes and noncoronary atherosclerotic vascular disease had higher mean total cholesterol than patients with diabetes and CAD (152 mg/dL vs. 146 mg/dL; P = .019). Patients with diabetes and noncoronary atherosclerotic vascular disease also had higher mean levels of LDL (86 mg/dL vs. 80 mg/dL; P = .04). Although LDL was well controlled overall, the researchers observed a significant difference between the percentage of patients who achieved an LDL of less than 100 mg/dL (70% of patients with diabetes and noncoronary atherosclerotic vascular disease vs. 80% of patients with diabetes and CAD; P < .001). In addition, fewer patients with diabetes and noncoronary atherosclerotic vascular disease attained an LDL of less than 70 mg/dL (34% vs. 44%; P = .002). All patients with diabetes and CAD were using statins compared with 75% of patients with diabetes and noncoronary atherosclerotic vascular disease (P < .001). Powerful statins were less commonly used in the diabetes and noncoronary atherosclerotic vascular disease group, and mean statin doses were lower overall in these patients.

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June 01, 2015

Fasting Triglycerides Predict CVD Risk in Statin-Treated Patients
n patients with ACS treated with statin therapy, elevated fasting triglyceride levels were significantly associated with an increased risk of cardiovascular events in the short- and long-term follow-up of two major clinical trials, according to the results of a new post hoc analysis of MIRACL and dal-OUTCOMES studies which published in JACC. The present analysis included 15.817 patients with ACS in dal-OUTCOMES randomly assigned to dalcetrapib on top of statin therapy and followed for 31 months. Dalcetrapib had no effect on cardiovascular outcomes, and there was no significant interaction of triglyceride levels and treatment assignment on those outcomes. In MIRACL, 1501 patients were treated with high-dose atorvastatin following an acute coronary event and followed for 16 weeks. Like the long-term dal-OUTCOMES results, the researchers also observed a significantly increased risk of clinical events—defined as all-cause mortality, nonfatal MI, unstable angina, or cardiac arrest requiring resuscitation—among the MIRACL participants with elevated baseline triglyceride levels. In both studies, each 10-mg/dL increment in triglycerides was associated with a similar increase in adjusted relative cardiovascular risk: 1.4% in MIRACL and 1.8% in dal-OUTCOMES. In MIRACL, individuals with the highest baseline levels, those in the highest tertile with triglycerides >195 mg/dL, had a 50% increased risk of the composite primary end point compared with those in the lowest tertile (<135 mg/dL).

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Current but not past smoking increases the risk of cardiac events.
Smoking is a major risk factor for coronary artery disease (CAD) and adverse cardiac events. Several previous studies have shown that risk of adverse cardiac events in individuals who have quit smoking is similar with those who have never smoked. Why event rates do not remain elevated in individuals who have quit smoking is not clear. In a new study published in European Heart Journal, the authors evaluated the presence, extent, severity of CAD and major adverse cardiac events in patients who never smoked, past, and current smokers. The study included 9456 patients without known CAD from patients enrolled in the CONFIRM (Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter) registry whose smoking status was known. The patients were classified as never smokers (n=5685), past smokers who quit smoking ≥3 months ago (n=2183), and current smokers who currently smoking or quit <3 months ago (n=1588). Compared with never smokers, current and past smokers had greater prevalence of obstructive CAD. The extent of atherosclerotic plaques was also higher in current and past smokers. In a mean follow-up of 2.8+1.9 years, 297 major adverse cardiac events occurred. Compared with never smokers, risk of major adverse cardiac events was higher in current smokers (HR 1.9, 95% CI: 1.4-2.6, p<0.001) whereas it was slightly but not significantly higher in past smokers (HR 1.2, 95% CI: 0.8–1.6, p=0.35). Current smokers had higher rates of all-cause death whereas past smokers did not. The same results were obtained in groups formed by propensity score matching.

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Beta-Blockade Risky for Noncardiac Surgery in Low-Risk Patients
Perioperative β-blockade was associated with lower 30-day mortality in patients with three to four cardiac risk factors undergoing noncardiac surgery (NCS), but with increased mortality in patients with no cardiac risk factors, according to a retrospective cohort study published online in JAMA Surgery. The goal of this retrospective observational analysis was to examine the effect of perioperative β-blockade on patients undergoing NCS, particularly among those with no cardiovascular risk factors. The study cohort consisted of 326,489 patients undergoing NCS surgery (n = 314,114) or cardiac surgery (n = 12,375) from October 1, 2008, through September 31, 2013, at Veterans Affairs hospitals. The investigators calculated a 4-point cardiac risk score by assigning 1 point each for renal failure, coronary artery disease, diabetes mellitus, and surgery in a major body cavity. Among patients with three or four cardiac risk factors who had NCS, β-blockade at any time between 8 hours before surgery and 24 hours postoperatively significantly lowered the odds ratio for unadjusted 30-day surgical mortality (odds ratio, 0.63; 95% confidence interval, 0.43 - 0.93). However, β-blockade had no effect on patients with one or two cardiac risk factors, and it was associated with significantly increased mortality in patients with no risk factors (odds ratio, 1.19; 95% confidence interval, 1.06 - 1.35). Unadjusted 30-day mortality rates for NCS among patients not receiving β-blockers were 0.5% for patients with no cardiac risk factors, 1.4% for those with one or two risk factors, and 6.7% for those with three or four risk factors. Among patients treated with β-blockers, these rates were 1.0%, 1.7%, and 3.5%, respectively.

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May 25, 2015

EMA Committee Recommends Approval of Evolocumab
Evolocumab, an investigational human monoclonal antibody for proprotein convertase subtilisin-kexin type 9 (PCSK9), is one step closer to being available in Europe. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approving evolocumab as an adjunct to diet in patients with elevated cholesterol levels who are unable to reach their recommended LDL-cholesterol goal despite taking an optimal dose of statin. Patients deemed statin intolerant or those in whom a statin is contraindicated would also be eligible for treatment with evolocumab. The committee also recommended that the PCSK9 inhibitor, the first in its class to receive a positive opinion from CHMP, be available to treat patients with homozygous familial hypercholesterolemia (FH). The drug, which requires a subcutaneous injection every 2 or 4 weeks depending on the dose, works by blocking the PCSK9 protein. PSCK9 limits the number of LDL receptors available in the liver and reduces the body's ability to remove LDL cholesterol from the bloodstream. EMA stated that the positive review from CHMP is based on the efficacy of evolocumab for lowering LDL-cholesterol levels in nine studies of patients with hypercholesterolemia/mixed dyslipidemia and in two studies of patients with homozygous FH. The PCSK9 inhibitor was considered safe based on data from more than 6000 patients followed for at least 6 months and more than 1100 patients followed for at least 2 years.

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Sitagliptin may prevent heart disease in HIV patients
The antidiabetic drug sitagliptin demonstrated beneficial systemic and adipose anti-inflammatory effects in HIV-infected adults with impaired glucose tolerance, according to research published in the Journal of Clinical Endocrinology and Metabolism. It is a randomized, placebo-controlled, double blind study of 36 men and women with HIV, aged 18 to 65 years, who had received combination ART (cART) for the past 6 months and whose immune and virologic statuses were stable. None of the patients had type 2 diabetes or were taking antidiabetes medications, nor did they have an AIDS-defining diagnosis, history of heart failure, chronic kidney or liver dysfunction, pancreatitis, or active malignancy, according to the researchers. Participants were given either 100 mg sitagliptin daily or placebo for 8 weeks. Both glucose area under the curve (P = .002) and oral glucose insulin sensitivity index (P = .04) improved more in patients assigned sitagliptin compared with controls. At 8 weeks, those who received sitagliptin experienced a decrease in plasma high-sensitivity C-reactive protein (hsCRP) and CXCL10 (P ≤ .008) — both discriminative markers for inflammation, particularly in cART-treated HIV patients. This was in sharp contrast to the placebo group, which saw an increase in hsCRP. In addition, in terms of immune regulation, adipose tissue monocyte chemoattractant protein-1 mRNA abundance declined more in patients receiving sitagliptin (P = .01), and epidermal growth factor-like module containing mucin-like hormone receptor 1 mRNA abundance tended to decline more in the treatment arm as well, although this was not statistically significant.

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Perioperative Dabigatran Protocol Seems Safe, Doable, Effective
In a multicenter Canadian study of more than 500 patients who had to have dabigatran therapy interrupted when they underwent major or minor surgery, adherence to a new specific protocol for stopping and resuming dabigatran was high and the incidence of major bleeding was low. The protocol was largely based on the recommendations that were implemented partway through the phase 3 RE-LY study of the novel oral anticoagulant (NOAC) in patients with atrial fibrillation. However, the current protocol specified exactly when to stop dabigatran, "4 hours, 48 hours, or 96 hours [prior to surgery], depending on the patient's kidney function and [the procedure-related] risk of bleeding. A total of 217 patients (40%) underwent surgery that entailed a high bleeding risk, notably implantable cardioverter defibrillator (ICD) or pacemaker insertion, endoscopy/bronchoscopy with combined polyp removal, abdominal surgery, orthopedic surgery, and brain surgery. The other 324 patients (60%) underwent surgeries classed as having a standard bleeding risk, notably endoscopy (without polyp removal), ablation therapy, and cardiac catheterization. For surgeries with a standard risk of bleeding, the study protocol specified that dabigatran should be stopped 24 hours earlier, 2 days earlier, or 4 days earlier, if a patient's calculated creatinine clearance was >50 mL/min, >30 to 50 mL/min, or <30 mL/min, respectively. For procedures with a high risk of bleeding, the protocol specified that dabigatran should be stopped 2 days earlier, 4 days earlier, or 6 days earlier, respectively, for these levels of creatinine clearance. Dabigatran was stopped according to protocol in 89% of cases and resumed according to protocol in 77% of the cases. Preoperative bridging with heparin was not used, but nine patients received postoperative heparin mainly after bowel surgery when they could not take any oral medication. During the 30-day follow-up, 10 patients (1.8%) each had a major bleeding event, which was managed with a transfusion in six of 10 cases. Another 28 patients (5.2%) had 35 minor bleeding events. One patient had a TIA, which was the only thromboembolic complication in this cohort. There were four deaths unrelated to bleeding or thrombosis.

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May 18, 2015

Use of Digoxin Raises Mortality in a new Meta-analysis
Digoxin use was linked with a 29% increased risk of mortality in more than 235,000 patients with atrial fibrillation (AF) and with a 14% increased risk of death in more than 91,000 patients with congestive heart failure (CHF) during an average follow-up of 2.5 years, according a new metanalysis published online in the European Heart Journal. The metanalysis includes studies of digoxin published since 1993, comprising 326,426 patients: nine studies in patients with AF, seven in patients with CHF, and three in patients with both conditions. In follow-up ranging from 0.83 to 4.7 years, digoxin use was associated with an increased risk of all-cause mortality. Among all patients, digoxin was associated with an increased relative risk for all-cause mortality (HR = 1.21; 95% CI, 1.07-1.38). In the subgroup of 235,047 patients with AF, those assigned digoxin had a 29% increased mortality risk compared with those not receiving glycosides (HR = 1.29; 95% CI, 1.21-1.39), and in the subgroup of 91,379 patients with congestive HF, digoxin was associated with a 14% increased mortality risk (HR = 1.14; 95% CI, 1.06-1.22). The results are consistent with a post hoc analysis of the DIG trial of digoxin in patients with HF, which found that higher serum digoxin levels (≥ 1.2 ng/mL) were significantly associated with mortality.

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Long-term depression may increase stroke risk
Long-term depressive symptoms are associated with increased risk for stroke, and this association persists even if the depressive symptoms remit, according to new findings of a study published online in J. Am. Heart Assoc. Researchers evaluated 16,178 participants in the Health and Retirement Study (mean age, 65.7 years; 41.5% men; 78.2% white) who were aged at least 50 years, stroke-free and not institutionalized at baseline. Participants were interviewed biennially from 1998 to 2010.It was observed 1,192 strokes during the study period (mean follow-up, 8.88 years). The authors found that, compared with those who had stable low/no depressive systems, participants with stable high depressive symptoms had elevated risk for stroke (adjusted HR = 2.14; 95% CI, 1.69-2.71), as did those with remitted depressive symptoms (adjusted HR = 1.66; 95% CI, 1.22-2.26). The risk for stroke was not significantly different between those with stable high or remitted symptoms. Stable high depressive symptoms were associated with higher stroke risk across all age, sex and race/ethnicity subgroups. Remitted depressive symptoms were associated with higher stroke risk in women (adjusted HR = 1.86; 95% CI, 1.3-2.66) and non-Hispanic whites (adjusted HR = 1.66; 95% CI, 1.18-2.33), and marginally so in Hispanics (adjusted HR = 2.36; 95% CI, 0.98-5.67).

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Physical Activity Linked to Survival in ICD Patients ( ALTITUDE Study)
Physical activity may improve survival rates in patients with implantable cardioverter-defibrillators (ICDs), suggests a new analysis from the ALTITUDE registry. The findings, which were published in the Journal of the American Heart Association and included almost 100,000 ICD patients, showed 4-year postprocedure survival rates of 91% in the subgroup that was most active at baseline (mean 33 min/day) vs 50% in the least active group (mean 208 min/day; P&ly;0.001). There was also an adjusted hazard ratio of 1.44 for death (95% CI 1.4–1.5) in participants who had lower mean baseline activity, defined as incremental difference of 30 min/day. The current analysis examined data on 98,437 participants at baseline (defined as 30 to 60 days postimplantation) and at a mean follow-up of 2.2 years. Baseline physical activity was 107.5 min/day. Not surprisingly, the least active group was older than the other five subgroups, in which activity levels ranged from 68 to 208 min/day. A larger percentage of the least active group also had a CRT vs the most active group (53.2% vs 30.4%, P<0.0001). One-year follow-up for the most and least active groups showed survival rates of 98.7% and 86.5%, respectively (P<0.001). The between-group difference in survival became more pronounced over time, with rates of 96.5% vs 71.3%, respectively, at 2 years; 93.9% vs 59.3% at 3 years; and 90.5% vs 50.0% at 4 years.

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May 11, 2015

Neprilysin inhibition may accelerate the progression of Alzheimer’s disease.
According a new study published online in Eur. Heart Journal , the authors draw attention the potential deleterious effect of neprilysin inhibition on Alzheimer disease. Neprilysin which is also known as the neutral endopeptidase is a protease with a broad range of substrates including natriuretic peptides, vasoactive peptides (endothelin-1, bradykinins), neuropeptides (substance P, enkephalins), and the b-amyloid peptide. Due to its central role in the metabolism of cardiovascular peptides and the b-amyloid peptide, neprilysin has become a research subject for both cardiovascular diseases and Alzheimer’s disease. Neprilysin is responsible for the degradation of natriuretic peptides and other cardiovascular peptides. Neprilysin inhibitors prolong and potentiate the beneficial effects of vasoactive/natriuretic peptides. However, neprilysin degrades both vasoconstrictor and vasodilator peptides. In order to eliminate this limitation, neprilysin inhibitors are combined with an ACEI (omapatrilat) or an ARB (LCZ696). The PARADIGM-HF trial showed that LCZ696 is superior to enalapril for the treatment of chronic heart failure with reduced EF. In Alzheimer’s disease and cerebral amyloid angiopathy, b-amyloid peptide accumulates in the brain. Several proteases degrade b-amyloid peptide, of which the most effective is neprilysin. There are multiple lines of evidence showing the crucial role of neprilysin in Alzheimer’s disease. Therefore, numerous researches are being conducted to modulate neprilysin activity in the brain. When neprilysin inhibitors are used for the treatment of cardiovascular diseases, there is a risk of b-amyloid accumulation in the brain and thus accelerating the progression of Alzheimer’s disease and cerebral amyloid angiopathy. Indeed, since intracerebral infusion of the NEPi provokes Alzheimer disease lesions in animal models. The ongoing PARAGON-HF trial assessing the effect of LCZ696 in heart failure with preserved EF will evaluate cognitive function. However, the duration of follow-up of this trial may not be sufficient to show any deleterious effect of LCZ696 on cognitive function. Therefore, it is important to continue follow-up of the patients after the end of the trials in order to confirm the safety of LCZ696. In summary, the authors draw attention to a potential serious side effect of neprilysin inhibition. Indeed, inhibition of an enzyme responsible from the degradation of a broad range of peptides has a potential for serious side effects. As known from other drugs, some side effects are noticeable after a long time.

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Spontaneous bleeding after PCI is as dangerous as MI
Percutaneous coronary intervention related bleeding is associated with increased mortality according a new study published in JACC. The effect of spontaneous bleeding occurring after hospital discharge on prognosis is unclear. The study enrolled 32,906 patients (14% with acute coronary syndrome) who had PCI between January, 1996 and December, 2008 in Kaiser Permanente Northern California healthcare delivery system. During 7 and 365 days post-discharge, 530 patients (2.14 per 100 person-years) had spontaneous bleeding. Patients who had a bleeding were older, more likely to be women, had a greater comorbidity burden and more likely to receive warfarin compared to patients without bleeding. The use of antiplatelet therapy was similar between the groups. In the same period, 991 patients (4.26 per 100 person-years) had myocardial infarction. Patients who experienced an MI were older, more likely to be women, had a greater comorbidity burden and lower levels of GFR and Hb compared to patients who did not experience an MI. During mean follow-up of 4.4 years, 4048 deaths occurred. At follow-up, 31% of the patients with spontaneous bleeding died, 32% of the patients with spontaneous MI died, 53.8 of the patients with both spontaneous bleeding and MI died, and 11.4% of the patients without spontaneous bleeding and MI died. The crude annual death rate after spontaneous bleeding (9.4%) and after spontaneous MI (7.6%) was higher compared with patients who experienced neither event (2.6%). The multivariate analysis revealed that bleeding was associated with an increased mortality and risk of death increased by 61% in patients who had bleeding compared to the reference group who had neither bleeding nor MI (adjusted HR: 1.61, 95% CI: 1.30-2.00). Risk of death increased by 91% in patients who had MI compared to the reference group who had neither bleeding nor MI (adjusted HR after MI: 1.91, 95% CI: 1.62 to 2.25). The results were similar in subgroups of elective or urgent PCI.

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Outpatient treatment safe for select patients with acute PE
Favorable short-term outcomes of patients with pulmonary embolisms after hospital discharge suggest these patients can safely receive outpatient treatment, according to a study published in JAMA Int. Med. The analysis included data from the Cardiovascular Research Network Venous Thromboembolism study, a collaboration of four geographically diverse health care delivery systems. Researchers identified 494 patients (median age, 61 years; range, 48-73) who were diagnosed with PE between 2004 and 2010 and who were discharged from hospital EDs with an anticoagulant prescription within 7 days. The cohort was 73.9% white and 49.2% (n = 243) female. Hospital readmission within 30 days and death within 90 days served as the primary endpoints. Researchers observed that 18.6% (n = 92) of patients with PE returned to the hospital within 30 days, and 7.9% (n = 39) of those patients were readmitted. Eleven patients (2.2%) had a primary diagnosis of hemorrhage during a subsequent hospital visit within 30 days. Researchers noted mortality rates were low. No deaths were reported within the first 7 days after discharge, and only two deaths occurred after 90 days. Patient discharge rates significantly increased during the study period. Approximately 11% of patients with PE were discharged in 2010 vs. 5.6% of patients with PE discharged in 2004 (P ˂ .001 for trend). The investigators acknowledged limitations to their study, including the reliance on ICD-9 codes and pharmacy data to identify patients, as well as the lack of appropriate data to calculate a complete PE severity risk classification. The investigators also were unable to identify the specific reasons for patient disposition plans. Still, mortality rates from this analysis are similar to those from previous clinical trials and suggest outpatient care can be implemented safety for select patients with acute PE, according to the researchers.

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May 04, 2015

The 61% of TAVR Patients Alive at 3 Years: UK Registry Analysis
Three years after transcatheter aortic-valve replacement (TAVR), 61% of individuals with severe symptomatic aortic stenosis who receive the new valve remain alive, according to data from the UK Transcatheter Aortic Valve Implantation (TAVI) Registry which published in the last issue of JACC: Cardiovascular Interventions . At 5 years, 45.5% of the UK patients who underwent TAVR were still alive. Survival to 3 years was largely predicated on patient characteristics, with baseline renal dysfunction, atrial fibrillation, respiratory disease, impaired left ventricular function, and a higher EuroSCORE (>18.5) associated with an increased risk of mortality, report investigators. The data is based on 870 patients who underwent TAVR in the UK between 2007 and 2009. The mean age of patients at the time of implantation was 82 years, and the minimum time from TAVR to data census was 4.1 years (maximum 7.0 years). Patients in the registry received either the Sapien balloon-expandable valve or the self-expanding CoreValve.

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AF is associated with increased risk for non-STEMI
After a median follow-up of more than 20 years, researchers found an increased risk of non-ST elevation myocardial infarction (non-STEMI) in patients with atrial fibrillation even when adjusting for cardiovascular and other risk factors. However, there was no association between atrial fibrillation and STEMI. These are the results of Atherosclerosis Risk in Communities study which published online in Circulation. Approximately two-thirds of MI’s in the U.S. each year are non-STEMI, according to the researchers. In addition, an estimated 2.7 million to 6.1 million people in the U.S. have atrial fibrillation, which is a risk factor for stroke. However, researchers said it was unclear if the disease was a risk factor for MI. In this community-based population study, researchers examined 15,792 adults who were interviewed and visited a clinic between 1987 and 1989. They followed up with them on several occasions from 1990 to 2013 and excluded patients who did not have quality echocardiograms at baseline and those with coronary heart disease. The final analysis included 14,462 patients. The mean age was 54 years, 56% of patients were women. Of the patients, 31 had atrial fibrillation at baseline and 1,514 had atrial fibrillation during the follow-up period before having MI. During a median follow-up period of 21.6 years, researchers identified 1,374 incident MI events by contacting patients and examining hospital medical records. There were 829 non-STEMI events and 249 STEMI events. The mean time from atrial fibrillation diagnosis to MI was 4.82 years. Researchers found atrial fibrillation was associated with a 63% increased risk of MI. There was a significantly higher rate of MI in women with atrial fibrillation compared with men.

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ISAR-TRIPLE: Net clinical outcomes similar for 6-week vs. 6-month triple therapy
Six weeks of triple therapy with oral anticoagulation, aspirin and clopidogrel was not superior to a 6-month regimen for the primary outcome of death, MI, definite stent thrombosis, stroke or TIMI major bleeding at 9 months, according to data from the ISAR-TRIPLE trial. published in the Journal of the American College of Cardiology. The randomized, open-label trial included 614 patients who were receiving concomitant oral anticoagulation and aspirin therapy and underwent drug-eluting stent implantation for stable angina or ACS at centers in Denmark and Germany from September 2008 to December 2013. Patients were randomly assigned to a 6-week (n = 307) or 6-month (n = 307) regimen of clopidogrel therapy 75 mg on top of oral anticoagulation and aspirin. Patients were followed up by phone or at the physician’s office after 6 weeks, 6 months and 9 months. The primary endpoint occurred in 9.8% of the 6-week therapy group vs. 8.8% of the 6-month therapy group (HR = 1.14; 95% CI, 0.68-1.91). Researchers reported no significant difference in the secondary combined ischemic endpoint of cardiac death, MI, definite stent thrombosis and ischemic stroke between the two groups (6 weeks, 4%; 6 months, 4.3%; HR = 0.93; 95% CI, 0.43-2.05). Both durations also were associated with similar rates of TIMI major bleeding (6 weeks, 5.3%; 6 months, 4%; HR = 1.35; 95% CI, 0.64-2.84). In a post-hoc landmark analysis, the 6-month therapy group experienced significantly more bleeding events, as defined by Bleeding Academic Research Consortium (BARC) classifications.

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April 27, 2015

Bococizumab reduces LDL in patients with hypercholesterolemia
Use of the PCSK9 monoclonal antibody bococizumab in patients with hypercholesterolemia was associated with significant reductions in LDL across all doses according the results of a phase 2b, multicenter, double blind, placebo-controlled, dose-ranging trial which published in Am. J. Cardiol. The study population were 351 adults with hypercholesterolemia (baseline fasting LDL, ≥ 80 mg/dL; triglycerides, ≤ 400 mg/dL; no incidence of CV events within past 6 months). Patients were randomly assigned subcutaneous placebo or bococizumab 50 mg, 100 mg or 10 mg every 2 weeks or bococizumab 200 mg or 300 mg every 4 weeks. The dose was reduced if LDL persistently deceased to 25 mg/dL or lower. The primary endpoint was mean difference in LDL from baseline to week 12. Randomized treatment continued for another 12 weeks to assess the safety of bococizumab. 16% of patients assigned bococizumab 100 mg or 150 mg every 2 weeks had their dose reduced during the study. At 12 weeks, mean change in LDL was –35.4 mg/dL in the 50-mg group, –52.3 mg/dL in the 100-mg group and –54.2 mg/dL in the 150-mg group compared with –2.8 mg/dL in the placebo group. A pharmacokinetic/pharmacodynamics (PK/PD) model-predicted and placebo-adjusted mean change in LDL from baseline to 12 weeks ranged from –36.4 mg/dL for the 50-mg every 2 weeks dose to –72.2 mg/dL for the 150-mg every 2 weeks dose. 44% of patients assigned bococizumab 200 mg and 39% assigned 300 mg every 4 weeks had their dose reduced during the study. At 12 weeks, mean change in LDL was –21.3 mg/dL in the 200-mg group and –38.3 mg/dL in the 300-mg group compared with –1.3 mg/dL in the placebo group. Approximately 70% of patients in the 300 mg-group showed LDL reductions after 2 weeks.

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EU Approval Recommended for Edoxaban for Stroke, Systemic Embolism in AF Patients
The new oral anticoagulant edoxaban (factor Xa inhibitor) has received approval recommendation from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for use in the prevention of stroke and systemic embolism in patients with nonvalvular AF, as well as for prevention and treatment of recurrent venous thromboembolism. CHMP is recommending marketing authorization for the medication, which will be available as film-coated tablets in doses of 15, 30, and 60 mg. CHMP reports that soft tissue hemorrhage is the most common treatment-related adverse event, followed by epistaxis and vaginal hemorrhage. The agency also adding that anemia, rash, and abnormal liver-function tests are other common side effects. The full indication notes that it should be used for stroke and systemic embolism in nonvalvular AF patients with congestive heart failure, diabetes, or hypertension who are older than 74 years or who had a transient ischemic attack or stroke previously; and for treatment and prevention in patients with pulmonary embolism (PE) and deep vein thrombosis (DVT). In January of this year, FDA also approved edoxaban to reduce risk of stroke and systemic embolism in patients with nonvalvular AF and to treat DVT and PE. Its approval was based on results from the ENGAGE AF-TIMI 48 trial, which showed that the medication was noninferior to warfarin.

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Heart Risk From Amiodarone Plus Hepatitis C Antivirals (EMA)
The European Medicines Agancy (EMA) has confirmed a risk of severe bradycardia or heart block when the hepatitis C medicines (sofosbuvir with ledipasvir) or a combination of sofosbuvir and daclatasvir which are used in patients who are also taking the medicine amiodarone. To manage this risk the Agency recommends that amiodarone should only be used in patients taking these hepatitis C medicines if other antiarrhythmics cannot be given. If concomitant use with amiodarone cannot be avoided, patients should be closely monitored. Because amiodarone persists for a long time in the body, monitoring is also needed if patients start such hepatitis C treatments within a few months of stopping amiodarone. The recommendations follow a review of cases of severe bradycardia or heart block in patients taking amiodarone who started treatment with the hepatitis C combinations. It was considered that there was a likely relationship of these events to the medicines. The possible mechanism behind these effects is unknown and further investigation of other cases with sofosbuvir and other hepatitis C medicines is ongoing.

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April 20, 2015

FDA approves ivabradine for treatment of HF
A drug already available in Europe has been approved by the US Food and Drug Administration for reducing the risk for hospitalization from worsening heart failure. The agent, ivabradine, is indicated for stable patients with heart failure and a heart rate of >70 per minute on maximally tolerated beta-blockers. The approval is based on the international, placebo-controlled SHIFT trial, published in 2010, which randomized >6500 patients in New York Heart Association class II-IV heart failure and left ventricular ejection fraction ≤35%. The trial saw a highly significant 18% drop in risk for cardiovascular death or hospitalization for worsening heart failure over an average of 23 months in patients treated with ivabradine.

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FDA Advisory Panel Gives the green light for Cangrelor in PCI
The Cardiovascular and Renal Drugs Advisory Committee of the US Food and Drug Administration (FDA) voted 9 to 2, with one member abstaining, that the injectable antiplatelet agent cangrelor should be approved for reducing thrombotic events in PCI. Last year, the committee voted 7 to 2 against recommending cangrelor for PCI because of data problems and they felt that the risk/benefit profile was not sufficiently strong enough. The Medicines Company then underwent further sensitivity analyses and supplied a more simplified application. Earlier this week, FDA reviewers gave a favorable review that the agent now be approved "in patients in whom treatment with an oral P2Y12 platelet inhibitor prior to PCI is not feasible and when glycoprotein IIb/IIIa receptor antagonists are not anticipated to be used." They also noted that PHOENIX was sufficient enough as a stand-alone trial to warrant approval of cangrelor.

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Micra Miniature Leadless Pacemaker Gains CE Mark Approval
European physicians will now have access to a second leadless pacemaker, as Medtronic announced today the Micra transcatheter pacing system (TPS) has gained CE Mark approval in Europe. The Micra, which is not much larger than a one Euro coin (or nickel) at one-tenth the size of a traditional pacemaker, was approved in Europe as part of the Micra TPS Global Clinical Trial, a larger ongoing study. For the CE Mark approval, European regulators approved the device on safety and efficacy outcomes of 60 patients who had the tiny pacemaker implanted and were followed for 3 months. The device, which is delivered via catheter and eliminates the traditional surgical "pocket," is not approved in the US, but researchers plan to enroll as many as 780 patients from 50 clinical centers as part of the ongoing global trial.

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LDL variability predicts CV events in patients with CAD
Visit-to-visit LDL variability was independently predictive of CV events in patients with CAD, according to new data from the TNT trial which published in JACC. Researchers evaluated 9,572 patients with CAD and LDL level less than 130 mg/dL who were randomly assigned atorvastatin at doses of 80 mg/day or 10 mg/day. They evaluated visit-to-visit LDL variability from 3 months after randomization to determine its potential impact on CV outcomes. LDL variability measurements included standard deviation, average successive variability, coefficient of variation and variation independent of mean. The primary outcome was incidence of any coronary event. Secondary outcomes were any CV event, death, MI and stroke. in the population studied, standard deviation and average successive variability were lower among those assigned atorvastatin 80 mg/day than in those assigned atorvastatin 10 mg/day (standard deviation, 12.03 ± 9.7 vs. 12.52 ± 7.43; P = .005; average successive variability, 12.84 ± 10.48 vs. 13.76 ± 8.69; P < .0001). The authors also found that each 1-unit standard deviation increase in LDL variability by average successive variability increased the risk of any coronary event by 16% on adjusted analysis (HR = 1.16; 95% CI, 1.1-1.23). They also observed increases in the risk for any CV event (HR = 1.11; 95% CI, 1.07-1.15), death (HR = 1.23; 95% CI, 1.14-1.34), MI (HR = 1.1; 95% CI, 1.02-1.19) and stroke (HR = 1.17; 95% CI, 1.04-1.31). These results were independent of treatment effect and achieved LDL levels, and were consistent after adjustment for medication adherence, according to the researchers.

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April 14, 2015

Lead-free cardiac pacemaker shows good safety, performance at 1 year (LEADLESS published)
Confirming a previous report, a leadless cardiac pacemaker system demonstrated stable performance and good safety results at 1 year, according to data from the LEADLESS trial which published online in JACC. The researchers assessed 6-month and 1-year follow-up data for 31 of the 33 patients implanted with the leadless pacemaker between December 2012 and April 2013 (mean age, 76 years; 65% men). At implantation, one patient had cardiac tamponade and died due to massive cerebral artery ischemic infarct, and another required an implantable cardioverter defibrillator and underwent successful retrieval of the leadless pacemaker 7 days after implantation.
There were no pacemaker-related adverse events reported between 3 months and 1 year, the researchers wrote.
Mean pacing threshold at a 0.4-ms pulse width was 0.4 V at 6 months and 0.43 V at 1 year, R-wave amplitude was 10.6 mV at 6 months and 10.3 mV at 1 year, and impedance was 625 ohms at 6 months and 627 ohms at 1 year, according to the researchers.
At 1 year, the rate response sector was activated in 61% of patients, all of whom had an adequate rate response, the researchers found.

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EMA Committee Warns of Cardiovascular Risk With High-Dose Ibuprofen
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is warning of an increased risk of cardiovascular events in patients who take high doses of the anti-inflammatory ibuprofen. The committee, states there is a small increase in the risk of MI and stroke with ibuprofen when taken at doses of 2400 mg/day or higher. The risk, according to the committee, is similar to the risk observed with other nonsteroidal anti-inflammatory drugs (NSAIDs), such as COX-2 inhibitors and diclofenac.
The committee is recommending physicians assess patients' risk factors for cardiovascular conditions before starting them on long-term high-dose ibuprofen. Overall, PRAC says the benefits of high-dose ibuprofen outweigh the small increased risk of cardiovascular events, but physicians should use caution when prescribing and avoid high-dose ibuprofen in select patients. High doses of ibuprofen (2400 mg per day or higher) should be avoided in patients with serious underlying heart or circulatory conditions, such as heart failure, heart disease, and circulatory problems or in those who have previously had a heart attack or stroke," according to PRAC. With 1200 mg of ibuprofen, the most commonly used over-the-counter dose of ibuprofen in the European Union, there is no signal of harm, according to PRAC. The recommendations of the committee also extend to dexibuprofen, which is similar to ibuprofen. A high-dose of dexibuprofen is 1200 mg/day or more.
The recommendations of PRAC will now be sent to the Coordination Group for Mutual Recognition for Decentralized Procedures—Human (CMDh). The CMDh reviews the recommendations of PRAC and will adopt a final position.

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Bivalirudin Bests Heparin for Fewer Bleeding Events During PCI (BRIGHT study)
Publication of the multicenter Chinese BRIGHT study has reopened the bivalirudin-heparin debate on treatment for patients undergoing PCI. The randomized trial showed that patients who received bivalirudin after an acute MI had significantly fewer net adverse clinical events (NACE) and bleeding events at 30 days and 1 year than those receiving heparin plus the GP IIb/IIIa inhibitor tirofiban and those receiving heparin alone.
There were no between-group differences in major cardiac events or stroke, in rates of stent thrombosis or acute stent thrombosis, or acquired thrombocytopenia.
The results, are published in the Journal of the American Medical Association.
A total of 2194 adult patients with acute MI were enrolled between August 2012 and June 2013 at 82 centers in China. All were randomly assigned to one of three treatment arms upon arrival in the cath lab for emergency PCI: bivalirudin (n=735; 82.7% men; mean age 57.3 years), heparin (n=729; 81.6% men; mean age 58.1 years), or heparin/tirofiban (n=730; 82.1% men; mean age 58.2 years).
Bivalirudin was given as a bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg/h during the PCI procedure and for at least 30 minutes but no more than 4 hours afterward. The heparin-only group received a dose of 100 U/kg; the combination group received heparin 60 U/kg and tirofiban 10 µg/kg followed by postprocedure infusions of tirofiban at 0.15 µg/kg/min for 18 to 36 hours.
NACE at 30 days' postprocedure, the primary end point, were reported for 8.8% of the bivalirudin group vs 17% of the heparin/tirofiban group (relative risk [RR] 0.52; 95% CI 0.39–0.69; P<\0.001).NACE also occurred in 13.2% of the heparin-only group (RR 0.67; 95% CI 0.50–0.90; P=0.008).
The 30-day bleeding rate occurred in 4.1% of the patients receiving bivalirudin vs 12.3% of those receiving heparin/tirofiban vs 7.5% of those receiving heparin alone.
One-year follow-up results were similar. At that time, NACE occurred in 12.8% of the bivalirudin group vs 20.5% of the heparin/tirofiban group (P <\0.001) vs 16.5% of the heparin-only group (P=0.05). Bleeding rates at 1 year were 6.3% vs 14.2% and 9.9%, respectively.

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April 6, 2015

Dronedarone in Middle Age Linked to More Admissions
Treatment with dronedarone was associated with a higher risk for hospitalization than treatment with amiodarone or other antiarrhythmic drugs, in an observational study involving nongeriatric atrial fibrillation (AF) patients without cardiovascular disease, which published in the last issue of Circulation: Cardiovascular Quality and Outcomes.. In patients age 61 and younger (median age 56) , the risk of AF-related hospitalization was greater with dronedarone than Class Ic (propafenone and flecainide) drugs (hazard ratio 1.59, 95% CI 1.13-2.24), amiodarone (HR 2.63, 95% CI 1.77-3.89) and sotalol (HR 1.72, 95% CI 1.17-2.54). Cardiovascular hospitalization risk also was lower with amiodarone (HR 0.80, 95% CI 0.70-0.92) and sotalol (HR 0.63, 95% CI 0.53-0.75) compared with class Ic drugs.
The study included 8,562 AFpatients between the ages of 49 and 61 without known heart disease identified using health plan claims data. All were prescribed antiarrhythmic drugs (AADs) from the beginning of 2006 to the end of 2010.
The primary outcome was time from first prescription to AF hospitalization, and secondary outcomes were time to cardiovascular and all-cause hospitalization. Just 608 of the 8,562 study participants were treated with dronedarone, compared with 2,984 patients treated with class Ic drugs, 2,065 patients treated with Sotalol, and 2,905 patients treated with amiodarone.

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Smoking linked to poor outcomes after revascularization in patients with complex CAD
Cigarette smoking was associated with adverse clinical outcomes, including recurrent MI, stroke and death, in patients with complex CAD undergoing revascularization with CABG or PCI, according to 5-year follow-up data from the SYNTAX trial in a study published online in the Journal of the American College of Cardiology. Researchers analyzed data on smoking status and history collected at baseline, 6 months, 1 year, 3 years and 5 years among participants of the SYNTAX trial (n = 1,793) who underwent CABG or PCI.
At baseline, 1 in 5 patients with complex CAD reported smoking. Of those, 60% stopped smoking after revascularization. Overall, 17.9% of patients had changes in smoking status during the 5-year follow-up.
According to the results, smoking at baseline did not influence death/MI/stroke or major adverse CV and cerebrovascular events at 5-year follow-up. However, when smoking was considered a time-dependent variable, smoking increased the risk for death/MI/stroke (HR = 1.38; 95% CI, 1.02-1.86) and major adverse cardiovascular/cerebrovascular events (HR = 1.28; 95% CI, 1.01-1.61) at follow-up. Baseline smoking status was associated with increased risk for MI, specifically. During follow-up, the effect of smoking as a time-dependent covariate was predominantly on subsequent MI (adjusted HR = 2.08; 95% CI, 1.3-3.32).
During follow-up, 98 patients reported always smoking and 1,374 reported never smoking. Risk for MI and stent thrombosis/graft occlusion was significantly higher among always smokers, but this group did not have increased risk for all-cause revascularization, compared with never smokers.
Additionally, smoking was identified as an independent predictor of death/MI/stroke (HR = 1.8; 95% CI, 1.3-2.5) and major adverse cardiovascular/cerebrovascular events (HR = 1.4; 95% CI, 1.1-1.7). In subgroup analyses, smoking independent predicted poor outcomes in patients who underwent CABG (HR = 1.52; 95% CI, 1.02-2.25) and PCI (HR = 1.26; 95% CI, 0.9-1.75).

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SPYRAL HTN program to evaluate renal denervation for uncontrolled hypertension
Medtronic announced with a press release the launch of a clinical trial program that will assess the use of renal denervation in patients with uncontrolled hypertension. The SPYRAL HTN global clinical trial program comprises two prospective, randomized, sham-controlled trials: SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED. The trials will be conducted simultaneously. In both, participants will undergo renal denervation by experienced operators with the Symplicity Spyral catheter and Symplicity G3 radiofrequency generator. SPYRAL HTN-OFF MED will evaluate the impact of renal denervation on BP reduction without the use of antihypertensive medications. SPYRAL HTN-ON MED will assess renal denervation in patients with uncontrolled hypertension despite treatment with three antihypertensive medications; these drugs are not required to be prescribed at maximum tolerated medication dosages, a factor which may have contributed to variability in patient adherence and the large number of medication changes during the SYMPLICITY HTN-3 trial, according to the release.
The trials will include approximately 100 patients with moderate- to high-risk hypertension, enrolled at 20 centers worldwide.

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March 23, 2015

CoreValve Bests Surgery at Two-Year Mark
Data from a U.S. pivotal trial showed patients who underwent transcatheter aortic valve replacement using CoreValve had a higher two-year survival rate than those who had their valves surgically replaced. The difference in all-cause mortality between the two groups jumped from 4.8 percent at one year to 6.5 percent at the end of the second year. Patients in the TAVR arm also had a lower stroke rate than those in the control group — 10.9 percent versus 16.6 percent. The multicenter clinical trial randomized 747 patients with advanced forms of aortic stenosis to with TAVR or open-heart surgery. The patients had an estimated mortality risk of 15 percent or greater at 30 days and preexisting surgical risk factors such as frailty and disability. The FDA approved the CoreValve system last year for patients in need of aortic valve replacement who are at high or severe risk for surgery. The device is also available in countries that recognize the CE mark

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Next-generation subcutaneous ICD system receives FDA approval, CE Mark
Boston Scientific Corporation has received FDA and CE Mark approval of the EMBLEM™ Subcutaneous Implantable Defibrillator (S-ICD) System. The EMBLEM S-ICD System is a treatment option that provides protection for patients at risk of sudden cardiac arrest (SCA), yet leaves the heart and vasculature untouched, minimizing the risk of complications associated with conventional transvenous implantable cardioverter-defibrillators (TV-ICDs). A controlled and limited market release has begun in a small number of European centers with a broad European launch scheduled for May 2015 and subsequent U.S. launch planned for the third quarter of 2015. Unlike traditional ICDs that require placement of at least one lead in or on the heart, the S-ICD System is implanted just under the skin and provides the patient the same protection from cardiac arrest without invading the heart and blood vessels. Leads in the heart may be associated with infrequent but serious complications, including lead displacement, fracture and systemic blood infections, or the need for lead extraction, which may lead to hospital readmission, increased mortality and associated costs. The new generation EMBLEM S-ICD System is 19% thinner and is projected to last 40% longer than the previous S-ICD System. These improvements will further improve patient comfort and cosmetic outcomes while reducing the number of times the device will require replacement. The EMBLEM S-ICD System is also enabled for remote patient management through the LATITUDE™ NXT Patient Management System for increased patient convenience.

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Anacetrapib lowers LDL in patients with familial hypercholesterolemia (REALIZE trial)
One-year treatment with anacetrapib in patients with heterozygous familial hypercholesterolemia was well tolerated and yielded significant decreases in LDL cholesterol. For the phase 3, multicenter, double-blind, randomized, placebo-controlled REALIZE study, researchers evaluated 306 patients with a genotype-confirmed heterozygous familial hypercholesterolemia. Patients were included if they were on a therapeutic dose of statin, such as simvastatin (Zocor, Merck) 40 mg, atorvastatin 20 mg, rosuvastatin (Crestor, AstraZeneca) 5 mg, pitavastatin (Livalo, Kowa Pharmaceuticals) 4 mg, lovastatin 80 mg, or pravastatin 80 mg or higher, or one or more additional lipid-modifying drugs for 6 or more weeks prior to screening. Patients also were required to have LDL levels ≥ 2.59 mmol/L with no history of CVD, or LDL levels ≥ 1.81 mmol/L with a history of CVD. After a 2-week placebo run-in period, patients were randomly assigned 2:1 to daily anacetrapib (Merck) 100 mg (n=204) or matching placebo (n=102) for 1 year. The patients were seen for a 12-week follow-up after the conclusion of anacetrapib treatment to evaluate patient safety when off treatment. The primary efficacy endpoint was s percentage change from baseline in LDL to 1 year. At 1 year, anacetrapib decreased mean LDL levels from 3.3 mmol/L to 2.1 mmol/L (percentage change, 36%; 95% CI, – 39.5 to – 32.5) compared with an increase in LDL with placebo from 3.4 mmol/L to 3.5 mmol/L (percentage change, 3.7%; 95% CI, – 1.2 to 8.6). The difference in percentage change between anacetrapib and placebo was – 39.7% (95% CI, – 45.7 to – 33.7; P < .0001). Patients in the anacetrapib group experienced a higher number of CV events vs. those in the placebo group (4 [2%] of 203 patients vs. 0 of 102 patients; P = .1544), but the percentage of those with adverse events that prompted discontinuation was comparable (12 (6%) of 203 patients vs. 5 [5%] of 102 patients).

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Smoking Worsens Outcomes for Patients Following PCI/CABG
Smoking is associated with worse clinical outcomes, especially MI, following coronary revascularization, indicating that there is no "smoker's paradox" when smoking status is accounted for across time, the SYNTAX trial shows. The study was published in the last issue of the Journal of the American College of Cardiology. The SYNTAX trial was a prospective, multicenter, randomized trial that compared PCI with CABG surgery in patients with complex CAD. Complex CAD included left main stem disease, triple-vessel disease, or both. A total of 1793 patients were included in the analysis. Smoking status was ascertained for all patients at baseline and at 6 months and 1, 3, and 5 years. The study end point was the impact of smoking on a composite end point of death, MI or stroke after 5 years of follow-up. Some 20% of the cohort was smoking at baseline, but this dropped to 8.6% at 6 months and was still 8.7% at 1 year. At 5 years, smoking was associated with a 38% increased risk of the composite end point of death, MI, or stroke (hazard ratio [HR] 1.38, 95% CI 1.02–1.86; P=0.035). Smoking was also associated with a 28% increased risk of major adverse cardiac and cerebrovascular (MACCE) events (HR 1.28, 95% CI 1.01–1.61; P =0.041). Patients who always smoked had significantly higher rates of MI and stent thrombosis or graft occlusion as well, although not all-cause revascularization, compared with those who had never smoked.Subgroup analysis also showed that smoking independently increased the risk of poor outcomes by 52% in CABG patients (HR 1.52; 95% CI 1.02–2.25; P =0.038) and by 26% for PCI patients (HR 1.26, 95% CI 0.90–1.75; P=0.177). Baseline smoking status was also associated with poor outcomes.

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March 16, 2015

FDA approves left atrial appendage closure device
The U.S. Food and Drug Administration (FDA) approved the WATCHMAN Left Atrial Appendage (LAA) Closure Device, a first-of-its kind treatment that gives patients with non-valvular atrial fibrillation (AF) an alternative option to long-term warfarin therapy. Watchman is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are deemed by their physicians to be suitable for warfarin; and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin. The PROTECT AF trial concluded that use of the watchman device for LAA ligation is feasible among patients with nonvalvular AF. The trial demonstrated a noninferior rate of cardiovascular death, stroke or systemic embolism, compared with warfarin alone, which was sustained to five years of follow-up. The PREVAIL trial found that percutaneous closure of the LAA is feasible in patients with AF. Compared with the PROTECT AF trial, there was improved procedural implant success with reduced device-related complications.

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Apixaban does not increase bleeding in patients with renal insufficiencies
Compared with conventional anticoagulants, use of apixaban resulted in a lower bleeding risk in patients with mild or moderate-to-severe renal impairment, according to results of a meta-analysis published online in Am. J. Cardiol. The researchers performed a meta-analysis and systematic review to assess this risk. They included six randomized controlled trials involving 40.145 patients in their meta-analysis. The results showed that apixaban had a statistically significant lower bleeding risk in patients with mild renal impairment compared with conventional anticoagulants (vitamin K antagonist, warfarin, aspirin, placebo) (RR = 0.80; 95% CI, 0.66-0.96, I2 = 13%). The bleeding risk was similar in patients with moderate-to-severe renal insufficiency (RR = 1.01; 95% CI, 0.49-2.10, I2 = 72%). The study did not examine severe renal impairment, which may have led to underestimation of bleeding risk in the moderate-to-severe renal impairment subgroup.

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One-Year, Real-World TAVR Data Help Identify Risks, Benefits
In a study published in the Journal of the American Medical Association, with 12.182 patients who underwent transcatheter aortic-valve replacement (TAVR) in clinical practice in the US from November 2011 through June 30, 2013, 1 year after the procedure, 23.7% had died, 4.1% had a stroke, and 26% had either died or had a stroke. Furthermore, following TAVR, 59.8% of the patients, who had a median age of 84, went home rather than to a nursing home or extended-care facility. At 1 year, 46.8% of patients who were alive had not been hospitalized again. Being very elderly, on dialysis, with severe lung disease, or a high STS Predicted Risk of Operative Mortality (STS PROM) score was linked with a higher risk of 1-year mortality, and women who underwent TAVR had a higher risk of stroke than men. Most patients (57.4%) had STS PROM scores below 8%; 30.8% had scores between 8% and 15%; and 11.9% had scores above 15%—which indicates low risk of death from surgery, high risk of death from surgery, and inoperable, respectively. The median STS PROM score was 7.1%, which was lower than in PARTNER A and PARTNER B (11.8% and 11.2%, respectively), but similar to that in the CoreValve study (7.3%), the researchers note. Most patients were either 75 to 84 years old (38.2%) or 85 to 94 years old (47%). Only 12.7% were younger than 75 and 2.1% were 95 or older. About half were women. At 30 days after TAVR, 7% of patients had died and 2.5% had had a stroke.

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Low Prevalence of Diabetes Found Among Patients With Familial Hypercholesterolemia
The prevalence of type 2 diabetes among patients with familial hypercholesterolemia is significantly lower than unaffected relatives, with the prevalence varying by the type of gene mutation, according to a study published in the last issue of JAMA. Statins have been associated with increased risk for diabetes, but the cause for this is not clear. One theory is that statins increase expression of low-density lipoprotein (LDL) receptors and increase cholesterol uptake into cells including the pancreas, which could cause pancreatic dysfunction. Familial hypercholesterolemia causes decreased LDL transport into cells. Researchers have hypothesised, in patients with familial hypercholesterolemia, decreased pancreatic LDL transport would lessen cell death and ultimately lead to lower rates of diabetes. In the study was assessed the prevalence of type 2 diabetes between patients with familial hypercholesterolemia and their unaffected relatives. The study included all individuals (n = 63,320) who underwent DNA testing for familial hypercholesterolemia in the national Dutch screening program between 1994 and 2014. The prevalence of type 2 diabetes was 1.75% in patients with familial hypercholesterolemia (n = 440/25,137) versus 2.93% in unaffected relatives (n = 1,119/38,183), with adjusted figures indicating that patients with familial hypercholesterolemia had a 51% lower odds of having type 2 diabetes. Prevalence varied by the type of gene mutation. The researchers observed an inverse dose-response relationship between the severity of the familial hypercholesterolemia causing mutation and prevalence of type 2 diabetes.

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March 09, 2015

Idarucizumab filed with EMA and Health Canada as Antidote for Dabigatran
Boehringer has submitted BI 655075 (idarucizumab) for approval of marketing authorization to the European Medicines Agency (EMA) and Health Canada, for use in patients who require rapid reversal of the anticoagulant effect of dabigatran, the active ingredient in Pradaxa. This follows filing with the FDA. The submissions are based on the results from clinical trials of idarucizumab in volunteers, including elderly and renally impaired individuals. Phase I data showed an immediate, complete and sustained reversal of the anticoagulant effect of dabigatran following the administration of idarucizumab and no pro-thrombotic effect. The submissions also include first interim data from the ongoing RE-VERSE ADTM study. RE-VERSE ADTM is an ongoing global Phase III patient study in which Boehringer Ingelheim continues to evaluate idarucizumab in patients treated with Pradaxa who are in need of emergency intervention, or experience an uncontrolled or life-threatening bleeding event.

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TAVR improves quality of life in patients at extreme surgical risk
Transcatheter aortic valve replacement yielded substantial improvements in disease-specific and health-related quality of life among patients with severe aortic stenosis at extreme surgical risk, according to new data from the CoreValve U.S. Extreme Risk Pivotal Trial which published online in JACC Intrev. Journal. The new analysis characterized health status outcomes after TAVR with a self-expanding prosthesis. Researchers assessed the health status of patients at baseline and at 1, 6 and 12 months after the procedure using the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Short Form-12 and the EuroQol-5D surveys. Death, KCCQ overall summary score less than 45 or decline in KCCQ overall summary score of 10 points at 6 months indicated poor outcome after TAVR. The transfemoral approach was used in 471 patients. Of those, 93% completed the baseline health status survey, the results of which indicated considerable impairment in all health status measures at baseline. The KCCQ overall summary scores increased by 23.9 points at 1 month, 27.4 points at 6 months and 27.4 points at 12 months (P < .001 for all comparisons). Individual KCCQ subscales that measured total symptoms, physical limitations, social limitations and quality of life showed similar results. Short Form-12 physical and mental scores improved by approximately 5 points from baseline to follow-up at 6 and 12 months (P < .001 for all comparisons). Substantial increases in EuroQOL-5D utilities from baseline to follow-up at 6 and 12 months were also reported (P < .003). The proportion of patients with large KCCQ overall summary score improvement was 58% at 1 month and 59% at 12 months. The proportion of patients with an excellent outcome, defined as survival with a large improvement in KCCQ overall summary score, was 52% at 1 month and 41% at 12 months. In contrast, the proportion of patients with a poor outcome was 39% at 6 months; 22% had died and 16% had very poor quality of life. Preprocedural factors independently associated with poor outcome included wheelchair dependency, lower aortic valve gradient, previous CABG, need for home oxygen and Society of Thoracic Surgeons mortality risk greater than 15%.

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Anacetrapib on Top of Optimal Therapy Provides Large LDL-Lowering Benefit in FH (REALIZE study)
For patients with heterozygous familial hypercholesterolemia (FH) well treated with existing medical therapy, including high-intensity statins and ezetimibe , the addition of anacetrapib for 1 year further reduced LDL-cholesterol levels and other atherogenic lipoproteins, according to the results of REALIZE study which published in Lancet. Among 204 patients who received anacetrapib, LDL-cholesterol levels were reduced from 127 mg/dL at baseline to 81 mg/dL at 1 year. For the 102 patients who received a placebo, LDL-cholesterol levels increased slightly over the 52 weeks. Treatment with anacetrapib also resulted in a significant increase in HDL-cholesterol levels, with baseline levels doubling after 1 year of treatment (up from 54 mg/dL to 108 mg/dL). The investigators say anacetrapib was well tolerated, with no reported differences in serious adverse events, drug-related adverse events, or adverse events leading to drug discontinuation between the anacetrapib- and placebo-treated patients. The researchers did not observe any changes in blood pressure among the anacetrapib-treated patients, an off-target effect that was observed with torcetrapib. This study was not powered for changes in clinical outcomes, but they did observe a numerically higher, although statistically nonsignificant, number of cardiovascular events among the anacetrapib-treated patients. In total, four patients who received anacetrapib had an adjudicated cardiovascular event (stroke, MI, or unstable angina) vs none in the placebo arm, a finding that warrants watching, say the researchers.

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Recent AF Guidelines Would Significantly Expand OAC Use
An update of the guidelines for the management of patients with atrial fibrillation (AF)—one that saw a shift from the CHADS2 score to the CHA2DS2-VASc score for stroke risk assessment—significantly increases the number of patients eligible for oral anticoagulant therapy, according to the results of a new analysis published in JAMA: Internal Medicine. Using data from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF), the researchers found that the overall proportion of patients recommended for oral anticoagulation increased from 71.8% under the 2011 American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Rhythm Society (HRS) guidelines to 90.8% with the 2014 AHA/ACC/HRS clinical recommendations. Using the new CHA2DS2-VASc score, researchers say that nearly every AF patient older than 65 years of age and nearly every woman with AF would be eligible for oral anticoagulation. In fact, with the 2014 recommendations guiding the management of AF, 98.5% of patients 65 years of age and older and 97.7% of women would receive a definitive recommendation for oral anticoagulant therapy.

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March 02, 2015

Heart failure patients who struggle with daily tasks are hospitalised more often and die earlier
Heart failure patients who struggle doing daily tasks are more likely to be hospitalised and die early, according to new research published online in the American Heart Association journal Circulation: Heart Failure. The risk is higher for older women, unmarried people and those with chronic conditions that affect mobility and ability, including obesity, dementia, anemia and diabetes, researchers said. Researchers reviewed questionnaires from 1,128 heart failure patients. Half were female, the average age was about 75, and half were married. Eighteen per cent were obese and most had other medical conditions including high blood pressure (87.4%), anemia (57%), diabetes (36.5%), peripheral vascular disease (26.5%) and cerebrovascular disease (almost 30%). Patients were grouped as having minimal, moderate or severe difficulty with daily activities that included getting dressed, using the bathroom, cleaning the house, climbing stairs and taking medications. Most patients had a hard time with at least one daily activity, but there was a corresponding relationship between how easily one could go about their day and overall mortality.

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Subcutaneous-ICD patients may be able to undergo MRI scans at 1.5T safely
Subcutaneous implantable cardioverter-defibrillator patients may be safe to be exposed to magnetic resonance imaging (MRI) procedures at 1.5T with a pre-specified scanning and monitoring protocol. The results of a first-of-its-kind study exploring the potential for safely imaging patients with the subcutaneous implantable cardioverter system was reported—ahead-of-print in Europace. According the authors, it is estimated that as many as 75% of active cardiac device recipients will become indicated for MRI. However, the majority of such devices are contraindicated for MRI due to potential hazards such as heating of the electrode that resides in the heart, damage to myocardium, elevation of pacing thresholds, unintended induction of ventricular tachycardia or ventricular fibrillation, pacing inhibition, permanent device malfunction, and distortion of the MRI scan. The authors note that none of the components of the S-ICD system are on or in the heart, hence heating near or around the electrode cannot harm the myocardium. However, they say, heating near the S-ICD’s electrode and can may still cause serious patient discomfort. In this single-centre prospective non-controlled study, 15 patients (12 males, mean age 53 years) were enrolled for MRI testing over a period of 18 months. They underwent a total of 22 randomised examinations, which included cardiac, brain, cervical, lumbar and knee scans. Keller et al comment that there was not a specific requirement for an MRI. The S-ICD is currently not certified for use with an MRI. For the scanning protocol, the S-ICD was programmed off to minimise the risk of inappropriate therapy and patients were monitored throughout the procedure with pulse oximetry and standard ECG to detect any arrhythmia. An external defibrillator was available. The S-ICD was evaluated prior and immediately after the scan to verify proper functioning. Patients were also asked to report immediately any pain, torqueing movement, or heating sensation in the area of pocket or electrode. They were also questioned immediately following the MRI to assess any discomfort around the can or electrode.

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Tandem Troponin-BNP Readings Predict CRT Outcomes in Heart Failure
Tandem measurements of cardiac troponin T (TnT) and brain-type natriuretic peptide (BNP) provide insight into how well patients scheduled for cardiac resynchronization therapy (CRT) will do at 12 months, suggests a multicenter, prospective study published online in Pacing and Clinical Electrophysiology Journal. Classification of patients into high-, intermediate-, and low-risk categories based on the initial biomarkers significantly predicted mortality and risk of heart-failure hospitalization. The study stratified 267 patients at 32 centers, prior to implantation of biventricular pacemakers with defibrillators (CRT-D), into three risk groups based on whether TnT was detectable and BNP elevated. A detectable TnT meant >0.01 ng/mL, whereas an elevated BNP was defined as >440 pg/mL. Patients were defined as high risk when they had both a detectable TnT and a high BNP; intermediate risk if they had either a detectable TnT or a high BNP and low-risk if they had an undetectable TnT and a low BNP. Most of the cohort consisted of men, their mean LVEF was 25%, and just over half had ischemic cardiomyopathy; their mean QRS interval was 155 ms. Within the first year of follow-up, there were 13 deaths and 25 first hospitalizations for heart-failure events among 19 patients. Patients in both the high and the intermediate categories of biomarker risk had significantly worse survival at 1 year than those categorized in the low-risk group (P <0.001). In the multivariate model containing risk group, age, NYHA class, ejection fraction, and QRS duration, the risk group into which patients had been initially categorized retained its independent predictive power for death or HF hospitalization, with a hazard ratio (HR) of 7.34 (95% CI 2.48–021.69) for the high-risk group compared with the low-risk group and 2.50 (95% CI 1.04–6.04) for the intermediate-risk group compared with the low-risk group (P =0.001 for both comparisons). Risk group at baseline was not associated with response to CRT or with likelihood of defibrillator shocks, the authors point out.

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