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January 26, 2015

Benefit of paclitaxel-coated balloon maintained at 5 years (THUNDER study)
Use of a paclitaxel-coated balloon was associated with reduced late lumen loss, binary stenosis and target lesion revascularization at 5-year follow-up according the results of THUNDER study which published in JACC Interventions. Researchers for the THUNDER trial reported 5-year follow-up data on patients with femoropopliteal arteries that were treated with paclitaxel-coated balloons (PCB), angioplasty with paclitaxel in contrast medium or no paclitaxel. The primary outcome of the trial was late lumen loss at 6 months. Freedom from TLR, binary restenosis rate and amputation served as secondary endpoints. The present study evaluated outcomes in patients treated with PCB vs. control, and analyzed late lumen loss at 6 months and TLR up to 5 years based on sex and lesion length. According to the results, the cumulative incidence of TLR was significantly lower in the PCB group compared with the control group during the 5-year follow-up (21% vs. 56%; P=.0005). The researchers also examined patients with angiographic and duplex sonographic follow-up at 5 years (n=31). In those patients, the binary restenosis rate was lower for the PCB group compared with the control group (17% vs. 54%; P=.04). Eight of 54 evaluable patients (15%) died between 24 months and 5 years (12.5% of control group, 16.7% of PCB group). Late lumen loss at 6 months was significantly lower in the PCB group (0.4 ± 1.2 mm vs. 1.7 ± 1.8 mm; P<.001). At 12 months, mean late lumen loss was determined in 69% of the PCB group and 67% of the control group. TLR was performed before 12-month re-angiography in two patients in the PCB group and 14 in the control group. The researchers reported a significant difference in favor of the PCB group (0.7 ± 1.5 mm vs. 1.9 ± 1.9 mm; P=.01). Analysis by sex revealed a similar rate of late lumen loss at 6-month follow-up between men and women in the control group (1.76 mm vs. 1.61 mm) and PCB group (0.42 mm vs. 0.37 mm). However, at 5 years, the cumulative rate of TLR was lower after treatment with a PCB in men compared with women (17% vs. 38%). The cumulative 5-year TLR rate in the control group was higher for men (71% vs. 52%).

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Statin therapy benefited real-world patients with heart failure with reduced EF
Statin use was associated with improved survival in a registry population of patients with HF with reduced ejection fraction in a study published in Circulation Heart Failure. Previously, statin use was not associated with improved outcomes in patients with HF with reduced ejection fraction (HFrEF) in randomized controlled trials, but the issue had not been studied in an unselected population, or studied in relation to ischemic heart disease, according to the study background. Researchers for the new study analyzed 21,684 patients from the Swedish Heart Failure Registry with HFrEF (mean age, 72 years; 29% women). The cohort included 47% who were treated with statins. The researchers estimated propensity scores for treatment with statins for each patient; 42 baseline characteristics served as independent variables and statin treatment served as the dependent variable. Association between statin use and outcomes were assessed in a 1:1 population match based on propensity score and age. The primary outcome was all-cause mortality. Secondary outcomes included CV mortality, hospitalization for HF and combined all-cause mortality or CV hospitalization. In the matched population, 1-year survival was better for patients treated with statins (83% vs. 79%; HR=0.81; 95% CI, 0.76-0.86). The same was true in the unmatched population after adjustment for propensity score and age (statin group, 85%; no-statin group, 79%; HR=0.84; 95% CI, 0.8-0.89). Survival rates also were higher at 3 years for patients treated with statins (unmatched population, 68% vs. 60%; matched population, 65% vs. 58%) and 5 years (unmatched population, 53% vs. 48%; matched population, 51% vs. 45%). Ischemic heart disease was the only baseline variable that interacted with statin use (P=.001). According to the researchers, patients with ischemic heart disease had better survival rates if on statin treatment (HR=0.76; 95% CI, 0.7-0.82), but statin use did not affect survival rates in those without ischemic heart disease (HR=0.95; 95% CI, 0.85-1.07). Statin use was also associated with lower CV mortality (HR=0.8; 95% CI, 0.75-0.87), HF hospitalization (HR=0.92; 95% CI, 0.86-0.97) and all-cause mortality plus CV hospitalization (HR=0.9; 95% CI, 0.86-0.95), according to the results.

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ACC announces late-breaking clinical trials slated for presentation at annual meeting
The American College of Cardiology has announced the line-up of late-breaking clinical trials and featured clinical research at the Annual Scientific Session and Expo, held March 14 to 16 in San Diego. According to the ACC, the meeting will highlight five late-breaking clinical trial sessions; two featured clinical research sessions; a “Deep Dive” session to address key elements of the late-breaking clinical trials and implications for patients and practice; and much more. Some of the late-breaking clinical trials slated for presentation include: PROMISE: A randomized comparison of anatomic vs. functional strategies for diagnostic testing in symptomatic patients with suspected CAD. PEGASUS-TIMI 54: A randomized comparison of ticagrelor vs. placebo on a background of aspirin for the prevention of CV events in patients with prior MI. OLSER-1 and 2: Two trials designed to assess the impact of evolocumab on CV outcomes. REGULATE-PCI: A randomized comparison of the REG1 anticoagulation system vs. bivalirudin in patients undergoing PCI. 5-year outcomes of the PARTNER 1 trial, which assessed transcatheter vs. surgical aortic valve replacement. 2-year outcomes of the CoreValve US Pivotal High Risk Trial, which compared self-expanding transcatheter and surgical aortic valve replacement in patients with severe aortic stenosis at high surgical risk. BEST: A comparison of everolimus-eluting stents and bypass surgery in patients with multivessel CAD. Other research scheduled for presentation during featured clinical research sessions include an assessment of dual antiplatelet therapy for longer than 1 year among patients with ACS treated with coronary stents; additional data from IMPROVE-IT on the effect of ezetimibe and simvastatin vs. simvastatin alone on CV events after ACS; the AUGMENT-HF trial of the Algisyl-LVR device with standard medical therapy among patients with advanced HF.

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January 19, 2015

Macitentan linked to decreased hospitalization risk in npatients with pulmonary hypertension (SERAPHIN stydy)
Treatment with a 10 mg dose of macitentan significantly decreased the risk for and prevalence of all-cause hospitalization among patients with symptomatic pulmonary arterial hypertension, according to findings from the SERAPHIN study which published in JACC Heart Failure Journal. This decrease was driven by a reduction in the risk and rate of hospitalizations due to pulmonary arterial hypertension (PAH) specifically according to the authors. In a multicenter, double-blind, event-driven phase 3 trial, researchers randomly assigned 742 patients aged 12 years or older with symptomatic PAH to receive placebo (n=250), macitentan 3 mg (n=250) or macitentan 10 mg (n=242) once daily until a patient experienced a primary endpoint event or a total of 285 events had occurred across the population (median 115 weeks). The researchers assessed the effects of both macitentan (Opsumit, Actelion Pharmaceuticals) doses on the risk for, rate and duration of all-cause and PAH-specific hospitalization compared with placebo. The effect on the risk for and causes of non-PAH-related hospitalizations were also evaluated. Patients were collected from a total of 151 centers across 39 countries. The cohort was 76.5% female and had a mean age of 45.6 ± 16.1 years. In the 3 mg macitentan group, researchers observed a nonsignificant decrease in the risk for all-cause hospitalization (HR=0.911; 95% CI, 0.623-1.057), while the all-cause hospitalization rate was significantly reduced by 20.5% compared with placebo (P=.0378). The mean number of hospital days for all-cause hospitalization was also 30.6% lower in this group (P=.0278) vs. placebo recipients. Risk for PAH-specific hospitalization was 42.7% lower in the 3 mg group (HR=0.573; 95% CI, 0.405-0.811), while the hospitalization rate was 44.5% lower (P=.0004) and the mean number of PAH-related hospital days decreased by 53.3% (P=.0001) compared with placebo. In the 10 mg macitentan group, risk for all-cause hospitalization was significantly lower (HR=0.677; 95% CI, 0.514-0.891), and researchers also noted a significant 33.1% reduction in the rate of all-cause hospitalization (P=.0005) compared with placebo. The mean number of hospital days decreased by 31% (P=.0336). Risk for PAH-specific hospitalization decreased by 51.6% among these patients (HR=0.484; 95% CI, 0.337-0.697), while the hospitalization rate decreased by 49.8% (P<.0001) and the number of PAH-related days in hospital were reduced by 52.3% (P=.0003) compared with placebo.

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Antidote to novel oral anticoagulant ( Factor Xa inhibitors) met primary endpoint (ANNEXA-R study)
It was announced the topline results of the phase 3 ANNEXA-R study demonstrating that andexanet alfa, an antidote to the anticoagulant effects of Factor Xa inhibitors, met the primary endpoint with high statistical significance. IV bolus of andexanet alfa was associated with significant and immediate reversal of the anticoagulant activity of rivaroxaban in the first part of the ANNEXA-R study. Andexanet alfa also was well tolerated. The first part of this study included 41 healthy volunteers aged 50 to 75 years who received 20 mg once-daily rivaroxaban for 4 days followed by random assignment to placebo (n=14) or an 800 mg IV bolus of andexanet alfa (n=27). The primary endpoint was anti-Factor Xa levels. It is expected that the full data set will presented at the American College of Cardiology Scientific Sessions in March. The second, ongoing part of the ANNEXA-R study will include 40 healthy volunteers who will receive 20 mg once-daily rivaroxaban for 4 days and will then be randomly assigned to placebo or an 800 mg IV bolus of andexanet alfa followed by a continuous infusion of 8 mg/min for 120 minutes. Data from the second part of this study are anticipated in mid-2015.

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Biomarker May Predict Best Smoking Cessation Treatment
A genetic biomarker may help predict response to specific smoking cessation treatments, new research published online in Lancet Respiratory Medicine suggests. A multicenter, randomized controlled trial (RCT) of more than 1200 smokers showed that those who had a normal nicotine metabolite ratio had significantly higher quit rates after receiving varenicline for 11 weeks than those receiving a nicotine patch. Although for those who metabolized nicotine slowly, the efficacy of both treatments was equivalent, there were significantly more overall side effects with varenicline. The investigators note that because effectiveness and adverse effects vary widely among pharmacotherapies for treating tobacco dependence, they wanted to examine whether biomarkers in individual smokers could improve outcomes. "The NMR reflects the activity of the liver enzyme CYP2A6, the major nicotine-metabolizing and cotinine-metabolizing enzyme," the researchers report, adding that NMR also reflects both environmental and genetic effects ― unlike CYP2A6 genotyping. The RCT included 1246 adult smokers seeking treatment at one of four North American sites between November 2010 and September 2014. NMR status was determined at baseline through blood samples; 662 of the participants were found to be slow metabolizers of nicotine, and 584 found to be normal metabolizers. The slow metabolizers were less likely than normal metabolizers to be white (P < .0001) and more likely to be male (P = .001), younger (P = .02), and to smoke fewer cigarettes per day (P < .001). Results showed that normal metabolizers had more success with varenicline than with the patch at end of treatment (odds ratio [OR], 2.17; 95% confidence interval, 1.38 - 3.42; P = .001) and 6 months later (OR, 1.81; 95% CI, 1.05 - 3.11; P = .03). Quit rates at end of treatment in this group were 38.5% and 22.5%, respectively; at 6 months, the rates were 22.0% and 13.6%. There was no difference between varenicline and patch for the slow metabolizers at any time point. Although the quit rates were 30.4% and 27.7%, respectively, at end of treatment and 19.1% and 21.6, respectively, at 6 months, these were not significant. However, according to NMR-by-treatment interactions, for the slow metabolizers, side effects were more severe overall with varenicline than with placebo (P = .04). These differences included increases in nausea (P = .0003) and abnormal dreams (P = .005). The NMR-by-treatment interaction was not significant for side effects from the patch vs placebo. Finally, the number needed to treat was 4.9 for varenicline and 26.0 for nicotine patch in the normal metabolizers and 8.1 vs 10.3 in the slow metabolizers

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January 12, 2015

Hospital-acquired infections after cardiac surgery linked to cost, length of stay, readmission
Hospital cost, length of stay and readmissions were strongly associated with hospital-acquired infections following cardiac surgery, according to data from a new study published in JACC. In this study was investigated the cost associated with major types of hospital-acquired infections within 2 months after cardiac surgery. The researchers prospectively collected data from an observational study in which patients (n=4,320; mean age, 64 years; 66% men) were monitored for infection for 65 days after cardiac surgery, and merged that data with routinely collected financial data. The 2.8% of patients experienced a major hospital-acquired infection during index hospitalization. The most common major infections were pneumonia (48%), sepsis (20%) and Clostridium difficile colitis (18%). The estimated annual cost associated with an infection was $38,000, with 47% of that amount related to ICU services, according to the researchers. They found that on average, the length of stay of patients who had a major hospital-acquired infection was 14 days longer than those who did not. They also found that of the 849 readmissions in the study population, 8.7% were related to major hospital-acquired infections. The cost of readmissions due to infection was approximately threefold higher than the cost of readmissions due to other reasons, according to the researchers.

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Niacin lowered PCSK9 levels
Niacin is associated with a reduction in PCSK9 levels, according to a new study published in Am. J. Cardiol and this association could help explain how niacin reduces LDL, and could offset increases in PCSK9 levels associated with other lipid-lowering therapies. The researchers conducted three studies to determine the dose-dependence effects of statins on PCSK9 levels, to assess the effect of a fibrate on PCSK9 levels when added to a statin, and to investigate the impact of niacin on PCSK9 levels on the background of statin and/or fibrate therapy. In the first study, 74 people with hyperlipidemia were randomly assigned atorvastatin 10 mg/day, atorvastatin 80 mg/day or placebo for 16 weeks. They found that PCSK9 levels were increased in a dose-dependent fashion with statin therapy compared with placebo (placebo, mean increase 7%; 95% CI, –7 to 21; atorvastatin 10 mg/day, mean increase 19%; 95% CI, –5 to 42; atorvastatin 80 mg/day, mean increase 27%; 95% CI, 12-42; P=.02 vs. placebo). In the second study, 70 patients with carotid atherosclerosis were randomly assigned simvastatin 20 mg/day, simvastatin 80 mg/day or simvastatin 20 mg/day plus extended-release niacin 2 g/day for 12 months. The researchers found that PCSK9 levels increased with statin therapy (simvastatin 20 mg/day, mean change 13%; 95% CI, –14 to 40; simvastatin 80 mg/day, mean change 41%; 95% CI, 27-76; P<.0001), but that PCSK9 decreased with combination simvastatin/niacin therapy (mean change –13%; 95% CI, –3 to –23). In a third, open-label lipid kinetics study, 19 people with dyslipidemia were treated with atorvastatin 10 mg/day for 4 weeks, followed by the addition of fenofibric acid 135 mg/day for 8 weeks, and then the further addition of extended-release niacin 2 g/day for 10 weeks. Adding fenofibric acid led to a 23% (95% CI, 10-36) increase in PCSK9 (P=.001), but the addition of niacin resulted in a subsequent 17% (95% CI, –19 to –5) decrease in PCSK9 (P=.004), according to the researchers. They also found a positive association between changes in PCSK9 levels and changes in LDL levels (P=.006) induced by the addition of niacin.

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Elevated blood glucose linked to early death, other events in patients with acute HF
Slight elevation in blood glucose was associated with early mortality, future diabetes and future hospitalization among patients with acute HF, even those without diabetes, in a recent study published in Eur. Heart J. In a competing-risk analysis, the researchers evaluated 30-day mortality, new diabetes diagnoses and hospitalization outcomes in a population-based cohort of 16,524 patients (median age, 79 years; 49% men) who presented with acute HF in Ontario, Canada, between 2004 and 2007. Patients were stratified by concentration of blood glucose at presentation: 3.9 mmol/L to 6.1 mmol/L, >6.1 mmol/L to 7.8 mmol/L, >7.8 mmol/L to 9.4 mmol/L, >9.4 mmol/L to 11.1 mmol/L and >11.1 mmol/L. Evaluated outcomes included death at 30 days and 1 year after presentation, CV readmissions, HF readmissions, diabetes-related hospitalizations among patients with pre-existing diabetes and new diabetes diagnoses in those without pre-existing diabetes. Among 9.275 patients without diabetes, blood glucose >6.1 mmol/L at presentation was associated with increased risk for all-cause mortality (HR range=1.26 [95% CI, 1.05-1.5] to 1.5 [95% CI, 1.11-2.02]) and CV-related death (HR range=1.28 [95% CI, 1.03-1.59] to 1.64 [95% CI, 1.16-2.33]). Among 7,249 patients with diabetes, blood glucose >11.1 mmol/L at presentation was associated with increased risk for all-cause mortality (HR=1.48; 95% CI, 1.1-2) and diabetes-related hospitalization (HR=1.39; 95% CI, 1.2-1.61). In all patients, blood glucose >9.4 mmol/L at presentation was associated with increased risk for HF- or CV-related hospitalization (HR range=1.09 [95% CI, 1.02-1.17] to 1.15 [95% CI, 1.07-1.24)]. Among those without diabetes at baseline, the risk for diagnosis of incident diabetes increased with the level of blood glucose at presentation (HR range=1.61 [95% CI, 1.39-1.87] for >6.1-7.8 mmol/L to 3.61 [95% CI, 2.78-4.68] for >11.1 mmol/L).

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December 21, 2014

Higher fitness level reduced hypertension risk
People with high fitness levels may be less likely to have or develop hypertension, regardless of baseline risk factors, according to new findings from a study published in Journal of American Heart Association (JAHA). The researchers analyzed the association between fitness and hypertension in 57,284 participants from the Henry Ford Exercise Testing (FIT) Project, which was conducted between 1991 and 2009. The participants’ mean age was 53 years, 49% were women and 29% were black. They measured participants’ fitness via a clinician-referred treadmill stress test. Physical fitness was expressed in metabolic equivalents (METs) and was based on the workload derived from the maximal speed and grade achieved during total treadmill time. Participants were stratified into four groups: <6 METs, 6 to 9 METs, 10 to 11 METs and ≥12 METs. The primary outcomes were prevalent hypertension, defined as prior or baseline diagnosis of hypertension and use of antihypertensive medications, and incident hypertension, defined as a new diagnosis of hypertension confirmed by at least three separate consecutive encounters. The ≥12 METs group had lower odds of prevalent hypertension compared with the <6 METs group (adjusted OR=0.73; 95% CI, 0.67-0.8). During a median follow-up period of 4.4 years (interquartile range, 2.2-7.7), 36.4% of the 22,109 participants without hypertension at baseline were diagnosed with hypertension, according to the researchers. Unadjusted 5-year incidence rates were 49% for participants with <6 METs, 41% for those with 6 to 9 METs, 30% for those with 10 to 11 METs and 21% for those with ≥12 METs. After adjustment, participants with ≥12 METs had a 20% lower risk for incident hypertension compared with those with <6 METs (HR=0.8; 95% CI, 0.72-0.89). The results were consistent across age, sex, race, obesity, resting BP and diabetes status.

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Late Post-TAVR Bleeding Linked With Significant Mortality Risks (PARTNER subanalysis)
Nearly 6% of patients undergoing transcatheter aortic-valve replacement (TAVR) will experience a late major bleeding complication, and these bleeding events are associated with a significantly increased risk of death, according to a new analysis of the PARTNER study published in JACC. Between 30 days and one year, major late bleeding complications occurred in 142 of 2401 patients (5.9%) undergoing TAVR, the most common complication being gastrointestinal bleeds, neurological bleeds, and bleeding resulting from a traumatic fall. Individuals with late bleeding were nearly four times more likely die between 30 days and 1 year, report investigators. The researchers also identified significant predictors of late bleeding. These included the presence of low hemoglobin levels at baseline, atrial fibrillation or flutter at baseline, the presence of a moderate or severe paravalvular leak at 30 days, and a larger left ventricular mass at 30 days. The median time between the procedure and the late major bleeding event was 132 days. Gastrointestinal bleeding occurred in 40.8% of patients, neurological bleeding occurred in 15.5% of patients, and falls or trauma were responsible for bleeding in 7.8% of patients. Access-site bleeding related to the procedure occurred in 2.1% of patients.

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Confounding factors may partially explain results of SYMPLICITY HTN-3
Post-hoc analyses derived from patient subgroups indicated several potential confounding factors that may help explain the unexpected BP results in the control and intervention groups from the SYMPLICITY HTN-3 trial, researchers reported. They performed post-hoc analyses to identify predictors of systolic BP change, examine the influence of medication changes, review results from selected subgroups and assess procedural factors and they published online in Eur. Heart Journal their results. They found that 39% of patients underwent medication changes between randomization and 6 months. Predictors of reduction in office systolic BP in both groups included a baseline office systolic BP ≥180 mm Hg, use of aldosterone antagonists and nonuse of vasodilators. In the renal denervation group, number of ablations also was identified as a predictor. The treatment effect of renal denervation was more pronounced in nonblack patients compared with black patients, according to the study. Nonblack patients assigned renal denervation had a greater reduction in office systolic BP at 6 months compared with nonblack patients assigned the sham procedure (–15.2 mm Hg vs. –8.6 mm Hg; P=.012). When the groups were propensity-score matched by baseline characteristics, differences in office systolic BP, ambulatory systolic BP and heart rate increased with a rising number of ablations in the treatment group; it was statistically significant for office systolic BP (P for trend=.01) and heart rate (P for trend<.01), as well as for ambulatory systolic BP in patients who received 12 or 13 ablations (P=.002). A similar but nonsignificant trend was observed in patients who had delivery of ablations in a four-quadrant pattern to at least one renal artery.

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December 15, 2014

Dual-chamber settings in ICDs reduced risk for inappropriate shock (OPTION study)
Compared with single-chamber settings, dual-chamber settings for implantable cardioverter defibrillators were associated with reduced risk for inappropriate shock without increases in morbidity and mortality, according to the results of the OPTION study which published in JACC Heart Failure Journal. According to the study background, use of dual-chamber ICDs may allow better discrimination of supraventricular arrhythmias and therefore reduce inappropriate shocks, but also may be linked to detrimental ventricular pacing. In the study were enrolled 462 patients with de novo primary or secondary prevention indications for ICD placement and left ventricular ejection fraction ≤40% despite an optimal pharmacotherapy regimen in the single blind OPTION trial. Patients received atrial leads and dual-chamber defibrillators) that were randomly assigned to programming with single- or dual-chamber settings. The primary outcomes were time to first occurrence of inappropriate ICD shock and occurrence of all-cause death or CV hospitalization, defined as hospitalization for congestive HF, symptomatic atrial fibrillation, cardioversion of AF, stroke and undetected/untreated ventricular tachycardia. Follow-up was 27 months. During the study period, time to first inappropriate shock was longer in the dual-chamber group than the single-chamber group (HR=2.5; 95% CI, 1.2-5.3). Inappropriate shocks were received by 4.3% of those in the dual-chamber group vs. 10.3% in the single-chamber group (P=.015). Rates of all-cause death or CV hospitalization were 20% for the dual-chamber group vs. 22.4% for the single-chamber group, satisfying the predefined margin for equivalence (P for equivalence <.001), according to the researchers. There were no significant differences between the groups in system-related complications.

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Higher insulin dosage for type 2 diabetes may increase mortality risk
Patients with type 2 diabetes taking exogenous insulin could be at increased risk for death from all causes, major adverse cardiovascular events and cancer with increasing dosage, according to research published in Diabetes, Obesity and Metabolism. There was an association between the dose of prescribed insulin and increased risk of all-cause mortality. A statistically significant association with major adverse cardiovascular events and cancer was also observed. Using the UK Clinical Practice Research Datalink, the researchers identified 6.484 patients (mean age at baseline, 64 years) with type 2 diabetes who progressed to insulin monotherapy from 2000 onward and followed them for an average of 3.3 years. Risks of progression to serious adverse outcomes — all-cause mortality, incident major adverse cardiovascular events (MACE) and incident cancer — were compared using Cox proportional hazards models. Insulin exposure as a cumulative, continuous, annually updated, time-dependent covariable was introduced into the model as prescribed international units per kilogram per day; results were reported in four patient groups, defined by the doses ranging from <0.5 units per kilogram of bodyweight per day, up to doses >1.5 units. The analysis of medical history showed 1,110 deaths, 342 MACE and 382 incident cancers. Unadjusted event rates, per 1,000 person-years, were 61.3 deaths, 26.4 incident MACE and 24.6 incident cancers. Adjusted HRs, relative to 1-unit increases in insulin dose, were 1.54 (95% CI, 1.32-1.78) for all-cause mortality, 1.37 (95% CI, 1.05-1.81) for MACE and 1.35 (95% CI, 1.04-1.75) for cancer. When compared to patients who received doses of less than 0.5 units, our findings indicate that patients receiving doses of between 1 to 1.5 units and more than 1.5 units were associated with a much greater death rate over time.

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Cataracts From Statins? More Signals Emerge in Analyses
Statin therapy significantly elevates the risk of developing cataracts severe enough to warrant surgery, suggests analyses of two distinct cohorts, one from Canada and another from the US, that add to a hazy landscape of prior studies variously concluding for or against such a risk for the widely used drugs. For now, the possibility of such a risk from statins and its potential mechanisms should be explored in prospective trials, "especially in light of increased statin use for primary prevention of cardiovascular disease and the importance of acceptable vision in old age, when cardiovascular disease is common," according to the report, published in the December 2014 issue of the Canadian Journal of Cardiology. One of the cohorts consisted of men and women who went to ophthalmologists from 2000 to 2007, as recorded in British Columbia Ministry of Health databases. Cases consisted of 162 501 patients who during follow-up became candidates for surgery to correct cataracts; they were matched on the basis of age and follow-up time with 650 004 control subjects with no such history of cataracts. Together, their mean age was 73 years and they were followed for about 1.7 years. For this group, the relative risk (RR) of cataracts severe enough for surgery associated with statin use for at least a year was 1.27 (95% CI 1.24–1.30) adjusted for age, follow-up time, sex, and cataract risk factors prior to cohort entry, including diabetes, hypertension, glaucoma, MI or stroke, and treatment with steroids or selective serotonin reuptake inhibitors (SSRIs). The adjusted RR for lovastatin was 1.14 (95% CI 1.04–1.26) and for rosuvastatin (Crestor, AstraZeneca) was 1.42 (95% CI 1.27–1.59), with risks for other statins falling in between. The other cohort derived from USA and included men aged 40 to 85 years (mean about 72 years) seen from 2001 to 2011; the 45 065 patients who developed cataracts made up the cases and 450 650 subjects with no history of cataracts were the controls. Follow-up averaged 1.9 years. The similarly adjusted RR for surgery-indicated cataracts associated with at least a year of statin therapy was 1.07 (95% CI 1.04–1.10). The RRs ranged from 1.03 for fluvastatin to 1.14 for lovastatin and reached significance for the latter agent and simvastatin, atorvastatin, and use of more than one statin; the risk was nonsignificant for pravastatin and rosuvastatin as well as fluvastatin.

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December 08, 2014

NSAIDs linked to bleeding, thromboembolism risk in AF
The use of nonsteroidal anti-inflammatory drugs is associated with an increased risk for serious bleeding and thromboembolism among patients with atrial fibrillation, according to recent findings of an observational cohort study which published in the Ann. Int. Med. Journal In this study, the researchers reviewed data on 150,900 patients collected from a nationwide registry in Denmark. All patients were aged at least 30 years (median age, 75 years) and had been hospitalized with a first-time diagnosis of AF between 1997 and 2011. The cohort was 47% female. Use of the following treatment regimens was recorded: single-antiplatelet therapy with aspirin or clopidogrel; monotherapy with an oral anticoagulant, or dual therapy with an oral anticoagulant and a single antiplatelet. NSAID use also was recorded. The primary outcome was serious bleeding, defined as hospitalization or death due to intracranial, gastrointestinal or respiratory/urinary tract bleeding, or anemia resulting from bleeding during a median follow-up of 6.2 years. Secondary endpoints included death or hospitalization due to thromboembolism, along with all-cause mortality. Patients received an antiplatelet or oral anticoagulant at baseline in 69.8% of cases, whereas 5% received a concomitant NSAID. During follow-up, 35.6% of the patients were prescribed an NSAID. Serious bleeding events occurred in 11.4% of patients, and 13% experienced thromboembolism. Death occurred in 48.8% of the population, and 12.4% of observed bleeding events were fatal. At 3 months, the absolute risk for serious bleeding within 14 days of taking an NSAID was 3.5 events per 1,000 patients vs. 1.5 events per 1,000 patients among those who did not take an NSAID (risk difference, 1.9 events per 1,000 patients). Among patients placed on a regimen of oral anticoagulants, the difference in absolute risk compared with those on NSAIDs was 2.5 events per 1,000 patients. Risk for serious bleeding (HR=2.27; 95% CI, 2.15-2.4) and thromboembolism (HR=1.36; 95% CI, 1.27-1.45) was associated with NSAID use compared with nonuse across all antithrombotic regimens and NSAID types. Risk for all-cause mortality was significantly increased among concomitant NSAID users. Among patients hospitalized for a nonfatal bleeding incident, prognosis was poorer among those with NSAID exposure at the time of the event (HR=1.22; 95% CI, 1.12-1.33). An NSAID dosage exceeding the minimum recommended dose further increased bleeding risk, the researchers wrote, even with short-term NSAID use.

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Early valve surgery did not affect mortality in S. aureus endocarditis
Early valve surgery did not reduce 1-year mortality among patients with Staphylococcus aureus prosthetic valve infective endocarditis, according to recent study published in Clinical Infectious Diseases Journal. The researchers examined data from the International Collaboration on Endocarditis – Prospective Cohort Study. There were 5,668 cases prospectively recorded from January 2000 to December 2006. The researchers excluded cases in IV drug users, cases of right-sided valve infective endocarditis or native valve infective endocarditis and cases with missing data. Among the 747 patients with left-sided prosthetic valve infective endocarditis (PVIE), 168 were due to S. aureus and underwent evaluation. Patients who had early valve surgery (44.3%) showed lower 1-year mortality rate than patients who did not receive early valve surgery (33.8% vs. 59.1%; P=.001). However, the association did not persist in a multivariate, propensity-adjusted model (RR=0.67; 95% CI, 0.39-1.15). The researchers identified three variables associated with 1-year mortality: age (per 1-year increment, HR=1.03; 95% CI, 1.01-1.05), stroke (time-dependent HR=2.56; 95% CI, 1.62-4.05) and congestive heart failure (HR=2.06; 95% CI, 1.29-3.3).

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Rosuvastatin failed to reduce fracture risk in JUPITER analysis
Rosuvastatin was not associated with a reduced risk for fracture in men and women with elevated high-sensitivity C-reactive protein enrolled in the JUPITER trial according to a new study published online in JAMA Int. Med. Previous observational studies have suggested a link between statin use and reduced risk for fractures, possibly because inflammation can play a role in both CVD and osteoporosis; however, there was little evidence from randomized trials, according to the study background. The researchers analyzed participants from the JUPITER trial, which enrolled 17,802 men aged 50 years or older and women aged 60 years or older with high-sensitivity CRP ≥2 mg/L. Participants were randomly assigned rosuvastatin (Crestor, AstraZeneca) 20 mg/day or placebo and were observed for up to 5 years. Median follow-up was 1.9 years. Incident fracture was a prespecified secondary endpoint of the JUPITER trial. Overall, 431 incident fractures occurred during the study period. Of those, 221 occurred in the rosuvastatin group and 210 in the placebo group. The incidence of fracture was 1.2 per 100 person-years in the rosuvastatin group vs. 1.14 per 100 person-years in the placebo group (adjusted HR=1.06; 95% CI, 0.88-1.28).

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December 01, 2014

Non–infarct-related artery disease common in patients with STEMI
Results from a retrospective pooled analysis of eight clinical trials which published in JAMA suggest that obstructive non–infarct-related artery disease is common in patients who present with STEMI, and it may increase the risk for 30-day mortality. Researchers evaluated data on 68,765 patients extracted from eight independent, international, randomized clinical trials of STEMI published from 1993 to 2007. They examined demographics, clinical risk factors, comorbidities, cardiac manifestations, hemodynamic status and left ventricular function, angiographic information regarding infarct-related artery disease and non–infarct-related artery disease for each vessel territory, in-hospital medications and mortality data. Angiographic data were available for 28,282 patients. The primary outcome was all-cause mortality within 30 days after STEMI. Obstructive non–infarct-related artery disease was found in 52.8% of patients (n=14,929). Of those, 29.6% involved a single vessel and 18.8% involved two vessels, according to the results. The researchers reported no difference in the degree or distribution of non–infarct-related artery disease based on the infarct-related artery territory. In unadjusted and adjusted analyses, patients with non–infarct-related artery disease had significantly higher rates of 30-day mortality compared with patients without non–infarct-related artery disease (unadjusted: 4.3% vs. 1.7%; P<.001; adjusted: 3.3% vs. 1.9%; P<.001).

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Cardiac troponin I levels predicted STEMI outcomes (PROTECTION AMI study)
In a new analysis published online in Circulation, researchers reported an independent association between measurement of cardiac troponin I levels after primary PCI for STEMI and clinical outcomes and cardiac function. Circulating levels of cardiac troponin I after STEMI have been linked to infarct size and chronic left ventricular dysfunction; however, there are fewer data on how cardiac troponin I levels affect clinical endpoints and biochemical markers of global cardiac function, according to background information in the study.The post-hoc analysis included 1,066 participants who received primary PCI in the PROTECTION AMI trial. Cardiac troponin I levels were measured at several points during the index hospitalization. At 3 months, the patients were reassessed for N-terminal pro–B-type natriuretic peptide and LV ejection fraction. Upon admission, the median cardiac troponin I level was 0.4 mcg/L. This increased to 33.1 mcg/L after 16 to 24 hours and 9.1 mcg/L at 70 to 80 hours, according to the results. Adjusted analysis indicated independent associations between all post-PCI single-points, peak and area under the curve with clinical events, NT-proBNP >118 pmol/L and LVEF <40% (P<.001 for all). The researchers added circulating cardiac troponin I to the baseline risk model with the aim of predicting clinical events. This addition was associated with an improvement in C-statistic of 0.779 to 0.846 at 16 to 24 hours and 0.859 at 70 to 80 hours. When the researchers quantified the improvement by integrated discrimination improvement, they observed a significant increase in predictive ability (relative integrated discrimination improvement: 44% to 154%; P<.001) with the addition of cardiac troponin I to the model. They also reported significant improvements in discrimination of NT-proBNP >118 pmol/L and LVEF <40%, according to the results.

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Beta-blockers lowered all-cause mortality in patients with heart failure with preserved ejection fraction
Patients with HF with preserved ejection fraction who received treatment with beta-blockers had lower rates of all-cause mortality, according to new study data which published in JAMA. However, the same trend was not observed with beta-blocker use and combined all-cause mortality and hospitalization for HF in this patient population. The researchers reviewed data on 41.976 consecutive patients with clinician-judged HF enrolled in the Swedish Heart Failure Registry from July 1, 2005, to Dec. 30, 2012. For this study, HFpEF was defined as EF of ≥40%. In total, 19.083 patients had HFpEF. Patients with HFpEF were matched 2:1 for beta-blocker use.The overall patient population was followed for a median of 755 days and the matched cohort was followed for a median of 709 days. Among the patients with HFpEF, those treated with beta-blockers had a 1-year survival rate of 80% compared with 79% for those who were untreated. The 5-year survival rate was 45% in the treated group vs. 42% in the untreated group. Overall, 2.279 total deaths (41%; 177 per 1,000 patient-years) occurred in patients with HFpEF treated with beta-blockers vs. 1,244 total deaths (42%; 191 per 1,000 patient-years) in the patients who were untreated (HR=0.93; 95% CI, 0.86-0.996). The researchers found no reduction in combined mortality or HF hospitalization related to beta-blocker use. The treated group experienced 3,368 (61%) total first events vs. 1,753 (64%) total first events in the untreated group. There were 371 first events per 1,000 patient-years in the treated group vs. 378 first events per 1,000 patient-years in the untreated group (HR=0.98; 95% CI, 0.92-1.04). The authors also studied 22,893 patients with HF with reduced EF (HFrEF) for a positive-control consistency analysis. Of those, 6,081 were matched (4,054 treated patients, 2,027 untreated patients). In the matched group of patients with HFrEF, the researchers observed an association between beta-blocker use and decreased mortality (HR=0.89; 95% CI, 0.82-0.97) and with reduced combined mortality or HF hospitalization (HR=0.89; 95% CI, 0.84-0.95).

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November 24, 2014

Η Γερουσία των ΗΠΑ διεξάγει έρευνα για την απότομη αύξηση της τιμής των γενοσήμων φαρμάκων
Η απότομη αύξηση του κόστους των γενόσημων φαρμάκων κατά τη διάρκεια των τελευταίων 18 μηνών είναι στο επίκεντρο ομοσπονδιακής έρευνας και αφορμή για την κατάθεση ενός νέου νομοσχεδίου που κατατέθηκε από ειδική επιτροπή της Γερουσίας των ΗΠΑ. Τον Οκτώβριο, τα μέλη του Κογκρέσου είχαν στείλει επιστολές σε 14 κατασκευαστές γενοσήμων φαρμάκων απαιτώντας μια εξήγηση για την άνοδο των τιμών. Είναι χαρακτηριστικό ότι το κόστος που καλείται να πληρώσει ο ασθενής για την αγορά διγοξίνης οχταπλασιάστηκε, αυξανόμενο από 15$ το περασμένο έτος σε 120$ το 2014. Όπως ανέφερε Αμερικανός αξιωματούχος ένας στους τέσσερις Αμερικανούς δεν μπορεί να λάβει την φαρμακευτική του αγωγή, επειδή δεν μπορεί να αντέξει το κόστος. Σύμφωνα με τα ομοσπονδιακά αρχεία που παρουσιάστηκαν τεκμηριώνεται ότι από τον Ιούλιο του 2013 μέχρι τον Ιούλιο του 2014 σχεδόν στο 10% των γενόσημων φαρμάκων η τιμή υπερδιπλασιάστηκε. Κατά την ίδια περίοδο σε 1.215 γενόσημα φάρμακα η τιμή αυξήθηκε κατά 448%.

CABG outperformed PCI in patients with diabetes
PCI was associated with increases in mortality and a composite of adverse events compared with CABG in patients with diabetes, leading researchers to conclude that CABG may be the preferred revascularization technique in this patient population.Researchers of the retrospective analysis, which was published in the Annals of Internal Medicine, reviewed several databases for randomized controlled trials comparing PCI with drug-eluting or bare-metal stents and CABG in patients with diabetes and multivessel or left main CAD. Forty studies conducted between Jan. 1, 1990 and June 1, 2014 underwent analysis for study design, quality, patient characteristics, follow-up duration and patient outcomes. According to the researchers, the studies were combined using a Bayesian network meta-analysis, which accounted for the variation in stent choice. A composite of all-cause death, non-fatal MI and stroke served as the primary outcome measure. PCI was associated with an increase in this composite outcome (OR=1.33; 95% credible interval [CrI], 1.01-1.65). Mortality also increased with PCI (OR=1.44; 95% CrI, 1.05-1.91), but there was no significant difference in the frequency of MI (OR=1.33; 95% CrI, 0.86-1.95). In addition, there were fewer strokes in the PCI group (OR=0.56; 95% CrI, 0.36-0.88). The researchers noted heterogeneity in study design as a limitation, along with the fact that the mortality findings were largely driven by a single study, and that cost and nonvascular complications did not undergo analysis.

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Co-trimoxazole linked to sudden death in older patients on renin-angiotensin inhibitors
The use of co-trimoxazole increased risk for sudden death among older patients on a regimen of ACE inhibitors or angiotensin receptor blockers, according to recent findings. In a population-based, nested case-control study, researchers evaluated data from 1.601.542 Ontario, Canada, residents aged at least 66 years who had been on a regimen of ACE inhibitor or angiotensin receptor blocker from 1994 to 2011. Researchers reviewed prescription drug claims from the Ontario drug benefit database and acquired hospital admission data from the Canadian Institute for Health Information discharge abstract database. Among 39.879 patients who experienced sudden death within this population, 1.027 occurred within 7 days of receiving one of the following antibiotics: co-trimoxazole, ciprofloxacin, norfloxacin, nitrofurantoin and amoxicillin. For each case of sudden death, up to four age-matched controls were selected who were alive at the index date and had received one of the evaluated antibiotics in the 7 days before the index date (n=3,733). The primary outcome measure was the odds ratio for the correlation between sudden death and exposure to each antibiotic in relation to amoxicillin, which served as the reference drug. Compared with amoxicillin, co-trimoxazole was associated with an increased risk for sudden death within 7 days (adjusted OR=1.38; 95% CI, 1.09-1.76), whereas a weaker association with increased risk for sudden death was observed with ciprofloxacin (adjusted OR=1.29; 95% CI, 1.03-1.62), but not with norfloxacin (adjusted OR=0.74; 95% CI, 0.53-1.02). Researchers noted a reduced risk for sudden death among nitrofurantoin recipients compared with amoxicillin recipients (adjusted OR=0.64; 95% CI, 0.46-0.88). In a supplementary analysis in which sudden death was defined as death within 14 days of antibiotic prescription, 1,827 cases of sudden death were matched to 6,771 controls. The association between sudden death and co-trimoxazole prescription persisted (adjusted OR=1.54; 95% CI, 1.29-1.84 vs. amoxicillin), but no associations were observed with the other evaluated antibiotics. According to the researchers, the link between co-trimoxazole and sudden death may be attributable to co-trimoxazole–induced hyperkalemia in a particularly susceptible population.

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WOSCOPS at 20 Years: Study Shows Lifetime Benefit With 5 Years of Statin Therapy
Twenty-year follow-up of the West of Scotland Coronary Prevention Study (WOSCOPS) has shown that treatment with a statin for 5 years provides a "persistent reduction in cardiovascular disease outcomes" over the course of 2 decades. In the follow-up study, which was presented at the American Heart Association (AHA) 2014 Scientific Sessions, Dr Chris Packard (University of Glasgow, Scotland) suggested that just 5 years of treatment with pravastatin might provide a legacy effect over the course of an individual's lifetime. For the primary end point, by the time 20 years had passed, we could see that it's actually taking an extra 5 years for the statin-treated group to reach the same level of risk as the placebo-treated group. In other words, there is a 5-year gain in event-free years if you start LDL lowering at the age we started, which is around 50 years old. The study shows a "remarkable persistence" in terms of cardiovascular risk reduction over such a long period of time, suggesting that statin treatment alters the natural history of the disease in some way by lowering LDL cholesterol. The 20-year follow-up data are based on a 5-year difference in LDL-cholesterol lowering with pravastatin. In the trial, pravastatin lowered LDL-cholesterol levels by 26% and total-cholesterol levels by 20%. For clinical outcomes, the reduction in the primary end point in WOSCOPS was sustained over the 20-year follow-up period. At 20 years, coronary heart disease mortality was reduced 27% and all-cause mortality by 13%. Also, the need for coronary revascularization was reduced by 19%, heart failure by 31%; there was no effect on stroke. Importantly, the investigators observed no signal of cancer with statin therapy, a finding that would have been uncovered over such a long follow-up period if one existed. There was a significant reduction in the number of days patients were hospitalized for any cardiovascular event over the two decades, including a reduction in days hospitalized for MI.

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November 17, 2014

Beta-Blockers Reduce Mortality in Diastolic Heart Failure
The use of beta-blockers in patients with heart failure and preserved ejection fraction (HFPEF) is associated with a lower risk of all-cause mortality but not the combined end point of all-cause mortality or first hospitalization for heart failure according to a new study published in JAMA. The authors found that after a median of 755 days, 36% of patients who received a beta-blocker had died compared with 46% of those who did not receive one (P<0.001). Of those who received a beta-blocker, 84% were still alive at 1 year compared with 78% of those who did not. At 5 years, 51% of those who received a beta-blocker were still alive compared with 41% of those who did not (P<0.001). The unadjusted hazard ratio (HR) for all-cause mortality throughout follow-up was 0.73 (P<0.001). Investigators identified 19 083 patients with HFPEF; 15 786 had received beta-blockers and 3297 did not. Of these patients, 8244 patients with HFPEF were matched using a 2:1 ratio based on age and propensity scores for beta-blocker use. In this propensity-matched cohort, 5496 patients had received beta-blockers and 2748 had not. In the propensity-score–matched HFPEF cohort, all-cause mortality at a median follow-up of 709 days was also lower, at 41% in the beta-blocker group compared with 45% in the non–beta-blocker group (P=0.04). At 1 year, 80% of the beta-blocker group were still alive compared with 79% of those who did not receive beta-blockers. At 5 years, 45% of the beta-blocker group vs 42% of the non-beta-blocker group were alive. The HR throughout follow-up for all-cause mortality in the propensity-score–matched HFPEF was 0.93 (P=0.04). Of the overall cohort who received beta-blockers, 62% were also free from heart-failure hospitalization at 1 year compared with 58% of the non-beta-blocker group. In the propensity-score matched cohort, 58% of the beta-blocker group were free from heart failure hospitalization at 1 year compared with 59% of those who did not receive beta-blockers.

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Atrial fibrillation before TAVR linked with poorer outcomes
Among patients undergoing transcatheter aortic valve replacement, prior atrial fibrillation was associated with a nearly threefold increase in risk for adverse outcomes, according to recent findings in a study published in Am. J. Cardiol. The researchers aimed to evaluate the extent to which AF impacts procedural outcomes in TAVR in a cohort of 137 patients with severe aortic stenosis. The researchers assessed factors that predicted new-onset AF, including post-procedural outcomes and adverse events with a focus on the presence or absence of previous or post-procedural AF. Forty-nine percent of the cohort demonstrated AF before TAVR. New-onset AF was reported in 21% of patients after TAVR. The cumulative incidence of post-procedural AF was 60%, according to the results. Half of the episodes of new-onset AF occurred within 24 hours of TAVR. New-onset AF occurred more frequently among patients who underwent transapical TAVR (adjusted OR=5.05; 95% CI, 1.40-18.20). Patients with prior AF were significantly more likely to experience the composite outcome of all-cause death, stroke, vascular complications and repeat hospitalizations at 1 month than patients who did not previously have AF (adjusted OR=2.60; 95% CI, 1.22-5.54). Patients who experienced AF after TAVR stayed in the ICU an average of 70 hours longer than patients without AF (95% CI, 25-114.7). Patients with AF also stayed in the hospital longer, with an increased duration of 6.7 days (95% CI, 4.69-8.73).

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Most Patients With CKD Should Take Statins, but Only Half Do
At least 92.0% of patients aged 50 to 79 years with chronic kidney disease (CKD) should be taking statins, according to two different sets of guidelines, researchers report in an article published online in the Journal of the American Society of Nephrology. Although the American College of Cardiology/American Heart Association (ACC/AHA) guidelines do not consider CKD a risk factor for heart disease, the investigators found that most patients with CKD fit at least one of the criteria. Only 50.0% of the patients studied were already taking statins. In the current study, the researchers analyzed data from 4726 patients with CKD from the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study to determine how many patients fall into a category in which one guideline recommends they receive statins and the other does not. (The REGARDS study was originally designed to compare stroke risk factors across the United States.) The included patients were not receiving dialysis and were in the age range of 50 to 79 years; the KDIGO guidelines recommend statins for all patients aged 50 years and older, whereas the ACC/AHA guidelines do not recommend initiating statins for primary prevention past age 79 years. Among the patients, 50.0% were already taking statins, 35.5% had a history of atherosclerotic cardiovascular disease, 39.9% had diabetes, and 3.2% had low-density lipoprotein cholesterol levels of at least 190 mg/dL. Overall, just 8.0% of the patients did not meet the ACC/AHA criteria to recommend statins. (These patients, because of their age and kidney disease, would all be recommended statins under the KDIGO guidelines.) For 19.8% of the patients, the recommendation to take statins comes from their 10-year risk, as calculated by Pooled Cohort equations.

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November 10, 2014

European Medicines Agency Recommends Closer Monitoring of Ivabradine-Treated Patients
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of ivabradine and has made recommendations aimed at reducing the risk of heart problems, including heart attack and bradycardia, in patients taking the medicine.
The PRAC made recommendations about the resting heart rate of patients before starting treatment or when the dose is adjusted, recommendations on when treatment should be stopped andrecommendations regarding use with other medicines. Because patients treated with ivabradine are at an increased risk of developing atrial fibrillation the PRAC recommended monitoring for this condition in patients treated with ivabradine. In addition, the PRAC recommended that, when used for angina, the drug should only be used to alleviate symptoms as the available data do not indicate that the medicine provides benefits on outcomes such as reducing heart attack or cardiovascular death . These recommendations follow a review of the final data from the SIGNIFY study, which evaluated whether treatment with ivabradine in patients with coronary heart disease
without heart failure reduces the rate of events such as heart attacks when compared with placebo (a dummy treatment). The study showed that in a subgroup of patients who had symptomatic angina (Canadian Cardiovascular Society class II - IV) there was a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with Corlentor/Procoralan compared with placebo (3.4% vs 2.9% yearly incidence rates). The data also indicated a higher risk of bradycardia with ivabradine compared with placebo (17.9% vs. 2.1%).
In its evaluation the PRAC also assessed other available data on the safety and effectiveness of ivabradine which showed that the risk of atrial fibrillation is increased in patients treated with ivabradine compared with controls (4.86% vs 4.08%).
The PRAC considered that the higher dose used in the study did not fully explain the findings. However, the Committee reiterated that the starting dose for angina should not exceed 5 mg twice a day and that the maximum dose should not exceed 7.5 mg twice a day. The PRAC recommendations will now be forwarded to the Committee for Medicinal Products for Human Use (CHMP), which will adopt the Agency’s final opinion and provide clear guidance to patients and healthcare professionals.

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HbA1c Levels, Not Fasting Plasma Glucose, Predict LV Dysfunction After STEMI
HbA1c levels are predictive of left ventricular diastolic dysfunction and impaired filling pressures following ST-segment-elevation MI (STEMI), whereas fasting plasma glucose levels had poor prognostic value, according to the results of a new report published in the Canadian Journal of Cardiology. The study also showed that HbA1c levels identified previously undiagnosed diabetic patients and that the concordance between HbA1c and fasting plasma glucose levels was poor. Researchers say the reason for the poor concordance between HbA1c and fasting plasma glucose as criteria for diagnosing diabetes in the study is likely the result of "stress hyperglycemia" that can develop in the setting of acute illnesses.
Of the 142 STEMI patients, the mean fasting plasma glucose and HbA1c levels were 7.7 mmol/L and 6.5%, respectively. In this population, there were 33 patients already known to be diabetic. Of the 109 patients not known to be diabetic at the time of admission, HbA1c levels identified another 18 patients as having diabetes. For these 109 patients, 31 had a fasting plasma glucose >7.0 mmol/L, but only 29% had an HbA1c >6.5%. The kappa, which measures the degree to which HbA1c and fasting plasma glucose levels agreed with each other in the diagnosis of new diabetics, was 0.27, which the researchers say is poor.
In their analysis, left ventricular function was was measured as the average septal and lateral early diastolic velocities. In a multivariable analysis, impaired left ventricular function was independently associated with HbA1c levels but not with fasting plasma glucose. Similarly, filling pressure was independently associated with HbA1c but not fasting glucose levels. An HbA1c cutoff of 6.4% was associated with increased filling pressures, report investigators.

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Real-World Analysis Supports Culprit-Lesion Over Multivessel PCI in STEMI Patients
A real-world analysis of ST-segment-elevation MI (STEMI) patients undergoing primary PCI has shown that treating the culprit lesion only is associated with a lower rate of in-hospital major adverse cardiovascular events (MACE) and lower mortality at 30 days and 1 year compared with individuals who undergo a more comprehensive multivessel intervention. For those undergoing culprit-lesion primary PCI, the in-hospital MACE, 30-day mortality, and 1-year mortality rates were 4.6%, 4.7%, and 7.4%, respectively, whereas the corresponding event rates were 7.2%, 7.7%, and 10.1% for patients undergoing multivessel PCI. These differences were statistically significant and support the current European practice guidelines that recommend culprit-lesion PCI in STEMI patients, according to the researchers.
For the analysis of the London Heart Attack Center Group, included 3984 STEMI patients with multivessel disease undergoing primary PCI at eight tertiary cardiac centers in London, UK. Of these, 3429 patients underwent culprit-lesion revascularization and 555 patients were treated with complete revascularization. In their analysis, culprit-lesion PCI was associated with lower mortality at 30 days and 1 year. For in-hospital outcomes, treating the culprit lesion resulted only in lower in-hospital MACE, a reduction that was driven by significant reductions in reinfarction, reintervention, and mortality. In a multivariate-adjusted model, culprit-lesion PCI was an independent predictor of death at 30 days (hazard ratio 0.45; P<0.001) and 1 year (hazard ratio 0.65; P=0.011). For the in-hospital outcomes, culprit-lesion PCI was an independent predictor of MACE, as well as in-hospital reinfarction and in-hospital mortality. In a propensity-matched analysis adjusted for differences in demographics and clinical, anatomic, and procedural variables, the results were consistent with the overall findings.

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November 3, 2014

Cotrimoxazole Combined With ACE Inhibitor or ARB Could Raise Risk of Sudden Death
The risk of sudden death went up by more than a third in older patients taking ACE inhibitors or angiotensin-receptor blockers (ARBs) who were also put on the antibacterial agent cotrimoxazole, compared with those who were instead given amoxicillin, in a case-control studyb published in BMJ. The finding was independent of comorbidities, other medications, recent procedures, and other potential influencers of sudden-death risk. he elevated risk with cotrimoxazole, a combination of sulfamethoxazole and trimethoprim widely used for decades, was likely caused by its capacity for raising serum potassium, which became fatal on top of other medications known for causing hyperkalemia.
Tapping data from patients aged 66 or older who received ACE inhibitors or ARBs in Ontario from 1994 to 2012, the researchers identified outpatients who died of sudden death within 7 days of being prescribed cotrimoxazole, amoxicillin, ciprofloxacin, norfloxacin, or nitrofurantoin. Those 1027 cases were matched to 3733 controls alive within that time frame relative to the antibiotic prescriptions, based on, among other things, age, sex, chronic kidney disease, and diabetes. The adjusted odds ratios (95% CI) for sudden death within 7 days of an antibiotic prescription on top of an ACE inhibitor or ARB, by antibiotic, relative to amoxicillin (which does not pose a hyperkalemia risk itself or prolong the QT interval) were: 1.38 (1.09–1.76) for cotrimoxazole, 1.29 (1.03–1.62) for ciprofloxacin, 0.74 (0.53–1.02) for norfloxacin and 0.64 (0.46–0.88) for nitrofurantoin. When they looked at the adjusted odds of sudden death within 2 weeks of the antibiotic prescription, rather than 7 days, the OR with cotrimoxazole went up slightly to 1.54 (95% CI 1.29–1.84). But the elevated OR with ciprofloxacin seen over 7 days had attenuated over the longer time window to 1.18 (1.00–1.39).

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Platelet activation linked to MI in patients with pneumonia
Myocardial infarction (MI) appears to be an early complication of pneumonia and is associated with in vivo platelet reactivation, according to study data published in the Journal of the American College of Cardiology. Researchers investigated the relationship between troponin elevation and in vivo biomarkers of platelet activation, including plasma soluble P-selectin, soluble CD40 ligand and serum thromboxane B2, in the early phase of hospitalization. The study included 278 patients with community-acquired pneumonia. Serum high-sensitivity cardiac troponin T levels were obtained every 12 hours and ECGs were taken every 24 hours. Patients were followed until end of hospital stay. The primary endpoint was MI. Of the 144 patients with elevated high-sensitivity cardiac troponin T levels, defined as >0.14 mcg/L, 31 had signs of MI and 113 did not.
Compared with patients who did not develop signs of MI, those who developed signs of MI had higher baseline levels of soluble P-selectin (P<.001), soluble CD40 ligand (P<.001) and serum thromboxane B2 (P=0.004). When the researchers performed logistic regression analysis, plasma soluble CD40 ligand (P<0.001), soluble P-selectin (P<0.001), serum thromboxane B2 (P=0.03), mean platelet volume (P=0.037), pneumonia severity index score (P=.03) and ejection fraction (P=.001) were identified as independent predictors of MI. The researchers found no difference in rate of MI between patients taking aspirin (12%) and those not taking aspirin (10%; P=ns). However, among those treated with aspirin, those with MI had higher serum thromboxane B2 compared with those without MI (P=0.005).

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PFO closure may be cost-effective in long term
Percutaneous patent foramen ovale closure was more cost effective than medical therapy during the long term in a recent study published in the American Journal of Cardiology. The researchers conducted a cost effectiveness analysis of PFO closure using outcome and complication rates from a number of sources, including randomized controlled trials, Medicare cost tables and wholesale drug prices. Outcomes included cost for each life year gained and each quality-adjusted life-year (QALY) gained by use of PFO closure. The cost-effectiveness threshold was defined as <$50,000 per QALY gained.
The mean duration of follow-up in the randomized trials was 2.6 years. At this point, it was determined that PFO closure cost $16,213 (95% CI, 15,753-16,749) per patient. The cost per life-year gained was $103,607 (95% CI, 5,826-2,544,750) at this time point. Other results indicated a cost of $1.09 million (95% CI, 1.04 million-1.20 million) required to prevent one combined endpoint of transient ischemic attack, stroke or death at 2.6 years follow-up.
When the researchers prospectively modeled the cost of the intervention, PFO closure reached the endpoint of <$50,000 per QALY gained at 2.6 years (95% CI, 1.5-44.2).
The per-patient mean cost of medical therapy was greater than the cost of PFO closure by 30.2 years (95% CI, 28.2-36.2).

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October 27, 2014

Multivessel PCI outperformed culprit-vessel PCI in STEMI
Among patients with acute STEMI and multivessel disease, multivessel PCI significantly reduced the risk for MACE when compared with culprit-vessel PCI, according to a meta-analysis which published online in the Cardiovascular Revascularization Medicine Journal.

Currently, the American College of Cardiology Foundation/American Heart Association guidelines recommend culprit-vessel PCI for patients with acute STEMI and multivessel disease in the absence of hemodynamic instability. To better understand the role of multivessel PCI in this patient population, researchers from four US institutions searched PubMed, Embase and Central databases for publications from inception to December 2013. They culled four randomized controlled trials that included 840 patients with STEMI and multivessel disease. The primary outcome measure was MACE, defined as a composite of MI, revascularization and all-cause mortality. Compared with culprit-vessel PCI, multivessel PCI significantly reduced the risk for MACE (RR=0.46; P<.00001), which was driven by reductions in MI (RR=0.35; P=.004) and revascularization (RR=0.35; P<.00001). There were no significant reductions reported in all-cause mortality (RR=0.69; P=.19). In other results, multivessel PCI when compared with staged PCI led to similar rates of MACE (RR=0.96; P=.87), as well as its individual components: MI (RR=0.6; P=.36); revascularization (RR=0.86; P=.6); and all-cause mortality (RR=1.5; P=.57).

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NICE Advisors Recommend Rivaroxaban for Secondary Prevention in ACS Patients
An independent appraisal committee for the UK's National Institute for Health and Care Excellence (NICE) is supporting the use of rivaroxaban as part of a secondary-prevention strategy in acute coronary syndrome (ACS) patients. In its review of the data, the NICE appraisal committee states that rivaroxaban 2.5 mg twice daily with aspirin alone or aspirin plus clopidogrel or ticlopidine is an option for biomarker-confirmed ACS patients without a prior history of stroke or transient ischemic attack. Before starting treatment, clinicians should carefully assess the patient's risk of bleeding, according to the review. In their conclusions, the committee states that rivaroxaban is a "cost-effective" use of the National Health Service (NHS) resources. The NICE decision is not yet final—it is only the opinion of the independent committee—but a final appraisal determination is expected soon. In the UK, the department of health asks NICE for guidance on using drugs, treatments, and technologies within the NHS.

Rivaroxaban, an oral factor Xa inhibitor, was approved for the ACS indication throughout Europe after the European Commission gave its approval in May 2013. The approval was based on the ATLAS ACS 2-TIMI 51 study.

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Treating Sleep Apnea in HF May Cut 30-Day Readmissions
Undiagnosed sleep-disordered breathing (SDB) is common in patients hospitalized for heart failure or other heart issues and should be looked for with in-hospital sleep studies in those showing signs of it, according to a prospective study published in the last issue of the Journal of Clinical Sleep Medicine . It further suggests that prescribing continuous-positive-airway-pressure (CPAP) therapy after discharge in such patients who test positive for sleep apnea cuts the risk of 30-day readmission, at least among those who comply fully with CPAP therapy. Using a portable sleep monitor, the researchers identified sleep-disordered breathing in 79% of patients with HF, arrhythmias, or acute MI who had not been diagnosed with sleep apnea but showed SDB symptoms, such as snoring. Of the 19 patients discharged with a CPAP machine and confirmed to be fully compliant, none were readmitted within a month. That compared with a readmission rate of 29% for the 17 discharged with the machine who didn't use it. A group that used CPAP only some of the time didn't fare much better.

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October 20, 2014

Restenosis after coronary stenting predicted 4-year mortality  Restenosis detected by angiography independently predicted 4-year mortality in a large cohort of patients undergoing coronary stenting, according the findings of a study published online in Eur. Heart Journal.

In the study, investigators aimed to determine 4-year survival outcomes in a cohort of 10,004 patients (15,004 treated lesions) undergoing routine control angiography in the setting of coronary stenting. Eligible participants included all individuals who underwent successful coronary stenting for de novo lesions between 1998 and 2009 in Germany. The cohort also included individuals who underwent routine control angiography after 6 to 8 months at two centers in Munich. Clinicians defined restenosis as diameter stenosis ≥50% in the in-segment area when angiography was conducted at follow-up. Results indicated a restenosis rate of 26.4%. The researchers reported that 702 deaths occurred during the follow-up period. Restenosis was found in 218 of the patients who died, while no restenosis was reported for 484 deaths (unadjusted HR=1.19; 95% CI, 1.02-1.40).

Multivariate analysis results showed that restenosis independently predicted 4-year mortality (HR=1.23; 95% CI, 1.03-1.46).

Each 10-year increase in age (HR=2.34; 95% CI, 2.12-2.60), diabetes (HR=1.68; 95% CI, 1.41-1.99), current smoking habit (HR=1.39; 95% CI, 1.09-1.76) and each 5% decrease in left ventricular ejection fraction (HR=1.39; 95% CI, 1.31-1.48) also independently predicted 4-year mortality.

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Atherosclerosis risk increased among men with diabetes and low testosterone   A greater risk for developing atherosclerosis is found among middle-aged men with low testosterone and type 2 diabetes, according to recent study findings published in the Journal of Clinical Endocrinology & Metabolism.

This cross-sectional prospective study among 115 men younger than 70 years with type 2 diabetes and no history of CVD was determined the effect of testosterone levels on the development of atherosclerosis. Participants were divided into either normal (≥12.1 nmol/L; n=79) or low (≤12.1 nmol/L; n=36) total testosterone levels, whereas free testosterone levels <70 pg/mL were present in 48 participants. All participants underwent measurements for highly sensitive C-reactive protein (Hs-CRP), carotid artery carotid intima-media thickness (IMT) and atherosclerotic plaque, as well as being assessed for endothelial function.

The normal testosterone level group had higher HDL cholesterol levels (P<.002). The low total testosterone group had lower mean total testosterone levels, free testosterone levels and sex hormone-binding globulin. Participants with low and normal testosterone had similar treatments for type 2 diabetes and other pharmacological treatments. The most common treatment was metformin (55%), followed by insulin secretagogues (approximately 30%), DPP-IV (10%) and insulin (5.5%). Forty-five percent of the low and normal testosterone groups used statins, whereas 48.6% of those in the low testosterone group and 53% in the normal testosterone group used angiotensin-converting enzyme inhibitors.

Patients with low testosterone had higher IMT compared with those with normal testosterone (P<0.0001). Compared with the normal free testosterone group, those in the low free testosterone group had higher IMT (P<0.0001). More patients in the low testosterone group (80%) had an IMT of ≥0.1 cm compared with those with low testosterone (39%). Atherosclerotic plaques were found more often among participants with low testosterone (68.5%) vs. those with normal testostero0ne (44.8%; P<.02). Participants with normal or low free testosterone had similar plaque presence (P<0.65).

Participants with positive endothelial function had serum total testosterone levels of 13.52 nmol/L and free testosterone levels of 96.5 pg/mL, whereas participants without endothelial dysfunction had serum total testosterone levels of 18 nmol/L and free testosterone levels of 66.1 pg/mL (P<0.001). The low total testosterone group had significantly higher Hs-CRP concentrations compared with the normal testosterone group (P<0.0001). A higher risk for vascular disease was found among 54% of participants with low total testosterone and 10% with normal testosterone.

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Hemodynamically guided HF management reduced hospitalization rates (CHAMPION study)  Hemodynamically guided HF management was associated with approximately 50% fewer hospitalizations than standard HF management, according to findings from the CHAMPION trial which published in Circulation. The prospective, single-blinded, randomized controlled trial was conducted to determine treatment options for 550 patients with HF and preserved ejection fraction. Specifically, the researchers aimed to test the hypothesis that hemodynamically guided management of HF can decrease compensation that results in hospitalization. The analysis included 119 patients with left ventricular ejection fraction (LVEF) ≥40% (mean, 50.6%), 430 patients with LVEF <40% (mean, 23.3%) and one patient with undocumented LVEF. All patients underwent catheter-based implantation of a microelectromechanical systems pressure sensor during right heart catheterization. Patients were then randomly assigned in a single-blind fashion to the treatment or control group.

Treatment involved daily uploaded pressures that were used for HF management, while controls underwent standard HF management with weight monitoring. Pressures were uploaded for controls but not used by the investigators.

The rate of HF hospitalization during 6 months for patients with preserved ejection fraction served as the primary outcome measure.

Patients in the treatment group experienced a 46% lower rate of the primary endpoint compared with controls (95% CI, 0.38-0.70; P<0.0001).

The follow-up duration lasted an average of 17.6 months. During that period, hospitalization among patients in the treatment arm was 50% lower than in the control arm (95% CI, 0.35-0.70; P<0.0001).

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October 13, 2014

The world Thrombosis day is on October 13  World Thrombosis Day (WTD) is one day – October 13 – around the world dedicated to focusing attention on the often overlooked and misunderstood disease burden caused by thrombosis globally. The date was selected because it is the birthday of Rudolf Virchow, the pioneer in the pathophysiology of thrombosis. It was this German physician and pathologist who first developed the concept of “thrombosis” and made crucial advances in our understanding of this often mis- or undiagnosed condition through the concept of pathological processes.

WTD is an annual day that also will energize a collective drive to increase awareness and action through educational activities for the public and health professionals throughout the year, year to year.

At the heart of WTD are dozens of thrombosis and hemostasis societies, patient advocacy groups, medical/scientific organizations and other interested parties from around the world who seek to:

  • Increase the awareness about the prevalence and risks from thrombosis
  • Reduce the number of undiagnosed cases
  • Increase the implementation of evidence-based prevention
  • Encourage health care systems to implement strategies to ensure “best practices” for prevention, diagnosis and treatment
  • Advocate for adequate resources for these efforts and increased support for research to reduce the disease burden from thrombosis
  • Ultimately save lives

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Calcium-channel blockers & heart failure with preserved ejection fraction: No harm, no benefit   Heart failure patients with preserved ejection fraction using calcium-channel blockers (CCBs) were no worse for taking them. But, they also didn’t experience much benefit either, according to a study published online in Circulation: Heart Failure. Researchers found that all-cause mortality or heart failure hospitalization occurred in 82% of patients receiving and 81% of patients not receiving CCBs at six-year follow-up. The researchers used data from the OPTIMIZE-HF and Medicare databases to follow a matched cohort of 1,620 elderly patients with heart failure and preserved ejection fraction for six years. OPTIMIZE-AF is a national registry of hospitalized heart failure patients. Half of these patients were prescribed CCBs following a heart failure discharge between March 2003 and December 2004. Reviewing all-cause mortality, heart failure hospitalization and all-cause hospitalization separately, they found patients had a 1.05, 1.05 and 1.03 risk, respectively, when taking CCBs.

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Echo flags potential heart disease risk in obese kids  In a new study published online in the Journal of the American College of Cardiology: Cardiovascular Imaging the authors comparing echocardiograms of obese and non-obese children found increased risks for early onset cardiovascular disease. Changes to the shape and function of obese children’s hearts were similar to those seen in obese adults at risk for cardiovascular disease.

While left ventricular ejection fraction was comparable between obese and non-obese children, other markers, such as blood pressure, were increased in obese children.

Using tissue Doppler imaging, 2D echocardiograms and 2D-speckled tracking analysis, the German research team found enlarged left- and right-sided cardiac chambers and thicker left ventricular walls in obese children. Obese and overweight children comprised 61 of the 101 children recruited. Both groups were homogenously Caucasian. The research team, however, noted that the changes to cardiac geometry and function were comparable to those seen in other studies.

Researchers also collected metabolic data and found elevated low-density lipoprotein cholesterol, triglycerides, total cholesterol, insulin and glucose in obese children. However, non-obese children had higher levels of high-density lipoprotein cholesterol.

Obese children also showed decreased regional basoseptal strain and peak systolic velocity. Left ventricle strain was reduced in longitudinal and circumferential data derived from 2D speckle tracking. Diastolic function was likewise impaired in obese children.

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Dual-chamber setting in ICDs leads to fewer inappropriate shocks  When comparing risk of inappropriate implantable cardioverter-defibrillator (ICD) shocks in two types of therapy, researchers in the OPTION study found a significant advantage in dual-chamber therapy. Fewer inappropriate shocks were delivered to patients on dual-chamber than on single-chamber settings, especially those programmed with algorithms for minimizing ventricular pacing.

OPTION study compared long-term outcomes for 462 patients with left ventricular ejection fraction of less than or equal to 40 percent with implanted ICDs. The patients followed for 27 months.

All patients received dual-chamber devices. Of that group, 230 were in the dual-chamber setting arm and 223 in the single-chamber setting arm. To those assigned the dual-chamber setting arm, an algorithm was activated. There was no increase in adverse events in the use of dual- vs. single-chamber implantations. Patients with single-chamber settings were 2.5 times as likely to receive inappropriate shocks. Fewer dual-chamber setting patients received at least one shock than those in the single-chamber group (16.1% vs. 22.9 % ).

Inappropriate shocks occurred at a rate of 7.3% total over the 27-month period with no time-point clustering; 2.6% of patients in the dual-chamber group and 7.6% of patients in the single-chamber group received at least one inappropriate shock over 12 months. At the end of 27 months, 4.3% of dual-chamber patients and 10.3% of single-chamber patients received at least one inappropriate shock. Supraventricular tachycardia and lead failure were responsible for most events (73.6% and 25.5% respectively). Appropriate shock rates were similar in both groups.

All-cause death or cardiovascular hospitalizations happened at a rate of 20% of dual-chamber setting patients and 22.4% of single-chamber setting patients over 27 months. Ventricular pacing did not differ significantly between the two groups, nor did system-related complication rates. However, there was a high crossover rate from dual-chamber to single-chamber therapy that may have diluted some findings between the two groups.

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October 07, 2014

Beta-Blockers No Use in CAD Patients With No Prior MI  According a post hoc analysis of the CHARISMA trial published online in Circulation: Cardiovascular Quality and Outcomes Journal there are more signs that beta-blockers are of no use—and may potentially be harmful—in patients with stable coronary artery disease (CAD) or with CAD risk factors only. The authors looked at nonfatal MI, stroke, or cardiovascular mortality among patients who participated in the CHARISMA trial, grouped according to whether they'd had a prior MI (4772 patients), known atherothrombotic disease (7804 patients), or risk factors only, but no heart failure (2101 patients) at the study outset. Each group was then further analyzed according to whether or not they were taking beta-blockers at baseline.

Over 28 months of follow-up, baseline beta-blocker use was associated with a 31% reduced risk of the primary composite outcome among patients with prior MI—a finding driven by a roughly 40% reduced risk of new MI. No mortality difference, however, was seen between prior MI patients in the beta-blocker vs no beta-blocker group.

In both the known-atherothrombotic-disease group and the risk-factors-only group, no advantage was seen among those taking beta-blockers as compared with those not taking beta-blockers.

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Fish Oil Does Not Prevent AF Recurrence in Low-Risk Patients (AFFORD trial)   In low-risk patients with symptomatic paroxysmal or persistent atrial fibrillation who are not currently taking antiarrhythmic medication, a high-dose fish oil does not prevent the recurrence of AF, nor does it appear to reduce inflammation or oxidative stress. These are the primary results of the Multicenter Study to Evaluate the Effect of n-3 Fatty Acids on Arrhythmia Recurrence in Atrial Fibrillation (AFFORD) study, which ) published in the last issue of the Journal of the American College of Cardiology.

In total, 337 patients with symptomatic paroxysmal or persistent AF (mean duration 2.5 years since first AF diagnosis in the fish-oil arm) were randomized to 4 g of fish oil per day or to placebo. The 4-g dose included 1600 mg of eicosapentaenoic acid (EPA) and 800 mg of docosahexaenoic acid (DHA). The trial included a three-week loading phase to ensure the adequate incorporation of the omega-3 fatty acids into the tissue. After an average follow-up of 271 days, the AF-recurrence rate was 64.1% in the fish-oil arm and 63.2% in the placebo arm, a difference that was not statistically significant. Regarding inflammation and oxidative stress, which was assessed by high-sensitivity C-reactive protein (CRP) and myeloperoxidase (MPO), respectively, there was no significant improvement with fish oil compared with placebo. The investigators point out, however, that CRP and MPO levels were within normal limits at baseline. In an analysis looking at the omega-3 index, which measures EPA and DHA content in erythrocyte membranes as a percentage of total membrane fatty acids and which is used to assess adherence, the results showed there was a doubling of the omega-3 index in the fish-oil arm, from 4% to 8%.

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Long-term survival, stroke rates similar between bioprosthetic, mechanical aortic valve replacement  Bioprosthetic and mechanical aortic valve replacement were associated with similar 15-year rates of all-cause mortality and stroke, according to a new study published in JAMA. Researchers evaluated 4,253 patients aged 50 to 69 years who underwent primary isolated aortic valve replacement in New York from 1997 to 2004. All patients received either bioprosthetic (n=1,466) or mechanical valves (n=2,787). Propensity score matching yielded 1,001 patient pairs between the two groups for analysis. All-cause mortality was the primary outcome of the analysis; secondary outcomes included stroke, reoperation and incidences of major bleeding. Median follow-up was 10.8 years (maximum, 16.9 years).

The prevalence of bioprosthetic aortic valve replacement increased significantly during the study period, from 15% in 1997 to 74% in 2012 (P<.001).

During follow-up, 322 patients who received a bioprosthetic valve and 318 who received a mechanical valve died. The researchers calculated that actuarial 15-year survival was 60.6% in the bioprosthetic-valve group compared with 62.1% in the mechanical-valve group (HR=0.97; 95% CI, 0.83-1.14). Stroke occurred in 68 patients who received a bioprosthetic valve and 71 who received a mechanical valve. The cumulative incidence of stroke at 15 years was also similar between the groups (7.7% bioprosthetic valve vs. 8.6% mechanical valve; HR=1.04; 95% CI, 0.75-1.43). The researchers noted a lower rate of reoperation in the mechanical-valve group compared with the bioprosthetic-valve group (6.9% vs. 12.1%; HR=0.52; 95% CI, 0.36-0.75). Major bleeding was significantly more common among mechanical-valve recipients (13% vs. 6.6%; HR=1.75; 95% CI, 1.27-2.43).

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September 29, 2014

New Guidelines for the Prevention and Management of Postoperative AF were published  The American Association for Thoracic Surgery (AATS) has issued new guidelines to help prevent the development of atrial fibrillation (AF) during or after surgery as well as for the clinical management of patients in whom AF or atrial flutter does develop. In addition, the guidelines provide direction for managing patients with preexisting AF undergoing thoracic surgery, noting that these patients are at high risk for stroke, heart failure, and other complications. Managing their antiarrhythmic medications and perioperative anticoagulation can pose a challenge, so a preoperative cardiology consultation can be useful in these patients. The AATS task force charged with drafting the new guidelines included cardiologists, electrophysiologists, intensivists, anesthesiologists, and thoracic and cardiac surgeons, as well as a clinical pharmacist. Their recommendations are published in the Journal of Thoracic and Cardiovascular Surgery.

In the new guidelines, the experts recommend that all patients taking beta-blockers before surgery should continue to take them in the postoperative period to prevent the onset of AF or flutter (class I, level of evidence A). Following surgery, a patient's blood pressure can be significantly reduced, and this might lead some physicians to stop the drug, which would be wrong. Instead of stopping beta-blockade if low blood pressure occurs, the AATS recommendation is to reduce the dose very significantly or to space the drug out over longer intervals.

Intravenous magnesium supplementation can also be considered to prevent postoperative AF if serum magnesium levels are low or if operators suspect total body magnesium is depleted (class IIb, level of evidence C). The guideline writers state that digoxin should not be used for AF prophylaxis, nor should catheter-based or surgical pulmonary vein isolation be performed at the time of surgery to prevent AF or flutter.

For AF or flutter prevention in patients at intermediate or high risk for developing perioperative/postoperative AF or flutter, such as those at advanced age, with hypertension, or prior history of AF, diltiazem may be considered in patients with preserved cardiac function who are not taking preoperative beta-blockers (class IIa, level of evidence B).

Amiodarone given postoperatively can be considered in patients undergoing certain procedures, such as pulmonary resection or esophagectomy. Frendl notes that amiodarone can be problematic because it carries pulmonary toxicity if taken long term and at higher doses.

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NSAIDs Linked to Increased Venous Thromboembolism Risk  Nonsteroidal anti-inflammatory drugs (NSAIDs) may almost double the risk for venous thromboembolism (VTE), including deep venous thrombosis and pulmonary embolism, according to an article published online in Rheumatology. This is the first systematic review and meta-analysis of published observational studies to examine the association between NSAID use and VTE. The authors used observational studies for their analysis because the complication is too rare to show up reliably in most randomized clinical trials.

Of 597 potential published studies, the researchers included 6, representing 21,401 VTE events, in their final analysis. The studies reported odds ratios, relative risks, hazard ratios, or standardized incidence ratios for VTEs among NSAID users compared with nonusers.

The studies, 1 cohort (n= 19,293; 215 events) and 5 case-control studies (cases, 21,186; controls, 110,824), were conducted in the United Kingdom, France, the Netherlands, Denmark, and Sweden between 2007 and 2013. The pooled risk ratio among NSAID users was 1.8-fold for VTE (95% confidence interval, 1.28 - 2.52). Among participants who used selective cyclooxygenase 2 (COX-2) inhibitors, the pooled risk ratio was 1.99 (95% confidence interval, 1.44 - 2.75). Both measures reached statistical significance.

Increased VTE risk may come primarily from COX-2 inhibitors, the researchers write, because aspirin, a COX-1 inhibitor, has been shown to be effective in VTE prevention. The mechanism for risk for VTE remains unclear, however

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Diabetes is on-target effect of statins according to a new genetic study  A new analysis which published confirms that statin therapy is associated with a significantly increased risk of type 2 diabetes and the reason for this, according to researchers, is partially explained by genetic variants near the gene encoding the HMG-coenzyme A (HMG-CoA) reductase protein. The researchers, also suggest a potential new mechanism for the increased risk of diabetes. Among statin-treated patients in their analysis, the alleles associated with lower LDL cholesterol and increased diabetes risk, were also associated with a small but statistically significant increase in weight.

Each additional allele of one single nucleotide polymorphism (SNP), for example, was associated with an increased body weight of 0.30 kg. In the randomized trial data, statin-treated patients gained 0.24 kg, which is consistent with the genetic analysis.

In total, the researchers had data from 223 463 individuals participating in 43 genetic studies. Each additional allele of rs17238484-G was associated with a mean 0.06-mmol/L lower LDL-cholesterol level. Similar reductions were associated with the rs12916 SNP. In addition, they found that each additional allele of rs17238484-G was associated with a higher body weight (0.30 kg), waist circumference (0.32 cm), and plasma insulin concentration (1.62%) and plasma glucose concentration (0.23%). Again, the rs12916 SNP had similar effects.

Overall, each additional rs17238484-G allele was associated with a higher risk of diabetes (hazard ratio 1.02; 95% CI 1.00–1.05). Each rs12916-T allele also increased the risk of diabetes (hazard ratio 1.06; 95% CI 1.03–1.09).

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September 22, 2014

Regular exercise prevented age-related left ventricular stiffening  In a new study, published in the last issue of JACC, regular exercise was associated with preservation of left ventricular compliance and distensibility,but the same link was not observed with casual exercise. In the study was studied whether moderate lifelong exercise training could preserve LV compliance and distensibility. A total of 102 healthy people aged 65 years and older were recruited. Participants were stratified by lifelong pattern of exercise training: sedentary (no more than once per week; n=27), casual (two or three times per week; n=25), committed (four or five times per week; n=25) and competitive (six or seven times per week; n=25). The researchers performed right heart catheterization and echocardiography on all participants to determine LV compliance and distensibility and performed cardiac MRI to determine LV mass. Normalized peak oxygen intake rose (P<.001) and body mass and BMI fell with increasing doses of lifelong exercise training, the researchers found. At baseline, LV distensibility was greater in committed (21%) and competitive (36%) exercisers compared with the sedentary group, according to the results. LV stiffness constants by group were as follows: sedentary, 0.062; casual, 0.079; committed, 0.055; and competitive, 0.035.

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AHA discouraged routine ECG screening for young people  In a new statement, published online in Circulation, the American Heart Association and American College of Cardiology do not recommend mass screening with 12-lead ECGs for CV abnormalities in the general population of healthy young people aged 12 to 25 years. A writing panel for the two organizations cited low evidence of CV-related sudden death in young people, a high rate of false positives and false negatives associated with ECGs, and high costs and difficult logistics of setting up a national or other large-scale general screening program.
Instead, the panel recommends used of the AHA’s 14-point screening guidelines as part of a comprehensive medical history and physical examination to detect physical abnormalities. According to those guidelines, preparticipation screening of competitive athletes is only necessary in certain cases depending on medical history, family history and physical examination results. Screening with 12-lead ECGs or echocardiograms in conjunction with medical history and physical examination to detect CV abnormalities may be considered in small cohorts of young people aged 12 to 25 years. This recommendation is not necessarily limited to athletes, according to the statement. However, such programs should only be undertaken if close physician involvement and proper quality control are achieved. If such a program is undertaken, known and anticipated limitations of the 12-lead ECG as a screening test, the expected frequency of false-positive and false-negative results, and the required costs must be understood.

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Regular exercise prevented age-related left ventricular stiffening  In a new study, published in JACC, regular exercise was associated with preservation of left ventricular compliance and distensibility, but the same link was not observed with casual exercise. Researchers studied whether moderate lifelong exercise training could preserve LV compliance and distensibility. They recruited 102 healthy people aged 65 years and older from prespecified backgrounds. Participants were stratified by lifelong pattern of exercise training: sedentary (no more than once per week; n=27), casual (two or three times per week; n=25), committed (four or five times per week; n=25) and competitive (six or seven times per week; n=25). The researchers performed right heart catheterization and echocardiography on all participants to determine LV compliance and distensibility and performed cardiac MRI to determine LV mass. Normalized peak oxygen intake rose (P<.001) and body mass and BMI fell with increasing doses of lifelong exercise training, the researchers found. LV mass index, resting LV end-diastolic index and resting LV end-diastolic index indexed to body surface area all increased with increasing doses of lifelong exercise training.

… more More

September 15, 2014

Age and diabetes duration increases risk for macrovascular complications  For patients with type 2 diabetes, macrovascular events and death are associated with age or age at diagnosis and diabetes duration, according to a study published online in the last issue of Diabetologia.

Microvascular events, however, are only connected with diabetes duration and the effect is greater in younger patients, a study involving patients from ADVANCE trial showed.

The researchers studied 11.140 patients who were randomly assigned to intensive or standard glucose control during ADVANCE. The mean age of patients was 65.8±6.4 years, age at diagnosis 57.8±8.7 years and diabetes duration 7.9±6.4 years.

The researchers examined associations between age (or age at diagnosis), diabetes duration and major macrovascular events, all-cause death and major microvascular events. The team calculated rates by 5-year baseline age (or age at diagnosis) and diabetes duration strata and estimated risks using Cox models, with adjustments for treatment assignment and HbA1c.

Diabetes duration was associated with the risk of macrovascular events (HR=1.13; 95% CI, 1.08– 1.17), microvascular events (HR=1.28; 95% CI, 1.23–1.33) and death (HR=1.15; 95%, 1.1–1.2). However, age (or age at diagnosis) was only associated with the risk of macrovascular events (HR=1.33; 95% CI, 1.27–1.39) and death (HR=1.56; 95% CI, 1.48–1.64).

Interaction was not seen between diabetes duration, age and the risk of macrovascular events or death (both P>.4) but was seen between diabetes duration, age and the risk of microvascular events (P=.002); the effects of increasing diabetes duration were greatest at younger ages.

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Low BP in patients with AF may be harmful  For patients with atrial fibrillation, the optimal BP target may be higher than that for the general population, according to new findings from the AFFIRM study which published in American Journal of Cardiology.

Researchers conducted a post-hoc analysis of patients with AF and at least one risk factor for stroke who participated in the AFFIRM trial (n=3,947). In that trial, patients were randomly assigned to a rate-control strategy or a rhythm-control strategy.

Optimal BP in patients with AF had not been studied or addressed in guidelines, so the researchers sought to determine the relationship between BP and all-cause mortality in the AFFIRM participants.

The primary outcome of the study was all-cause mortality. The secondary outcome was a composite of all-cause mortality, ventricular tachycardia and/or ventricular fibrillation, pulseless electrical activity, significant bradycardia, stroke, major bleeding, MI and pulmonary embolism. During the mean follow-up period of 42.4 months, 15.6% of participants died.

Compared with patients who achieved systolic BP 130 mm Hg to 140 mm Hg, the risk for all-cause mortality increased by 3.9-fold in those with systolic BP ≤110 mm Hg and increased by 1.9-fold in those with systolic BP >160 mm Hg (P<.001 for both). Compared with patients who achieved diastolic BP >80 mm Hg to 90 mm Hg, the risk for all-cause mortality increased by 3.9-fold in those with diastolic BP ≤60 mm Hg (P<.001) and increased by 1.8-fold in those with diastolic BP >90 mm Hg (P=.02).

The secondary outcome occurred in 24.6% of participants, according to the researchers. Compared with patients who achieved systolic BP 130 mm Hg to 140 mm Hg, the risk for the secondary outcome increased by 2.4-fold in those with systolic BP ≤110 mm Hg (P<.001) and by 1.5-fold in those with systolic BP >160 mm Hg (P=.02). Compared with patients who achieved diastolic BP >80 mm Hg to 90 mm Hg, the risk for the secondary outcome increased by 2.5-fold in those with diastolic BP ≤60 mm Hg (P<.001) and by 1.5-fold in those with diastolic BP >90 mm Hg (P=.04).

Another interesting finding is that in this population with AF, if systolic BP goes below 110 mm Hg or diastolic BP goes below 60 mm Hg, the mortality risk is even higher than that for people with high BP. For both systolic and diastolic BP, the group with the lowest BP had greater mortality than the group with the highest BP (HR=3.9; P<.001 for both).

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Statins before diabetes diagnosis did not increase microvascular disease risk  Patients treated with statins before being diagnosed with diabetes are not at increased risk for microvascular disease, according to data published in The Lancet Diabetes & Endocrinology. Using data from the Danish Patient Registry and the Danish Registry of Medicinal Product Statistics, the researchers randomly selected 15,679 individuals treated with statins regularly until their diabetes diagnosis. The group was matched in a 1:3 ratio with 47,037 individuals who had never used statins before diagnosis.

The researchers analyzed data with Cox regression models to compare the cumulative incidence of diabetic retinopathy, diabetic neuropathy, diabetic nephropathy or gangrene of the foot between cohorts. Adjustments were made for covariates, including sex, age at diabetes diagnosis and diagnosis method; a propensity score was also added to address potential biases between statin users and non-statin users.

At an average 2.7 years of follow-up, 2,866 patients developed diabetic retinopathy; 1,406 diabetic neuropathy; 1,248 diabetic nephropathy; and 2,392 gangrene of the foot. Statin users demonstrated a lower cumulative incidence of diabetic retinopathy (HR=0.6; 95% CI:0.54-0.66), diabetic neuropathy (HR=0.66; 95% CI, 0.57-0.75) and gangrene of the foot (HR=0.88; 95% CI, 0.8-0.97) compared with non-statin users. This was not the case for diabetic nephropathy (HR=0.97; 95% CI, 0.85-1.1).

Similar results were observed with adjustments for the competing risk of death, visits to a family doctor, covariate stratification and matching propensity score. The corresponding multivariable adjusted HR for diabetes in the total population was 1.17 (95% CI, 1.14-1.21).

… more More

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  9. Arora P, Song Y, Dusek J et al. Vitamin D Therapy in Individuals With Prehypertension or Hypertension: The DAYLIGHT Trial. Circulation. 2015;131:254-262. … more More
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