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The editorial "EDUCATION AND ADVANCEMENT: A CONTINUOUS PRIORITY" by professor P. Vardas, published in HJC, is available here….

April 14, 2014

Efficacy and Safety of Apixaban is comparable with warfarin in Patients After Cardioversion for Atrial Fibrillation  In a post hoc analysis of ARISTOTLE which published in JACC, the apixaban is comparable to warfarin in terms of efficacy and safety in patients with atrial fibrillation the first 30 days after cardioversion. A total of 743 cardioversions were performed in 540 patients: 265 first cardioversions in patients assigned to apixaban and 275 in those assigned to warfarin. The mean time to the first cardioversion for patients assigned to warfarin and apixaban was 243 ± 231 days and 251 ± 248 days, respectively; 75% of the cardioversions occurred by 1 year. Baseline characteristics were similar between groups. In patients undergoing cardioversion, no stroke or systemic emboli occurred in the 30-day follow-up period. Myocardial infarction occurred in 1 patient (0.2%) receiving warfarin and 1 patient receiving apixaban (0.3%). Major bleeding occurred in 1 patient (0.2%) receiving warfarin and 1 patient receiving apixaban (0.3%). Death occurred in 2 patients (0.5%) receiving warfarin and 2 patients receiving apixaban (0.6%). There is no statistical significant difference between the two groups.

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EMA published a warning to not Combine ARBs, ACE Inhibitors, and Direct Renin Inhibitors  No two drug classes that act separately on the renin-angiotensin system (RAS) should be used in combination, the European Medicines Agency (EMA) warned. According to the European drug regulator, angiotensin-receptor blockers (ARBs), ACE inhibitors, and direct renin inhibitors should not routinely be used in combination. In particular, patients with diabetic nephropathy should not be given an ARB with an ACE inhibitor, the agency concluded. The recommendation from the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) comes after a 10-month revie. A final decision rests with the Committee for Medicinal Products for Human Use (CHMP), which typically adopts the PRAC recommendation. Where such combination (dual blockade) is considered absolutely necessary, it must be carried out under specialist supervision with close monitoring of kidney function, fluid and salt balance, and blood pressure.

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Spironolactone doesn’t improve the prognosis of patients with heart failure with preserved ejection fraction (TOPCAT)  It was published in the New England Journal of Medicine the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial in which treatment with spironolactone failed to improve the composite primary end point of CV death, aborted cardiac arrest, or HF hospitalization in patients with HFPEF over a mean of 3.3 years, compared with placebo. Active therapy also raised serum creatinine levels and risk of hyperkalemia. The >3000-patient trial was conducted at 233 centers in North and South America and in Russia and the Republic of Georgia.

TOPCAT had randomized 3445 patients with heart failure and an LVEF >45% to receive the aldosterone antagonist at 15 to 45 mg/day or placebo; patients with severe renal dysfunction had been excluded. There were no significant spironolactone effects on the secondary end points of death from any cause, hospitalization for any cause, MI, and stroke. Those receiving spironolactone showed twice the rate of hyperkalemia but about 30% less hypokalemia. The risks of elevated serum creatinine (specifically to two or more times baseline and greater than the upper limit of normal) were 10.2% and 7.0% for spironolactone and placebo, respectively.

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April 7, 2014

Herpes zoster increased stroke risk  The incidence of herpes zoster increased the risk for stroke within the first 6 months of infection, according to a new study published in Clinical Infectious Diseases Journal. However, antiviral therapy may decrease that risk. The authors identified 6,584 patients in the United Kingdom who had a first-ever diagnosis of herpes zoster and stroke between 1987 and 2012. The researchers compared the incidence of stroke after infection with herpes zoster with other periods in which patients were not recently exposed to the infection. They also examined patient health records to determine whether antiviral therapy had been delivered.

The incidence of stroke increased significantly within the first 4 weeks of infection with herpes zoster compared with the rate at baseline (incidence ratio [IR]=1.63; 95% CI, 1.32-2.02), and the stroke risk slowly diminished during the next 6 months (weeks 5-12: IR=1.42; 95% CI, 1.21-1.68; weeks 13-26: IR=1.23; 95% CI, 1.07-1.42).

In particular, patients with herpes zoster ophthalmicus faced more than a threefold increased risk for stroke 5 to 12 weeks after infection (IR=3.38; 95% CI, 2.18-5.24).

According to the researchers, 55% of patients with herpes zoster were treated with oral antiviral therapy, and the stroke risk for these patients was significantly lower vs. those who received no antivirals (weeks 1-4: IR=2.14; 95% CI, 1.62-2.84), suggesting a protective effect of antiviral treatment.

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Brugada-ECG highly prevalent among schizophrenic patients  A study published ahead-of-print in Circulation Arrhythmia and Electrophysiology has found that Brugada syndrome ECG is more prevalent among patients with schizophrenia than patients without schizophrenia. Use of sodium-channel blocking antipsychotics is not attributable to this prevalence. In this cross-sectional study, the authors compared ECGs of a cohort of 275 schizophrenia patients to ECGs of two cohorts of non-schizophrenia patients. One cohort (n=179), with participants without psyhcopathology from the ongoing longitudinal Netherlands study of depression and anxiety (NESDA) was age comparable with the schizophrenia group. The other control cohort (n=1,168) was 20 years older than the study cohort with participants randomly selected from the population in a region of the Netherlands. The authors reported that 32 patients (11.6%) in the schizophrenia group had Brugada-ECG at baseline (one had type 1 Brugada-ECG and 32 had type 2/3). This was significantly more than the two non-schizophrenia groups where no patients had type 1 Brugada ECG, while 2 (1.1%) patients (NESDA group) and 28 (2.4%) patients (Hoorn group) had type 2/3 Brugada-ECG. Furthermore, patients with schizophrenia had longer QT-interval, an increased proportion of mild or severe QTc-prolongation and higher heart rates than non-schizophrenic patients. Increased QTc-prolongation was, however, largely explained by confounding factors, including use of QTc-prolonging (antipsychotic) drugs.

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Major depression after HF diagnosis predictive of all-cause mortality  Major depression after HF is predictive of ensuing all-cause mortality, but mild depression does not seem to have a similar prognostic effect, according to a new metanalysis published in Preventive medicine Journal. Additionally, depressed mood after HF diagnosis was an apparent predictor of CV-related mortality.

Researchers conducted a meta-analysis of nine prospective studies of 4,012 patients with HF, including 1,652 with depression and 2,360 nondepressed participants. All selected studies included characterization of prospective relationships between post-HF diagnosis depression and CV and all-cause mortality; provided an adjusted HR for the risk for CV and all-cause mortality among depressed vs. nondepressed patients; and had at least 1 year of follow-up.

All-cause mortality according to depression status was analyzed in seven studies of 2,823 patients, including 1,334 with depression. Across these studies, the pooled HR for all-cause mortality among patients with depression and HF was 1.51 (95% CI, 1.19-1.91) compared with nondepressed patients, with significant heterogeneity and evidence of publication bias observed. In a subgroup analysis of four studies assessing all-cause mortality according to depression severity, major depression was significantly correlated with all-cause mortality (HR=1.98; 95% CI, 1.23-3.19), whereas mild depression was not (HR=1.04; 95% CI, 0.75-1.45). Significant heterogeneity was also observed for the analysis of major depression, but not mild depression.

Researchers calculated a pooled HR of 2.19 (95% CI, 1.46-3.29) for CV-related mortality among patients with depression vs. nondepressed patients, using data from two studies on 679 patients, including 446 with depression. Significant heterogeneity was not present in this analysis.

In a subgroup analysis based on age, patients with depression and HF younger than 70 years were at increased mortality risk, whereas those older than 70 years had a less increased risk.

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March 31, 2014

New atrial fibrillation (AF) Guideline from AHA and ACC  A new AF guideline by the American Heart Association (AHA), American College of Cardiology (ACC), and Heart Rhythm Society (HRS), in collaboration with the Society of Thoracic Surgery, published online in the Journal of the American College of Cardiology, Circulation, and Heart Rhythm describes a more precise stroke-risk calculator and when to use aspirin, novel oral anticoagulants, and catheter ablation.

Simultaneously, the guideline supersedes the AF guideline published in 2006 and two updates published in 2011 and reflects some but not all changes to a 2012 European update. The guideline contains four significant changes.

1. CHA2DS2-VASc replaces CHADS2
2. Aspirin's role diminished
3. New Anticoagulants (dabigatran etexilate, rivaroxaban and apixaban ) join treatment options
4. More prominent role for catheter ablation

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FDA Advisory Panel don't Approve Novel Acute HF Drug Serelaxin  An FDA advisory panel, finally convening after a February postponement, gave the agency an 11 to 0 vote against approving serelaxin, a bioengineered hormone with important CV effects, for patients with acute heart failure. In general, members of the FDA Cardiovascular and Renal Drugs Advisory Committee were impressed by the agent and felt it probably relieves dyspnoea and may help prevent worsening heart failure. But one wouldn't know it for sure from the evidence presented, they concluded. Early on in the meeting, the panelists aired their reservations about how some of the critical end points were defined, observed, and documented in the drug's pivotal clinical trial and skeptical that it showed a true clinical benefit. And that largely set the tone for rest of the day's discussions. The native hormone relaxin is primarily known for mediating CV responses to pregnancy through effects on vasodilation and renal function that affect systemic vascular resistance, pulmonary capillary wedge pressure, natriuretic peptide levels, and cardiac output. The manufacturer based its case for the drug primarily on the Relaxin for the Treatment of Acute Heart Failure (RELAX-AHF) study. In the trial, treatment with serelaxin, a recombinant form of human hormone relaxin 2 that Novartis would market as Reasanz, reduced dyspnea by one measure that was a co–primary end point. But dyspnea by another measure, also a co–primary end point, didn't improve. Nor were two secondary end points—out-of-hospital days alive at day 60 or CV death, and 60-day heart-failure/renal-failure hospitalizations—significantly improved with serelaxin.

The trial had randomized 1160 patients with acute heart failure and systolic BP >125 mm Hg to serelaxin in a 48-hour IV infusion within 16 hours of presentation or to placebo. Active therapy was followed by a 19% improvement in the first co–primary end point, area-under-the-curve (AUC) from baseline to day 5 on a dyspnea visual analog scale. There was only moderate, non significant dyspnea improvement measured using the Likert scale, the second co–primary end point. The trialists concluded, and the FDA agrees, that the drug was well tolerated and seemed without safety concerns.

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Addition of Ranolazine Added to Standard-of-Care Treatment in Patients With Chronic Stable Angina Pectoris is Cost-Effectivene.  The addition of ranolazine on top of the standard care treatment in patients with weekly or daily chronic stable angina is cost effective according to a new study published in American Journal of Cardiology. The investigators assessed the cost-effectiveness of ranolazine when added to standard-of-care (SoC) antianginals compared with SoC alone in patients with stable coronary disease experiencing ≥3 attacks/week. A Markov model utilizing a societal perspective, a 1-month cycle length, and a 1-year time horizon was developed to estimate costs (2013 US$) and quality-adjusted life years (QALYs) for patients receiving and not receiving ranolazine. Ranolazine patients lived a mean of 0.700 QALYs at a cost of $15,661. Those not receiving ranolazine lived 0.659 QALYs and at a cost of $14,321. The incremental cost-effectiveness ratio (ICER) for the addition of ranolazine was $32,682/QALY. The ICER was most sensitive to ranolazine cost but only exceeded $50,000/QALY when the cost of ranolazine increased >32% above base case. The ICER remained <$50,000/QALY when indirect costs were excluded, and mortality rates were assumed equivalent between SAQAF health states.

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Ranolazine reduces anginal symptoms among patients with symptomatic Chronic Stable Angina Pectoris (CSAP)  According to a new review of the published trials which is published in American Journal of Cardiology ranolazine reduces anginal symptoms among patients with symptomatic CSAP despite their use of traditional antianginal medications. The authors systematically searched the Cochrane Register of Controlled Trials, EMBASE, and MEDLINE through July 2013 for RCTs comparing ranolazine with placebo or antianginal medications administered as part of usual care for the management of CSAP. End points of interest included exercise stress test performance (duration, time to angina, and time to ST-segment depression), frequency of angina attacks/week, nitroglycerin use/week, and quality of life. It was identified 7 RCTs (n = 3,317) of patients with CSAP due to coronary artery disease. Comparators included placebo, amlodipine, and atenolol. All but 1 trial showed a statistically significant improvement in all 3 exercise stress test parameters with ranolazine compared with placebo. Ranolazine also reduced angina frequency and nitroglycerin use compared with placebo.

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March 26, 2014

New Guidelines from AHA and ACC for the treatment of hyperlipidemia extend statins use  The new American College of Cardiology (ACC) and American Heart Association (AHA) guidelines for the treatment of cholesterol would increase the number of individuals eligible for statin therapy by nearly 13 million people, an increase that is largely driven by older patients and treating individuals without cardiovascular disease, according to a new analysis which published online in NEJM.

Among older adults, those aged 60 to 75 years old, 87.4% of men would now be eligible for the lipid-lowering medication, which is up from one-third under the old Adult Treatment Panel (ATP) III guidelines. For women of the same age, the percentage of those now eligible for statins would increase from 21.2% under ATP III to 53.6% with the new 2013 clinical guidelines.

The increase, say investigators, is the result of more patients being eligible based on their 10-year risk of cardiovascular disease.

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Drug-eluting balloons show promise in superficial femoral artery in-stent restenosis  A primary patency rate of more than 70% was reported in a cohort of patients who received drug-eluting balloons for superficial femoral artery (SFA) in-stent restenosis. Researchers in Italy in a study published in JACC suggested that the use of drug-eluting balloons (DEB) for superficial femoral artery (SFA) in-stent restenosis has yielded acceptable primary patency outcomes at 1 year, but that little research has been conducted for outcomes beyond that time point. They added that restenosis may increase by 50% between the first and second years of follow-up in this patient population.

The current prospective registry was conducted to determine 2-year safety and efficacy outcomes of DEB in SFA in-stent restenosis in a cohort of 39 patients accrued at a single center in Italy. Consecutive patients were enrolled between December 2009 and December 2010.

Clinicians performed conventional SFA transluminal angioplasty to the entire patient population. All patients then underwent final post-dilation using the In.Pact paclitaxel-eluting balloon (Medtronic) and were evaluated for up to 24 months. There were two fatalities during follow-up, for a 2-year mortality rate of 5.12%. One death was attributed to HF and the other to sudden death.

A 70.3% primary patency rate was reported at 2 years. Eleven patients experienced restenosis during follow-up. Class I in-stent restenosis lesions were associated with a 12.5% rate of recurrent restenosis compared with 33.3% for class II lesions and 36.3% for class III (P=.005).

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DES bested BMS in reducing clinical restenosis in chronic kidney disease  Ischemia-driven target vessel revascularization was significantly lower in vessels treated with drug-eluting stents than those treated with bare-metal stents in a cohort of patients with chronic kidney disease, concluded recent findings. Researchers from several sites in Italy cited poor results associated with PCI in individuals with chronic kidney disease as a reason for the current study. They suggested that DES may be more effective than BMS in reducing TVR in this patient cohort, but that assessing neointimal growth after PCI has proven difficult. The prospective, randomized, multicenter RENAL-DES trial which published in Circulation compared the Xience V and Multi-Link Vision Coronary stents in terms of efficacy in preventing clinical restenosis in a cohort of 215 patients. The Xience V DES has an identical design as the Multi-Link Vision BMS. Both devices were implanted in the same patient with multivessel CAD and chronic kidney disease, which was defined as estimated glomerular filtration rate <60 mL/min. Ischemia-driven TVR as detected by myocardial scintigraphy at 12 months served as the primary outcome measure. The analysis included 512 coronary vessels. The DES was implanted in 257 of those vessels, and 255 were treated with BMS. The 1-year rate of ischemia-driven TVR was significantly lower for the DES (2.7% vs. 11.4%; P <.001). Multivariable analysis results indicated that BMS independently predicted ischemia-driven TVR (OR=4.95; 95% CI, 2.1-11.6), as did vessel size (OR=0.32; 95% CI, 0.1-0.7).

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March 17, 2014

FDA approved apixaban for DVT/PE Prophylaxis Post-Hip or Knee Replacement  The US Food and Drug Administration (FDA) has accepted the supplemental new drug application for apixaban, extending its indication for use to prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults who have undergone hip- or knee-replacement surgery. The new indication for the oral direct factor Xa inhibitor is supported by the ADVANCE 1 , 2 , and 3 clinical trials that enrolled nearly 12 000 patients. Full prescribing information for the drug warns about the increased risk of stroke in patients with nonvalvular atrial fibrillation who discontinue the drug without some other form of anticoagulation, "and for the increased risk of epidural or spinal hematoma, which may cause long-term or permanent paralysis, in patients using apixaban and undergoing spinal epidural anesthesia or spinal puncture.

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Big Waists Linked with Early Death Regardless of BMI  A larger waist, irrespective of body-mass index (BMI), is associated with an increased risk of mortality, according to a new pooled analysis of more than 650 000 men and women from 11 cohort studies which published in Mayo Clinic Proceedings Journal. Researchers suggest that waist circumference should be measured in combination with BMI, even for those within the normal BMI range, to help stratify patients who might be at risk for obesity-related mortality. Obesity is frequently measured using BMI, and obese individuals have higher all-cause mortality than individuals with normal BMI, which is defined as 18.5 to 24.9 kg/m2. However, the relationship between BMI and mortality is not linear—studies have documented lower BMI being associated with higher mortality—and is confounded by tobacco use, preexisting illness, weight loss, or short follow-up, explain the researchers. Given these and other limitations, the group sought to assess the independent effect of waist circumference on mortality across the entire BMI range. In an analysis adjusted for multiple demographic and lifestyle characteristics, physical-activity levels, and BMI, each 5-cm increment in waist circumference was associated with a 7% higher risk of all-cause mortality in men and a 9% higher risk in women. The elevated risk with higher waist circumferences was evident for both men and women across the entire range of BMI levels. The association with waist circumference was stronger for respiratory and cardiovascular mortality than for deaths from cancer.

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Azithromycin and levofloxacin linked to increased risk of death and serious arrhythmia  Physicians may want to consider prescribing antibiotics other than azithromycin and levofloxacin to older patients, based on the findings of a study published in the Annals of Family Medicine Journal. Researchers found that both antibiotics increase the risk of mortality and arrhythmia during different time frames. Compared with amoxicillin, patients who took azithromycin for the first five days had a significantly higher risk of death (hazard ratio [HR] 1.48) and serious arrhythmia (HR 1.77). On days six through 10, however, there was no statistically significant difference in risk. The risk of death and the risk of serious arrhythmia for patients taking levofloxacin were also significantly higher compared with amoxicillin (HR 2.49 and 2.43), and this difference persisted through all 10 days of treatment (HR 1.95 and 1.75).

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March 6, 2014

High-Potency Statins Benefit in Post-MI patients  New data from a population-based study published in the in Heart Journal appears to support the latest recommendation that physicians use a potent statin in patients with established cardiovascular disease . The researchers report that post-MI patients treated with a high-potency statin, such as atorvastatin or rosuvastatin had a statistically significant 28% lower risk of death when compared with simvastatin monotherapy over a mean follow-up of 3.2 years. For patients who received ezetimibe on top of simvastatin, there was no reduction in mortality.

The researchers state that just 274 of the 9597 patients were treated with ezetimibe/simvastatin. Given that 6990 patients were treated with simvastatin monotherapy and 1883 treated with rosuvastatin or atorvastatin, the study lacked statistical power to determine any mortality effect with ezetimibe.

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Valvular heart disease guideline from AHA/ACC lowers intervention threshold, provides new disease classification  The American College of Cardiology and American Heart Association have issued a new guideline for the management of patients with valvular heart disease, with recommendations that lower the threshold for intervention in certain patients and provide updated definitions of disease severity which published online on JACC & Circulation Journal.

The document defines four stages of progression of valvular heart disease: Stage A includes patients with risk factors for valvular heart disease; Stage B includes patients with progressive valvular heart disease of mild to moderate severity and who are asymptomatic; Stage C includes asymptomatic patients who meet criteria for severe valvular heart disease; and Stage D includes patients with severe valvular heart disease who have developed symptoms.

The guideline contains a risk-assessment algorithm which can be applied to any patient under consideration for intervention. The algorithm combines the Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM), frailty indices, major organ system compromise and procedure-specific impediments.

Patients classified as low risk for surgery or intervention must meet all of the following criteria: STS PROM <4%; no frailty; no major organ system compromises; and no procedure-specific impediments.

Patients classified as intermediate risk have at least one of the following: STS PROM 4% to 8%; mild frailty based on one index; one major organ system compromise; and a possible procedure-specific impediment.

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RADAR: Transradial access safe, feasible regardless of Allen's test results  Thumb capillary lactate after transradial procedures was similar among patients with normal, intermediate or abnormal Allen’s test results, providing what researchers called a proof of concept for a paradigm shift in CV intervention.

In the RADAR study, researchers examined whether transradial coronary catheterization across the whole spectrum of Allen’s test results was safe and feasible to address the current uncertainty about the predictive capacity of the Allen’s test for transradial access.

The accrual period ran from October 2007 to June 2009. From the 942 screened patients, 203 were recruited for the study. Eighty-three patients presented a normal Allen’s test result, whereas 60 were intermediate and 60 were abnormal.

Clinicians assessed the thumb capillary lactate of the patient population, the study’s primary endpoint. They also evaluated thumb plethysmography and ulnar frame count, the aim of which was to investigate patency of the ulnopalmar arches. Other tests included a handgrip strength test to examine isometric strength of the hand and forearm muscles, and discomfort rating.

No difference was reported among the three arms in terms of lactate after the procedure. The result in the normal group was 1.85 ± 0.93 mmol/L compared with 1.85 ± 0.66 mmol/L for intermediate and 1.97 ± 0.71 mmol/L for abnormal (P=0.59). This result held through all time points of the study.

Patients with non-normal Allen’s test results demonstrated improvement in ulnopalmar collaterization, according to plethysmography readings. However, these readings indicated decreases in ulnar frame count in this group. The investigators suggested that this may be a sign of enhanced ulnar flow in abnormal patients.

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February 24, 2014

Depressive symptoms causally linked to CHD, not stroke  A dose-response relationship may exist between depressive symptoms and CHD, but an association between depressive symptoms and stroke appears to be partly or entirely retrocausal, according to data in a recent prospective cohort study published in European Journal of Preventive Cardiology. Researchers evaluated 10,036 participants enrolled in the Whitehall 2 Study, a cohort study of CVD among civil servants in 20 London-based departments. The participants, with a mean age of 44.4 years at the initiation of the study (range, 35-55 years), were assessed for 20 years.

At different phases of the study, the participants responded up to six times to a 30-question General Health Questionnaire (GHQ-30), and also received the 20-item Center for Epidemiologic Studies Depression Scale (CES-D) during the final phase. A score of 5 or higher on the GHQ-30 was classified as GHQ caseness, whereas a score of 16 or higher on the CES-D scale was categorized as CES-D caseness. Besides these measurements, the participants were followed for incidence of major coronary events, including coronary death, nonfatal MI and stroke death/morbidity, during four 5-year and three 10-year periods.

GHQ-30 caseness was observed in approximately 23% of participants across the 5- and 10-year cycles, whereas CES-D caseness was 15%. After adjustment for age, sex and ethnicity, GHQ caseness was predictive of stroke during 0 to 5 years of follow-up (HR=1.6; 95% CI, 1.13-2.26), but not during 5 to 10 years (HR=0.94; 95% CI, 0.64-1.37). A dose-response relationship was established between cumulative GHQ caseness and incident CHD during the final 5-year observation cycle (HR=1.12; 95% CI, 0.72-1.74 for one to two incidences of caseness; HR=2.06; 95% CI, 1.15-3.69 for three to four incidences), but not between GHQ caseness and stroke (HR=0.48; 95% CI, 0.26-0.89 for one to two incidences; HR=0.76; 95% CI, 0.3-1.94 for three or four incidences). The researchers also wrote that CES-D caseness was predictive of CHD (HR=1.81; 95% CI, 1.07-3.06), but not stroke.

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Success Rate of AF Ablation Without Antiarrhythmic Drugs Is 40% in Europe  A European pilot study of patients with atrial fibrillation (AF) undergoing catheter ablation reveals that just over 40% of patients are free from AF at one year without the use of antiarrhythmic medications. AF patients with paroxysmal AF had higher success rates than those with persistent or long-lasting persistent AF, according to the authors of the new report. The data in the report, published online in the European Heart Journal, are taken from the Euro-Observational Research Program (EORP) AF Ablation Pilot Study conducted by the European Heart Rhythm Association (EHRA). In the pilot study, 1391 patients underwent AF ablation at 72 medium- to high-volume centers in 10 European countries. Each hospital enrolled 20 consecutive patients undergoing a first AF catheter-ablation procedure, and clinical outcomes were assessed at one year.

Regarding treatment success, 73.7% had no documented arrhythmia from the three-month blanking period until the end of follow-up at 12 months. In total, 40.7% were successfully treated with ablation and free from antiarrhythmic medication at one year, although, as the researchers point out, the protocol did not require physicians to stop antiarrhythmic drug therapy after the blanking period. Success rates were highest in the paroxysmal-AF patients (43.7%) and lowest in those with persistent AF (30.2%). A second ablation was performed in 18.3% of patients, and 43.4% were still taking antiarrhythmic medication at 12 months.

At one year, 65% of patients were taking some type of anticoagulant medication. Among those at highest risk from thrombosis, those with a CHADS 2-Vasc score >1, just 76.2% were taking an oral anticoagulant. By contrast, roughly half of the patients at low cardioembolic risk (CHADS 2-Vasc 0) were still taking anticoagulation.

Adverse events occurred in 2.5% of the treated patients, and four patients died, including one patient from hemorrhagic stroke. Regarding the adverse events, there were 13 pacemaker implantations, nine vascular injuries, seven cerebrovascular injuries, two phrenic-nerve injuries, and one case of pulmonary vein stenosis. In the 12-month follow-up, left atrial tachycardia, including atrial flutter, was reported in one out of every five patients.

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Intracranial Atherosclerosis a Major Stroke Risk in Whites  Although intracranial carotid artery calcification (ICAC) is a recognized risk factor for stroke in African Americans and Asians, a new study published online in JAMA Neurology, shows that it is also an important cause of strokes among whites. The association between ICAC and stroke shown in the study was independent of conventional cardiovascular risk factors and of calcification in other vessel beds.

The analysis included 2323 exclusively white participants in the Rotterdam Study, a prospective, population-based study investigating determinants of chronic diseases in the elderly. The mean age of study participants was 69.5 years, and 52.2 % were women.

During examinations at baseline, researchers verified through medical records that study participants did not have a history of stroke. Linkage of the study database with general practice files allowed for continuous monitoring of participants for incident strokes. These were verified by an experienced stroke neurologist and were categorized as ischemic or hemorrhagic. Also through interviews, as well as physical examinations and blood samples, investigators collected information on cardiovascular risk factors, including obesity, diabetes, hypertension, hypercholesterolemia, and smoking.

Using nonenhanced computerized tomography (CT), researchers scanned the coronary arteries, aortic arch, extra-cranial carotid arteries, and intracranial carotid arteries. To measure atherosclerosis, they calculated calcification volume (expressed in number of cubic millimeters).

The researchers did not collect data on the size, location, or vascular territory of brain infarcts. During a mean follow up of 6.1 years, 91 patients suffered a stroke (71 ischemic, 10 hemorrhagic, and 7 unspecified). The researchers found that larger ICAC volumes were associated with a higher risk for all strokes and for ischemic stroke. Adjustment for cardiovascular risk factors did not change these results.

After additional adjustment for ultrasound carotid plaque score and calcification volumes in other vessel beds, the association remained significant for all strokes (hazard ratio per increase of 1 standard deviation in ICAC volume: 1.43; 95% confidence interval [CI], 1.04 - 1.96), and for ischemic stroke (HR, 1.39; 95% CI, 0.98 - 1.99).

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February 17, 2014

Insertable cardiac monitor detected AF in patients with cryptogenic stroke (CRYSTAL AF)  The likelihood of AF detection was more than sixfold for patients with cryptogenic stroke wearing the insertable cardiac monitor compared with those undergoing standard cardiac monitoring according the results of CRYSTAL AF which anoounced at the International Stroke Conference.

In the study were enrolled 441 patients (mean age, 61.5 years; 63% men) with cryptogenic stroke in the CRYSTAL AF study. Patients received the insertable cardiac monitor (n=221) or standardized cardiac monitoring (n=220). The primary endpoint was detection of AF (>30 seconds) within 6 months of randomization. At 6 months, AF was detected in 8.9% of patients in the insertable cardiac monitor arm vs. 1.4% of patients in the standardized cardiac monitoring arm (HR=6.43; 95% CI, 1.9-21.74). At 12 months, the primary endpoint occurred in 12.4% of patients in the insertable cardiac monitor arm vs. 2% of controls (HR=7.32; 95% CI, 2.57-20.81). At 6 months, 74% of patients in the insertable cardiac monitor arm found to have AF had asymptomatic episodes, compared with 33% of those in the standardized cardiac monitoring arm with AF, Passman said. At 12 months, the rates were 79% in the insertable cardiac monitor arm and 50% standardized cardiac monitoring arm.

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Anticoagulants prescribed more frequently in AF patients, underused in elderly  The use of oral anticoagulation in patients with atrial fibrillation has increased in the past decade, but antiplatelet therapy remains common in this population, according to data from recent study which published in the Am. J. Med. Notably, the researchers also found that oral anticoagulation may be underused in the elderly population, possibly due to concerns of bleeding risk. The analysis of the baseline dataset of the EURO-AF pilot survey addressed antithrombotic therapy prescriptions, specifically focusing on the risk factors guiding treatment approaches. The study included 3,119 patients with AF, with enrollment between February 2012 and March 2013. In cases where oral anticoagulation was prescribed to hospitalized patients not treated or scheduled for pharmacological or electrical cardioversion or catheter ablation, most were prescribed vitamin K antagonist therapy (72.2%), whereas 7.7% received novel oral anticoagulants. No significant differences in bleeding risk factors were observed between patients treated on the different antithrombotic therapies, with the exception of patients with chronic kidney disease, for whom oral anticoagulation was less commonly used (P=.0318). Prescription of antiplatelet therapy was more common among patients with HAS-BLED scores of 2 or higher (P<.0001). Inverse associations were observed between novel oral anticoagulant use and valvular heart disease (P<.0001), chronic HF (P=.001), CAD (P<.0001) and peripheral arterial disease (P=.0092). Combination therapy consisting of oral anticoagulation plus an antiplatelet drug was most often prescribed for CAD (OR=8.54; P<.0001). Other factors associated with the prescription of combination therapy included age, valvular heart disease, chronic HF, hypertension, PAD and diabetes (P<.0001 for all). When prescription decisions were based upon CHA2DS2-VASc score, 95.6% of patients with a score of ≥1 received antithrombotic therapy, whereas 80.5% received oral anticoagulation. Among patients with a CHA2DS2-VASc score ≥2, 83.7% received antithrombotic therapy, and 70.9% of these patients received oral anticoagulation. For these participants, vitamin K antagonists were prescribed in 64.1% of cases, whereas novel oral anticoagulants were prescribed in 6.9%.

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FDA panel voted against approval of Xarelto  An FDA advisory panel voted 10-0 with one abstention against approval of the oral anticoagulant rivaroxaban to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS).

It was submitted a supplemental new drug application for rivaroxaban (Xarelto) which won FDA approval previously for reducing the risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) after knee or hip replacement surgery; to reduce the risk of recurrent DVT and PE following initial treatment; and to reduce the risk of stroke in patients with nonvalvular atrial fibrillation. The FDA’s Cardiovascular and Renal Drugs Advisory Committee has voiced concern over possible bleeding risks and missing data in the ATLAS ACS 2 TIMI trial (nti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome). The study evaluated the efficacy of rivaroxaban compared to placebo in preventing cardiovascular death, MI or stroke in patients after an ACS.

The FDA will take the panel’s recommendation into consideration when it makes its decision.

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February 10, 2014

Low-Dose Aspirin Ups Survival in Heart Failure  Daily low-dose aspirin, defined as 75 mg/day, was followed by a 42% mortality reduction over several years in a cohort of patients participating in a heart-failure disease-management program . Aspirin prolonged survival regardless of whether patients had a standard aspirin indication, such as ischemic heart disease, peripheral vascular disease, or stroke, reported investigators in their study, published online in Circulation: Heart Failure. There was no such survival benefit, however, at dosages higher than 75 mg/day, although both low- and higher-dose aspirin improved heart-failure hospitalizations. Of the 1476 patients in the retrospective analysis, who were followed for a median of 2.15 years (range one day to 12 years), 892 (about 60%) were prescribed aspirin at baseline. Of those, 91% received aspirin at 75 mg/day and the remainder received aspirin at higher dosages. Another antiplatelet, such as clopidogrel, was also given to 18.4% of the aspirin group, while 27.8% of them took added warfarin, and 2.1% received dual antiplatelets and warfarin.

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Shock-Energy Testing with ICDs Provides No Benefit  Defibrillation-threshold (DFT) testing performed at the time of ICD implantation failed to reduce the risk of death, malignant ventricular arrhythmias, or inappropriate shocks when compared with individuals implanted without DFT, a new study published online in Heart Rhythm Journal shows . The results, from a prospective cohort analysis of 3596 patients implanted with an ICD between 2010 and 2013, add to a growing body of evidence that DFT testing with more modern ICDs might not be necessary at the time of implantation.

Of those included in the Israeli ICD Registry analysis, 17% underwent DFT testing and 83% did not. Those undergoing DFT testing were more likely to be receiving an ICD for secondary prevention, have a prior ventricular arrhythmia, and be undergoing treatment with the use of antiarrhythmic medication.

DFT testing was not associated with improved one-year mortality, the delivery of appropriate or inappropriate shocks, or the rate of ventricular arrhythmias/death. There was no difference in clinical outcomes when the patients were stratified into those who received ICDs for primary vs secondary prevention.

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Depression Linked to Heart Disease  Chronic episodes of depression may be "causally linked" to an increased risk for coronary heart disease (CHD) according to a new study published online in the European Journal of Preventive Cardiology. The latest findings from the ongoing Whitehall II study, which began more than 2 decades ago, showed that those who had depressive symptoms during 1 or 2 assessments over time did not have an added risk for CHD. However, there was a highly significant increase in risk if they reported symptoms during 3 or more assessments.

Interestingly, the researchers found no significant link between long-term depressive symptoms and an increased risk for stroke.

Launched in 1985, the aim of the Whitehall II study was to track cardiovascular disease over time. The study included 10,308 civil servants (mean age at start, 44.4 years; 67% men; 90% white) from London. This analysis examined multiple measurements during four 5-year observation cycles and three 10-year cycles, for a total follow-up of 24 years.

The 30-item General Health Questionnaire (GHQ-30) was used to measure depressive symptoms at baseline and at up to 6 additional timepoints. The 20-item Center for Epidemiologic Studies Depression Scale (CES-D) was also used, but only at 1 timepoint (2003-2004).

Records of any major CHD events and/or strokes in all participants were also examined.

Results showed that 23% of all participants qualified as "GHQ-30 caseness," indicating that they had depressive symptoms during at least 1 of the observation cycles, and 15% had CES-D caseness. Cumulative GHQ-30 caseness was significantly associated with incident CHD in a dose-response manner. The age- and sex-adjusted hazard ratio (HR) for CHD when depressive symptoms were recorded on 1 or 2 questionnaires was 1.12 (95% confidence interval [CI], 0.7 - 1.7). However, the adjusted HR for 3 or 4 questionnaires was 2.06 (95% CI, 1.2 - 3.7).

CES-D caseness also predicted increased risk for CHD (adjusted HR, 1.81; 95% CI, 1.1 - 3.1; p = .03).

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February 5, 2014

No Benefit of Antiplatelet therapy in AF Patients With Stable CAD  Data from a large cohort study which is published online in Circulation confirm the heightened risk of serious bleeding in atrial fibrillation (AF) patients with stable coronary artery disease treated with a vitamin-K antagonist and antiplatelet medication, such as aspirin or clopidogrel. Despite adding the antiplatelet to the anticoagulant, there was no significant reduction in the risk of MI or coronary death when compared with those who received anticoagulation alone, yet there was a significantly increased risk of serious bleeding.

In the study, were included 8700 AF patients with stable coronary disease (defined as 12 months from an acute coronary event) treated between 2002 and 2011. During a mean follow-up of 3.3 years, the risk of MI/coronary death was similar for those treated with warfarin, those who received warfarin plus aspirin, and those treated with warfarin plus aspirin and clopidogrel. The risk of thromboembolic events was also similar in all three treatment groups. For bleeding, however, those treated with aspirin on top of warfarin had a 50% higher risk and those treated with aspirin and clopidogrel on top of warfarin had an 84% higher risk. The only significant p values in this particular paper, as well as in other analyses, are for the increase in major bleeding and for the increase in intracranial hemorrhage.

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Risk Score Predicts Long-term Mortality After PCI  Long-term mortality after percutaneous coronary intervention (PCI) can be predicted using a simple score that employs 12 risk factors, according to a paper published online in Circulation: Cardiovascular Interventions Journal. The authors developed the model based on 11,897 patients who underwent PCI from October through December 2003 in New York State. Mortality was tracked using the National Death Index through the end of 2008. Death rates in the data set were 4.0% at 1 year, 9.8% at 3 years, and 16.1% at 5 years. Using a Cox proportional hazards model, the researchers identified 12 separate risk factors for mortality:

  • Older age
  • BMI < 25 or > 40 kg/m2
  • Multivessel disease
  • Lower EF
  • Unstable hemodynamic state or shock
  • Cerebrovascular disease
  • Peripheral vascular disease
  • Congestive heart failure
  • COPD
  • Diabetes
  • Renal failure
  • History of CABG

Each of these factors was assigned a point value ranging from 0 to 11, with the highest value given to shock. For individual patients assessed using the risk score, point totals ranged from 0 to 39. Predicted mortality rates at 1, 3, and 5 years were calculated for the various point totals. For example, for a patient with a score of 0, the risk of death was 0.58% at 1 year and 2.98% at 5 years. Meanwhile a patient with a score of ≥ 19 had estimated risks higher than 60% and higher than 99%, respectively. A validation sample used to test the discriminatory power of the model showed good agreement between patients observed and predicted risks of death, with a C statistics of 0.787, 0.785, and 0.773 at 1, 3, and 5 years, respectively.

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Intensive BP Lowering Shows No Cognitive Benefit in Diabetes (ACCORD MIND study)  Intensive blood-pressure lowering in those with type 2 diabetes does not reduce or prevent cognitive decline, and efforts are better spent on disease prevention and early intervention, concludes a new study published online in JAMA Internal Medicine. The authors evaluated 2977 diabetic participants in the Memory in Diabetes (MIND) substudy of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, who had no baseline cognitive impairment or dementia and HbA 1c levels less than 7.5%. The subjects were randomized to either "intensive" lowering of systolic blood pressure, to less than 120 mm Hg, or to a "standard" goal of less than 140 mm Hg (n = 1439) or to the addition of a fibrate or placebo in patients with already well-controlled LDL-cholesterol levels (less than 100 mg/dL) achieved through study-supplied simvastatin (n = 1538).

ACCORD MIND had 2 primary outcomes: cognition and total brain volume.

Subjects' cognition was assessed at baseline and at 20 and 40 months with a battery of verbal memory, processing speed, and executive function tests, including the Mini-Mental State Examination. A subset of 503 subjects was also evaluated with brain MRI at baseline and at the 40 month follow-up. At 40 months, no differences were observed in cognitive function between the intensive and standard blood pressure-lowering part of the trial or in the fibrate-vs-placebo arm. Decline in total brain volume, as observed on MRI, was greater in the intensive-vs-standard blood-pressure–lowering group ( P = .01), but the significance of that, considering that there were no differences in cognitive function, is unclear.

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January 27, 2014

EMA Says No to Serelaxin  The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has taken a negative stand against serelaxin for the treatment of acute heart failure (AHF). Serelaxin is a first-in-class recombinant form of human hormone relaxin 2. During pregnancy, the hormone modulates cardiovascular responses by increasing vasodilation and renal function. Relaxin can also modulate various hemodynamic and neurohormonal effects, such as increases in cardiac output and decreases in systemic vascular resistance, pulmonary capillary wedge pressure, and N-terminal pro–brain natriuretic peptide (NT-proBNP). Although the safety of seralaxin seemed acceptable, in view of the uncertainties about the benefits of treatment, the CHMP was of the opinion at that point in time that the benefits of the drug did not outweigh its risks and recommended that it be refused marketing authorization. The CHMP review was based on the results of the Relaxin for the Treatment of Acute Heart Failure (RELAX-AHF) study in which the treatment reduced shortness of breath as assessed using one of two dyspnea end points. Days alive out of the hospital at day 60 and cardiovascular death or heart-failure/renal-failure hospitalizations up to day 60, the secondary end points, were not significantly improved with serelaxin. In its review, the CHMP questioned the effect of serelaxin for the short-term relief of dyspnea beyond 24 hours. It also had concerns about the trial's analysis and calculations of the number of patients who died or who required additional treatment for worsening heart failure. Finally, it also questioned whether the differences in the background treatment in the placebo and serelaxin arms might have influenced the results.

RELAX-AHF was the sole trial submitted to CHMP for review in support of the serelaxin indication, so the EMA said further studies will be needed.

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Future Trials Unlikely to Support Vitamin D Supplementation  A new meta-analysis of trials of vitamin D supplements for the prevention of myocardial infarction (MI), stroke, cancer, or hip fracture in seniors finds that, in general, taking vitamin D does not lower the incidence of these outcomes. Moreover, in a sequential meta-analysis, the researchers showed that any future clinical trials would also likely find that vitamin D supplements would not reduce the incidence of these outcomes by 15% or more. It was unclear whether taking vitamin D supplements with or without calcium might reduce the risk for death by 5%, however. The study was published online in Lancet Diabetes & Endocrinology. In the new paper, the researchers examined meta-analyses of studies looking at vitamin D supplements and MI, stroke, cancer, fractures, and mortality. Then they did a sequential analysis to see whether the risk estimates would be altered by future trials.

They obtained data from 44 reports of 40 individual randomized controlled trials. The vitamin D doses in the supplements ranged from 200 to 1100 IU/day, or 100,000 to 150,000 IU every 3 months.

In 23 of the 32 trials (73%) that reported baseline 25-hydroxyvitamin-D levels, the average baseline level was less than 50 nmol/L, "which is widely considered to be normal, although some people think higher levels, eg, from higher than 75 to 80 nmol/L, are normal," Dr. Bolland explained. In most studies, among participants who took the supplements, 25-hydroxyvitamin-D levels increased to normal levels. The study participants were typically women in their 70s or 80s, and most trials lasted longer than a year.

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Adverse event rates for hospitalized MI, CHF declining  Adverse events among patients hospitalized with acute MI and congestive heart failure (CHF) significantly decreased between 2005 and 2011, a study published online in The New England Journal of Medicine found. The trend was very different, however, among patients admitted for pneumonia and other conditions that required surgery.

The authors used Medicare Patient Safety Monitoring System data on 21 adverse events among patients in U.S. hospitals for acute MI, CHF, pneumonia or conditions needing surgery. They determined the patterns of adverse events related to each condition among 61,523 patients. Between 2005 and 2011, the rate of MI-related adverse events decreased from 5 percent to 3.7 percent. The proportion of MI patients with at least one adverse event decreased from 26 percent to 19.4 percent and the number of adverse events per 1,000 hospitalizations decreased from 401.9 to 262.2. The rate of adverse events also declined among patients with CHF (3.7 percent to 2.7 percent). The proportion of patients with at least one adverse event decreased from 17.5 percent to 14.2 percent and the number of adverse events per 1,000 hospitalizations decreased from 235.2 to 166.9. The rates of adverse events among patients with pneumonia or other conditions did not significantly decline. The authors found the trends for pneumonia and other conditions requiring surgery “disappointing” and suggestive of the need to better ensure patient safety.

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January 20, 2014

Renal Denervation Fails in SYMPLICITY HTN-3.  In a large study of adults newly diagnosed with type 2 diabetes, which is published in the New England Journal of Medicine, those who were overweight or obese did not have a lower risk of dying from CVD, cancer, or other causes, compared with those who had a normal weight. This is the largest study which investigate the relationship between body-mass index (BMI) and mortality and does essentially conclude that there is no obesity paradox; it dispels the notion that obesity or overweight provides a survival advantage compared with normal weight among patients with diabetes.

They observed a J-shaped relationship between BMI and mortality among all participants. Smokers in the lower-normal BMI range—18.5 to 22.4—had a much higher risk of mortality than patients with a BMI in the upper-normal reference range—22.5 to 24.9—and were more likely to die from cancer. Among nonsmokers, however, as BMI increased, mortality from cancer and CVD also increased, in a linear relationship.

At study entry, the participants had a BMI of at least 18.5. The studies were started in 1976 and 1986, and about 54% to 62% of the participants in different BMI categories were current or former smokers. The participants had a mean age of 62 when they were diagnosed with diabetes. The study subjects replied to surveys every two years, which provided information including weight, smoking status (ever smoked vs never smoked), and new diagnosis of type 2 diabetes. Based on their BMI just prior to being diagnosed with diabetes, they were divided into six categories: 18.5–22.4, 22.5–24.9 (reference), 25.0–27.4, 27.5–29.9, 30.0–34.9, and >35.0. During a mean follow-up of 15.8 years, there were 3083 deaths: 941 from cardiovascular disease, 784 from cancer, and 1358 from other causes.

There was a J-shaped relationship between all-cause mortality and BMI at the time of diagnosis of diabetes, with the lowest risk among those with a BMI of 22.5 to 24.9.

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FDA approves CoreValve for inoperable patients  The FDA gave CoreValve its blessing, approving the device in patients with severe aortic stenosis who are considered too high risk of death for standard open-heart surgery and instead undergo transcatheter aortic valve replacement (TAVR).

CoreValve’s approval was widely anticipated after Medtronic announced that the FDA planned to make its decision without the assistance of an advisory panel. Medtronic’s announcement followed release of safety and efficacy results of its pivotal CoreValve Extreme Risk Iliofemoral study at the Transcatheter Cardiovascular Therapeutics (TCT) scientific session in San Francisco in late 2013.

The study, in which surgeons implanted the CoreValve system in 471 patients with symptomatic severe aortic stenosis during TAVR, found all-cause mortality or major stroke rates of 9.3 percent at one month and 25.5 percent at 12 months; mortality rates of 7.9 percent at one month and 24 percent at one year; and major stroke rates of 2.4 percent at one month and 4.1 percent at one year. Major vascular complication rates totaled 8.3 percent at one month and 8.5 percent at one year and mild paravalvular leak rates were 11.5 percent at one month and 4.1 percent at one year. The study showed a permanent pacemaker rate of 22.2 percent at one month.

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FDA panel united against approval of Xarelto for ACS  An FDA advisory panel voted 10-0 with one abstention against approval of the oral anticoagulant rivaroxaban to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS). It was submitted a supplemental new drug application for rivaroxaban (Xarelto) which won FDA approval previously for reducing the risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) after knee or hip replacement surgery; to reduce the risk of recurrent DVT and PE following initial treatment; and to reduce the risk of stroke in patients with nonvalvular atrial fibrillation. The FDA’s Cardiovascular and Renal Drugs Advisory Committee has voiced concern over possible bleeding risks and missing data in the ATLAS ACS 2 TIMI trial (Anti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome). The study evaluated the efficacy of rivaroxaban compared to placebo in preventing cardiovascular death, MI or stroke in patients after an ACS.

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January 13, 2014

Renal Denervation Fails in SYMPLICITY HTN-3.  The SYMPLICITY HTN-3 trial, a phase 3 study testing catheter-based renal denervation for the treatment of resistant hypertension, failed to achieve its primary efficacy end point. Despite no safety concerns, the study, which randomized 535 treatment-resistant hypertension patients, failed to show that treatment with the investigational procedure resulted in a sustained reduction in systolic blood pressure.

The results are surprising, given the positive findings from the SYMPLICITY 2 study, a study that did not include a sham-control arm. In contrast, the SYMPLICITY HTN-3 study was more rigorously designed to assess the efficacy of the procedure, as all patients randomized to the control arm underwent a sham procedure. The primary end point of the study was the change in office systolic blood pressure at six months, while the six-month change in the average 24-hour systolic blood pressure assessed by ambulatory blood pressure monitoring was a secondary end point.

The primary safety end point was the incidence of major adverse events that occurred one month after treatment until six months. According to Medtronic, no safety issues arose during the trial.

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ESC strongly advice cardiologists to be aware of radiation doses.  In a new position paper, published online in the European Heart Journal the European Society of Cardiology (ESC) calls for cardiologists to be more aware of radiation doses in cardiac imaging tests. The paper, from the Cardiovascular Imaging, Percutaneous Cardiovascular Interventions, and Electrophysiology associations of the ESC, summarizes current knowledge on effective radiation doses and risks related to cardiac imaging procedures.

This position paper aimed to summarize the current knowledge on radiation effective doses and risks related to cardiac imaging procedures.

They found that based on an effective dose of 10 to 100 mSv, the additional lifetime risk of fatal and nonfatal cancer for one PCI ranges from one in 1000 to one in 100 for a healthy 50-year-old man and is 1.38 times higher in women and four times higher in children.

On the positive side, there has been progress in reducing the dose of radiation, the researchers note. During the past decade radiation dose has decreased dramatically in CT scanning through increasing dose-saving measures and improved scanner technology. If the heart rate is sufficiently slow and regular, gated cardiac CT can produce diagnostic-quality images with a mean effective radiation dose of <2 mSv or even <1 mSv.

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Drug Combo Boosts Early Quit Rates in Smokers.  For smokers motivated to quit, the combination of varenicline and bupropion may boost early, but not long-term, quit rates compared with varenicline alone, a new study published online in JAMA shows. The study involved 506 generally healthy, well-educated adults who had smoked at least 10 cigarettes daily for at least 6 months and were motivated to quit. They were randomly allocated to 12 weeks of varenicline plus bupropion SR (n = 249) or varenicline plus placebo (n = 257), with follow-up through week 52. In total, 315 participants (62%) completed the study, 158 on combination therapy and 157 on monotherapy.

The primary outcome was abstinence rates at week 12, defined as prolonged abstinence (no smoking from 2 weeks after the target quit date) and 7-day point-prevalence abstinence (no smoking in the past 7 days). The outcomes were biochemically confirmed. The researchers found that the combined treatment boosted quit rates at 12 and 26 weeks, but not at 52 weeks.

At week 12, 53.0% of the combination group achieved prolonged smoking abstinence, and 56.2% achieved 7-day point-prevalence smoking abstinence, compared with 43.2% and 48.6% of the patients on varenicline monotherapy, yielding odds ratios (ORs) of 1.49 (P = .03) and 1.36 (P = 0.09), respectively.

At week 26, 36.6% of the combination therapy group had quit, and 38.2% had not smoked in the past 7 days, compared with 27.6% and 31.9% on varenicline monotherapy (OR, 1.52; P = .03; and OR, 1.32; P = .14, respectively).

At the end of follow-up (52 weeks), 30.9% of the combination group had quit, and 36.6% achieved 7-day point-prevalence abstinence, compared with 24.5% and 29.2% on varenicline monotherapy (OR, 1.39; P = .11; and OR, 1.40; P = .08, respectively). Heavier smokers (at least a pack a day) on combination therapy were more likely to achieve prolonged abstinence at weeks 12, 26, and 52, and 7-day point-prevalence abstinence at 26 and 52 weeks.

Participants on combination therapy reported more anxiety (7.2% vs 3.1%; P = .04) and depressive symptoms (3.6% vs 0.8%; P = .03) than the monotherapy group.

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January 3, 2014

Re-vascularised STEMI patients with severely impaired LV function but no inducible VT have favourable long term prognosis without the protection of an ICD.  Post–myocardial infarction (MI) patients with severe left ventricular dysfunction who have a negative electrophysiologic study (EPS) showing no inducible ventricular tachycardia (VT) can do without the protection of an implantable cardioverter defibrillator (ICD), a new study published online at the last day of 2013, shows.

The patients in the series, all with a left ventricular ejection fraction (LVEF) lower than 30% or LVEF lower than 35% with heart failure, had low long-term rates of arrhythmia or death if VT could not be induced during electrophysiology testing, report investigators. In this study, consecutive patients treated with PCI for ST-segment elevation MI (STEMI) underwent early LVEF assessment. Of these, 128 patients with LVEF lower than 30%, or lower than 35% with New York Heart Association class II or III heart failure, also underwent electrophysiology testing. ICDs were implanted in less than 0.1% of control patients (the 1286 post-MI patients with a LVEF greater than 40%), 4% of those with a negative electrophysiology study (against study protocol), and 90% of patients with a positive study. Regarding the primary endpoint, defined as survival free of resuscitated cardiac arrest or sustained VT/ventricular fibrillation (VF), the results were similar in the control group and in those with left ventricular dysfunction and an EPS-negative study. At three years, 91.8% of control patients and 93.4% of the EPS-negative patients were alive and without arrhythmia (resuscitated cardiac arrest/sustained VT/VF). Comparatively, just 62.7% of patients with left ventricular dysfunction and a positive EPS test were alive and without arrhythmia at three years.

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Herpes Zoster (HZ) is an independent risk factor for vascular disease.  More evidence links herpes zoster (HZ) with vascular disease events.

A new study published online in Neurology, shows HZ to be an independent risk factor for transient ischemic attack (TIA) and myocardial infarction (MI) in all adults up to 24 years after an acute episode, and for stroke as well, although only among people whose HZ occurred when they were under 40 years of age.

Researchers used The Health Improvement Network (THIN) primary care database, which includes information on more than 3 million patients and is representative of the UK population. The analysis included 106,601 cases of HZ as well as 213,202 controls (2 for every case) who did not have a record of HZ and were matched for age, sex, and general practice.

To reduce miscoding, the study excluded recurrent HZ, which can be confused with herpes simplex.

After adjustment for sex, age, obesity, smoking status, history of elevated cholesterol, hypertension, diabetes, ischemic heart disease, atrial fibrillation, intermittent arterial claudication, carotid stenosis, and valvular heart disease, the study showed a 15% increased risk for TIA and a 10% increased risk for MI associated with HZ.

TIA itself was a risk factor for stroke, increasing the incidence 7-fold compared with age-matched controls (14.32% vs 2.07%).

However, the analysis showed no significant difference in stroke risk for cases compared with controls.

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Meaningful, Long-term Weight Loss Is Possible ( Look AHEAD study).  The 8-year weight-loss results from the Look AHEAD: Action for Health in Diabetes study of overweight or obese patients with type 2 diabetes suggest it is possible to lose and keep weight off with a program of intensive lifestyle counseling, researchers report in an article published online in Obesity Journal. In Look AHEAD, at 1 year, 68.0% of participants who received intensive lifestyle counseling vs 13.3% of participants who received usual care lost at least 5% of their initial body weight. At 8 years, these percentages were 50.3% vs 35.7%, respectively. A 5% weight loss can result in significant improvements in type 2 diabetes, sleep apnea, depression, and physical functioning.

The Look AHEAD researchers enrolled 5145 ethnically diverse overweight or obese adults aged 45 to 76 years who had type 2 diabetes and randomly assigned them to either an intensive behavioral intervention or usual care.

The intervention, adapted from the Diabetes Prevention Program, consisted of frequent group and individual counseling sessions given by a dietician, psychologist, or exercise specialist in the first year, followed by monthly individual counseling in years 2 to 8. Usual care consisted of a limited number of group sessions that provided diabetes support and education.

The trial was stopped in September 2012 after a mean follow-up of 9.6 years, when researchers failed to show that the intervention would reduce the risk for cardiovascular morbidity and mortality, the trial's primary outcome.

On average, participants in the intervention group lost 8.5% of their initial weight at 1 year and 4.7% of their initial weight at 8 years. Participants in the usual-care group lost 0.6% of their initial weight at 1 year and 2.1% of their initial weight at 8 years.

In the intervention arm, about a third of participants (37.7%) lost at least 10% of their initial weight at 1 year, and about 40% of these individuals maintained this weight loss at 8 years.

Importantly, the trial showed that the individuals who lost the most weight (10% or more) were also more likely to engage in good health practices: to walk most days; eat a lower-calorie, lower-fat diet; and weigh themselves at least weekly.

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December 23, 2013

New JNC 8 Hypertension Guidelines  After years of delay and many twists and turns, the hypertension guideline originally commissioned by the NIH has now finally been published in JAMA. The evidence-based document contains a major revision of hypertension treatment targets and includes new and somewhat simplified recommendations for drug treatment.. The Eighth Joint National Committee (JNC 8) has released its new guidelines on the management of adult hypertension, which contain two key departures from JNC 7 that the authors say will simplify care. For one, the expert writing group recommends a relaxing of the more aggressive JNC 7 target blood pressures and treatment-initiation thresholds in elderly patients and in patients under age 60 with diabetes and kidney disease. JNC 8 also backs away from the recommendation that thiazide-type diuretics should be initial therapy in most patients, suggesting an ACE inhibitor, angiotensin-receptor blocker (ARB), calcium-channel blocker (CCB), or thiazide-type diuretic are reasonable choices.

The authors formed nine recommendations which are discussed in detail along with the supporting evidence. Evidence was taken from randomized controlled trials, the gold standard for establishing efficacy and effectiveness.

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WHO Data Confirm the Worldwide 'Epidemic' of AF   The prevalence and incidence of atrial fibrillation (AF) is increasing globally, and the arrhythmia is having a profound impact on patient disability and mortality, according to new analysis. In total, 33.5 million individuals, or 0.5% of the world's population, have AF, and this new epidemiological data on AF confirms the emergence of this condition as a global epidemic. In the study, which published online in Circulation, the researchers analyzed the numbers from the Global Burden of Disease (GBD) database. The GBD is an international collaborative effort of multiple universities and the World Health Organization designed to assess morbidity and mortality from all diseases and injuries. The AF review included 184 studies, one-third of which were conducted in North America and another one-third in Western Europe.
Regarding the increases from 1990 to 2010, the researchers observed a small increase in AF prevalence and an increase in the overall incidence of AF:

•In 1990, the estimated AF prevalence rate per 100 000 individuals was 569.5 in males and 359.9 in females; this increased to 596.2 in males and 373.1 in females in 2010.

•In 1990, the overall incidence of AF per 100 000 individuals was 60.7 in males and 43.8 in females; by 2010, this incidence of AF increased to 77.5 in males and 59.5 in females.

Over the 20-year period, the age-adjusted mortality rate for AF increased twofold in men and women. By 2010, the age-adjusted mortality rate per 100 000 individuals was 1.6 and 1.7 for men and women, respectively. "Mortality increased steadily through 1995, 2000, and 2005, especially in the developed world.

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More Evidence That Blood Transfusions Raise Thrombosis Risk in ACS Patients   Many patients hospitalized with acute coronary syndromes receive blood or blood products due to bleeding complications or in response to anemia, yet there is also evidence that transfusions may be an independent risk factor for ischemic events, according a new study published online in the Journal of the American College of Cardiology. In this prospective study was explored the mechanisms of platelet function in patients receiving red blood cell (RBC) infusions for anemia, the second Impact of Transfusion of Red Blood Cell on Platelet Activation and Aggregation Studied with Flow Cytometry Use and Light Transmission Aggregometry (TRANSFUSION-2) study, 33 patients had suspected ACS and were on dual antiplatelet therapy with aspirin and a thienopyridine (usually clopidogrel) and 28 had other heart disease and were taking either aspirin or no antiplatelet agent. Their cohort was high risk, they write; one-fifth had diabetes and 41% had renal insufficiency.

In the study, mean maximum platelet aggregation rose 11.6% (p=0.004) and mean residual platelet aggregation rose 10.8% (p=0.005) from baseline to post-RBC infusion using an ADP-induced light-transmission aggregometry assay. The mean vasodilator-stimulated phosphoprotein platelet-reactivity index (VASP PRI) went up 20.7% (p=0.002). There was no significant effect on platelet reactivity in assays based on the arachidonic-acid pathway or collagen provocation. Inflammatory biomarker levels were unaffected, and little effect of RBC storage time on platelet function was seen.

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December 16, 2013

BNP Predicts Death in Stroke  A new meta-analysis which published in last issue of Neurology has shown that levels of B-type natriuretic peptide (BNP) are associated with poststroke mortality independent of stroke severity, age, and sex. However, measuring BNP in clinical practice seems difficult because levels add only minor predictive value to clinical information, the authors conclude. The literature-based meta-analysis included 3498 stroke patients from 16 studies and showed that BNP/NT-proBNP levels were a mean of 255.78 pg/mL higher in patients who died (P = .001), but after accounting for publication bias this association was lost. The individual-participant data analysis included 2258 stroke patients. Patients in the highest quartile for BNP and NT-proBNP levels had double the risk for death compared with the rest of the population, after adjustment for clinical variables. However, only NT-proBNP showed a slight added value to clinical prognostic variables, increasing discrimination by 0.028 points, and reclassifying 8.1% of patients into correct mortality risk categories, with a net reclassification improvement index of 0.003. Neither cause nor time from onset to death affected the association of BNP/NT-proBNP with mortality.

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CPAP Reduces Blood Pressure in Resistant Hypertension   Individuals with sleep apnea and resistant hypertension treated with continuous positive airway pressure (CPAP) over the course of 12 weeks had significant improvements in their 24-hour mean and diastolic blood pressures, but no change in their systolic blood pressure, according to the results of a new study published in the last issue of Journal of the American Medical Association . In this study (HIPARCO trial), individuals randomized to CPAP therapy also showed an improvement in their nocturnal blood-pressure pattern, with more patients treated with CPAP displaying the nocturnal dipper pattern when compared with individuals who did not receive CPAP. In the present study, including 98 patients randomized to CPAP therapy and 96 who were not, all patients were diagnosed with resistant hypertension for more than a decade and were taking, on average, 3.8 antihypertensive medications. At baseline, the 24-hour mean, systolic, and diastolic blood pressures were 103 mm Hg, 144 mm Hg, and 83 mm Hg, respectively. At baseline, 25% of patients had a dipper nocturnal blood-pressure pattern, which was defined as a >10% decrease in the average nighttime pressure compared with the average daytime pressure. After 12 weeks of CPAP, the reduction in the 24-hour mean and diastolic blood pressures was 3.1 mm Hg and 3.2 mm Hg, respectively, but there was no change observed in the 24-hour mean systolic blood pressure. In the per-protocol analysis, the reductions in the 24-hour mean and diastolic blood pressure were 4.4 mm Hg and 4.1 mm Hg, respectively. In addition, the per-protocol analysis showed a significant 4.9-mm-Hg decrease in the 24-hour systolic blood pressure. In terms of the nighttime blood-pressure patterns, 36% of the CPAP patients had a nocturnal dipper pattern after 12 weeks vs just 21.6% in the control arm.

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FDA advisory panel votes favourably on Watchman left atrial appendage closure device   On 11 December, the FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee voted favourably by a majority, Yes: 13, No: 1, that the benefits of the Watchman left atrial appendage closure device outweigh the risks. The FDA panel was further asked if there is reasonable assurance that the device is safe, for what it voted Yes: 13, No: 1. On the question of reasonable assurance of efficacy, the panel voted Yes: 13, No: 1. The FDA will take into account the panel’s vote in its decision on approval of the Watchman device. The company expects a decision from the FDA in the first half of 2014. The vote of the committee followed a review of clinical data from two randomised control trials, PROTECT AF and PREVAIL, as well as from the CAP (Continued access protocol) registry. The Watchman device received CE Mark in 2005.

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December 9, 2013

New Oral Anticoagulant Stroke-Protection Benefits in AF Cut Across Subgroups  Collectively, four new oral anticoagulants (NOACs) protect against stroke or systemic embolism better than warfarin and compare favorably on safety in patients with atrial fibrillation (AF), concludes a meta-analysis of four big randomized trials, all major showcases for the agents' potential value in AF which published in the Lancet. "NOAC" in the current analysis meant four warfarin alternatives that are already available or seem headed for approval in AF: the direct thrombin inhibitor dabigatran and factor Xa inhibitors rivaroxaban apixaban and edoxaban. The metanalysis was based on the results of of the new agents' pivotal clinical trials, RE-LY , ROCKET AF , ARISTOTLE , and ENGAGE AF–TIMI 48.

For the meta-analysis, the authors looked only at phase 3 NOAC-warfarin comparisons that reported both efficacy and safety outcomes; the four trials that turned up encompassed 42 411 patients who received a NOAC and 29 272 warfarin recipients. The trials' median follow-ups ranged from 1.8 years to 2.8 years.

The risk of stroke or systemic embolic events, the primary outcome of the analysis, fell by 19% on NOACs compared with warfarin (p<0.0001). Hemorrhagic strokes accounted for much of the reduction (p<0.0001), while the risk of ischemic stroke wasn't affected by NOAC use vs warfarin.

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Renal denervation's structural and functional heart benefits may be independent of BP  In a small study of patients undergoing renal denervation for resistant hypertension, which published online in the Journal of the American College of Cardiology, left-ventricular hypertrophy and diastolic function improved independently of changes in blood pressure and heart rate. In the study were enrolled enrolled 66 consecutive patients who underwent renal denervation during 2010 and 2011 for treatment of resistant hypertension (office systolic blood pressure > 140 mmHg). Patients had a mean age of 64 years and 55% were men. They were on a mean of 4.3 antihypertensive drugs. All were taking a diuretic, 89% were taking a beta blocker, and 55% were taking an angiotensin-receptor blocker.

Six months after renal denervation, mean blood pressure decreased from 172.9/92.5 to 151.3/85.5 mmHg, confirmed by 24-hour ambulatory monitoring, if available (n=50). Mean heart rate decreased from 67.7 to 60.5 bpm. Mean left-ventricular mass index decreased from 61.5 to 53.4 g/m 2. Measures of diastolic function also improved.

The changes in cardiac function and ventricular size were not tied to the magnitude of the blood-pressure reduction, which "suggests a direct effect of the sympathetic nervous systems on myocardial morphology and function".

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Stroke Mortality Continues to Fall  Mortality from stroke has declined dramatically in recent decades in the United States because of improved treatment and prevention, according to a new scientific statement from the American Heart Association/American Stroke Association which published online in Stroke Journal . The statement reports that stroke deaths declined all through the last century, with numbers falling from about 250 per 100,000 population in 1900 to about 60 per 100,000 by 2000. In the last decade this reduction has continued, with stroke mortality rates of 40 per 100,000 in 2010 (all age-adjusted figures standardized for the 2000 population). In addition, stroke has now fallen from the third to the fourth leading cause of death in the United States. In terms of prevention, many different factors have probably contributed to the falling stroke rates, but the number 1 reason is thought to be better blood pressure control.

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December 2, 2013

BP, Cholesterol, and Glucose Explain CHD Risk With High BMI  Blood pressure, cholesterol, and glucose together explained about half of the heightened risk of coronary heart disease (CHD) among individuals with a high body mass index (BMI) in a large review of 97 international studies which published online in the Lancet . These three risk factors also explained three-quarters of the excess risk of stroke in overweight and obese individuals. Of the three risk factors, blood pressure was the most important, followed by glucose and cholesterol. The authors identified 97 prospective cohort studies that collectively enrolled 1.8 million participants around the world between 1948 and 2005. Participants were at least 18 years old and had a BMI >20 kg/m2 and no history of CVD at enrollment, as well as complete data for the three mediators, potential confounders (including age, sex, and smoking), and the primary outcome of first occurrence of fatal and/or nonfatal CHD or stroke. During a median follow-up of 13.3 years, there were 57 161 CHD events and 31 093 strokes. After adjusting for confounders, each 5 kg/m2 increase in BMI was associated with a hazard ratio (HR) of 1.27 for CHD and 1.18 for stroke.

Adjusting for blood pressure, cholesterol, and glucose reduced the HRs to 1.15 for CHD and 1.04 for stroke, suggesting that among patients with a high BMI, 46% of the excess risk for CHD and 76% of the excess risk for stroke is mediated by these three risk factors.

Blood pressure accounted for 31% of the excess risk for CHD and 65% of the excess risk for stroke.

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Unexpected Abrupt Increase in Left Ventricular Assist Device (Heart Mate II) Thrombosis  Researchers are warning about "unexpectedly" and "abruptly" increased rates of thrombosis with the HeartMate II left ventricular assist device (LVAD) occurring early after implantation according to a study published online in the New England Journal of Medicine. The study compared outcomes in LVAD patients at three centers from January 2004 to March 2011 vs March 2011 to April 2013. During these periods, the rate of confirmed thrombosis three months after LVAD implantation increased sharply from 2.2% to 8.4%, and median time from implantation until the development of blood clots with the devices decreased from 18.6 to 2.7 months. Elevated lactate dehydrogenase (LDH) levels in the first weeks after implantation of the device often preceded confirmed pump thrombosis.

The researchers reviewed data of 895 HeartMate II devices implanted in 837 patients from 2004 to 2013. Each center carried out a similar number of procedures. The primary end point was confirmed pump thrombosis, and secondary end points were confirmed and suspected thrombosis, longitudinal LDH levels, and outcomes after pump thrombosis.

There were 72 cases of confirmed pump thrombosis in 66 patients, defined as a thrombosis detected at the time of pump replacement, heart transplant, or autopsy. The frequency of device thrombosis increased steeply around March 2011 at the three institutions.
Even though this is a potentially life-threatening complication, patients who developed clots in their devices and received a replacement device or an urgent heart transplant had a similar mortality rate at six months compared with patients who did not have device thrombosis

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FDA lifts certain safety restrictions on use of diabetes drug rosiglitazone  The U.S. Food and Drug Administration has announced that it removes certain restrictions on prescribing and use of diabetes drug rosiglitazone. This decision is based on new information regarding the cardiovascular risk of the medicine. In 2010, in response to data from a meta-analysis of placebo-controlled randomised trials that suggested an elevated risk of cardiovascular events in association with rosiglitazone use, the FDA announced it would restrict the drug to use in patients with type 2 diabetes who could not control their diabetes on other medications.

The FDA required to the product company to convene an independent group of scientists to readjudicate key aspects of Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) clinical trial, which studied the cardiovascular safety of Avandia compared to standard diabetes drugs to provide clarity about the integrity of the study findings. In June 2013, the readjudicated results of RECORD, which were consistent with the original findings of the trial, were discussed at a joint meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. Committee members generally agreed that the readjudication was well-conducted and provided reassurance that the original study findings were accurate. A majority of the committee members voted to recommend that restrictions be lifted. Thus, results from the RECORD clinical trial showed no elevated risk of heart attack or death in patients being treated with rosiglitazone when compared to standard-of-care diabetes drugs. These data do not confirm the signal of increased risk of heart attacks that was found in a meta-analysis of clinical trials first reported in 2007.

Once the changes are final, rosiglitazone’s indication for use will no longer be limited to certain patients. The FDA anticipates that the new indication will state that the drug may be used along with diet and exercise to improve control of blood sugar in patients with type 2 diabetes mellitus, an indication similar to other diabetes drugs currently available.

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November 25, 2013

Vanoxerine shows strong safety efficacy signals for treatment of atrial fibrillation in a Phase IIb study  In the recent annual congress of AHA was announced positive safety and statistically significant efficacy data from a phase IIb study of vanoxerine , a drug in development for the treatment of atrial fibrillation.

In the randomised, placebo-controlled trial, 104 patients presenting with symptomatic atrial fibrillation or atrial flutter of recent onset were assigned to one of three doses of vanoxerine or placebo. Vanoxerine was found to be well tolerated at all doses. No episodes of monomorphic or polymorphic ventricular tachycardia were seen.

Patients participating in the trial were measured for conversion from atrial fibrillation or flutter to normal sinus rhythm. Overall, there was a highly statistically significant dose-dependent increase in the conversion to normal sinus rhythm (p-value for all doses=0.0005) compared to placebo. The highest oral dose (400mg) achieved a conversion rate of 76% at eight hours and 84% within the first 24 hours, a rate approaching that of direct current cardioversion. Patients taking placebo achieved a 25% conversion rate at eight hours and a 38% conversion rate at 24 hours.

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Devices may be safer than manual closure during PCI  Using vascular closure devices (VCDs) during PCI may be safer than manual closure, according to a study published online in Annals of Internal Medicine. The devices were associated with fewer vascular complications and a reduced need for transfusions in patients undergoing transfemoral PCI. The investigators identified consecutive patients who had PCIs between 2007 and 2009. There were 85,048 who met their criteria and 68,874 were analyzed.

Their outcomes were vascular complications related to the access site, defined as either an acute thrombosis, loss of limb, retroperitoneal bleeding, surgical repair, pseudoaneurysm or hematoma that needed transfusion or arteriovenous fistula. Death was considered post-PCI death before discharge.

Thirty-seven percent of the procedures used VCDs. There was an association between VCDs and a lower risk of vascular complications (odds ratio [OR] 0.78) and post-PCI transfusions (OR 0.85). The reductions were attenuated among patients with a low body mass index (less than 25 kg/m 2) and patients treated with a platelet glycoprotein IIb/IIIa inhibitor, however. Although there was a lower risk of hematomas (OR 0.69) and pseudoaneurysms (OR 0.54), there was a higher risk of retroperitoneal bleeding (OR 1.57).

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Edoxaban meets primary efficacy endpoint for stroke prevention to warfarin for atrial fibrillation patients  The results from ENGAGE AF-TIMI 48 were presented as a late-breaking clinical trial at the American Heart Association (AHA) Scientific Sessions 2013 in Dallas, USA and published online in the New England Journal of Medicine. The clinical trial found that the investigational, oral, once daily direct factor Xa-inhibitor edoxaban met the primary efficacy endpoint of non-inferiority compared to warfarin for the prevention of stroke or systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF). Once-daily edoxaban also demonstrated significant reductions in major bleeding compared to warfarin, achieving superiority for the principal safety endpoint. ENGAGE AF-TIMI 48 compared two edoxaban treatment arms, 60mg and 30mg, with warfarin in 21,105 patients with NVAF for a median of 2.8 years. This represents the largest and longest trial with a novel anticoagulant in patients with atrial fibrillation performed to date. The edoxaban 60mg treatment arm had an annual incidence of stroke or SEE of 1.18% vs. 1.50% for warfarin (hazard ratio [HR], 0.79; 97.5% confidence interval [CI], 0.63 to 0.99; p:.001). The edoxaban 30mg treatment arm had an annual incidence of stroke or SEE of 1.61% vs. 1.50% for warfarin (HR, 1.07; 97.5% CI, 0.87 to 1.31; p=0.005 for non-inferiority), and significantly reduced major bleeding by 53% (1.61% vs. 3.43% per year, respectively) (HR, 0.47; 95% CI, 0.41 to 0.55; p:0.001)

In ENGAGE AF-TIMI 48, patient-specific dosing was applied according to the study protocol. In both edoxaban treatment arms, the edoxaban dose was halved for patients with clinical factors that were known to increase the risk of bleeding (renal impairment, low body weight or concomitant use of certain P-glycoprotein inhibitors). Patients receiving a reduced edoxaban dose in the 60mg treatment arm had an annual incidence of stroke or SEE of 2.32% vs. 2.68% for warfarin and a significantly reduced major bleeding incidence of 3.05% vs. 4.85%. Patients receiving a reduced edoxaban dose in the 30mg treatment arm had an annual incidence of stroke or SEE of 3.14% vs. 2.68% for warfarin and a significantly reduced major bleeding incidence of 1.50% vs. 4.85%.

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November 18, 2013

US Transcatheter Valve Outcomes in Line With RCTs; Non-CVD Deaths Still High:  It's been two years since the first transcatheter aortic valve was approved for use in the US, and in that time, more than 8000 patients have been treated this, according to new data published in the last issue of Journal of the American Medical Association. The 30-day outcomes in these patients, are in line with those from the randomized trials that led to the approval of the trnscatheter valve. In all, 8075 cases were entered into the registry between November 1, 2011 and May 31, 2013; 292 were missing key data and not included in the analysis.

Of the remaining 7710, treated at 224 hospitals, 1559 patients were deemed "inoperable" (TAVR for severe, symptomatic, inoperable aortic stenosis was approved in 2011) and 6151 were deemed high-risk operable (indication approved in 2012). Median age of treated patients was 84, roughly the same as patients in the PARTNER A and B cohorts. Two-thirds of patients were treated via a transfemoral approach.

Device implantation was successful in 92% of patients. In-hospital mortality and stroke rates were 5.5% and 2%, respectively—again, similar to patients in the PARTNER studies.

Thirty-day data were available for less than half of the cohort (n=3133), and in these patients, mortality was 7.6%, stroke 2.8%, new dialysis 2.5%, and reintervention 0.5%.

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Novel Method More Accurately Measures LDL Cholesterol:  US researchers have devised and validated a novel method of estimating LDL-cholesterol levels. The new method, which was tested and validated in more than 1.3 million individuals, uses an adjustable factor to estimate very low-density lipoprotein (VLDL) cholesterol to account for variance in triglyceride and non-HDL cholesterol levels used in the Friedewald equation. The results of the study are published in the last issue of Journal of the American Medical Association. LDL cholesterol is estimated using the Friedewald equation. In the Friedewald equation, there is an assumed fixed 5:1 ratio of triglyceride levels to VLDL cholesterol. However, the problem is assuming this fixed 5:1 ratio across a range of triglyceride and non-HDL-cholesterol levels. Other studies, for example, have shown evidence of variance in the ratio, ranging as high as 9:1 in one study. Instead of using the fixed ratio of triglycerides to VLDL cholesterol to estimate LDL, they used an adjustable ratio as determined from more than 900 000 patients in the derivation cohort. As expected, the derivation cohort showed wide interindividual variance in the triglyceride/VLDL ratio. In their analysis, triglyceride and non–HDL-cholesterol levels explained approximately two-thirds of the variance in the triglyceride/VLDL ratio.

The researchers then performed a regression analysis that accounted for lipids, age, and sex to determine strata-specific median triglyceride/VLDL-cholesterol ratios. Based on these values, a 180-cell table of median triglyceride and non-HDL cholesterol levels was devised. The adjusted ratio of triglycerides to VLDL cholesterol can be obtained in the table using the values of triglycerides and non-HDL cholesterol.

For those patients with triglycerides <400 mg/dL, the overall concordance of the novel method of measuring LDL was 91.7% when compared with the direct measurement of LDL cholesterol. In contrast, the Friedewald-estimated measurement of LDL using the fixed ratio had a concordance of just 85.4%.

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No Benefit of BP Reduction in Acute Phase of Stroke (CATIS study):  A randomized trial finds no benefit of treating acute ischemic stroke patients with elevated blood pressure using antihypertensive medications in the first 48 hours after an event.

Results of the China Antihypertensive Trial in Acute Ischemic Stroke (CATIS) trial showed that which published online in the Journal of the American Medical Association, compared with no antihypertensive treatment, treating patients to a target BP with antihypertensive medications did not reduce the risk for death or major disability at 14 days or hospital discharge; outcomes were virtually identical between groups. The CATIS trial was a single-blind, blinded end points, multicenter, randomized controlled trial looking at whether moderate BP reduction within 48 hours of stroke onset would reduce death and major disability, defined as a modified Rankin Scale (mRS) score of 3 or higher, at 14 days or hospital discharge. They also assessed the effect of antihypertensive treatment in the acute phase on 3-month mortality, major disability, and vascular events at a posttreatment follow-up visit.

Included were 4071 patients from 26 hospitals with acute ischemic stroke who were within 48 hours of symptom onset and had elevated BP. Patients who received thrombolytic therapy were excluded from this trial, they note. Although intravenous tissue plasminogen activator (tPA) is standard treatment for stroke, treatment rates remain low, at less than 6% in a recent US survey and around 2% in China, the authors say. Therefore, the findings most likely are applicable for the majority of patients, who currently do not receive thrombolytic therapy. Patients were randomized to receive antihypertensive therapy (n = 2038) with the aim of lowering systolic BP by 10% to 25% within 24 hours of randomization, achieving a level of less than 140 mm Hg by day 7, and maintaining it to that level during the entire hospitalization or to discontinue all hypertensive medications they'd been on prior to their stroke during their hospitalization (n = 2033).

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November 11, 2013

EU Strengthens Warning on Ponatinib:  After reviewing updated information on the anticancer drug, which is used to treat chronic myeloid leukemia (CML), the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has decided to keep ponatinib on the market, but with a strong warning about potential cardiovascular adverse effects.

At its meeting this month, the EMA reviewed new information on the drug that suggests serious cardiovascular toxicities, including vascular occlusive events, are occurring at a rate higher than what was initially reported when approval was granted by the European Union (EU) marketing authorization in July. Ponatinib has been temporarily pulled from the market in the United States at the request of the US Food and Drug Administration (FDA). The frequency of serious adverse vascular events has increased since the drug received accelerated approval in the United States in December 2012. The FDA announcement was not entirely unexpected. The agency had already been investigating an increase in life-threatening blood clots and blood vessel narrowing in patients taking ponatinib.

Current EU product information mentions the risk for myocardial infarction, cerebral infarction, and related disorders. Ponatinib is a tyrosine kinase inhibitor (TKI) used to treat patients with CML and Philadelphia-chromosome positive acute lymphoblastic leukemia (ALL). Since its initial approval in the EU, the agent has been limited to patients who are resistant or refractory to other therapies. Ponatinib works across a wide range of TKI resistance, including the threonine-to-isoleucine mutation at position 315 (T315I), which is present in up to 20% of patients who exhibit TKI resistance.

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No Advantage with Biodegradable-Polymer Stents according to a new Meta-Analysis:  New stents with a biodegradable polymer are superior to first-generation drug-eluting stents (DES) when it comes to reducing target vessel revascularization (TVR), but are not better than newer-generation stents with a durable polymer, according to the results of a new meta-analysis which published in BMJ. In fact, among the stents compared, newer-generation stents with durable polymer, such as the zotarolimus-eluting stent , cobalt-chromium everolimus-eluting stent and platinum-chromium everolimus-eluting stent , had the lowest rates of TVR whereas the cobalt-chromium everolimus-eluting stent was shown to be the safest.

The meta-analysis included 126 randomized trials and 258 544 patient–years of follow-up. Regarding efficacy, biodegradable-polymer DES were superior to first-generation paclitaxel- and zotarolimus-eluting stents in the reduction of TVR. However, there was no difference in the rate of TVR between biodegradable-polymer DES and newer-generation DES with durable polymers.

Regarding the long-term safety, the biodegradable-polymer DES reduced the rate of stent thrombosis compared with paclitaxel- and sirolimus-eluting stents, but was inferior to the cobalt-chromium everolimus-eluting stent. Compared with the cobalt-chromium everolimus-eluting stent, however, the biodegradable-polymer DES were associated with a 48% increased risk of death, according to a one-year landmark analysis.

In addition, the meta-analysis showed the cobalt-chromium stent to be the safest, with a 65% reduction in definite stent thrombosis, a 35% reduction in MI risk, and a 38% reduction in risk of death compared with bare-metal stents.

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No advantages of the addition of metformin on top of statins for non-diabetic patients with coronary heart disease:  The Carotid Atherosclerosis: Metformin For Insulin Resistance (CAMERA) trial which is published online in Lancet Diabetes & Endocrinology showed that metformin on top of statins does not slow the progression of cardiovascular disease in high-risk patients without diabetes. The study enrolled 173 patients with stable coronary artery disease and large waist circumference. After 18 months, the combination of metformin and a statin showed no improvements in carotid intima-media thickness (CIMT) progression or change in carotid plaque score; it also failed to show improvements in cholesterol and fasting glucose levels. The trial did, however, show that the 86 patients randomized to receive metformin on top of a statin lost a mean of 3.2 kg, whereas the statin-only group lost none. There were also significantly greater declines in body-mass index (BMI) in the metformin group.

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October 29, 2013

More Data Showing Flu Vaccine Lowers CVD Risk:  According a new meta-analysis of six randomized, controlled clinical trials that included 6735 patients which published in JAMAt influenza vaccination was associated with a 36% lower risk of cardiovascular events. The influenza vaccine was associated with 55% lower risk of major adverse cardiovascular events in patients with a recent acute coronary syndrome (ACS). In these ACS patients, investigators say just eight patients would need to be treated with the influenza vaccine to prevent one major cardiovascular event.

Overall, major cardiovascular events, defined as a composite of cardiovascular death, hospitalization for MI, unstable angina, stroke, heart failure, or urgent revascularization, occurred in 2.9% of the 3238 patients treated with the vaccine and 4.7% of the 3231 patients treated with placebo/control (relative risk [RR] 0.64; 95% CI 0.48–0.86). This translated into a number needed to treat of 58 to prevent one event.

In the 789 ACS patients, major cardiovascular events occurred in 10.25% of patients treated with the vaccine and 23.1% of those treated with placebo (RR 0.45; 95% CI 0.32–0.63). When analyzed separately, the reduction in risk among the stable coronary artery disease patients was not statistically significant (RR 0.94; 95% CI 0.55–1.61).

The researchers say the mechanisms underlying acute influenza infection and cardiovascular risk are not clear right now, but the evidence supporting an association between the two is considerable. They add that even though the recent flu outbreak of 2012–2013 is a good reminder of potential cardiovascular complications that can occur in association with respiratory infections, less than one-third of North Americans and less than 50% of high-risk patients get vaccinated each year.

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Anacetrapib Detected Years After Drug Stopped: DEFINE study:  It was published online in the American Journal of Cardiology a new study which found that anacetrapib appears to stick around much longer than investigators testing the novel cholesteryl ester transfer protein (CETP) inhibitor initially believed. residual concentrations of anacetrapib remain significantly elevated after the cessation of therapy. Twelve weeks after stopping treatment, investigators found that anacetrapib levels were approximately 40% of the on-treatment levels.

In a small subset of patients, low concentrations of anacetrapib were detectable in plasma as late as four years after the last treatment dose. In these 30 patients, all of whom were off the drug for 2.4 to 4.0 years, residual levels of the CETP inhibitor were at concentrations that indicated low pharmacological activity. These data indicate that the terminal half-life of anacetrapib is longer than previously estimated from phase 1 and phase 2 studies.

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EMA's CHMP: Restrict IV Nicardipine to Proven Scenarios:  Intravenous nicardipine should be used only to treat acute life-threatening high blood pressure or control high blood pressure after surgery, the European Medicines Agency (EMA) Committee on Medicinal Products for Human Use (CHMP) has concluded after conducting an EU-wide review. EMA also specified that nicardipine agents should be given only by specialists in a hospital or intensive-care unit and only by continuous venous infusion with continuous blood-pressure monitoring.

The EMA notes that nicardipine had been used in some EU countries for controlled hypotension during anesthesia, controlling hypertension during surgery, and treating acute severe hypertension with left ventricular decompensation and pulmonary edema. "These uses are no longer recommended because the available data are insufficient to support use in these conditions," the EMA states.

The review was requested by regulators in the UK faced with a request from a company seeking approval of a generic form of IV nicardipine. That submission failed to adequately document the risk/benefits of the drug.

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October 21, 2013

Mortality reduction with Bivalirudin only partially due to bleeding (HORIZON AMI post hoc analysis):  Even in the absence of major bleeding, patients with ST-segment elevation myocardial infarction (STEMI) who receive bivalirudin rather than unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor (GPI) during percutaneous coronary intervention (PCI) are less likely to die of cardiac causes by 3 years. The findings, from a post hoc analysis of HORIZONS-AMI data published online in the Journal of the American College of Cardiology, suggest that bivalirudin may carry non-hematologic benefits.

In the main HORIZONS-AMI (Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction) trial, 3,602 STEMI patients were randomized to bivalirudin (n = 1,800) or heparin plus a GPI (n = 1,802). As reported previously, 3-year follow-up showed an advantage for bivalirudin over heparin plus GPI use in terms of both cardiac mortality (2.9% vs. 5.1%; P = 0.001) and non-CABG major bleeding (6.9% vs. 10.5%; P < 0.0001). Reinfarction also was less common with bivalirudin (6.2% vs. 8.2%; P = 0.04).

Major bleeding occurred in 7.2% of patients within 30 days and 8.5% within 3 years. Notably, 3-year cardiac mortality was reduced in patients who received bivalirudin whether they experienced major bleeding or not. On multivariate analysis adjusting for baseline characteristics as well as in-hospital thrombocytopenia and 3-year major bleeding and reinfarction, bivalirudin treatment was still independently associated with a 3-year reduction in cardiac mortality (adjusted HR 0.57; 95% CI 0.39-0.83; P = 0.003).

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Early Quality of life advantage of CABG over PCI for diabetic patients disappears after 2 years (substudy of FREEDOM trial):  Percutaneous coronary intervention (PCI) with stenting and coronary artery bypass graft surgery (CABG) result in similar long-term health status and quality of life (QOL) for patients with diabetes and multivessel disease, according to a substudy from the FREEDOM trial. The findings were published in the last issue of the Journal of the American Medical Association.

The primary results of FREEDOM demonstrated that CABG led to a benefit over PCI for the composite endpoint of death, MI, or stroke, driven by reductions in all-cause mortality and MI, in diabetic patients with multivessel disease.

For the substudy, the investigators compared the relative effects of CABG vs. PCI on health status and QOL in a cohort of 1,880 patients from the FREEDOM trial randomized to CABG (n = 935) or PCI with DES (n = 945). Health status was assessed using the angina frequency, physical limitations, and QOL domains of the Seattle Angina Questionnaire at baseline, 1, 6, and 12 months and annually thereafter. For each scale, scores range from 0 to 100, with higher scores representing better health.

At 1 month, PCI resulted in greater improvement on both the physical limitations (P < 0.001) and QOL (P = 0.03) subscales compared with CABG. By 6 months, the QOL subscales were similar, but there was a modest advantage for PCI on the physical limitations subscale (P = 0.002). However, by 1 year, scores on both subscales were higher with CABG (P = 0.01 for both) and remained higher through years 2 and 3 of follow-up.

Additionally, both interventions resulted in substantial reductions in dyspnea over time. The rate of improvement initially was more rapid with PCI vs. CABG, but between-group differences were no longer apparent by 6 months (P = 0.99).

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Anticoagulants among leading causes of adverse drug events:  Anticoagulants are among the drugs that cause the most adverse drug events during hospital stays in 2011 (ADEs), according to a report published by the federal Agency for Healthcare Research and Quality (AHRQ).

Using data from 20,172,966 discharges from 32 states in 2011, agency researchers found that steroids, antibiotics, opiates and narcotics, and anticoagulants were the top four causes of ADEs. ADEs occurred in about 8 in 1,000 adults 65 and older. Rates were highest among the oldest adults.

Anticoagulants led to ADEs in 6.7 per 10,000 discharges and were also more common in hospitals that were urban and non-teaching, private and non-profit and large in terms of the number of beds. The rate of ADEs caused by these drugs was 20 percent lower in females.

Approximately 380,000 to 450,000 patients experience ADEs during hospital stays every year. The data are published in the October Healthcare Cost and Utilization Project report.

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October 14, 2013

Esmolol Stabilize Heart Rate in Septic Shock Patients:  For patients in septic shock who have an excessively high heartbeat, use of the beta blocker esmolol helped to lower and maintain heartbeat rates without adverse effects, according to a study published online in JAMA. In the study were randomly assigned 154 patients whose heartbeats exceeded 95 beats per minute (BPM) and who required high doses of norepinephrine to receive either continuous infusion of esmolol to maintain heart rate between 80 and 94 BPM (n = 77) or to receive standard treatment (n = 77) of norepinephrine during intensive care unit stays.The target heartbeat rate was achieved in all patients in the esmolol group and was significantly lower than for patients in the control group. The median heart rate reduction came to −28 BPM for the esmolol group compared with −6 BPM for the control group (P < .001). The median continuously infused dose for esmolol was 100 mg/h (interquartile range [IQR], 50 - 300 mg/h).

The mortality rate for the esmolol group came to 49.4% for the esmolol group compared with 80.5% for the control group (P < .001). Stroke volume index was significantly higher in the esmolol group (P = .02), as was the left ventricular stroke work index (P = .03). Fluid requirements were reduced in the esmolol group compared with controls (P < .001), although no clinically relevant differences existed between groups for some other cardiopulmonary variables.

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FDA Approves Riociguat for PAH and CTEPH:  The US Food and Drug Administration (FDA) has approved riociguat for the treatment of pulmonary arterial hypertension (PAH) and the treatment of chronic thromboembolic pulmonary hypertension (CTEPH). Riociguat belongs to a class of drugs called soluble guanylate cyclase stimulators that help arteries relax to increase blood flow and decrease blood pressure. It is intended for patients with chronic thromboembolic pulmonary hypertension (CTEPH) after surgery or patients who cannot undergo surgery, to improve their ability to exercise. Adempas is also indicated for patients with pulmonary arterial hypertension (PAH) of unknown causes, inherited or associated with connective tissue diseases, to improve their ability to exercise and to delay clinical worsening of their condition. The drug carries a Boxed Warning, alerting patients and health care professionals that the drug should not be used in pregnant women because it can harm the developing fetus.

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FDA Panel Supports AV Block Indication for BiV Pacing:  Indications for biventricular (BiV) pacing should be extended to include patients with systolic heart failure and first-, second-, or third-degree atrioventricular (AV) block according the FDA's Circulatory System Devices advisory panel. BiV pacing in first-degree AV block should be only for patients for whom there is "a verifiable confidence that ventricular pacing is going to be necessary most of the time". The decision were driven by the BLOCK HF trial results. The trial was a prospective, multisite, randomized, double-blinded, parallel-controlled investigational device exemption (IDE) study. The primary objective of the trial was to demonstrate that the time until the first event of all-cause mortality, heart-failure-related urgent care, or a significant increase in left ventricular end systolic volume index (LVESVI) for subjects programmed to biventricular pacing is superior to that of subjects programmed to right ventricular pacing.

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October 7, 2013

Pulmonary Embolism Misdiagnosed in 33.5% of ED Patients:  One third of patients who arrived at the emergency department with pulmonary embolism (PE) were misdiagnosed before being sent home or hospitalized, according to a retrospective observational study which published online in the American Journal of Emergency Medicine. Chronic lung conditions such as asthma frequently contributed to the delay in diagnosis.

The researchers studied the clinical charts of patients older than 18 years who had been admitted to 3 university-affiliated hospitals in Madrid, Spain, with a diagnosis of acute symptomatic PE from April 2008 to December 2011. Of 436 patients included in the study, 146, or 33.5%, had a delayed diagnosis of PE.

In a multivariate analysis, the investigators found that patients with a history of chronic obstructive pulmonary disease were more likely to have a delayed diagnosis (odds ratio [OR], 4.3; 95% confidence interval [CI], 2.2 - 8.6; P = .00), as were those with a history of asthma (OR, 3.4; 95% CI, 1.2 - 9.7; P = .01). Patients with a cough (OR, 2.5; 95% CI, 1.4 - 4.7; P = .002) or the absence of syncope (OR, 4.3; 95% CI, 1.2 - 14.7; P = .02) on clinical presentation were also more likely to have delays in diagnosis. Other factors associated with delayed PE diagnosis included dyspnea (OR, 2.3; 95% CI, 1.1 - 4.8; P = .02), the presence of pleuro-mechanic thoracic pain (OR, 3.6; 95% CI, 1.3 - 9.5; P = .01), fever (OR, 2.7; 95% CI, 1.2 - 7.8; P = .04), hemoptysis (OR, 5; 95% CI, 1.4 - 17.1; P = .009), and the presence of a pulmonary infiltrate on chest radiography (OR, 2.5; 95% CI, 1.1 - 6.2; P = .04).

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Major Bleeds Less Daunting With Dabigatran Than Warfarin in a new Meta-Analysis:  Major bleeding complications from dabigatran etexilate in trials of atrial fibrillation (AF) and venous thromboembolism (VTE) prevention tended to be less critical and more manageable than those attributed to the warfarin comparator, suggests a new meta-analysis, published online in Circulation. The worst major bleeds, for example, tended to be gastrointestinal with dabigatran and the more daunting intracranial hemorrhage (ICH) on warfarin. At the same time, major bleeding events in the meta-analysis were no more common with the newer oral anticoagulant and were in higher-risk patients.

The meta-analysis was based on pooled patient-level data from the AF trial RE-LY and the VTE-prevention trials RECOVER, RECOVER II, RE-MEDY and RESONATE , which encompassed 1121 major bleeds in >27 000 patients. For the meta-analysis' purposes, major bleeds included only those developing within three days of the last dose of oral anticoagulant.

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Long-term clopidogrel therapy after stroke safer than dual-antiplatelet therapy:  Using clopidogrel monotherapy over a long period of time may be a safer option than long-term dual-antiplatelet therapy for stroke prevention in patients with ischemic stroke or transient ischemic attack (TIA). A meta-analysis published in Annals of Internal Medicine found that dual-antiplatelet therapy did not reduce overall risk of stroke compared with clopidogrel alone or aspirin alone, but was associated with a higher risk of intracranial hemorrhage (ICH). The studies in the analysis included 39,574 participants who were randomly assigned to either single-antiplatelet therapy or dual-antiplatelet therapy. As endpoints, the authors assessed recurrent stroke and ICH. There was no difference between the aspirin monotherapy group and the dual-antiplatelet therapy group (relative risk [RR] 0.89). There was also no difference between the clopidogrel group and the dual-therapy group (RR 1.01). They found a lower risk for gastrointestinal bleeding among the clopidogrel group compared with the aspirin group. When comparing risk for ICH, there was no difference between the aspirin group and the dual-therapy group (RR 0.99), but the dual-therapy risk was higher when compared with clopidogrel (RR 1.46).

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