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October 20, 2014

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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October 13, 2014

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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October 07, 2014

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

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

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

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

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

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

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

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

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September 29, 2014

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

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

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

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

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

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

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

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

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

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

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

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

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

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September 22, 2014

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

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

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

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September 15, 2014

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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September 08, 2014

Iron supplementation improved HF outcomes (CONFIRM-HF study)  Iron supplementation improved functional capacity, symptoms and quality of life in iron-deficient patients with HF, according to the results of the CONFIRM-HF study which presented in the ESC Congress and published online in European Heart Journal. Researchers randomly assigned 304 patients at 41 sites across nine European countries to IV iron, given as ferric carboxymaltose solution (median total dose, 1,500 mg), or saline placebo for 1 year. All patients had stable, symptomatic HF and iron deficiency, defined as serum ferritin level <100 ng/mL or, if transferrin saturation was less than 20%, 100 ng/dL to 300 ng/dL. The primary outcome was change in 6-minute walk distance between baseline and 24 weeks. Secondary endpoints included changes to NYHA functional class, Patient Global Assessment, health-related quality of life and fatigue score at 6, 12, 24, 36 and 52 weeks, as well as the effect of iron on the rate of hospitalization for worsening HF.

The results showed that at 24 weeks, the iron group had a least squares mean increase of 18 m in 6-minute walk distance vs. a least squares mean decrease of 16 m in 6-minute walk distance for the placebo group (difference, 33 ± 11 m; P=.002). At 52 weeks, the treatment effect of iron was sustained (difference, 36 ± 11 m; P<.001) and consistent across all evaluated subgroups. From 24 weeks on, the iron group had significant improvement in NYHA class (P<.001 at 52 weeks), Patient Global Assessment (P=.001 at 52 weeks), health-related quality of life (P=.01 at 52 weeks) and fatigue score. Treatment with iron was associated with reduced risk for hospitalization for worsening HF (HR=0.39; 95% CI, 0.19-0.82), according to the researchers. They also found that the number of deaths and adverse events were similar between the groups.

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Incidentally detected, asymptomatic AF increase the risk for stroke, but OACs lower risk  Incidentally detected atrial fibrillation (AF) in asymptomatic and ambulatory patients is associated with a significantly increased risk of stroke, MI, and all-cause mortality, but treating the detected arrhythmia with oral anticoagulants can significantly improve the prognosis of these patients, according to the results of a new study which published in the Thrombosis & Haemostasis Journal. The new data suggest that it would be worthwhile to initiate a communitywide screening program to detect and treat AF in these asymptomatic patients. The analysis identified patients with a first diagnosis of atrial fibrillation and excluded any patients who were sent to the hospital for AF, those with symptoms for AF, or those who had a clinical event associated with AF. In the end, 5555 patients with asymptomatic AF were included, and their outcomes were compared with 24 705 age- and gender-matched controls. Patients were followed for a mean of 3.5 years. Compared with the matched controls, there was a significant excess risk of stroke, MI, and all-cause mortality among individuals with silent AF. Regarding stroke, the incidence rate was 19.4 events per 1000 person-years among those with AF and 8.4 events per 1000 person-years among the controls. For all-cause mortality, the incidence rate was 40.1 deaths per 1000 person-years among the AF patients vs 20.9 per 1000 person-years in the control arm. In a multivariate-adjusted risk model, those who received a vitamin-K antagonist had a 65% lower risk of fatal and nonfatal stroke and a 44% lower risk of all-cause mortality compared with untreated incident AF individuals. Treatment with aspirin alone provided no benefit.

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Abdominal fat may be more risky for hypertension than total fat  Fat around the abdomen may be more of a cause of hypertension than overall body fat, according to an article published in the last issue of Journal of the American College of Cardiology. The researchers drew the study population from an original cohort of 2716 participants (aged 18 to 65 years with a median body mass index [BMI] of 27.5 kg/m2) who completed phase 1 of the study during 2000 to 2002. They excluded participants who had baseline hypertension (≥140 mm Hg/≥90 mm Hg), participants who were taking antihypertensive medications, and participants with elevated blood pressure readings.

From this cohort the authors analyzed the records of 903 participants who completed the second study phase and were followed for a mean of 7 years. Of the 903 participants, 230 (26%) had developed hypertension after a median of 7 years. Those participants were older, had higher prevalence of diabetes, were more commonly black, and had higher blood pressure at baseline, as well as higher measures of BMI, visceral adipose tissue (VAT), and subcutaneous adipose tissue (SAT) (all p < .01). Baseline BMI was higher among the participants who developed hypertension than among those who did not (29.9 kg/m2 vs 26.9 kg/m2; P < .0001). However, the median interval weight increase was almost the same between groups.

Using multivariable risk regression models, the researchers calculated that BMI was significantly associated with the development of hypertension (P < .0001). Then, when they added in VAT and SAT as variables, they found that higher VAT remained as the only fat parameter independently associated with developing hypertension (relative risk [RR], 1.22; 95% confidence interval [CI], 1.07-1.39; P = .004). They observed no differences in the association among sex, age, or race variables.

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September 01, 2014

PARADIGM-HF: New drug superior to ACE inhibition  Patients with chronic heart failure who take a newly developed drug that has effects both within and beyond the renin-angiotensin system, instead of the old-standby ACE inhibitor enalapril, will have fewer HF hospitalizations and die less often from cardiovascular causes, suggests a phase 3 trial that is huge both in size and its potential impact on clinical practice.

The risks of those two end points, as a composite as well as individually, fell by about 20% among the trial's patients with NYHA class 2–4 systolic heart failure who took the novel agent LCZ696 instead of the ACE inhibitor. All-cause mortality fell 16% on the novel agent. Follow-up averaged about 27 months. The PARADIGM-HF results announced today at a press conference at the European Society of Cardiology (ESC) 2014 Congress to coincide with its publication in the New England Journal of Medicine.

LCZ696 is the first apparently successful drug in the angiotensin receptor-neprilysin inhibitor (ARNI) class, an inhibitor of angiotensin that can also potentiate endogenous natriuretic peptides, which are vasodilators. Chemically, it consists of the angiotensin-receptor blocker (ARB) valsartan affixed to the neprilysin inhibitor sacubitril. The trial randomized 8399 patients with NYHA class 2–4 heart failure with an LV ejection fraction <35% and elevated natriuretic peptides who completed at least four weeks of treatment with an ACE inhibitor or ARB equivalent to enalapril at 10 mg/day. They were maintained as possible on stable doses of beta-blockers, preferably with aldosterone inhibitors. They were assigned to either 200-mg LCZ696 or 10-mg enalapril, both twice daily, on top of the other guidelines-based therapy. Over a median of 27 months, the rate of CV death or HF hospitalization was 21.8% among LCZ696 patients and 26.5% for those taking enalapril; all-cause mortality was 13.3% and 16.5%, respectively.

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SIGNIFY: No Ivabradine Effect on Clinical Outcomes in Patients With Stable CAD  Adding the drug ivabradine to standard therapy had no effect, overall, on cardiovascular events in a placebo-controlled trial that randomized >19 000 patients with stable CAD. Treatment with the drug was associated with a 10-beat-per-minute drop in heart rate, on average, compared with placebo, as measured after the trial's third month. But over a mean of almost 28 months, 6.8% of ivabradine patients and 6.4% of patients given placebo met the primary end point of cardiovascular death or nonfatal MI (p=0.20). There were no significant outcome differences for the primary end point's components.

The study was published today in the New England Journal of Medicine to coincide with the presentation of the trial, called Study Assessing the Morbidity-Mortality Benefits of the If Inhibitor Ivabradine in Patients with Coronary Artery Disease (SIGNIFY), at the European Society of Cardiology (ESC) 2014 Congress . Of the 19 102 patients randomized in SIGNIFY, nearly three-quarters had a history of MI, two-thirds had history of PCI or CABG, and 63.1% entered the study with "activity-limiting" angina, at least CCS class 2. The mean LV ejection fraction was 56.4%.

They were assigned to receive ivabradine titrated to a target heart rate of 55 to 60 beats per minute up to 10 mg twice daily or to placebo; ultimately, the mean ivabradine dosage was 8.2 mg twice daily. Beta-blockers were given per guidelines at dosages established for each patient before randomization, as tolerated, and ultimately were taken by 83% of the population.To enter the trial, patients had to be in sinus rhythm with a heart rate of at least 70 beats per minute and at least one other major CAD risk factor (such as CCS angina class >2 or recent hospitalization for a coronary event) or two minor risk factors (such as low HDL cholesterol, smoking, or age >70 years). Over a median of 27.8 months, the hazard ratio (HR) for the primary end point was 1.08 (95% CI 0.96–1.20) for the 9550 patients randomized to ivabradine compared with the 9552 given placebo. The rate of bradycardia was significantly higher in the ivabradine group, 18.0%, vs 2.3% in the placebo group (p<0.001). Of those assigned to ivabradine, 20.6% withdrew from taking the drug (compared with 14.5% who withdrew in the placebo group), primarily because of bradycardia.

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Darapladib No Benefit in ACS Patients: SOLID-TIMI 52  Acute coronary syndrome (ACS) patients who received darapladib, a selective inhibitor of lipoprotein-associated phospholipase A2 (Lp-PLA2), on top of optimal medical therapy fared no better than ACS patients who received optimal medical therapy alone, according to the results of a new study which presented today at the European Society of Cardiology 2104 Congress . It was published concurrently in the Journal of the American Medical Association.

During a median follow-up of 2.5 years, darapladib failed to reduce the risk of CHD death, MI, and urgent coronary revascularization compared with placebo in 13 026 patients stabilized following an ACS event. In fact, treatment with darapladib failed to positively affect any cardiovascular end point, including the individual components of the primary end point. The study, known as SOLID-TIMI 52 , do not support a role for Lp-PLA2 as a therapeutic target.

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August 25, 2014

FDA Approves Apixaban for DVT/PE Treatment, Recurrences  The US Food and Drug Administration (FDA) has agreed to extended indications for the novel oral anticoagulant apixaban, now approved for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) and for the reduction in the risk of recurrent DVT and PE following initial therapy.

Apixaban is already approved for use in reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation and for the prophylaxis of DVT and PE in patients who have undergone hip- or knee-replacement surgery.

Last month the European Commission granted a similar extension of apixaban in countries where drug policies are covered by the European Medicines Agency. Support for the DVT/PE treatment and reduction in recurrences indication comes from the AMPLIFY and AMPLIFY-EXT trials.

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Coronary Artery Calcium Best Predicts cardiovascular risk in CKD Patients  A coronary artery calcium (CAC) score was better able to predict the risk for cardiovascular events among patients with chronic kidney disease (CKD) than either carotid intima-media thickness (IMT) or ankle brachial index (ABI), according to a study published online in the Journal of the American Society of Nephrology. The study population included 1284 people with CKD and 5269 without the disease, aged 45 to 84 years, with no history of CVD.

The investigators compared the performance of the calcium score with 2 other measures of subclinical atherosclerosis, IMT and ABI, as predictors for CVD, including coronary heart disease, stroke, heart failure, and peripheral artery disease. Previous studies have found that conventional risk factors are not good predictors of CVD in patients with CKD. Cardiovascular disease is the leading killer among people with CKD, accounting for about half the deaths among people with the chronic condition.

In a median follow-up period of 8.4 years, the researchers identified 650 cardiovascular events, including 236 among patients with CKD.

When the researchers split the CKD group into quartiles based on predictive measures, they found that CAC outperformed the other 2 tests. Specifically, those in the highest quartile of risk based on CAC had a hazard ratio (HR) for CVD of 3.02 (95% confidence interval [CI], 2.03 - 4.50; P < .001) compared with patients in the lowest 2 quartiles. In comparison, patients in the highest quartile for ABI scores had a hazard ratio of 1.63 (95% CI, 1.09 - 2.45; P = .004) compared with those in the lowest quartile. The HR for IMT failed to reach significance in the CKD group. Among those in the cohort without CKD, the HR in the top quartile for CAC was 4.11 (95% CI, 3.11 - 5.44; P < .001). For IMT, the HR in the top quartile was 1.37 (95% CI, 0.98 - 1.92; P < .01), and for ABI, the HR in the top quartile was 1.60 (95% CI, 1.21 - 2.13; P = .001). The results were adjusted for race, sex, systolic BP, antihypertensive medications, total cholesterol, high-density lipoprotein cholesterol, smoking, and diabetes. The authors report the HRs for third quartile scores for CAC were also statistically significant for both groups.

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AHA releases policy statement on e-cigarettes  The American Heart Association has issued policy recommendations for the regulation and oversight of electronic cigarettes.

The association recommends a federal ban on e-cigarettes for minors, citing concerns about e-cigarettes' potential to lead to nicotine addiction among youth.

In their policy statement, published in Circulation, the AHA wrote that it supports:

  • The inclusion of e-cigarettes in smoke-free air laws.
  • Prohibiting the sale of e-cigarettes to minors via both state and federal law.
  • Restricted marketing and advertising of e-cigarettes to minors.
  • Taxing e-cigarettes at a rate high enough to discourage use by youth, as well as increasing taxes on combustibles and using the revenue to support tobacco cessation and prevention programs.
  • FDA regulation that addresses marketing, access for minors, labeling, quality control over manufacturing, free sampling and standards for contaminants. However, "regulation should allow for quality-controlled products for adults who want to transition from conventional cigarettes to e-cigarettes or to quit or reduce smoking."
  • Warning labels and child-proof packaging on refill cartridges.
  • Tobacco screening at clinical visits and work/community health screenings should include questions about e-cigarettes. Additionally, clinicians should be knowledgeable about e-cigarettes and counsel patients on tobacco cessation plans.
  • Improved surveillance of e-cigarette use throughout the US, as well as additional research to determine the impact of e-cigarettes on public health.
  • Defining e-cigarettes as tobacco products under state laws, rather than creating a separate definition for the product.

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August 18, 2014

New AF in Noncardiac Surgery increase One-Year Stroke Risk  New-onset perioperative atrial fibrillation during surgery—especially noncardiac surgery—was linked to an increased risk of stroke within a year, in a new study published in JAMA. This large retrospective cohort study based on data from California hospitals highlights that even if AF is provoked only by the stress of surgery, it could be a harbinger of stroke.

Perioperative AF during cardiac surgery has repeatedly been linked with an increased risk of perioperative stroke. However, the risk of ischemic stroke in the long term after new-onset AF during cardiac and noncardiac surgery is unclear.

To investigate this, the researchers performed a cohort study of patients who underwent major surgery in nonfederal, acute-care hospitals in California between 2007 and 2011. Of the 1 729 360 eligible patients they identified, 24 711 (1.43%) had new-onset perioperative AF during the index hospitalization and 13 952 (0.81%) experienced an ischemic stroke after discharge, during a mean follow-up of 2.1 years. Perioperative AF during both cardiac and noncardiac surgery was associated with a greater long-term risk of stroke after accounting for age, sex, race, insurance status, and cardiovascular comorbidities that up risk of stroke or perioperative AF (hypertension, type 2 diabetes, coronary heart disease, congestive heart failure, peripheral vascular disease, chronic kidney disease, and chronic obstructive pulmonary disease). However, the association of perioperative AF with stroke was significantly stronger with noncardiac vs cardiac surgery (p<0.001 for interaction).

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IN-TIME: Implant-based telemonitoring improved outcomes for patients with HF  Patients with HF who received an implantable cardioverter defibrillator or cardiac resynchronization defibrillator had improved clinical outcomes if they also received daily, automatic, implant-based telemonitoring, according to new data from the IN-TIME trial.

The randomized controlled trial was conducted at 36 centers in Australia, Europe and Israel. In total, 664 patients were randomly assigned standard care plus telemonitoring (n=333) or standard care without telemonitoring (n=331). The characteristics of the patients were as follows: chronic HF, NYHA class II/III symptoms, ejection fraction ≤35%, optimal drug therapy, no atrial fibrillation and recent ICD or CRT-D implant equipped with a Home Monitoring function, according to the study.

The primary outcome was a composite score incorporating all-cause mortality, overnight admission for HF, change in NYHA class and change in global self-assessment. At 1 year, 18.9% of patients assigned telemonitoring and 27.2% assigned standard care alone had a worsened composite score (OR=0.63; 95% CI, 0.43-0.9). According to the researchers, the difference in clinical outcome between the two groups was driven by lower mortality among patients assigned telemonitoring (10 deaths vs. 27 deaths). Eight CV-related deaths were reported in the telemonitoring group vs. 21 in the standard care group.

The telemonitoring and standard care groups had a similar number of hospital admissions for worsening HF (44 vs. 47; P=.38) and median length of stay (8 days vs. 7 days; P=0.21).

The researchers also assessed the primary outcome within subgroups in a post-hoc exploratory analysis. The data revealed no significant interaction between subgroups, except for patients with a history of AF, who were more likely to benefit from telemonitoring compared with patients without a history of AF.

Based on the telemonitoring data, the researchers contacted 238 patients (71%), for an average of 2.1 contacts per patient-year.

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Bivalirudin vs. heparin increases risk for MI, stent thrombosis, decreases bleeding  Results from a new meta-analysis published in Lancet have found that an anticoagulation regimen of bivalirudin vs. heparin increases the rate of MI and stent thrombosis while decreasing the risk for major bleeding in patients undergoing PCI. The extent of bleeding reduction with bivalirudin was dependent on concomitant glycoprotein IIb/IIIa inhibitor use, according to the researchers. The study, which was published in The Lancet, included 16 randomized controlled trials, totaling 33,958 patients. The trials were culled from searches of Medline and Cochrane Library databases for trials evaluating bivalirudin vs. heparin in patients planned for PCI. The primary efficacy endpoint was MACE incidence at 30 days and the primary safety endpoint was major bleeding at 30 days. Death, MI, ischemia-driven revascularization and stent thrombosis were defined as secondary efficacy endpoints.

Overall, 2,422 patients experienced MACE and 1,406 had a major bleed. Patients in the bivalirudin-based anticoagulation regimen group had a higher rate of MACE compared with those given heparin (RR=1.09; P=.0204). This difference was primarily driven by increased rates of MI (RR=1.12; 95% CI, 1.03-1.23) and ischemia-driven revascularization (RR=1.16; 0.997-1.34) in the bivalirudin group; however, these differences did not affect mortality, which was similar between groups.

In addition, compared with heparin, bivalirudin increased the risk for stent thrombosis (RR=1.38; P=.0074), which the researchers attributed to an increase in acute STEMI cases in that group (RR=4.27; P<.0001). Conversely, bivalirudin reduced the risk for major bleeding compared with heparin (RR=0.62; P<.0001), although the magnitude of the reduction differed greatly (P<.0001) depending on whether glycoprotein IIb/IIIa inhibitors were used primarily in the heparin arm only (RR=0.53; P<.0001), provisionally in both arms (RR=0.78; P=.25) or planned in both arms (RR=1.07; P=.53).

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August 11, 2014

ESC/ESA published new guidelines about cardiovascular assessment and management on non-cardiac surgery  The publication of the new joint ESC/ESA Guidelines on non-cardiac surgery: cardiovascular assessment and management introduces a number of recommendations in the field. Among other topics, the Guidelines include updated information on the use of clinical indices and biomarkers in risk assessment, and the use of novel anticoagulants, statins, aspirin and beta-blockers in risk mitigation. The 2014 ESC/ESA Guidelines cover the entire field including surgical risk assessment, pre-operative evaluation, and optimal peri-operative management, and will also address relevant cardiological and anaesthesiological issues in patients with specific cardiac diseases and common co-morbidities who are scheduled to undergo non-cardiac surgery. These 2014 Guidelines have been released simultaneously with the American College of Cardiology/American Heart Association Guidelines' on the same topic, published in both the Journal of the American College of Cardiology and Circulation.

The 2014 ESC/ESA Guidelines recommend two different clinical risk assessment models. The models show how best to evaluate potential risk of cardiac mortality or morbidity in patients before they undergo non-cardiac surgery. Together, these two models can provide physicians with information on the probability of a cardiac complication, such as heart attack or cardiac arrest that in turn can help the clinician in his/her decision-making process. The recommendations regarding non-VKA (non-warfarin) direct oral anticoagulants (NOACs) in the 2014 ESC/ESA Guidelines relate to how they should be used to reduce the risk of thromboembolic complications during and after non-cardiac surgery, while at the same time minimising the risk of any bleeding complication. The 2014 ESC/ESA Guidelines recommend that preoperative initiation of statin therapy should be considered in patients undergoing vascular surgery, optimally at least two weeks before surgery. For those non-cardiac surgery patients already receiving a statin, the 2014 guidelines recommend continuation of the statin into the recovery period following surgery.

Looking at the use of aspirin, the 2014 ESC/ESA Guidelines no longer support the routine use of aspirin in patients undergoing non-cardiac surgery. They state that the use of low-dose aspirin in patients undergoing non-cardiac surgery should be based on an individual decision, which depends on the perioperative bleeding risk weighed against the risk of thrombotic complications.

It was felt that clarification was needed on the use of beta-blockers in patients due to the uncertainties surrounding the DECREASE studies. The new Guidelines state that beta-blockers are no longer recommended in patients scheduled for low or intermediate risk surgery. The initiation of beta-blockers in patients who undergo non-cardiac surgery should not be considered routine. With most patients, the use of beta-blockers should be evaluated by their clinician unless specifically stated otherwise.

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FFR- and IVUS-Guided PCI Do Not Reduce Mortality Long-Term: Observational Study  The use of fractional flow reserve (FFR) or intravascular ultrasound (IVUS) during PCI is not associated with improved long-term mortality rates when compared with standard angiography-guided PCI, according to a new observational study which published in the last issue of the Journal of American Medical Association: Internal Medicine. The results are based on an analysis of 41 688 patients with stable angina and non-ST-segment-elevation MI (NSTEMI) included in the Pan-London (United Kingdom) PCI Registry. Compared with conventional PCI, there was no statistically significant difference in mortality among those treated with FFR- and IVUS-guided PCI after a median of 3.3 years.

In the UK PCI Registry, 2767 patients underwent FFR-guided PCI, and IVUS was used in 1831 patients. After adjustment for multiple variables, the FFR-guided mortality rate after 3.3 years was not significantly different from that of angiography-guided PCI (hazard ratio 0.88; 95% CI 0.67–1.16). Similarly, IVUS-guided PCI did not confer a mortality benefit compared with angiography-guided PCI (hazard ratio 1.39; 95% CI 1.09-1.78). A propensity-matched analysis showed similar results.

Individuals in the FFR group received significantly fewer implanted stents than those treated with IVUS and conventional PCI.

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Vast Majority of Eligible Patients Not Receiving Aspirin for Primary Prevention  The majority of men and women at risk for cardiovascular disease who are eligible for primary-prevention aspirin therapy have not received a recommendation for the drug from their physician, according to the results of a new study published online August 5, 2014 in the Journal of General Internal Medicine. Of men eligible on the basis of their Framingham risk score, just 34% recall their physician suggesting they take aspirin. For women, 42% of those eligible for aspirin recalled receiving a recommendation from the physician.

In the present study, the authors examined physician recommendations for aspirin in individuals 40 years of age and older in the 2011–2012 National Health and Nutrition Survey (NHANES). Among 2929 participants, 87% of men and 16% of women were eligible for aspirin based on the Framingham risk equation for men and a similar risk calculator for women. Using data from the NHANES home interview, just one-third of aspirin-eligible men said they recalled a recommendation from their physician that they "take low-dose aspirin each day to prevent heart attacks, stroke, or cancer." Just over 40% of eligible women recalled receiving the recommendation. Those with diabetes, those aged 65 to 79 years old, and those in poor health were more likely to have been recommended aspirin. In a sample of 470 individuals with cardiovascular disease, 76% recall their physicians recommending they take aspirin to prevent MI or stroke.

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August 04, 2014

Apixaban Approved in Europe for DVT, PE  Apixaban, is now approved in Europe for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for the recurrence of DVT and PE. The European Commission approved apixaban following a "positive opinion" from the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP). The CHMP opinion was based on its review of the AMPLIFY trial and AMPLIFY-EXT , an extension study. In AMPLIFY, a study of 5395 patients with acute, symptomatic VTE and/or PE reported by heartwire , apixaban was as effective as standard therapy with enoxaparin plus warfarin for the treatment of venous thromboembolism (VTE). Treatment with apixaban also significantly reduced the risk of bleeding. In the extension study, anticoagulation with apixaban significantly reduced the risk of recurrent VTE compared with placebo. The approval by the European Commission applies to all countries within the European Union as well as Iceland and Norway. Apixaban is currently approved in Europe for stroke and systemic embolism prevention in adults with nonvalvular atrial fibrillation and one or more risk factors. It is also approved for the prevention of VTE among patients who have undergoing hip- or knee-replacement surgery.

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Very Low Levels of LDL Linked With Reduced CV Events  The question of how low LDL-cholesterol levels should be in the present statin era, is once again questioned with the new publication of a patient-level meta-analysis of eight clinical trials investigating statin therapy. The new meta-analysis, published in the Journal of the American College of Cardiology, suggests that lowering LDL-cholesterol levels to very low levels results in a significant reduction in cardiovascular events. Individuals with LDL-cholesterol levels < 50 mg/dL had a significantly lower risk of major cardiovascular events compared with individuals who had higher LDL-cholesterol levels, including those with LDL levels 50 to < 75 mg/dL and 75 to < 100 mg/dL.

The investigators, analyzed eight trials and 38 153 patients treated with statin therapy. The studies included some of the landmark statin trials, including AFCAPS-TexCAPS , 4S , LIPID , SPARCL , TNT , IDEAL , and JUPITER . The investigators observed a large degree of interindividual variability in the reductions of LDL cholesterol, non-HDL cholesterol, and apolipoprotein B (apoB) levels with statin therapy. Among those treated with high-dose statin therapy, more than 40% of patients failed to achieve an LDL-cholesterol target of less than 70 mg/dL. Compared with individuals with LDL-cholesterol levels &rt;175 mg/dL, which served as the reference group, individuals who achieved lower levels of LDL cholesterol had a significantly lower risk of major cardiovascular events. For those with LDL-cholesterol levels < 50 mg/dL, 50 to < 75 mg/dL, and 75 to < 100 mg/dL, the relative reduction in risk was 56%, 49%, and 44%, respectively. Regarding the end point of major coronary events and cerebrovascular events, a similar trend was observed with lower LDL cholesterol levels.

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Update to stable ischemic heart disease guideline clarifies use of coronary angiography  A focused update to a guideline on the diagnosis and management of patients with stable ischemic heart disease clarifies when coronary angiography is appropriate to perform in that patient population.

The authors of the update also considered new evidence on chelation therapy for patients with stable ischemic heart disease and found its usefulness uncertain, and upgraded the recommendation that CABG is preferable to PCI in patients with type 2 diabetes and multivessel CAD. The document is an update of the 2012 guideline on diagnosis and management of patients with stable ischemic heart disease from the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. The writing group, consisted of representatives from ACC, AHA, the American Association for Thoracic Surgery, the Preventive Cardiovascular Nurses Association, the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons.

The panel concluded that coronary angiography:

  • Is useful in patients with presumed stable ischemic heart disease and unacceptable ischemic symptoms despite medical therapy and who are appropriate for and willing to undergo revascularization;
  • Is reasonable to define the extent and severity of CAD in patients whom noninvasive testing (but not stress testing) indicates a high probability of severe ischemic heart disease and who are appropriate for and willing to undergo revascularization;
  • Is reasonable in patients with suspected symptomatic stable ischemic heart disease who cannot undergo diagnostic stress testing or whose stress tests were inconclusive when it is likely that findings will result in important changes to therapy;
  • May be considered in patients with stress test results of acceptable quality that do not suggest CAD presence, but in whom clinical suspicion of CAD remains high and for whom it is likely that findings will result in important changes to therapy

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July 28, 2014

Simple Pulse Measure Can Detect AF After Stroke  Simple measurement of the peripheral pulse (MPP) at the radial artery is an effective screening tool for diagnosis of atrial fibrillation (AF) in patients who have had a stroke, a new pilot study published online in Neurology Journal suggests.The study, found that health professionals, relatives, and even patients can be trained to distinguish abnormal rhythms just by measuring the pulse. For the current study, 256 patients who had sustained a recent acute ischemic stroke and their relatives were instructed on how to detect an abnormal radial pulse. Three different modalities of pulse measurement were investigated: (1) measurement by a health care professional with positive experience on cardiovascular assessment of patients, (2) measurement by a relative of the patient after successful completion of the tutorial, and (3) self-measurement by the patient after successful completion of the tutorial. All these were performed as single measurements for at least 30 seconds, with examiners blinded to the current heart rate and rhythm. There was no upper time limit for MPP. Measurements were conducted during the daytime. Patients also underwent simultaneous blinded ECG, and the results of the pulse measurements and ECG observations were compared. Results showed that 90% of the patients were able to measure their own pulse reliably. Diagnostic sensitivity was highest for pulse measurements when taken by a healthcare professional, followed by relatives. But even patients managed a diagnostic sensitivity of 54%, and the researchers point out that this was derived from a single measurement and may increase by repeated testing. Specificity was high for pulse measurement by all groups.

False-positive results were limited to 6 cases (2.7%), with a positive predictive value of 76.9% and a negative predictive value of 90.0%.

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Major infections worsened mortality rates in patients undergoing cardiac surgery  Major infections substantially increased mortality after cardiac surgery, according to a new study published in the last issue of JACC. Researchers prospectively examined the frequency of postoperative infections and associated mortality, and they identified practices that were predictive of infections within 65 days of cardiac surgery. The study enrolled 5,158 patients who underwent any type of cardiac surgery at one of 10 Cardiothoracic Surgical Trials Network sites from February 2010 to October 2010. The primary endpoint was onset of one of 10 major infections within 65 days of index cardiac surgery. The infections included: deep incisional surgery site infection at the primary incision or a secondary incision site, mediastinitis, infectious myocarditis or pericarditis, endocarditis, cardiac device infection, pneumonia, empyema, C. difficile colitis and bloodstream infection.

Nearly 5% of patients experienced major infections. The following baseline characteristics were linked to higher risk for infection: chronic lung disease (HR=1.66; 95% CI, 1.21-2.26), HF (HR=1.47; 95% CI, 1.11-1.95) and longer surgery (HR=1.31; 95% CI, 1.21-1.41). Prophylaxis with second-generation cephalosporins reduced the risk for infection (HR=0.7; 95% CI, 0.52-0.94) and high levels of hemoglobin were protective against infection (HR=0.9; 95% CI, 0.84-0.97). According to the researchers, practices and conditions associated with increased infection risk included:

  • Postoperative antibiotic duration of more than 48 hours (HR=1.92; 95% CI, 1.28-2.88). By contrast, compared with antibiotic duration of 24 to 48 hours, duration of less than 24 hours was not associated with increased infection risk (HR=1; 95% CI, 0.72-1.38)
  • Stress hyperglycemia (HR=1.32; 95% CI, 1.01-1.73)
  • Intubation time of between 24 and 48 hours (HR=1.49; 95% CI, 1.04-2.14)
  • Ventilation time of more than 48 hours (HR=2.45; 95% CI, 1.66-3.63)

Blood transfusion during surgery conferred an elevated risk for infection after all surgery types, except procedures involving left ventricular assist devices (HR=1.13; 95% CI, 1.07-1.2), according to the researchers.

Patients who contracted major infections had a much higher mortality rate compared with those who did not (infected patients, 5%; noninfected patients, 0.7%; HR=10.02; 95% CI, 6.12-16.39).

Other factors associated with an adverse effect on survival in the study population included higher creatinine (HR=1.17; 95% CI, 1.06-1.29), HF (HR=2.09; 95% CI, 1.34-3), diabetes (HR=1.65; 95% CI, 1.08-2.51) and older age (HR=1.04; 95% CI, 1.02-1.06). Men had half the mortality risk of women (HR=0.49; 95% CI, 0.33-0.72).

The 30-day readmission rate for the study population was 14%, whereas the 65-day readmission rate was 19%. Infectious accounted for 16% of readmissions, according to the study.

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Low exercise capacity increased CABG mortality risk in ischemic LV dysfunction  Among patients with ischemic left ventricular dysfunction, those with poor exercise tolerance are at elevated early and 5-year risk for mortality after CABG compared with medical therapy, according to recent findings. Conversely, patients with a higher exercise capacity have better 5-year survival outcomes with CABG, the researchers wrote. In an exploratory analysis which published online in JACC Heart Failure Journal, researchers evaluated 1,212 patients enrolled in the STICH trial, in which participants, all of whom were diagnosed with ischemic LV dysfunction and CAD, were randomly assigned to medical intervention alone or medical therapy with CABG. Before randomization, the researchers evaluated the patients' physical activity level via a quality-of-life questionnaire and their performance during a 6-minute walk test. The questionnaire sought information on physical abilities and activities, as well as the extent to which the patients felt limited by HF. Based on the participants' responses, the researchers ascribed a numeric Physical Ability Score (PAS) between 0 and 100, with 100 indicating no limitation during physical activity, to each patient. During the walking test, patients were instructed to walk around an established course for 6 minutes and attempt to cover as much ground as possible, but also to stop and rest as needed. The primary outcome of the study was all-cause mortality during a median follow-up of 56 months. Patients were able to walk 300 m during the 6-minute walk test in 682 cases, whereas 530 participants were unable to do so. PAS was >55 in 749 cases, and 433 patients had a PAS ≤55. During the study period, 462 patients died, with most deaths due to CV-related causes (80%).

Among the patients randomly assigned to CABG who walked ≥300 m during the test, the risk for mortality was lower compared with nonrecipients who walked the same distance (HR=0.77; 95% CI, 0.59-0.99). Mortality risk was also lower for CABG-allocated patients among those with a PAS >55 (HR=0.79; 95% CI, 0.62-1.01 vs. medical therapy alone), but this trend did not reach statistical significance. Mortality rate did not differ significantly according to treatment among those unable to walk 300 m during the test.

The researchers noted that patients who walked ≥300 m during the test and had a PAS >55 (n=486) were at significantly reduced mortality risk with CABG (HR=0.71; 95% CI, 0.52-0.97). No difference in mortality risk was observed according to treatment among those who did not meet both criteria.

Patients who were unable to walk 300 m during the test or who had PAS ≤55 had significantly higher 60-day mortality risk after CABG (HR=3.24; 95% CI, 1.64-6.83 vs. medical therapy).

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July 22, 2014

HPS2-THRIVE published: Niacin did not benefit patients with vascular disease  Confirming findings presented at the American College of Cardiology 2013 Scientific Sessions, the HPS2-THRIVE data published in the last issue of New England Journal of Medicine indicate that the addition of niacin to statin-based therapy did not benefit patients with vascular disease and increased risk for adverse events. In the study were randomly assigned 25,673 adults with vascular disease taking statin-based therapy to 2 g extended-release niacin and 40 mg laropiprant or placebo daily. Median follow-up was 3.9 years.

As presented previously, the primary outcome, a composite of CV death, nonfatal MI, stroke and arterial revascularization, occurred in 13.2% of the niacin-laropiprant group vs. 13.7% of the placebo group (rate ratio=0.96; 95% CI, 0.9-1.03).

Assignment to niacin-laropiprant was also associated with the following: increased serious disturbances in diabetes control (absolute excess, 3.7 percentage points; P<.001), increased incidence of diabetes diagnosis (absolute excess, 1.3 percentage points; P<.001), increased gastrointestinal serious adverse events (absolute excess, 1 percentage point; P<.001), increased musculoskeletal system serious adverse events (absolute excess, 0.7 percentage points; P<.001), increased skin-related serious adverse events (absolute excess, 0.3 percentage points; P=.003), increased infection (absolute excess, 1.4 percentage points, P<.001) and increased bleeding (absolute excess, 0.7 percentage points; P<.001).

Adverse events reported in the niacin-laropiprant group, including a 9% increase in the risk for death (number needed to harm=200; P=.08).

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New Study Finds Diabetes Risk Rises With Statin Adherence but the benefits of statins still "clearly" outweigh the risks  The risk of new-onset type 2 diabetes rises with adherence to statin therapy, providing further confirmation of the previously reported link. However, the benefits of statins still "clearly" outweigh the risks, according to a large new population-based study and analysis which published online in Diabetes Care Journal. The study, involving a healthcare utilization database of 115,709 statin-using patients with an average 6.4 years of follow-up per patient, "extends earlier findings of an increased risk of diabetes with statin therapy by providing evidence of a clear-cut association between adherence to statin therapy and risk of new-onset diabetes in a real-world setting.

In the new study, the patients had a mean age of 62 years at the time of first statin prescription. None had been diagnosed with diabetes prior to that time. During follow-up, 9.6% of the entire cohort developed diabetes, at a rate of 14.9 per 1000 person-years.

Adherence was defined by the proportion of days during which the medication was available to the patient divided by the number of days of follow-up, called the "proportion of days covered (PDC)". Adherence was very low (PDC less than 25%) in 37.1% of patients, low (25% – 49%) in 20.2%, intermediate (50% – 75%) in 18.4%, and high (> 75%) in 24.4% of the participants.

After adjustment for age (continuous), sex, first-line statin therapy, concomitant use of other drugs, history of CVD, and Charlson morbidity index score category, the hazard ratios for developing diabetes compared with the very low adherence group were 1.12 for low adherence, 1.21 for intermediate, and 1.32 for high adherence. All were statistically significant (95% confidence intervals did not include 1).

Statins used by participants included simvastatin, pravastatin, fluvastatin, atorvastatin, and rosuvastatin (Crestor, AstraZeneca): a separate analysis of high- vs low-potency statins did not show a statistically significant difference in the statin effect on diabetes risk.

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Newer DES Up Survival vs Medications Only in Stable CAD according to a new metanalysis  A new meta-analysis which published in the BMJ suggests that medical therapy plus revascularization with PCI using "newer-generation" drug-eluting stents (DES)—defined as everolimus-eluting stents and the zotarolimus-eluting stent—improves survival better than an initial strategy of optimal medical therapy (OMT) only. No such advantage was seen for PCI using either bare-metal stents or "early-generation" DES, the latter of which includes the paclitaxel-eluting, sirolimus-eluting, and zotarolimus-eluting stents.

Of the observed revascularization methods, only CABG and newer-generation DES significantly cut the risk of MI compared with an initial med-based strategy. CABG also produced the steepest decline in need for subsequent revascularization. But that end point also fell significantly with all PCI options except plain-old balloon angioplasty. In general among stent options, newer-generation DES were associated with the lowest rates of subsequent revascularization, followed by early-generation DES and then bare-metal stents.

Their meta-analysis encompassing 93 553 patients with stable or unstable CAD was published June 23, 2014. It included 100 randomized trials with at least six months of follow-up and at least 100 patients per treatment arm, who entered with asymptomatic or symptomatic stable CAD; they were published from 1980 to 2013. It used outcomes data obtained at the assessment closest to five years for a total of 262 090 patient-years of follow-up. In all, a medication-dominated treatment strategy was compared with revascularization with FDA-approved devices.

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July 07, 2014

Hypertension and lengthy Beta-Blocker Use May Provoke Psoriasis  Older women who have had hypertension or been taking beta-blockers for several years are at increased risk of developing psoriasis according the results of the large, prospective Nurses' Health Study which published online in JAMA Dermatology. Specifically, women who had hypertension for at least 6 years had a 27% higher risk of developing psoriasis than women with normal blood pressure. Moreover, women who took beta-blockers for at least 6 years had a 39% higher risk of developing psoriasis than women who never used these medications. However, other commonly used antihypertensive drugs did not confer an increased risk of the skin disease.

To investigate how hypertension is linked with new cases of psoriasis, the researchers examined prospective data from 77 728 women in the Nurses' Health Study. The women, who were around age 60 in 2008, had replied to biennial questionnaires that included questions about antihypertensive medications and psoriasis.

The authors identified 843 incident cases of physician-diagnosed psoriasis during 1996 to 2008. Using a multivariate-adjusted model, they determined that women who had hypertension for 6 years or more had a significantly higher risk of developing psoriasis than women who did not have hypertension (hazard ratio [HR] 1.27; 95% CI, 1.03–1.57). Similarly, women who had hypertension and were not taking any antihypertensive therapy had a significantly higher risk of incident psoriasis than women with normal blood pressure (HR 1.49; 95% CI, 1.15–1.92). Beta-blocker use for 6 years or longer was linked with a significantly higher risk of developing psoriasis compared with not taking these agents (HR 1.39; 95% CI, 1.11–1.73). On the other hand, thiazide diuretics, calcium channel blockers, and ACE inhibitors were not associated with an increased risk of psoriasis.

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Rivaroxaban linked to higher treatment adherence than warfarin among AF patients  Rivaroxaban was linked to significantly higher medication adherence and lower rates of discontinuation compared with warfarin among patients with nonvalvular atrial fibrillation in a recent retrospective cohort analysis published online in Current Medical Research and Opinion Journal.

Researchers searched the databases for patients with at least one medical claim related to a primary or secondary diagnosis of nonvalvular AF from 2009 to March 2013. All patients identified for analysis (n=32,886) also received at least one prescription for rivaroxaban after November 2011 or for warfarin after July 2010 (n=25,627), and had at least 6 months of continuous medical and prescription benefits before the study. Rivaroxaban recipients were matched at a 1:1 ratio with warfarin recipients via propensity score. The follow-up interval was the time from the initial prescription to inpatient death or the end of the study period or of continuous enrollment with medical and prescription benefits (mean 184 days for rivaroxaban and 408 days for warfarin).

During follow-up, patients in the rivaroxaban group had a 77.1% rate of medication persistency vs. 57.8% in the warfarin group. Rivaroxaban recipients were less likely to be nonpersistent than warfarin recipients (adjusted HR=0.63; 95% CI, 0.59-0.68). Older age, higher CHADS2 scores, chronic kidney disease and treatment with multiple medications were linked to significantly decreased risk for nonpersistence.

In an analysis of 5,659 rivaroxaban recipients and 5,957 warfarin recipients with evaluable discontinuation data, patients in the rivaroxaban group discontinued medication less frequently than warfarin recipients (20.9% of cases vs. 41.5%). Adjustment for patient characteristics revealed that treatment with rivaroxaban was linked to a 46% lower risk of discontinuation vs. warfarin (adjusted HR=0.54; 95% CI: 0.49-0.58). The risk for discontinuation was further decreased in a subset of patients who did not switch anticoagulants during the study period (adjusted HR=0.44; 95% CI, 0.4-0.48). Patient factors linked to significantly lower risk for discontinuation included older age, chronic kidney disease and receipt of more medications.

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Glycoprotein IIb/IIIa inhibitors failed to improve outcomes with early invasive strategy  Glycoprotein IIb/IIIa inhibitor use during PCI did not improve the effectiveness of an early invasive strategy post-fibrinolysis compared with standard therapy, according to results of a substudy of the TRANSFER-AMI study which published in the Heart Journal.

In the study, investigators evaluated an early invasive strategy post-fibrinolysis in relation to glycoprotein IIb/IIIa inhibitor use for safety and efficacy outcomes in a cohort of 1,059 STEMI patients. Eligible participants were assigned an early invasive strategy or standard therapy and stratified by glycoprotein IIb/IIIa inhibitor use, which was permitted during PCI at the discretion of the treating physician. A composite of death, reinfarction, recurrent ischemia, new or worsening HF or cardiogenic shock at 30 days served as the primary outcome measure. Results indicated that 695 patients (65.6%) received glycoprotein IIb/IIIa inhibitors. The researchers reported significant heterogeneity (P<.001) in the early invasive group compared with the standard group with regard to efficacy. Patients in the glycoprotein IIb/IIIa inhibitor group who underwent the invasive strategy had a 9.6% rate of the primary endpoint compared with 22.3% for standard therapy (P<.001). For patients not receiving glycoprotein IIb/IIIa inhibitors, the rates were 14.8% for the invasive group and 10.4% for standard therapy (P=0.21). Median Global Registry of Acute Coronary Events (GRACE) risk scores were 121 in the inhibitor use group and 130 for those who did not receive inhibitors (P<.001). The invasive strategy no longer demonstrated effectiveness with respect to glycoprotein IIb/IIIa use in an analysis that adjusted for the interaction between risk score and treatment assignment (P for interaction=.08), according to the results.

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July 14, 2014

ESC issues triage strategy for urgent management of cardiac tamponade  The European Society of Cardiology) Working Group on Myocardial and Pericardial Diseases has developed a stepwise scoring system to identify patients who need immediate pericardiocentesis and patients who can safely be transferred to a specialized institution. The position statement was published online in the European Heart Journal.

Prompt recognition of cardiac tamponade is critical, and once it is diagnosed, patient management can be challenging because of the lack of validated criteria for risk stratification, the authors write. Moreover, the 2004 ESC guidelines on pericardial disease, the only cardiology or medical-society guidelines about this, do not cover certain important issues. The group aimed to use evidence-based data, where possible, to determine which patients need immediate drainage of the pericardial effusion; whether echocardiography is sufficient to guide pericardiocentesis; which patients should be transferred to a specialized/tertiary institution or surgical service; and what type of medical support is needed during transportation. To diagnose cardiac tamponade, the position statement advises that "cardiac tamponade should be suspected in patients presenting with hypotension, jugular venous distension, pulsus paradoxus, tachycardia, tachypnea, and/or severe dyspnea, [and] additional signs may include low QRS voltages, electrical alternans, and enlarged cardiac silhouette on chest X ray." Echocardiography should be carried out without delay, they note. Cardiac computed tomography and cardiovascular MRI are useful to rule out cancer or aortic dissection in patients with large pericardial effusions. Constrictive pericarditis, congestive heart failure, and advanced liver disease with cirrhosis need to be ruled out. Once cardiac tamponade is diagnosed, patients may require immediate, lifesaving pericardial drainage if they are in hemodynamic shock. If the patient is hemodynamically stable, the procedure should be performed within 12 to 24 hours of diagnosis, after obtaining laboratory test results including blood counts.

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EVAR improved safety vs. open repair in treating AAA  Among patients with abdominal aortic aneurysms, endovascular aneurysm repair was associated with improved safety compared with open repair, leading researchers to conclude that adoption of the endovascular technique can improve the safety of surgical admissions.

The study, which was published online in JAMA Surgery, involved cases of abdominal aortic aneurysm (AAA) repair that were taken from the Nationwide Inpatient Sample from 2003 — when Patient Safety Indicators (PSIs) were established to monitor preventable adverse events during hospitalizations — to 2010. Researchers used Agency for Healthcare Research and Quality software (Win QI, version 4.4) to calculate PSIs.

Year, age, sex, race/ethnicity, comorbidities, rupture status, hospital teaching status and emergency status were the variables included in the unadjusted analysis. In the multivariable analysis, researchers stratified data by year for any PSI in endovascular aneurysm repair (EVAR) or open aneurysm repair. Postoperative mortality served as the control for safety.

Overall, 43,385 EVARs and 27,561 open repairs were featured in the analysis, with those undergoing EVAR being less likely to have any PSI (3% vs. 11.2%; P<.001). EVAR patients were more likely to be male, older and white, seek care at teaching hospitals and have a lower Charlson Comorbidity Index.

Data from the multivariable analysis indicated a more than 40% reduction in the risk-adjusted odds of any PSI in the EVAR group (OR=0.58; 95% CI, 0.51-0.65). Additionally, when stratified by year, the risk-adjusted odds of any PSI were less likely in the EVAR group for every year but 2007, and the likelihood of death was less in every year for those receiving EVAR. Moreover, the annual percentage of PSIs decreased from 7.4% in 2003 to 4.4% in 2010 in the EVAR group, whereas it increased in the open repair group from 41.1% in 2003 to 75.3% in 2010.

In related data, the rate of mortality was significantly higher after open repair than EVAR (10.6% vs. 1.8%; P<.001; OR=0.28; 95% CI, 0.24-0.32).

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Painful Diabetic Neuropathy Linked to 'Nondipping' BP  Painful diabetic polyneuropathy (PDPN) is associated with higher nocturnal blood pressure (BP) independent of pain-related comorbidities, a new study published online in Diabetes Care.

The trial included a total of 113 diabetes patients: 34 with PDPN, 33 with painless diabetic polyneuropathy, and 46 without DPN. The patients with PDPN had higher neuropathic symptom and sign scores than did those with painless DPN, but the 2 groups had similar results on cardiovascular autonomic reflex tests (CARTs).

Nighttime systolic BPs were higher in the PDPN group than in either of the other 2 groups, 130.4 mm Hg vs 124.2 mm Hg for those with painless DPN (P < .05) and 119.9 mm Hg for those without DPN (P < .0001).

The PDPN group also experienced less change in systolic and diastolic BP overnight compared with the group without DPN (5.5 vs 8.6 mm Hg for systolic [ P < .05] and 10.8 vs 14.2 mm Hg for diastolic [P < .05]).

There were no differences in ambulatory BP monitoring results between the painless DPN and the non-DPN groups.

"Nondipping," or the absence of the normal nocturnal decrease in BP, was seen in 8 patients (7%) and was highly correlated with PDPN status (P = .007), as well as with a higher CART score (3.0 vs 1.3; P = .020).

In stepwise regression analysis, orthostatic hypotension, high risk for obstructive sleep apnea (OSA), and results on a neuropathic pain screening tool called the Douleur Neuropathique en 4 Questions (DN4) were all independent determinants of overnight change in systolic BP (P = .0001) and in nighttime systolic BP (P < .0001).

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July 07, 2014

Hypertension and lengthy Beta-Blocker Use May Provoke Psoriasis  Older women who have had hypertension or been taking beta-blockers for several years are at increased risk of developing psoriasis according the results of the large, prospective Nurses' Health Study which published online in JAMA Dermatology. Specifically, women who had hypertension for at least 6 years had a 27% higher risk of developing psoriasis than women with normal blood pressure. Moreover, women who took beta-blockers for at least 6 years had a 39% higher risk of developing psoriasis than women who never used these medications. However, other commonly used antihypertensive drugs did not confer an increased risk of the skin disease.

To investigate how hypertension is linked with new cases of psoriasis, the researchers examined prospective data from 77 728 women in the Nurses' Health Study. The women, who were around age 60 in 2008, had replied to biennial questionnaires that included questions about antihypertensive medications and psoriasis.

The authors identified 843 incident cases of physician-diagnosed psoriasis during 1996 to 2008. Using a multivariate-adjusted model, they determined that women who had hypertension for 6 years or more had a significantly higher risk of developing psoriasis than women who did not have hypertension (hazard ratio [HR] 1.27; 95% CI, 1.03–1.57). Similarly, women who had hypertension and were not taking any antihypertensive therapy had a significantly higher risk of incident psoriasis than women with normal blood pressure (HR 1.49; 95% CI, 1.15–1.92). Beta-blocker use for 6 years or longer was linked with a significantly higher risk of developing psoriasis compared with not taking these agents (HR 1.39; 95% CI, 1.11–1.73). On the other hand, thiazide diuretics, calcium channel blockers, and ACE inhibitors were not associated with an increased risk of psoriasis.

… more More

Rivaroxaban linked to higher treatment adherence than warfarin among AF patients  Rivaroxaban was linked to significantly higher medication adherence and lower rates of discontinuation compared with warfarin among patients with nonvalvular atrial fibrillation in a recent retrospective cohort analysis published online in Current Medical Research and Opinion Journal.

Researchers searched the databases for patients with at least one medical claim related to a primary or secondary diagnosis of nonvalvular AF from 2009 to March 2013. All patients identified for analysis (n=32,886) also received at least one prescription for rivaroxaban after November 2011 or for warfarin after July 2010 (n=25,627), and had at least 6 months of continuous medical and prescription benefits before the study. Rivaroxaban recipients were matched at a 1:1 ratio with warfarin recipients via propensity score. The follow-up interval was the time from the initial prescription to inpatient death or the end of the study period or of continuous enrollment with medical and prescription benefits (mean 184 days for rivaroxaban and 408 days for warfarin).

During follow-up, patients in the rivaroxaban group had a 77.1% rate of medication persistency vs. 57.8% in the warfarin group. Rivaroxaban recipients were less likely to be nonpersistent than warfarin recipients (adjusted HR=0.63; 95% CI, 0.59-0.68). Older age, higher CHADS2 scores, chronic kidney disease and treatment with multiple medications were linked to significantly decreased risk for nonpersistence.

In an analysis of 5,659 rivaroxaban recipients and 5,957 warfarin recipients with evaluable discontinuation data, patients in the rivaroxaban group discontinued medication less frequently than warfarin recipients (20.9% of cases vs. 41.5%). Adjustment for patient characteristics revealed that treatment with rivaroxaban was linked to a 46% lower risk of discontinuation vs. warfarin (adjusted HR=0.54; 95% CI: 0.49-0.58). The risk for discontinuation was further decreased in a subset of patients who did not switch anticoagulants during the study period (adjusted HR=0.44; 95% CI, 0.4-0.48). Patient factors linked to significantly lower risk for discontinuation included older age, chronic kidney disease and receipt of more medications.

… moreMore

Glycoprotein IIb/IIIa inhibitors failed to improve outcomes with early invasive strategy  Glycoprotein IIb/IIIa inhibitor use during PCI did not improve the effectiveness of an early invasive strategy post-fibrinolysis compared with standard therapy, according to results of a substudy of the TRANSFER-AMI study which published in the Heart Journal.

In the study, investigators evaluated an early invasive strategy post-fibrinolysis in relation to glycoprotein IIb/IIIa inhibitor use for safety and efficacy outcomes in a cohort of 1,059 STEMI patients. Eligible participants were assigned an early invasive strategy or standard therapy and stratified by glycoprotein IIb/IIIa inhibitor use, which was permitted during PCI at the discretion of the treating physician. A composite of death, reinfarction, recurrent ischemia, new or worsening HF or cardiogenic shock at 30 days served as the primary outcome measure. Results indicated that 695 patients (65.6%) received glycoprotein IIb/IIIa inhibitors. The researchers reported significant heterogeneity (P<.001) in the early invasive group compared with the standard group with regard to efficacy. Patients in the glycoprotein IIb/IIIa inhibitor group who underwent the invasive strategy had a 9.6% rate of the primary endpoint compared with 22.3% for standard therapy (P<.001). For patients not receiving glycoprotein IIb/IIIa inhibitors, the rates were 14.8% for the invasive group and 10.4% for standard therapy (P=0.21). Median Global Registry of Acute Coronary Events (GRACE) risk scores were 121 in the inhibitor use group and 130 for those who did not receive inhibitors (P<.001). The invasive strategy no longer demonstrated effectiveness with respect to glycoprotein IIb/IIIa use in an analysis that adjusted for the interaction between risk score and treatment assignment (P for interaction=.08), according to the results.

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June 30, 2014

CHMP Recommends Approval of Clopidogrel/Aspirin Combo  The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) is recommending the approval of a combination tablet that includes clopidogrel and aspirin for individuals at risk for atherothrombotic events who are already taking the two antiplatelet agents. Specifically, it recommends that the combination be made available for adult patients with non-ST-segment-elevation acute coronary syndrome, including patients undergoing PCI. In addition, the combination should be made available for patients with ST-segment-elevation MI eligible for thrombolytic therapy. On the overall "basis of quality, safety, and efficacy data submitted," CHMP says the positive risk-to-benefit balance favors the approval of the combination tablet. The drug would be available in two doses: clopidogrel 75 mg/aspirin 75 mg and clopidogrel 75 mg/aspirin 100 mg.

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Apixaban Recommended for DVT/PE Indications By EMA  The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) "has adopted a positive opinion" on extending the marketing authorization for apixaban to include treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), plus prevention of recurrences of these conditions in adults. A final decision on this recommendation will come after the European Commission reviews the recommendations. .

The CHMP's opinion comes on the basis of the AMPLIFY trial results and those of its extension study, AMPLIFY-EXT , in 5395 patients. In the trial, apixaban was as effective as standard enoxaparin plus warfarin in treating acute venous thromboembolism (VTE), but patients taking the newer drug saw a 69% drop in risk of major bleeding complications. In the one-year extension study, patients taking apixaban had significantly fewer recurrences of venous thromboembolism than those taking a placebo. Apixaban is an oral selective factor Xa inhibitor already approved in the EU, US, Japan, and elsewhere for the reduction of stroke and systemic embolism risk in patients with nonvalvular atrial fibrillation. It is also already approved for DVT prophylaxis in patients who have undergone elective hip or knee replacement in both the US and EU.

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FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label updates required  The US Food and Drug Administration (FDA) has completed its safety review of olmesartan in diabetic patients, stating there is no clear evidence of increased cardiovascular risk associated with the angiotensin-receptor blocker (ARB). The FDA conducted the safety review based on data from a large clinical trial testing whether olmesartan could slow the progression of kidney disease in patients with type 2 diabetes. In the trial, known as Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP), investigators observed that diabetic patients taking olmesartan had an increased risk of dying from cardiovascular causes. Following on ROADMAP, the FDA also reviewed an epidemiologic study of Medicare patients and found a similar suggestion of increased risk of cardiovascular mortality among the olmesartan-treated diabetic patients. According to the agency, while the results of the Medicare study appear to support ROADMAP, it had doubts about the results. As a result, the findings of the FDA review are not conclusive and not indicative of increased cardiovascular risk. The "evidence available at this time does not support changing our recommendations for olmesartan use and does not support recommending that its use be avoided in patients with diabetes," it states. The label, however, will be amended to highlight some of the data from these studies.

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June 23, 2014

Lower than optimal systolic BP may not further reduce CV risk  Once systolic BP is less than 140 mm Hg, there may not be any further benefit in lowering it to below 120 mm Hg, according to new data from the Atherosclerosis Risk in Communities (ARIC) Study which published online in JAMA Int. Medicine. There were studied 4.480 participants from the ARIC Study with hypertension but without CVD at baseline from 1987 to 1989. They evaluated incident CV events among participants stratified into three groups: those with systolic BP ≥140 mm Hg (elevated group), those with systolic BP between 120 mm Hg and 139 mm Hg (standard group) and those with systolic BP ≤120 mm Hg (low group). Systolic BP was measured at baseline and during three triennial visits. The primary outcome was a composite of HF, ischemic stroke, MI and CHD-related death. Median follow-up was 21.8 years.

After adjustment for baseline age, sex, diabetes, BMI, cholesterol level, smoking and alcohol intake, Rodriguez and colleagues found that the elevated group developed incident CV events at a much higher rate compared with the low group (adjusted HR=1.46; 95% CI, 1.26-1.69). However, there was no difference in incident CV event-free survival between the standard group and the low group (HR=1; 95% CI, 0.85-1.17). Adjusting for BP medication use and diastolic BP did not change the results.

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Loss-of-function mutations in APOC3 gene linked to lower CV risk  Loss-of-function mutations in the APOC3 gene are associated with lower levels of triglycerides and reduced risk for CHD and ischemic CVD, according to two studies published online in The New England Journal of Medicine. In the first study, the triglycerides and HDL working group of the NHLBI’s Exome Sequencing Project found four mutations of APOC3, three of them loss-of-function mutations, associated with lower levels of plasma triglycerides and reduced risk for CHD. In the other study, a Danish research team found that APOC3 loss-of-function mutations were associated with lower levels of triglycerides and reduced risk for ischemic vascular disease and ischemic heart disease.

In the Exome Sequencing Project, researchers sequenced 18,666 genes in 3,734 people of European or African descent. They performed tests to determine whether rare mutations were associated with plasma triglyceride levels. For the mutations determined to be associated with triglyceride levels, the researchers evaluated their association with CHD in 110,970 people. The researchers found four mutations of APOC3 linked to lower plasma triglyceride levels. They found that approximately 1 in 150 participants were heterozygous carriers of at least one of the four mutations. Those who had at least one of the mutations had triglyceride levels 39% lower (P<1x10-20) and circulating levels of APOC3 46% lower (P=8x10-10) compared with those who did not, the researchers found. The 498 carriers of at least one mutation had a CHD risk 40% lower compared with the 110,472 noncarriers (OR=0.6; 95% CI, 0.47-0.75), according to the researchers.

In the Danish study, were analyzed 75,725 participants from two general-population studies. They tested whether low levels of nonfasting triglycerides were associated with reduced risk for ischemic vascular disease and ischemic heart disease. Median follow-up was 4 years.

Median follow-up was 34 years, during which 10,797 participants developed ischemic vascular disease and 7,557 of those who developed ischemic vascular disease also developed ischemic heart disease. The researchers found that those with nonfasting triglyceride levels <1 mmol/L had a lower incidence of CVD compared with those with nonfasting triglyceride levels &tr;4 mmol/L (ischemic vascular disease, HR=0.43; 95% CI, 0.35-0.54; ischemic heart disease, HR=0.4; 95% CI, 0.31-0.52). Compared with those who had no loss-of-function mutations in APOC3, those with at least one had 44% lower nonfasting triglyceride levels (P<.001), according to the researchers. Compared with those who had no loss-of-function mutations in APOC3, those with at least one had lower incidence of and risk for ischemic vascular disease (HR=0.59; 95% CI, 0.41-0.86) and ischemic heart disease (HR=0.64; 95% CI, 0.41-0.99), Jørgensen and colleagues found.

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Depression associated with CV mortality in younger women  Depressive symptoms predicted CAD presence and risk for death in women aged 55 years or younger in a recent study published online in J. Am. Heart Ass. However, depressive symptoms did not predict CAD presence or risk for death in women aged older than 55 years or in men aged 55 years or younger. The researchers analyzed 3,237 patients undergoing coronary angiography for the evaluation of CAD (mean age, 62.5 years; 34% women).

Participants were stratified by presence or absence of CAD burden. Depressive symptoms were categorized by Patient Health Questionnaire-9 (PHQ-9) score. Median follow-up was 2.9 years. After multivariable adjustment for CAD risk factors, depressive symptoms predicted the presence of CAD in women aged 55 years or younger (OR=1.07; 95% CI, 1.02-1.13 per one-point increase in PHQ-9 score). They did not find a similar relationship among men aged 55 years or younger (OR=1; 95% CI, 0.95-1.04), women aged 56 to 64 years (OR=1.05; 95% CI, 0.99-1.12) or women aged at least 65 years (OR=0.98; 95% CI, 0.93-1.03).

Depressive symptoms predicted increased risk for death in women aged 55 years and younger (adjusted HR=1.07; 95% CI, 1.02-1.14 per one-point increase in PHQ-9 score), but not in men aged 55 years or younger (adjusted HR=0.97; 95% CI, 0.91-1.03), in women aged 56 to 64 years (adjusted HR=1.1; 95% CI, 0.95-1.07) or in women aged at least 65 years (adjusted HR=1.02; 95% CI, 0.97-1.07).

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June 16, 2014

Statins reduced physical activity among older men  Statin use is associated with a moderate decrease in physical activity among older men, according to recent findings of a study published online in JAMA Int. Med. Researchers evaluated 5,994 men aged at least 65 years enrolled in the multicenter, prospective Osteoporotic Fractures in Men (MrOS) cohort study. The present study included cross-sectional and longitudinal analysis of men who underwent a baseline examination as part of the MrOS trial between March 2000 and April 2002. The patients were seen for additional follow-up clinic visits at a mean of 4.6 years and 6.9 years after baseline, through 2009. For each visit, participants were asked to bring all medications they had taken within the past month. At each clinic visit, participants completed self-administered questionnaires pertaining to demographics, self-perceived health and physician-diagnosed conditions. Participants also responded to the Physical Activity Scale for the Elderly (PASE) questionnaire, which assessed workplace, household and leisure activity for 1 week. During the third clinic visit, participants were fitted with an accelerometer that monitored physiological data, represented as metabolic equivalents (METS), every minute for 1 week. Researchers estimated patients' activity levels and the amount of time they spent sedentary per day (≤1.5 METS), as well as the duration of moderate (≤3 METS) and vigorous physical activity (≥6 METS). For cross-sectional analysis (n=4,137), patients were classified as statin users (n=989) or nonusers (n=3,148). In the longitudinal analysis (n=3,039), patients were categorized as prevalent users (those using statins at baseline and throughout the study, n=727), new users (statin use commenced during the study period, n=845) and nonusers (n=1,467; 48%). The cross-sectional analysis revealed that statin users were more likely to report a previous MI or stroke, hypertension, diabetes, lower total cholesterol and a lower self-perception of health. After adjustment for confounders, the difference in PASE baseline scores was estimated at –5.8 points among users compared with nonusers. In the longitudinal analysis, the researchers observed an overall decline in physical activity among study participants during approximately 7 years of follow-up. Among nonusers, PASE score decreased by a mean of 2.5 points per year, whereas prevalent users exhibited a mean score decrease of 2.8 points per year. Among new statin users, PASE score declined at a faster rate compared with nonusers, with a difference of 0.9 points between groups per year. However, the observed decline in PASE score among the three groups was not statistically significant.

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Processed red meat consumption may increase risk for HF  Men who consumed higher amounts of processed red meat had a significantly higher risk for HF and related mortality compared with men whose consumption was lower, according to findings from a recent prospective study published online in Circ. Heart Fail. Journal.

Researchers evaluated data from 37,035 men enrolled in the population-based, prospective Cohort of Swedish Men, which was established in 1997. The men were aged 45 to 79 years and had no history of HF, ischemic heart disease or cancer at enrollment. Consumption of processed and unprocessed meat was determined via responses to a 96-item self-administered food-frequency questionnaire in 1997. Follow-up for HF incidence and mortality was conducted from 1998 until HF diagnosis, death or Dec. 31, 2010. Pork, beef/veal and minced meat were classified as unprocessed meats; sausage, cold cuts, liver pate and blood pudding/sausages were identified as processed meats. The researchers said dishes such as hamburger or ground beef were classified as unprocessed meat because they are typically prepared without food additives in Sweden. HF developed in 2,891 men and resulted in 266 deaths during the mean 11.8 years of follow-up. Multivariate analysis indicated a significant association between higher consumption of processed meat and risk for HF (≥75 g/day vs. <25 g/day: HR=1.28; 95% CI, 1.1-1.48) and HF-related mortality (≥75 g/day vs. <25 g/day: HR=2.43; 95% CI, 1.52-3.88). No association was observed between consumption of unprocessed meat and HF incidence or related mortality. Further adjustment for history of hypertension, elevated cholesterol and diabetes did not significantly alter results. For each additional 50 g/day of processed red meat, the risk for HF increased by 8% and the risk for HF mortality increased by 38%, according to dose-response analysis.

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CoreValve Indication Expanded to Include High-Risk Patients  The US Food and Drug Administration (FDA) has expanded the indication for the CoreValve transcatheter aortic valve to include high-risk surgical patients. The approval comes following the positive results of the CoreValve High-Risk cohort, release earlier this year at the American College of Cardiology 2014 Scientific Sessions. The CoreValve was noninferior to surgical aortic-valve replacement in a randomized trial of 795 patients. In the approval of FDA, the entire CoreValve platform was approved for use in high-risk surgery patients, including the 23-mm, 26-mm, 29-mm and 31-mm size valves. All four sizes can be delivered through an 18-French catheter, which, the company press release notes, is the smallest commercially available transcatheter aortic-valve replacement (TAVR) delivery system. The CoreValve was FDA-approved in January for use in patients too frail to undergo surgical aortic-valve replacement.

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