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Similar Outcomes with Bivalirudin and Unfractionated Heparin During PCI for Acute Coronary Syndromes

4 Nov, 15 | by flee

Approximately two-thirds of all PCI are performed for acute coronary syndromes.  In this setting, the optimal balance of anticoagulation to avoid thrombosis against the risk of major bleeding is a pivotal area of procedural management.  Multiple clinical trials have compared bivalirudin and heparin (+/- IIb/IIIa inhibitor), but the optimal strategy remains debated.  In particular, changes in clinical practice, namely increasing use of radial access and decreasing use of IIb/IIIa inhibitors, may influence the optimal antithrombotic treatment strategy.  In the MATRIX trial, 7213 patients with an acute coronary syndrome (55% with ST-elevation) were randomly allocated to receive either bivalirudin or heparin at 70-100u/kg peri-procedurally with an additional randomization step at procedural completion to either stop bivalirudin or continue the infusion for 4 to 6 hours.  Approximately 25% of the heparin group also received a IIb/IIIa inhibitor at the treating physician’s discretion.  There was no significant difference in rates of major adverse cardiovascular events between the bivalirudin and heparin groups (10.3% vs. 10.9%; RR, 0.94; 95% CI, 0.81 to 1.09; P=0.44), nor was there any difference in safety outcomes between the two arms (P=0.12).  In addition, prolonging bivalirudin infusion made no difference to clinical outcomes with no change in rates of stent thrombosis or other adverse clinical events (P=0.34).

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The Natural History of Takotsubo Cardiomyopathy

4 Nov, 15 | by flee

In the 25 years since first being described, takotsubo (stress) cardiomyopathy has gained increasing recognition as a common clinical entity.  Despite this, our understanding of the natural history of takotsubo cardiomyopathy remains limited.  The International Takotsubo Registry has been gathering data on takotsubo cases since 1998 and this publication describes their findings to date.  Among 1,750 patients with takotsubo cardiomyopathy, 90% were women, the mean age was 66.8 years, and psychiatric or neurological disorders were common (56%). Approximately one-quarter of presentations were triggered by an emotional event, slightly more than one-third by a physical event, and the remainder had no identified trigger. Rates of in-hospital cardiogenic shock and death were similar to rates of these events in a matched cohort of patients presenting with an acute coronary syndrome.  Predictors of in-hospital complications of takotsubo cardiomyopathy included a physical event triggering presentation, acute neurologic or psychiatric diseases, high troponin levels, and a low ejection fraction on admission.  In follow-up, the risk of major adverse events was 9.9% per patient-year and the risk of death was 5.6% per patient-year. In this observational analysis, treatment with an ACE I or ARB was associated with significantly improved prognosis, while no effect was observed with beta-blockade.  Rates of takotsubo recurrence were 1.8% per patient year. more…

Adaptive servo-ventilation increases mortality in systolic heart failure

22 Oct, 15 | by flee

Central sleep-apnea (CSA) with associated Cheyne-Stokes breathing patterns effects up to 40% of patients with low ejection fraction heart failure.   Given that CSA is an independent marker for poor prognosis and mortality, treatment of CSA has been identified as a potential target to improve heart failure outcomes.  This study randomized 1325 patients with low ejection fraction heart failure (mean EF 32%) and a diagnosis of CSA to either overnight adaptive servo-ventilation or guideline directed medical therapy alone. Adaptive servo-ventilation (ASV) is a noninvasive therapy that provides inspiratory pressure support in addition to expiratory positive airway pressure.  Trial patients were followed for a mean of 31 months, with a primary composite end-point of all-cause mortality, hospitalization for heart failure or life-saving cardiac intervention.  Although ASV resulted in a significant decrease in the apnea-hypopnea index among patients in the intervention arm, suggesting the treatment was effective in alleviating CSA.  However, ASV treatment of CSA resulted in increased all-cause mortality (hazard ratio, 1.28; 95% CI, 1.06 to 1.55; P=0.01) and cardiovascular mortality (hazard ratio, 1.34; 95% CI, 1.09 to 1.65; P=0.006) in this population of patients with low ejection fraction. more…

Empagliflozin reduces cardiovascular mortality in Type 2 Diabetics

22 Oct, 15 | by flee

The prevalence of type 2 diabetes is increasing rapidly and represents a major risk factor for cardiovascular disease.  Although glycemic control has been shown to reduce microvascular complications, the effect of glycemic control on macrovascular disease is more limited.  Furthermore, some glucose lowering drugs have been associated with worse cardiovascular outcomes.  Accordingly, ensuring the cardiovascular safety of new diabetic therapies is important. Empaglifozin is one of the first in a new class of drugs that lowers serum glucose levels by decreasing renal glucose reabsorption.  In this study of 7020 patients at high risk of cardiovascular events, patients were randomized to one of two doses of empagliflozin (10 mg or 25 mg) or placebo, as well as standard guideline based diabetic therapy.  The primary outcome was a composite of major adverse cardiovascular events or cardiovascular death.  Although powered as a non-inferiority study, empaglifozin demonstrated statistical superiority as add-on diabetic therapy, significantly reducing the incidence of the primary end-point (10.5% vs. 12.1%, HR 0.86; 95% CI, 0.74 to 0.99; P=0.04 for superiority), including a significant reduction in the risk of death (5.7% and 8.3%, respectively; 32% relative risk reduction).  Use of empaglifozin increased the rates of genital infection (although UTI rates were similar), presumably secondary to the increased amount of glucose present in urine.  No other adverse events were increased with use of empaglifozin. more…

Revascularization in response to identification of elevated high sensitivity troponin in stable patients does not improve outcomes

9 Oct, 15 | by flee

Among patients presenting with an acute coronary syndrome, cardiac troponin assays are the standard method for the identification of patients at high risk who benefit from early revascularization.  With advances in technology, high-sensitivity troponin (hsTn) assays are now available to identify levels of circulating troponin that were previously undetectable.  In this study, the authors sought to determine the impact of prompt revascularization on outcomes among patients with type 2 diabetes and stable ischemic heart disease. Utilizing patients from the BARI 2D study, a total of 2285 patients with stable ischemic heart disease and type 2 diabetes had hsTn measurements taken at baseline and 12 months.  Patients with an elevated hsTn were randomized to prompt revascularization or to ongoing medical therapy.  Over 5 years of follow-up from the point of revascularization, the primary composite end point was death from cardiovascular causes, myocardial infarction, or stroke.  A total of 897 (39.3%) patients were found to have a hsTn above the normal range (≥14 ng/l).  Compared with patients with normal hsTn levels, patients with elevated hsTn levels had a significantly increased risk for adverse events (27.1% vs 12.9% for the composite outcome; P<0.001) Early revascularization in response to elevated hsTn did not improve patient outcomes in this population of patients with stable ischemic heart disease. more…

Leadless pacemakers demonstrate promise

9 Oct, 15 | by flee

Approximately 10% of patients who receive a pacemaker experience complications related to the use of transvenous leads, the surgical pocket, or the pulse generator.  A leadless pacemaker inserted in the right ventricle by way of a transvenous catheter may result in lower complication rates. These leadless pacemakers include electronics, battery, and electrodes all in a single encapsulated device.  In this study, investigators report on a nonrandomized trial of nonsurgical implantation of a leadless cardiac pacemaker in patients who required permanent ventricular pacing.  The primary efficacy end-point was acceptable pacing and sensing thresholds with a safety end-point of device-related serious adverse events at 6 months.  Reporting on data from the initial 300 patients in the study, implantation was successful in 270 (90%) with 6.7% experiencing a device related complication by 6 months including dislodgement requiring percutaneous retrieval (1.7%), cardiac perforation and tamponade (1.2%) and pacing threshold increase requiring retrieval and repositioning (1.3%).  The study also suggested an operator learning curve with a complication rate of 6.8% for the initial 10 cases by each operator as compared with a 3.6% complication rate for subsequent implants. more…

A reversal agent for dabigatran

9 Oct, 15 | by flee

Unlike warfarin, non-vitamin K antagonist oral anticoagulants lack reversal agents for administration in the case of severe bleeding or perioperative management. Idarucizumab is a monoclonal antibody fragment that was developed to reverse the anticoagulant effects of the direct thrombin inhibitor dabigatran.  In this safety and efficacy study, idarucizumab was tested in a cohort of patients on dabigatran who either required an urgent surgical procedure or who had developed major bleeding. In an analysis of 90 patients (51 with hemorrhage and 39 requiring surgery) 5g of intravenous idarucizumab was administered to assess the impact on coagulation measures that included dilute thrombin time and ecarin clotting time.  Idarucizumab proved safe and effective with a median maximum percentage reversal of clotting measures of 100% within minutes of administration. Concentrations of free dabigatran remained essentially undetectable at 24 hours in 79% of patients.  Clinical hemostasis was achieved at a median of 11.4 hours in the hemorrhagic group and 3 (7.7%) patients in the surgical group had mild or moderately impaired hemostasis. more…

Lipid Lowering Therapy and Risk of Acute Memory Impairment

25 Sep, 15 | by flee

Prior data on the use of statin drugs and risk of acute memory impairment has been inconsistent.  In this study, Strom and colleagues sought to investigate use of statins in association with acute memory impairment and compare results to non-users and users of non-statin lipid lowering drugs (LLDs).  The authors performed a retrospective cohort study through The Health Improvement Network database (composed of primary medical records from general practitioners in the United Kingdom) identifying 482,543 patients with newly prescribed statin drugs without underlying cognitive dysfunction or dementia.  Propensity-matched control groups included 482,543 non-users of any LLDs and 26,484 users of non-statin LLDs.  The primary outcome of the analysis was the onset of acute, reversible memory impairment as determined by review of diagnosis codes. Exposure to statins was strongly associated with incident acute memory loss within 30 days of first use compared to matched non-users of LLDs (OR 4.40, CI 3.01-6.41).  The relationship persisted for users of non-statin LLDs compared to non-users (OR 3.60, CI 1.34-9.70) but was not reproduced in comparing statins with non-statin LLDs (OR 1.03, CI 0.63-1.66). more…

Testosterone Therapy: No Impact on Atherosclerosis…and No Improvements in Health

25 Sep, 15 | by flee

For men with age-related decline in testosterone levels, there is significant controversy over the risks and benefits of testosterone supplementation.  Despite a paucity of data, testosterone sales have increased markedly in the past decade.  The Testosterone’s Effects on Atherosclerosis Progression in Aging Men (TEAAM) Trial evaluated the impact of increasing testosterone concentrations on progression of atherosclerosis as determined by common carotid artery intima-media thickness and coronary artery calcium.  In addition, the investigators evaluated the effect of testosterone therapy on patient reported sexual function and health-related quality of life (SF-36). This randomized, double-blind, placebo-controlled trial enrolled 308 men >60 years old with low or low-normal testosterone (100-400ng/dL) levels and compared testosterone supplementation to levels between 500-900 ng/dL to placebo. For the measures of atherosclerosis progression, there was no difference between the treatment and placebo group.  Additionally, measures of sexual function and health-related quality of life did not differ between the treatment groups. more…

Coronary Computed Tomography Angiography Versus Radionuclide Myocardial Perfusion Imaging in Clinical Evaluation of Chest Pain Admissions

25 Sep, 15 | by flee

Chest pain concerning for a coronary syndrome leads to millions of hospital admissions each year that is often evaluated with diagnostic testing.  As a noninvasive diagnostic study, coronary computed tomography angiography (CCTA) has been shown to have excellent diagnostic capabilities.  However, concerns over CCTA remain, including radiation exposure, false-positives, and trials of the diagnostic modality that were mostly limited to low-risk patients with underrepresentation of minorities and women.  In this single-center randomized, controlled comparative effectiveness trial, 400 intermediate-risk patients (63% women, 54% Hispanic, 37% African-American) admitted to a telemetry floor were randomized to either CCTA or myocardial perfusion imaging (MPI) and followed for 40 months.  Patients with baseline renal dysfunction were excluded.  At 1 year, there were no significant differences in the primary outcome of coronary angiography that did not lead to revascularization (hazard ratio [HR], 0.77; 95% confidence interval [CI] 0.40-1.49; P = 0.44) or secondary outcomes that included length of stay, resource utilization, and patient experience.  All-cause radiation exposure was lower in the CCTA group (24 vs 29 millisieverts, P <0.0001) and more CCTA patients graded their experience favorably (P = 0.001).  Ten of 200 patients in the coronary CTA group were found to have non-cardiac diagnoses leading to chest pain (3 surgical), whereas no non-cardiac causes were found in the MPI group.   more…

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