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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…

Informed Decision Making for Percutaneous Coronary Intervention for Stable Coronary Disease

10 Sep, 15 | by flee

Prior studies suggest patients are often misinformed about the anticipated benefits of PCI for stable coronary disease.  However, there is little data on patient-provider discussions that may explain discrepancies in patient understanding about the limited benefits of PCI in this setting.   Rothberg and colleagues performed a cross-sectional analysis of 59 conversations between providers and patients about PCI.  The conversations included 23 cardiologists (all male, 6 interventionalists, median 19 years experience) representing all regions of the United States from 2008 to 2012.  Conversations were analyzed for discussion of 7 elements central to shared-decision making: more…

Lipid lowering drugs and risk of vascular events in older patients

7 Jul, 15 | by Alistair Lindsay

Although elderly patients are at higher risk of cardiovascular events, the majority cardiovascular trials exclude these patients.  Accordingly, little is known about the use of lipid lowering medications for prevention of cardiovascular events in elderly populations. This prospective cohort study evaluated the association between use of statins or fibrates for prevention of vascular events among a random sample of 7484 patients aged 65 years of older without prior vascular disease living in three French cities recruited from 1999-2000.  Patients were followed for a median of 9.1 years, with 732 vascular events (440 coronary events, 292 strokes) occurring during the study period.  The study found that 27.4% (n=2084) of patients reported baseline lipid lowering medication use (13.5% statins, 13.9% fibrates).   more…

Improved Atrial Fibrillation Outcomes Despite Rising Arrhythmia Prevalence

7 Jul, 15 | by Alistair Lindsay

Little is known about temporal trends in atrial fibrillation (AF) incidence, prevalence, and outcomes. Using the Framingham Heart Study, Schnabel and colleagues assessed AF incidence, prevalence, and outcomes over 50 years (202,417 person-years). Researchers drew on a cohort of 9,511 participants enrolled between 1958 and 2007 in which 1,544 incident AF cases (47% women) were identified. Over the study period, age-adjusted incidence increased threefold (3.7 to 13.4 new cases per 1000 person-years in men and from 2.5 to 8.6 new cases per 1000 person-years in women) and age-adjusted prevalence increased fourfold (20.4 to 96.2 cases per 1000 person-years in men and from 13.7 to 49.4 cases per 1000 person-years in women). more…

Investigating chest pain: anatomy or function?

22 May, 15 | by Alistair Lindsay

Among patients with chest pain, it is unclear if anatomic assessment of coronary obstruction or functional assessment with stress testing leads to better patient outcomes. In this randomized controlled trial of 10,003 symptomatic patients, individuals were randomly assigned in a 1:1 fashion to either anatomical testing with coronary CT angiography (CTA) or to functional testing by one of several different modalities (exercise ECG (10%), nuclear stress testing (67%) or stress echo (23%)).  Instead of diagnostic accuracy, as is seen with most such studies, the trial was powered for clinical outcomes with a primary composite endpoint of death, myocardial infarction, hospitalization for unstable angina, or major procedural complication.  more…

Antiplatelet therapy in long-term risk reduction after myocardial infarction

22 May, 15 | by Alistair Lindsay

The activated platelet is central to development of ischemic cardiovascular events. Guidelines recommend treatment with a P2Y12 receptor antagonist for 1-year after myocardial infarction (MI) to reduce the risk of recurrent events.  The PEGASUS trial sought to determine the impact of using the P2Y12 antagonist ticagrelor as part of long-term therapy after MI.  In this trial, a total of 21,162 clinically stable patients with a MI in the prior 1 to 3 years (median 18 months) were randomized in a 1:1:1 fashion to either placebo, ticagrelor 90mg twice daily, or ticagrelor 60mg twice daily.  All patients remained on aspirin and standard secondary prevention as tolerated.  Follow up was for a median of 33 months with the primary outcome being a composite of cardiovascular death, myocardial infarction, or stroke and the primary safety end-point of bleeding.  more…

Precision Medicine to Reduce Bleeding with PCI   

5 May, 15 | by Alistair Lindsay

 

Periprocedural bleeding remains one of the most common adverse events after percutaneous coronary intervention (PCI) and is associated with increased mortality.  Although strategies to minimize PCI bleeding have been identified, these strategies are infrequently applied to patients at highest bleeding risk.  Using a pre-post study design, Spertus et al. evaluated the impact of assessing individual patient bleeding risk from validated models and providing this bleeding risk estimate in personalized informed consent documents for PCI.  The intent of the intervention was to increase the procedural team’s awareness of patients at low, moderate, and risk for PCI related bleeding and thereby influence the use of bleeding avoidance strategies (i.e. bivalirudin, radial access, and vascular closure devices) and reduce periprocedural bleeding events.  more…

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