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Aspirin vs. War..

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Heart failure (HF) independently increases the risk of stroke and systemic thromboembolic events due to left ventricular stasis, a hypercoagulable state and endothelial dysfunction which provides a rationale for the use of oral anticoagulants to prevent morbidity and mortality.1,2,3 Retrospective analyses of subgroups have provided conflicting evidence as to the benefit of warfarin over aspirin in patients with chronic HF and in normal sinus rhythm (NSR).2 Several prospective trials including the HELAS (Heart Failure Long-Term Antithrombotic Study), WATCH (Warfarin and Antiplatelet Therapy in Chronic Heart Failure) and WASH (Warfarin/Aspirin Study in Heart Failure) studies have evaluated which antithrombotic is the best agent to use for patients with heart failure.4-6 However, these trials found no difference but were not adequately powered to be conclusive.3-6 Therefore, the debate about which is a better therapy to use in HF patients in NSR between aspirin and warfarin continues. The Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) trial was a larger study designed to try and settle this debate.2

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The WARCEF trial was a randomized, double-blind, double-dummy multi-center clinical trial comparing aspirin 325 mg daily to warfarin dosed to an INR between 2.0 to 3.5. Inclusion criteria consisted of patients 18 years or older with an LVEF ≤35%, any New York Heart Association (NYHA) class, and planned treatment with a beta-blocker, ACE-inhibitor (or ARB), or hydralazine and nitrates. Exclusion criteria were patients who had an indication for warfarin or aspirin or were at high risk for cerebral embolism. The primary endpoint was the composite of death, ischemic stroke, or intracerebral hemorrhage. Secondary outcomes consisted of the same outcomes as the primary with the addition of myocardial infarction and hospitalization due to heart failure. The primary safety endpoint of major bleeding events was defined as intracerebral, epidural, subdural, subarachnoid, spinal intramedullary, retinal hemorrhage and a loss of 2 g/dL on 48 hours.2

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A total of 2305 patients was followed for up to 6 years with a mean follow-up time of 3.5±1.8 years. The mean LVEF was 24.7±7.5%, approximately 43% of patients had ischemic cardiomyopathy, and the time in therapeutic range for the warfarin group was 62.6% with a mean INR of 2.5±0.95. There was no difference between aspirin and warfarin in the primary outcome with 7.93 events/100 patient-years in the aspirin group and 7.47 events/100 patient-years in the warfarin group (CI, 0.79-1.10, P= 0.40); however, a small benefit was observed in the warfarin group after 4 years of treatment (HR 0.75, P=0.04).2 There were significantly fewer ischemic strokes with warfarin compared with aspirin (0.72 events/100 patient-years versus 1.36 events/100 patient-years, CI, 0.33-0.82; P=0.005; number needed to treat, NNT 156); and there was a borderline significant higher rate of hospitalizations for heart failure with the warfarin group (P=0.053).2,3 The rate of major hemorrhage was significantly higher with warfarin than with aspirin (1.78 events/100 patient-years versus 0.87 events/100 patient-years; P< 0.001; number needed to harm, NNH 110).2,3 Intracerebral bleeding was similar between the ...

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