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WARCEF TRIAL |
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| Problem | HF (LVEF < 35%) |
| Format | Multicenter, double-blind, randomized trial |
| Treatment | Warfarin (INR 2-3.5) |
| Control | Aspirin (325mg) |
| Population | 2305 patients |
| Inclusion criteria | 18 years of age or older and had normal sinus rhythm No contraindication to warfarin therapy LVEF of 35% or less as assessed by quantitative echocardiography (or a wall-motion index of â‰_1.2) or as assessed by radionuclide or contrast ventriculography within 3 months before randomization. Patients in any New York Heart Association (NYHA) functional class were eligible -But patients in NYHA class I could account for no more than 20% of the total number of patients undergoing randomization Additional eligibility criteria were a modified Rankin score of 4 or less (on a scale of 0 to 6, with higher scores indicating more severe disability) |
| Exclusion criteria | Patients who had a clear indication for warfarin or aspirin were not eligible Patients were ineligible if they had a condition that conferred a high risk of cardiac embolism, such as atrial fibrillation, a mechanical cardiac valve, endocarditis, or an intracardiac mobile or pedunculated thrombus. |
| Follow-up | Range 1 - 6 years |
| Primary endpoint | Time to the first event in a composite end point of ischemic stroke, intracerebral hemorrhage, or death from any cause |
| Secondary endpoint(s) | First event in a composite of the primary outcome, myocardial infarction, or hospitalization for heart failure |
| Details | N.B. Mean age, 61 years; relatively young for a population with heart failure Only 43% of patients had evidence of underlying ischemic heart disease |
| Brief summary: | No benefit in SR & LVEF <35%; reduced ischaemic stroke offset by haemorrhage |
| PAPER: Warfarin and aspirin in patients with heart failure and sinus rhythm | |
|---|---|
| Date | 17 May 2012 |
| Journal | N Engl J Med. 2012 May 17;366(20):1859-69. |
| Information | Warfarin vs. Aspirin in HF with EF <35% in sinus rhythm -No reduced time to first stroke/death -Reduced ischemic stroke offset by increased major hemorrhage |