WARCEF TRIAL

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