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