Moon Township, PA, (July 19, 2012)
–Neither aspirin nor warfarin is superior for preventing a combined risk of death, stroke and cerebral hemorrhage in heart failure (HF) patients with normal heart rhythm, according to the 10-year WARCEF (Warfarin and Aspirin for Reduced Cardiac Ejection Fraction) trial. The trial, which was supported by the National Institute for Neurological Disorders and Stroke, part of the National Institutes of Health, was published May 2 in the New England Journal of Medicine
The WARCEF trial is the largest double-blind comparison of these medications for heart failure, including 2,305 patients for up to six years at 168 study sites in 11 countries on three continents. The Heritage Valley Heart & Vascular Center, part of Heritage Valley Health System, was one of the lead participating sites, having been involved with the WARCEF trial since 2006.
The researchers designed the trial to determine whether warfarin (with a target international normalized ratio of 2 to 3.5) or aspirin (at a dose of 325 mg per day) is a better treatment for patients in sinus rhythm who have a reduced left ventricular ejection fraction (LVEF). The primary outcome was the time to the first event in a composite endpoint of ischemic stroke, intracerebral hemorrhage or death from any cause.
In the head-to-head comparison, the combined risk of death, stroke, and cerebral hemorrhage was 7.47 percent per year for patients taking warfarin, and 7.93 percent per year for those taking aspirin—a difference that is not statistically significant.
Patients taking warfarin had close to half the stroke risk of those taking aspirin (0.72 percent vs. 1.36 percent per year), the study authors reported. However, warfarin patients had more than twice the risk for major hemorrhage (1.78 percent vs. 0.87 percent per year). The rates of intracerebral and intracranial hemorrhage did not differ significantly between the two treatment groups (0.27 events per 100 patient-years with warfarin and 0.22 with aspirin).
These results, the investigators reported, cancel each other out. However, in patients followed four years or longer, there was evidence that warfarin may be more effective in preventing the combined outcome of death, stroke and intracerebral hemorrhage.
The researchers added that follow-up analyses will further evaluate this evidence and seek to identify patients for whom one of the medications is preferred.
“Our research department has been proud to participate in this important NIH sponsored study and we’re hopeful that these results will lead to the improved care of our heart failure patients,” said Michael Malkowski, M.D., FACC, Cardiologist with the Heritage Valley Heart & Vascular Center and Principal Investigator for the WARCEF Trial at the Beaver and Leetsdale Heart & Vascular Center locations. “We are grateful to the patients who participated in the trial and thankful for their commitment. Our doctors and nurses have worked diligently on this trial and have been recognized for their accurate data collection and superb patient management.”