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Study: Aspirin, warfarin comparable in reducing risks

Friday May 4, 2012
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Neither aspirin nor warfarin is superior for preventing a combined risk of death, stroke and cerebral hemorrhage in heart failure patients with normal heart rhythm, according to a landmark clinical trial.

The 10-year Warfarin and Aspirin for Reduced Cardiac Ejection Fraction trial is the largest double-blind comparison of these medications for heart failure, according to the researchers, following 2,305 patients at 168 study sites in 11 countries on three continents. The research was led by investigators with Columbia University in New York City.

In the head-to-head comparison, the combined risk of death, stroke, and cerebral hemorrhage was 7.47% per year for patients taking warfarin, also known by its brand name Coumadin, and 7.93% per year for those taking aspirin. The difference is not statistically significant.

Patients taking warfarin had close to half the stroke risk of those taking aspirin (0.72% vs. 1.36% per year). However, warfarin patients had more than twice the risk of major bleeding (1.80% vs. 0.87% per year). These results cancel each other out, the investigators said.

However, in patients followed four years or longer, the researchers found evidence that warfarin may be more effective in preventing the combined outcome of death, stroke and intracerebral hemorrhage. Follow-up analyses will further evaluate this evidence and seek to identify patients for whom one of the medications is preferred.

"Since the overall risks and benefits are similar for aspirin and warfarin, the patient and his or her doctor are free to choose the treatment that best meets their particular medical needs," Shunichi Homma, MD, the study’s clinical principal investigator, affiliated with Columbia University Medical Center/NewYork-Presbyterian Hospital, said in a news release.

"However, given the convenience and low cost of aspirin, many may go this route."

The National Institute for Neurological Disorders and Stroke, part of the National Institutes of Health, funded the study.

"With at least 6 million Americans and many more around the world suffering from heart failure, the results of the WARCEF study will have a large public health impact," Walter Koroshetz, MD, deputy director of NINDS, said in the news release. "Patients and their physicians now have critical information to help select the optimum treatment approach.

"The key decision will be whether to accept the increased risk of stroke with aspirin, or the increased risk of primarily gastrointestinal hemorrhage with warfarin."

The randomized trial was double-blinded, meaning patient and clinician were both unaware of which drug the patient was taking. Previous studies established warfarin as superior to aspirin for preventing stroke in heart failure patients with atrial fibrillation. WARCEF is the first to authoritatively answer the question for heart failure patients with normal heart rhythm, according to the researchers.

The study appeared May 2 on the website of the New England Journal of Medicine. To read it, visit http://bit.ly/IvoQ3m.

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