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 landmarkclinical trial published in the New England Journal of Medicine. The 10-year Warfarin and Aspirin for Reduced Cardiac EjectionFraction (WARCEF) trial is the largest double-blind comparison ofthese medications for heart failure, following 2,305 patients at168 study sites in 11 countries on three continents. The researchwas led by clinical principal investigator Shunichi Homma, MD, ofColumbia University Medical Center/NewYork-Presbyterian Hospital,and statistical principal investigator John L.P. (Seamus) Thompson,PhD, of Columbia University's Mailman School of Public Health, andsupported by the National Institute for Neurological Disorders andStroke (NIH/NINDS), part of the National Institutes of Health. |
In the head-to-head comparison, the combined risk of death, stroke,and cerebral hemorrhage was 7.47% per year for patients taking theblood-thinner warfarin, also known by its brand name Coumadin, and7.93% per year for those taking aspirin - a difference that is notstatistically significant. Patients taking warfarin had close to half the stroke risk of thosetaking aspirin (0.72% vs. 1.36% per year). However, warfarinpatients had more than twice the risk for major bleeding (1.80% vs.0.87% per year).
These results, the investigators say, cancel eachother out. However, in patients followed four years or longer,there was evidence that warfarin may be more effective inpreventing the combined outcome of death, stroke, and intracerebralhemorrhage. Follow-up analyses will further evaluate this evidenceand seek to identify patients for whom one of the medications ispreferred. For patients with heart failure, a weakened heart means a greaterrisk for blood clots that can lead to a stroke, which can be fatalor disabling.
Aspirin prevents clotting and warfarin thins theblood, thus reducing the risk of stroke due to a clot or blockagein a cerebral artery. Unlike aspirin, warfarin requires aprescription and regular blood work to monitor clotting levels andadjust drug dosages. "Since the overall risks and benefits are similar for aspirin andwarfarin, the patient and his or her doctor are free to choose thetreatment that best meets their particular medical needs. However,given the convenience and low cost of aspirin, many may go thisroute," says Dr. Homma, who is Margaret Milliken Hatch Professor ofMedicine at Columbia's College of Physicians and Surgeons, andAssociate Chief of the Cardiology Division at NewYork-Presbyterian/Columbia.
"With at least 6 million Americans - and many more around the world- suffering from heart failure, the results of the WARCEF studywill have a large public health impact. Patients and theirphysicians now have critical information to help select the optimumtreatment approach. The key decision will be whether to accept theincreased risk of stroke with aspirin, or the increased risk ofprimarily gastrointestinal hemorrhage with warfarin," says WalterKoroshetz, MD, NINDS deputy director. The randomized trial was double-blinded so patient and clinicianwere both unaware of which drug the patient was taking. The patientwas instructed to take pills from two bottles, labeled aspirin andwarfarin; one was an active medication, and the other, a placebo.All patients took regular blood tests; results for patients onactive aspirin were generated using an algorithm designed by Dr.Thompson.
"This process gave great confidence that the trial wasconducted in an unbiased way," says Dr. Thompson, who is Professorof Clinical Biostatistics and Clinical Neurology at the MailmanSchool and College of Physicians and Surgeons, respectively. Previous studies established warfarin to be superior to aspirin forpreventing stroke in heart failure patients with atrial fibrillation . WARCEF is the first to authoritatively answer the question forthe majority of heart failure patients who have normal heartrhythm.
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