The 10-year WARCEF trial finds aspirin and warfarin have equivalent risks for hospitalization and death

Jul 31, 2017
Study Allays Concerns Over Aspirin’s Safety for Heart Failure Patients
New York - 

A study by researchers at NewYork-Presbyterian/Columbia University Medical Center and published in JACC: Heart Failure, a journal of the American College of Cardiology Foundation, allays concerns among cardiologists that aspirin could increase the risk of hospitalization and death related to heart failure for patients with heart failure who take one of the first-line therapies: angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs).

The 10-year Warfarin and Aspirin for Reduced Cardiac Ejection Fraction (WARCEF) trial is the largest randomized, double-blind comparison of aspirin and warfarin (also known by its brand name Coumadin) for heart failure, following 2,305 heart failure patients whose heart muscle pumps less oxygen-rich blood into the body, known as reduced ejection fraction, at 168 study sites in 11 countries on three continents. The patients in WARCEF were in normal sinus rhythm (experiencing a normal heart beat) and were taking heart failure medications.

The researchers in this sub-study found that aspirin does not increase heart failure events in heart failure patients. Earlier heart failure studies, smaller than WARCEF, raised concern about a negative effect of aspirin with heart failure medications, due to a potential biochemical interaction.

“These findings allay concerns regarding the safety of aspirin for heart failure patients,” says senior author Shunichi Homma, Margaret Milliken Hatch Professor of Medicine at Columbia’s College of Physicians and Surgeons, and Deputy Chief of the Cardiology Division at New York-Presbyterian/Columbia.

“Up to 40 percent of Americans take aspirin, and in heart failure patients, this number may be even higher,” says co-author Susan Graham, a cardiologist and professor of Medicine at the University of Buffalo. “It’s a great relief to learn that aspirin is safe for this population. One challenge in cardiology is that we may need to use many drugs, including two or three blood thinners. We always want to be sure we’re helping patients, not creating problems.

“Knowledge that aspirin is safe could have implications extending beyond the world of heart failure since ACE inhibitors are also used as a front-line therapy for hypertension and diabetes,” adds Graham.

The new study, a post-hoc analysis, follows the main WARCEF study published in 2012 in the New England Journal of Medicine, finding neither aspirin nor warfarin superior for preventing a combined risk of death, stroke, and cerebral hemorrhage in heart failure patients with normal heart rhythm.

The new study’s first author is John R. Teerlink, professor of medicine at the University of California San Francisco. Statistical analysis was led by senior author John (Seamus) L.P. Thompson, professor of Biostatistics and Clinical Neurology at the Mailman School and College of Physicians and Surgeons, respectively. Min Qian, assistant professor of Biostatistics at the Mailman School, used state-of-the-art statistical methods to study the recurrence of heart failure hospitalization events.

Additional co-authors are Natalie A. Bello, Bruce Levin, Marco R. Di Tullio, J.P. Mohr, and Seitetz C. Lee, NewYork-Presbyterian/Columbia; Ronald S. Freudenberger, Lehigh Valley Hospital, Allentown, Pennsylvania; Douglas L. Mann, Washington University, St. Louis, Missouri; Ralph L. Sacco, University of Miami, Miami, Florida; Gregory Y.H. Lip, Institute of Birmingham Centre for Cardiovascular Sciences, Birmingham, England, U.K.; Arthur J. Labovitz, University of South Florida, Tampa; Piotr Ponikowski, Military Hospital, Wroclaw, Poland; Dirk J. Lok, Deventer Hospital, Deventer, the Netherlands; and Stefan D. Anker, University Medical Center Göttingen, Göttingen, Germany.

The study is supported by grants from the National Institute of Neurological Disorders and Stroke to Homma (NS043975) and Thompson (NS039143). Teerlink has received support from Actelion, Amgen, Astra Zeneca, Bayer, Bristol-Myers Squibb, Celyad, Merck, Novartis, Relypsa, Stealth, St. Jude Medical/Abbott, Trevena, and ZS Pharma. Sacco has received research grants from NINDS, NCATS, AHA, the Evelyn McKnight Brain Foundation, and Boehringer-Ingelheim. Lip has received consultant fees from Bayer/Janssen, BMS/Pfizer, Bioitronik, Medtronic, Boehringer- Q2 Ingelheim, Microlife, and Daiichi-Sankyo; and has also been on the speakers board for Bayer, BMS/Pfizer, Medtronic, Boehringer-Ingelheim, Microlife, Roche, and Daiichi-Sankyo. Labovitz has received a research grant from Bristol-Myers

Squibb/Pfizer for the AREST trial. Anker has received consultant fees from Boehringer-Ingelheim, Bayer, and Janssen; and was on the steering committee for COMMANDER-HF. Homma has received consultant fees from St. Jude Medical.

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