Late-breaking Clinical Trial Results Announced at Heart Rhythm 2013: Operating Without Interrupting Warfarin Dramatically Reduces Risk of Bleeding Complications After Cardiac Device Surgery

Bruise Control trial found that patients who were operated on without interrupting warfarin were 80 percent less likely to develop a significant hematoma after surgery compared to patients who were bridged with heparin

DENVER, CO, May 9, 2013 /CNW/ - A new Canadian study shows that operating without interrupting warfarin treatment at the time of cardiac device surgery is safe and markedly reduces the incidence of clinically significant hematomas compared to the current standard of care. The new findings were released today at Heart Rhythm 2013, the Heart Rhythm Society's 34^th Annual Scientific Sessions, and will be published online today in The New England Journal of Medicine (NEJM).

At least a quarter of patients that require pacemaker or implantable defibrillator surgery are taking warfarin to reduce the risk of a stroke. Current guidelines recommend bridging many of these patients to heparin treatment and stopping anticoagulation therapy in the days leading up to surgery which can put a patient at risk of a stroke. The Bruise Control trial is the largest randomized clinical trial to compare continuing warfarin to temporary cessation with heparin bridging in patients before and after device surgery.

"We hope that Bruise Control will change how we are treating patients around the world," said lead author David Birnie, MD, Director of the Arrhythmia Service at the University of Ottawa Heart Institute, Canada. "Our study conclusively shows that treating patients with a high risk of stroke with continued warfarin instead of heparin bridging will improve patient outcomes, decrease complications and reduce hospitalization."

Bruise Control randomized 681 patients at 17 Canadian and 1 Brazilian center with a less than 5 percent annual risk of thrombo-embolic events. One group received continued warfarin, while the other patients were bridged to therapeutic doses of either intravenous heparin or subcutaneous low-molecular-weight heparin starting three days before the procedure and resuming 24 hours after surgery. Patients were evaluated after surgery and the study found that clinically significant hematomas were 80 percent less frequent in patients that received uninterrupted warfarin. Compared to the heparin arm of the trial, patients receiving warfarin had fewer prolonged hospital stays (1.2 percent vs. 4.8 percent), less re-interruption of anticoagulation (3.3 percent vs. 14.5 percent) and fewer re-operations (0.6 percent vs. 2.4 percent). Patients in the continued warfarin arm also had greater satisfaction with their peri-operative anticoagulation management.

Co-Principal Investigator Vidal Essebag, MD, PhD, Director of Cardiac Electrophysiology, McGill University Health Center, Montreal, stated, "To many, the substantial reduction in pocket hematoma that we observed with continued warfarin may be counterintuitive. One explanation that has been proposed is the concept of an 'anticoagulant stress test.' That is, if patients undergo surgery while fully anticoagulated, any excessive bleeding will be detectable and appropriately managed while the wound is still open. In contrast, when surgery is performed with heparin bridging, such bleeding may remain latent, and appear only when full anticoagulation is resumed postoperatively."

The Bruise Control trial was funded by the Canadian Institutes of Health Research (CIHR).

"This randomized clinical trial eliminates a dilemma faced by physicians throughout the world," said Dr. Jean Rouleau, Scientific Director of the CIHR Institute of Circulatory and Respiratory Health. "The study shows that patients requiring cardiac arrhythmia device surgery can remain on their current blood thinners, thus reducing the chance of stroke and hematoma. CIHR is pleased to support Dr. Birnie and his team. Our hope is that this research evidence will soon be brought to the point of care, so it can benefit patients around the world."

Session details:
"Pacemaker and Defibrillator Surgery Without Interruption of Oral Anticoagulation: Results of the Bridge Or warfarin For Device Surgery Randomized Controlled Trial (Bruise Control)" May 9, 2013, 10:30 a.m. - 12:00 p.m. MDT, Four Seasons Ballroom 3]

Heart Rhythm 2013 is the most comprehensive educational program for heart rhythm professionals, featuring more than 8,000 attendees, 250 educational sessions and more than 130 exhibitors showcasing innovative products and services. The Heart Rhythm Society's Annual Scientific Sessions have become the must-attend event of the year, allowing the exchange of new vital ideas and information among colleagues from every corner of the globe.

About the Heart Rhythm Society
The Heart Rhythm Society is the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education and optimal health care policies and standards. Incorporated in 1979 and based in Washington, DC, it has a membership of more than 5,800 heart rhythm professionals in more than 72 countries around the world. For more information, visit www.HRSonline.org, voted 2012's "Best in Class" website for a nonprofit by the Interactive Media Council.

About the University of Ottawa Heart Institute
The University of Ottawa Heart Institute (UOHI) is Canada's largest and foremost cardiovascular health centre dedicated to understanding, treating and preventing heart disease. UOHI delivers high-tech care with a personal touch, shapes the way cardiovascular medicine is practiced and revolutionizes cardiac treatment and understanding. It builds knowledge through research and translates discoveries into advanced care. UOHI serves the local, national and international community, and is pioneering a new era in heart health. For more information visit: www.ottawaheart.ca.

SOURCE: Ottawa Heart Institute, University of Ottawa

Media Contact:
Vincent Lamontagne
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University of Ottawa Heart Institute
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