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Low-dose anticoagulation therapy used with new design mechanical heart valve lowers bleeding risk
Date:5/6/2013

Minneapolis, MN, May 6, 2013 For more than 40 years, patients under 65 years of age requiring heart valve replacement have had to choose between a mechanical valve that offers life-long durability but requires aggressive warfarin anticoagulation or a biological (cow or pig) valve that will wear out in 10-20 years but does not require anticoagulation. Aggressive warfarin anticoagulation is accompanied by significant annual risk of bleeding, while inadequate anticoagulation of a mechanical artificial valve has been associated with high risk of clotting problems that can cause strokes.

A newer generation mechanical heart valve, manufactured by On-X Life Technologies, Austin, TX, has several design features that make it more efficient and less likely to clot. The FDA is allowing a randomized trial to be conducted to determine whether it is safe and effective to treat patients with an On-X mechanical aortic valve with less aggressive anticoagulation than has previously been recommended by the American Heart Association and American College of Cardiology.

In an interim report to be presented at the 93rd AATS Annual Meeting in Minneapolis on May 6, 2013, John D. Puskas, MD, Professor and Associate Chief of the Division of Cardiothoracic Surgery, Emory University School of Medicine, Athens, GA, and his co-investigators show that lower dose anticoagulation therapy, combined with low-dose aspirin, resulted in a reduction of 55 to 60% of the incidence of adverse bleeding events without significant increases in stroke, transient ischemic attack or total neurological events when used in conjunction with the On-X mechanical aortic valve.

As part of the Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT), a control group of patients received standard treatment of warfarin administered to maintain a target range of the International Normalized Ratio (INR) of 2.0-3.0. The second treatment group received low-dose warfarin, targeting a
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Contact: Nicole Baritot
press@aats.org
978-299-4520
American Association for Thoracic Surgery
Source:Eurekalert

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