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Low-dose anticoagulation therapy can be used safely with new design mechanical heart valve
Date:5/15/2014

is first phase of the three-phase Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT), conducted under an FDA investigational device exemption, 375 aortic valve replacement patients with elevated risk factors for clotting were randomized into control (190) and test (185) groups from September 2006 to December 2009 at 33 US centers. Patients in the control group received standard treatment of warfarin to maintain a target range of the International Normalized Ratio (INR) of 2.0-3.0. Patients in the treatment group received low-dose warfarin, targeting an INR of 1.5-2.0, after an initial 90 postoperative days of standard therapy. All patients received 81 mg aspirin daily.

The patients were followed up by in-person visits at three months, six months, and one year after surgery and then annually for between five and eight postoperative years to accrue the necessary 800 patient-years of follow-up mandated by the FDA. During these visits, electrocardiography or echocardiography was performed as required by the protocol and as clinically indicated. All patients maintained with warfarin therapy were followed up using weekly home INR testing through a central telephone or online database.

"The results show that anticoagulation may be safely reduced in patients following aortic valve replacement with this approved bileaflet mechanical prosthesis," says Dr. Puskas. "INR can be safely maintained between 1.5 and 2.0. With low-dose aspirin, this resulted in a significantly lower risk of bleeding, without a significant increase in thromboembolism. In high-risk recipients of On-X valves, the INR should be assiduously kept above 1.5 to maximize the safety and effectiveness of this therapeutic change," he concludes.

The investigators caution that results from the present trial should not be extrapolated to other prostheses, mechanical mitral valve replacements, or patients undergoing double aortic valve/mitral valve replacement. The pres
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Contact: Nicole Baritot
press@aats.org
978-299-4520
American Association for Thoracic Surgery
Source:Eurekalert

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