Artivion (NYSE:AORT) today announced positive results from a clinical trial for its On-X mechanical mitral valve replacement (MVR).
Atlanta-based Artivion (formerly CryoLife) published results in The Annals of Thoracic Surgery. The Proact clinical trial, a multicenter, non-inferiority, two-arm study assessed whether, after an On-X MVR, patients could be safely managed with lower-intensity warfarin plus aspirin.
The trial observed patients after their On-X mechanical MVR followed by at least three months of standard anticoagulation. In total, 401 patients across 44 North American centers were randomized to low-dose warfarin (target INR of 2.0 to 2.5) or standard-dose warfarin (target INR of 2.5 to 3.5). All patients were prescribed aspirin (81 mg daily) and encouraged to use home INR testing. Mean patient follow-up was 4.1 years with a maximum follow-up of eight years.
Artivion observed no differences in bleeding, valve thrombosis or thromboembolism rates…