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 between the two groups, demonstrating that a lower target INR is safe and feasible for patients with an On-X mechanical valve in the mitral position, according to a news release.
The company designed On-X with a length-to-diameter ratio similar to a native valve, an inlet flared orifice, a leaflet opening up to 90 degrees, an actuated pivot and pure pyrolytic carbon. Artivion said the features of the design create laminar flow, low gradients and reduced thrombogenicity.
Artivion said the FDA is currently reviewing the labeling change recommendation for the On-X mechanical mitral valve based on the Proact trial.
The U. S. Food and Drug Administration (FDA) is currently reviewing the labeling change recommendation for the On-X mechanical mitral valve based on this clinical trial.
“The Proact mitral results add to the data from clinical trials we have sponsored showing that patients with our On-X heart valves can be safely maintained with lower anticoagulation levels than required for competitors’ mechanical valves,” Artivion Chairman, President and CEO Pat Mackin said in the release. “We continue investing in scientific studies to improve and simplify the lives of prosthetic heart valve patients. In addition, the ongoing Proact Xa trial aims to prove that patients with the On-X aortic valve can be safely maintained on apixaban, without the need for routine anticoagulation blood tests.”