CryoLife Receives FDA Authorization to Begin PROACT Xa Clinical Trial

CryoLife has received authorization from the U.S. Food and Drug Administration (FDA) pursuant to an Investigational New Drug (IND) application to begin the PROACT Xa clinical trial, a prospective, randomized, trial to determine if patients with an On-X mechanical aortic valve can be maintained safely and effectively on apixaban (Eliquis®) rather than warfarin.

"We are pleased that the FDA has authorized us to study the use of apixaban in patients with the On-X Aortic Valve," Pat Mackin, Chairman, President, and Chief Executive Officer of CryoLife, said. "The On-X Aortic Valve was the first mechanical aortic heart valve to receive both FDA and CE Mark approval for labeling to permit use with a reduced warfarin dosage, based on results of the original PROACT trial which demonstrated a greater than a 60% reduction in bleeding events without increasing the risk of stroke." Mr. Mackin added, "If the PROACT Xa trial is successful in proving that On-X Aortic Valve recipients can be maintained safely on apixaban rather than warfarin, we believe that not only will we become the leader in the mechanical valve market, but also that the On-X Aortic Valve will take share from the existing bioprosthetic aortic valve market."

Patients with mechanical heart valves are anticoagulated with warfarin which requires routine blood testing to manage their INR (International Normalized Ratio) within a certain range to minimize the likelihood of bleeding and stroke. INR management within prescribed ranges can be challenging due to dietary restrictions and drug interactions. Despite multiple studies showing that tissue valves are associated with worse outcomes, including higher reoperation rates compared to mechanical valves, younger patients sometimes opt for a tissue valve to avoid the need to take warfarin due to its side effects. Providing an alternative to warfarin, such as apixaban, gives younger patients a strong incentive to choose an On-X Aortic Valve with greater durability, generally better long-term survival and better clinical outcomes.

The PROACT Xa trial is a prospective, multicenter, randomized clinical trial consisting of approximately 1,000 participants (500 participants in each arm) at up to 60 sites in North America, who are 18 years of age or older and have been implanted with the On-X Aortic Valve. Co-chairs for the PROACT Xa Steering Committee are Lars Svensson, MD, PhD, Chairman of the Heart and Vascular Institute at the Cleveland Clinic and John Alexander, Professor of Medicine in Cardiology, Duke University.

Participants will be randomized to either continue warfarin or switch to apixaban. Each participant will be followed for at least 2 years. The co-primary efficacy endpoints are to (1) determine if apixaban is non-inferior to warfarin (INR target range 2.0 - 3.0) for patients with an On-X Aortic Valve for the primary composite outcome of valve thrombosis and valve-related thromboembolism and (2) determine if apixaban provides acceptable anticoagulation for patients with an On-X Aortic Valve for the primary composite outcome of valve thrombosis and valve-related thromboembolism as compared with objective performance criteria. The primary safety endpoint is to determine if apixaban is superior to warfarin (INR target range 2.0 - 3.0) in the safety outcome of major bleeding in participants with an On-X Aortic Valve.

Worldwide, there are approximately 340,000 surgical aortic valves replaced annually placing the worldwide aortic surgical valve market at approximately $1.2 billion.

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