LITTLE ROCK - CryoLife, Inc., a leading cardiac and vascular surgery company focused on aortic disease, announced it has initiated enrollment in the PROACT Xa clinical trial to determine if patients with an On-X mechanical aortic valve can be maintained safely and effectively on apixaban (Eliquis®) rather than on warfarin.
Pat Mackin, Chairman, President, and CEO of CryoLife, said, "We are pleased to announce that the first patient in our PROACT Xa clinical trial has been enrolled at CHI St. Vincent Heart Institute...Under the PROACT Xa trial, we will study the use of apixaban in patients with the On-X Aortic Valve, the first and only mechanical aortic heart valve to receive both FDA approval and the CE Mark for labeling to permit use with a reduced warfarin dosage, based on results of the original PROACT trial that demonstrated a greater than a 60 percent reduction in bleeding events without increased risk of stroke. Despite the ongoing COVID-19 pandemic, many institutions are continuing to enroll patients in important clinical trials. As a result, if the trial meets its endpoints, we believe we can still achieve FDA approval for the use of apixaban with the On-X Aortic Valve in 2024."
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. 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.
Dr. Thomas Rayburn III, MD, CHI St. Vincent Heart Institute, said, "The CHI St. Vincent Heart Institute is pleased to be the first site in the United States to take the next step in this important research. We look forward to answering this vital clinical question and are especially excited that we can continue to collaborate remotely using telehealth technologies to maintain momentum at this time. Our role in this important research is indicative of CHI St. Vincent's healing ministry and commitment to delivering the most advanced, compassionate care to our communities."
The PROACT Xa trial consists of approximately 1,000 participants. Participants will be randomized to either continue warfarin or switch to apixaban. Each participant will be followed for at least 2 years.