Artivion Stops PROACT Xa Clinical Trial With Apixaban; Confirms Positive Top-line Outlook
Artivion, Inc. (AORT), a cardiac and vascular surgery company focused on aortic disease, announced Friday that it has stopped the PROACT Xa clinical trial following recommendation of the independent Data and Safety Monitoring Board or DSMB. The study was evaluating the use of apixaban in patients treated with mechanical aortic valves.
Despite stopping the trial, the company reiterated its 2022 outlook of delivering double-digit top-line growth. The company also continues to expect double digit top-line growth, expanding gross margins, and accelerated adjusted EBITDA growth through 2024.
The company said it had committed around $10 million in annual funding to this study through 2024, which will now be redirected to other development opportunities and to incremental EBITDA and cash flow in 2023 and 2024.
PROACT Xa clinical trial is a prospective, randomized, trial designed to determine if patients with an On-X mechanical aortic valve can be maintained safely and effectively on apixaban rather than on warfarin.
The PROACT Xa trial randomized patients having an On-X aortic valve replacement to receive either warfarin or apixaban as their anticoagulant to prevent blood clots. The trial began enrolling in April 2020.
The recommendation by the DSMB of the trial was due to lack of evidence supporting non-inferiority of apixaban to warfarin for valve thrombosis and thromboembolism.
The DSMB found that blood clots, resulting in stroke, occurred more frequently in patients receiving apixaban and that continuing the trial was unlikely to achieve the primary endpoint while possibly exposing patients to increased risk.
The company noted that physician investigators at the trial’s sites are being notified to change patients who are in the apixaban arm of the trial back to warfarin.
Pat Mackin, Chairman, President and Chief Executive Officer of Artivion said, “We are disappointed to stop the PROACT Xa trial as a successful trial would have significantly benefited patients and significantly increased our addressable market opportunity beginning in 2025.”
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