Artivion stops PROACT Xa trial; apixaban fails non-inferiority vs warfarin for On-X aortic valves

ARTIVION, INC.

DSMB recommended stopping PROACT Xa due to lack of evidence supporting non-inferiority of apixaban to warfarin.
Blood clots causing stroke occurred more frequently in patients receiving apixaban; trial continuation unlikely to achieve primary endpoint.
Physicians notified to switch apixaban-arm patients back to warfarin.
Successful trial would have significantly increased addressable market beginning in 2025; that opportunity is now lost.
Company reaffirms 2022 double-digit top-line growth and redirects ~$10M annual trial funding to other development and EBITDA.

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