StemCell Therapy

CryoLife Inc.(NYSE:CRY) announced that it had its investigational new drug application accepted by the FDA for a clinical trial to observe whether the On-X mechanical aortic valve can be maintained on apixaban instead of warfarin.

The On-X aortic valve is the first mechanical aortic heart valve to win FDA and CE Mark approval for labeling to permit use within a reduced warfarin dosage, according to a news release. Results of the original Proact trial showed a more than 60% reduction in bleeding events without increasing the risk of stroke.

Warfarin in patients with mechanical heart valves requires routine blood testing to manage the patients international normalized ratio within a certain range to minimize the likelihood of bleeding and stroke. The apixaban alternative CryoLife seeks to provide is intended to offer better durability, long-term survival and clinical outcomes.

The Proact Xa trial is slated to include 1,000 participants, randomizing 500 in each arm of the study at up to 60 sites in North America. Subjects are set to be 18 years of age or older and implanted with the On-X aortic valve and randomized to continue warfarin or switch to apixaban.

The trials co-primary efficacy endpoints are to determine if apixaban is non-inferior to warfarin and to determine if apixaban provides acceptable anticoagulation for patients with an On-X aortic valve for the primary outcome of valve thrombosis and valve-related thromboembolism. The primary safety endpoint is determining if apixaban is superior to warfarin in the safety outcome of major bleeding.

We are pleased that the FDA has authorized us to study the use of apixaban in patients with the On-X aortic valve, CryoLife chairman, president & CEO Pat Mackin said in a news release. 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.

Apixaban has been shown to reduce stroke and cause less bleeding than warfarin in patients with atrial fibrillation, added Duke University professor of medicine in cardiology Dr. John Alexander. If it can be done safely, the possibility of managing patients with an On-X aortic valve with apixaban and eliminating their need for warfarin represents a potential benefit to patients and the physicians who manage them.

Read this article:
CryoLife to begin investigational trial on using aortic valve without warfarin - Mass Device

This entry was posted on December 25, 2019 at 8:44 am and is filed under Veterinary Medicine. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |