On-X Aortic Valve Replacement Patients Treated With Low Dose Warfarin and Low Dose Aspirin

This paper reports the interim findings from the clinical registry that was initiated after FDA approval to validate the findings of the 386 PROACT trial for the On-X aortic valve. The original trial showed that low dose warfarin (INR range 1.5-2.0) and aspirin were safe starting at least three months after On-X aortic valve implantation. This interim report validates the findings of the trial in a real-world setting and explores outcomes (e.g., bleeding and thromboembolic events) among various subgroups of INR monitoring methods in patients.