Comparing Aspirin Alone to Warfarin Followed by Aspirin in Patients with Severe Aortic Regurgitation After TAVR

What this Trial Is About

The trial investigates the best antithrombotic approach after transcatheter aortic valve replacement TAVR in patients with severe aortic regurgitation who do not require long-term anticoagulation. It compares aspirin alone versus a sequential therapy of warfarin followed by aspirin, aiming to assess bleeding risks and major cardiovascular events. This multicenter randomized controlled trial evaluates whether aspirin alone is safer and not less effective than the combination strategy. Participants are randomly assigned to one of two groups one receiving aspirin 75-100 mg daily for 12 months, and the other receiving warfarin with dose adjusted to maintain INR 2-3 for 6 months followed by aspirin 75-100 mg daily for the remaining 6 months. The study monitors outcomes over one year with scheduled follow-ups at 30 days, 6 months, and 12 months. During the trial, participants undergo assessments to record events such as death, stroke, thrombosis, myocardial infarction, embolism, and major bleeding. Researchers collect data from clinical visits and diagnostic tests to evaluate heart valve function and adverse events. The primary outcome is a composite of these events at 12 months, with additional secondary measures to provide detailed safety and efficacy information throughout the study period.

Aspirin Monotherapy Versus Sequential Warfarin-Aspirin Therapy After TAVR in Patients With Pure Aortic Regurgitation