Personalized, CT-guided Antithrombotic Therapy Versus Lifelong Single Antiplatelet Therapy to Reduce Thromboembolic and Bleeding Events in Non-atrial Fibrillation Patients After Transcatheter Aortic Valve Implantation: a Pragmatic, International, Multicentre, Randomized Clinical Trial

What this Trial Is About

Researchers are evaluating a personalized approach to antithrombotic therapy compared to lifelong single antiplatelet therapy (SAPT) for patients who have undergone transcatheter aortic valve implantation (TAVI) and do not have a reason to take anticoagulants. The study aims to reduce the risk of blood clots and bleeding events, as the standard SAPT carries bleeding risks with only minimal protection against clots. The trial is pragmatic, international, and randomized, sponsored by St. Antonius Hospital. Participants in the experimental group will receive a CT scan three months after TAVI to check for valve thrombosis. If thrombosis is detected, they will begin anticoagulation treatment with apixaban, with doses adjusted based on specific criteria. If no thrombosis is found and there is no other reason to continue, SAPT will be stopped. The control group will continue standard care with lifelong SAPT. Treatment and monitoring will be guided by CT results. During the study, participants will be followed for about 2.5 years to track thromboembolic and bleeding events. Researchers will assess heart valve function annually using echocardiography and monitor quality of life with several questionnaires at baseline, 3, 12 months, and yearly thereafter. Medication adherence and cost-effectiveness of the CT-guided strategy will also be evaluated. The trial includes regular assessments to ensure safety and track outcomes over the median follow-up time.

Personalized, CT-guided Antithrombotic Therapy Versus Lifelong Single Antiplatelet Therapy to Reduce Thromboembolic and Bleeding Events in Non-atrial Fibrillation Patients After Transcatheter Aortic Valve Implantation