Impact of Continuation Versus Interruption of Oral Anticoagulation During TAVI on Health-Related Quality of Life

BACKGROUND: One-third of patients undergoing TAVR have a concomitant indication for oral anticoagulation. The impact of continuation as compared to interruption of oral anticoagulation during TAVR on health-related quality of life is unknown. AIMS: To investigate the impact of continuation as compared to interruption of oral anticoagulation on health-related quality of life. METHODS: The POPular PAUSE TAVI (Periprocedural Continuation vs. Interruption of Oral Anticoagulant Drugs during Transcatheter Aortic Valve Implantation) trial was an international, open-label, randomized, clinical trial performed at 22 European sites. Health-related quality of life was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and Short Form-12 (SF-12) before, and at 1 and 3 months after TAVR. RESULTS: A total of 8 patients were included: 431 were assigned to continuation and 427 to interruption of oral anticoagulation. Before TAVR, the mean overall KCCQ summary score was 53.6 (±26.0). At 1 month, the mean change in KCCQ summary score as compared to baseline was +11.4 points (95% confidence interval [CI] 8.0-14.8) in the continuation group and +12.2 points (95% CI 8.8-15.6) in the interruption group (difference -0.7 points; 95% CI -4.6 to 3.1). At 3 months, the mean change was +11.0 points (95% CI 7.3-14.6) versus +13.8 points (95% CI 10.2-17.4), respectively (difference -2.8 points; 95% CI -7.1 to 1.5). Mean changes in SF-12 physical and mental component summary scores showed no differences between both groups at 1 and 3 months after TAVR. CONCLUSIONS: In patients undergoing TAVR with a concomitant indication for oral anticoagulation, continuation as compared to interruption of oral anticoagulation during TAVR did not significantly impact health-related quality of life up to 3 months after TAVR.