Clinical outcomes of direct oral anticoagulant versus warfarin after transcatheter aortic valve replacement: From the STS/ACC TVT registry.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) recipients frequently have an indication for long-term oral anticoagulation, including atrial fibrillation or systemic thromboembolic disease. It remains unclear if there are differences in safety and effectiveness between direct oral anticoagulants (DOAC) and warfarin in this patient population. METHODS: Clinical outcomes were compared between TAVR recipients receiving DOACs or warfarin using data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) registry linked with Centers for Medicare & Medicaid Services claims data. The analysis included patients from the TVT registry who underwent successful TAVR and were discharged on either a DOAC or warfarin between January 2013 and May 2018. The primary outcome was any bleeding requiring hospitalization from discharge to 1 year. Secondary outcomes included all-cause mortality and stroke from discharge to 1 year. Multivariable Cox proportional hazards regression models were used to compare these outcomes between the 2 groups. RESULTS: A total of 29,142 patients underwent TAVR and were discharged on oral anticoagulation, among whom 10,973 (37.7%) were discharged on a DOAC. The use of DOACs increased throughout the study period and exceed the use of warfarin by the final year (2018). The cumulative incidence of bleeding requiring hospitalization at 1 year (11.8% vs 15.2%, P < .001) and all-cause mortality (15.5% vs 17.5%, P < .001) was significantly lower in DOAC group while stroke (2.47% vs 2.39%, P = .64) was not statistically different between groups. In an adjusted model, the use of a DOAC as opposed to warfarin was associated with a significantly lower risk of bleeding requiring hospitalization (adjusted hazard ratio 0.49, 95% confidence interval 0.43-0.56), all-cause mortality (adjusted hazard ratio 0.61, 95% confidence interval 0.57-0.66), and stroke (adjusted hazard ratio 0.86, 95% confidence interval 0.81-0.92) (all P < .001). CONCLUSIONS: In this analysis of TAVR recipients discharged on oral anticoagulation in a large U.S. registry, the use of a DOAC rather than warfarin was associated with a lower risk of bleeding requiring hospitalization, all-cause mortality, and stroke from discharge to 1 year. Future randomized studies will be necessary to establish the optimal choice of anticoagulant in TAVR patients.

Duke Scholars

Author Andrzej Stanislaw Kosinski Biostatistics & Bioinformatics, Division of Biostatistics

Author Sreekanth Vemulapalli Medicine, Cardiology