Abstract

Abstract Background Data on the comparative safety and effectiveness of direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) undergoing transcatheter aortic valve implantation (TAVI) are sparse. Purpose To examine the risk of thromboembolism, bleeding, and all-cause mortality in patients treated with DOACs versus VKAs. Methods Danish nationwide registries were used to identify all patients undergoing TAVI (2011–2016) with a history of AF and who were treated with oral anticoagulants. The risk of outcomes in patients treated with DOACs versus VKAs were examined by the Aalen-Johansen estimator and cause-specific Cox regression models. Results The study population comprised 762 patients (median age 82 [interquartile range 77–85], 52.9% men), of whom 216 (28.3%) and 546 (71.7%) patients were treated with DOACs and VKAs, respectively. The DOAC group was characterized by a higher prevalence of previous thromboembolism and a lower prevalence of chronic kidney disease compared with the VKA group. The distribution of age, sex, CHA2DS2-VASc and HAS-BLED score, and concomitant antiplatelet therapy was similar between groups. Compared with VKA, treatment with DOACs was not associated with a significantly different 3-year absolute risk of thromboembolism (9.5% [95% confidence interval [CI], 4.7%-16.2%] versus 7.7% [95% CI, 5.3%-10.8%] in the DOAC and VKA group, respectively), bleeding (5.3% [95% CI, 2.4%-10.0%] versus 6.3% [95% CI, 4.1%-9.0%]), and all-cause mortality (32.6% [95% CI, 21.9%-43.7%] versus 33.3% [95% CI, 28.3%-38.5%]). In adjusted analyses, treatment with DOACs, as compared with VKA treatment, was not associated with a significantly different risk of thromboembolism (hazard ratio [HR], 1.25 [95% CI, 0.61–2.57]), bleeding (HR, 1.22 [95% CI, 0.54–2.75]), and all-cause mortality (HR, 0.90 [95% CI, 0.60–1.35]). Conclusions In patients with atrial fibrillation undergoing TAVI, treatment with DOACs was not associated with a significantly different risk of thromboembolism, bleeding, and all-cause mortality compared with treatment with VKA. Acknowledgement/Funding None

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