Comparing Major Gastrointestinal Bleeding in Patients Receiving Edoxaban Versus Warfarin After Transcatheter Aortic Valve Replacement: Results From the Randomized ENVISAGE‐TAVI AF Trial

Background Non–vitamin K oral anticoagulants are recommended over vitamin K antagonists in patients with nonvalvular atrial fibrillation (AF). However, the risk of gastrointestinal bleeding may be higher with non–vitamin K oral anticoagulants versus vitamin K antagonists. Patients after successful transcatheter aortic valve replacement (TAVR) who are elderly and frail have worse outcomes with major gastrointestinal bleeding (MGIB), including death. This study evaluated incidence, predictors, and impact of MGIB among patients with AF after successful TAVR. Methods This on‐treatment analysis of ENVISAGE‐TAVI AF (Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation) included patients who received ≥1 dose of the study drug. Demographic, clinical, and procedural characteristics were compared between patients with versus without an MGIB event. Cox multivariable regression analysis identified predictors of MGIB. Results Of 1377 patients in this analysis, 83 (6.0%) experienced MGIB, with 56 (67.5%) of these patients receiving edoxaban. Patients with versus without MGIB were more likely to have undergone percutaneous coronary intervention ≤30 days before TAVR (9.6% versus 4.2%; P =0.03), a higher ejection fraction (mean±SD, 58.0±10.4 versus 55.3±11.5; P =0.04), and carotid artery disease (13.3% versus 6.6%; P =0.04). Edoxaban without dose adjustment versus vitamin K antagonist use ( P =0.003), smoking ( P =0.01), low hemoglobin levels ( P <0.0001), and percutaneous coronary intervention ≤30 days before TAVR ( P =0.01) emerged as predictors of MGIB. Conclusions In this ENVISAGE‐TAVI AF subanalysis, MGIB occurred in 6.0% of patients with prevalent or incident AF undergoing TAVR, and those receiving edoxaban versus vitamin K antagonists had a higher risk of MGIB. A priori identification of risk factors for MGIB may help optimize outcomes for patients with AF undergoing TAVR. Registration URL: https://www.clinicaltrials.gov ; unique identifier: NCT02943785.