Trial reportJournal of the American Heart Association2025
Comparing Major Gastrointestinal Bleeding in Patients Receiving Edoxaban Versus Warfarin After Transcatheter Aortic Valve Replacement: Results From the Randomized ENVISAGE-TAVI AF Trial.
Trial report in Journal of the American Heart Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02943785 (Edoxaban Versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Edoxaban Versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation (TAVI) - in Atrial Fibrillation
Who cites it
1 citing paper in PubMed.
- Thrombotic Versus Bleeding Risk After Transcatheter Aortic Valve Implantation.Journal of clinical medicine · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNon-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.
methodsThis 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.
resultsOf 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%;
conclusionsIn 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.
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