Clin Res Cardiol (2023). https://doi.org/10.1007/s00392-023-02180-w

Incidence and Predictors of Bleeding after Successful Transcatheter Aortic Valve Implantation: An In-Depth Analysis of the ENVISAGE-TAVI AF Trial
G. Dangas1, M. Unverdorben2, C. Hengstenberg3, H. Möllmann4, R. Mehran1, R. Moreno5, L. Nombela-Franco6, T. Kimura7, D. López-Otero8, P. Nordbeck9, Y. Watanabe10, H.-S. Kim11, C. Chen2, S. Saito12, S. Noble13, N. Van Mieghem14
1Mount Sinai Hospital, New York, US; 2Daiichi Sankyo, Inc., Basking Ridge, US; 3Innere Medizin II, Klinische Abteilung für Kardiologie, Allgemeines Krankenhaus der Stadt Wien - Medizinischer Universitätscampus, Wien, AT; 4St. Johannes-Hospital, Dortmund; 5University Hospital La Paz, Madrid, ES; 6Instituto de Investigación Sanitaria San Carlos, Madrid, ES; 7Daiichi Sankyo Co., Ltd., Tokyo, JP; 8Hospital Clínico Universitario Santiago de Compostela, A Coruña, ES; 9Medizinische Klinik und Poliklinik I, Universitätsklinikum Würzburg, Würzburg; 10Teikyo University Hospital, Tokyo, JP; 11Seoul National University Hospital, Seoul, KR; 12Shonan Kamakura General Hospital, Kamakura, JP; 13Hôpitaux Universitaires de Genève, Geneva, CH; 14Erasmus University Medical Center, Rotterdam, NL;

Lifelong oral anticoagulation (OAC) is recommended in patients with atrial fibrillation (AF), including those after trans catheter aortic valve implantation (TAVI). Although OAC is effective in preventing thromboembolic events, it increases the risk of bleeding complications that worsen the prognosis. We sought to determine the incidence and predictors of major and gastrointestinal (GI) bleeding after successful TAVI in patients with AF. ENVISAGE-TAVI AF was a prospective, multicenter, open-label, randomized, controlled trial comparing edoxaban vs. vitamin K antagonists (VKA) in patients with AF who underwent successful TAVI. We used baseline characteristics to determine the independent predictors of major bleeding using a multivariate Cox regression model, including baseline clinical variables. Major bleeding was defined according to the International Society on Thrombosis and Haemostasis definition as clinically overt bleeding associated with a reduced hemoglobin level, blood transfusion, symptomatic bleeding at a critical site, or death. Out of 1,426 randomized patients, major bleeding events occurred in 139 (10.1%) patients and were driven by GI bleeding. Independent predictors of major bleeding included excessive alcohol use, low hemoglobin level, percutaneous coronary intervention performed within 30 days of TAVI, and renal disease (Table 1). In contrast, predictors of GI bleeding included low hemoglobin level, percutaneous coronary intervention performed within 30 days of TAVI, excessive alcohol use, abnormal renal function, smoking, and use of edoxaban without dose adjustment vs. VKA (Table 1). In conclusion, we identified the predictors of major bleeding in patients receiving OAC after successful TAVI. Given the thrombotic risk of each patient, eliminating or reducing these risk factors in addition to adequate selection of OAC therapy may improve outcomes after TAVI.

 

  


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