Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR
Por:
Van Mieghem, NM, Unverdorben, M, Hengstenberg, C, Mollmann, H, Mehran, R, Lopez-Otero, D, Nombela-Franco, L, Moreno, R, Nordbeck, P, Thiele, H, Lang, IE, Zamorano, JL, Shawl, F, Yamamoto, M, Watanabe, Y, Hayashida, K, Hambrecht, R, Meincke, F, Vranckx, P, Jin, JM, Boersma, E, Rodes-Cabau, J, Ohlmann, P, Capranzano, P, Kim, HS, Pilgrim, T, Anderson, R, Baber, U, Duggal, A, Laeis, P, Lanz, H, Chen, C, Valgimigli, M, Veltkamp, R, Saito, S, Dangas, GD, Asmarats L., ENVISAGE TAVI AF Investigators
Publicada:
2 dic 2021
Ahead of Print:
1 ago 2021
Resumen:
Background The role of direct oral anticoagulants as compared with vitamin K antagonists for atrial fibrillation after successful transcatheter aortic-valve replacement (TAVR) has not been well studied. Methods We conducted a multicenter, prospective, randomized, open-label, adjudicator-masked trial comparing edoxaban with vitamin K antagonists in patients with prevalent or incident atrial fibrillation as the indication for oral anticoagulation after successful TAVR. The primary efficacy outcome was a composite of adverse events consisting of death from any cause, myocardial infarction, ischemic stroke, systemic thromboembolism, valve thrombosis, or major bleeding. The primary safety outcome was major bleeding. On the basis of a hierarchical testing plan, the primary efficacy and safety outcomes were tested sequentially for noninferiority, with noninferiority of edoxaban established if the upper boundary of the 95% confidence interval for the hazard ratio did not exceed 1.38. Superiority testing of edoxaban for efficacy would follow if noninferiority and superiority were established for major bleeding. Results A total of 1426 patients were enrolled (713 in each group). The mean age of the patients was 82.1 years, and 47.5% of the patients were women. Almost all the patients had atrial fibrillation before TAVR. The rate of the composite primary efficacy outcome was 17.3 per 100 person-years in the edoxaban group and 16.5 per 100 person-years in the vitamin K antagonist group (hazard ratio, 1.05; 95% confidence interval [CI], 0.85 to 1.31; P=0.01 for noninferiority). Rates of major bleeding were 9.7 per 100 person-years and 7.0 per 100 person-years, respectively (hazard ratio, 1.40; 95% CI, 1.03 to 1.91; P=0.93 for noninferiority); the difference between groups was mainly due to more gastrointestinal bleeding with edoxaban. Rates of death from any cause or stroke were 10.0 per 100 person-years in the edoxaban group and 11.7 per 100 person-years in the vitamin K antagonist group (hazard ratio, 0.85; 95% CI, 0.66 to 1.11). Conclusions In patients with mainly prevalent atrial fibrillation who underwent successful TAVR, edoxaban was noninferior to vitamin K antagonists as determined by a hazard ratio margin of 38% for a composite primary outcome of adverse clinical events. The incidence of major bleeding was higher with edoxaban than with vitamin K antagonists. (Funded by Daiichi Sankyo; ENVISAGE-TAVI AF ClinicalTrials.gov number, .)
Edoxaban for Atrial Fibrillation with TAVR In a randomized trial involving patients who had atrial fibrillation after TAVR, edoxaban was noninferior to vitamin K antagonists with respect to a composite outcome of death, MI, stroke, thromboembolism, valve thrombosis, or major bleeding but was associated with a higher incidence of major bleeding.
Filiaciones:
Van Mieghem, NM:
Erasmus Univ, Dept Cardiol, Thoraxctr, Med Ctr, Rotterdam, Netherlands
Unverdorben, M:
Daiichi Sankyo, Basking Ridge, NJ USA
Hengstenberg, C:
Med Univ, Vienna Gen Hosp, Div Cardiol, Dept Internal Med 2, Vienna, Austria
Mollmann, H:
St Jo hannes Hosp, Dept Internal Med, Dortmund, Germany
Mehran, R:
Univ Hosp Heidelberg, Dept Neurol, Heidelberg, Germany
Lopez-Otero, D:
Mt Sinai Hosp, Zena & Michael Wiener Cardio Vasc Inst, New York, NY USA
Nombela-Franco, L:
Hosp Clin Univ Santiago Compostela, Dept Cardiol, Ctr Invest Biomed Red Enfermedades Car, Santiago De Compostela, Spain
Moreno, R:
Hosp Clin San Carlos, Cardiovasc Inst, Inst Invest Sanitaria San Carlos, Santiago De Compostela, Spain
Nordbeck, P:
Univ Hosp Wurzburg, Dept Internal Med, Wurzburg, Germany
Thiele, H:
Univ Leipzig, Dept Internal Med Cardiol, Heart Ctr Leipzig, Leipzig, Germany
Lang, IE:
Med Univ, Vienna Gen Hosp, Div Cardiol, Dept Internal Med 2, Vienna, Austria
Zamorano, JL:
Univ Hosp Paz, Dept Cardiol, La Paz, Mexico
Shawl, F:
Univ Hosp Ramon y Cajal, Dept Cardiol, Madrid, Spain
Yamamoto, M:
Washington Adventist Hosp, Dept Cardiol, Takoma Pk, Washington, DC USA
Watanabe, Y:
Toyohashi Heart Ctr, Dept Cardiol, Toyohashi, Aichi, Japan
Hayashida, K:
Teikyo Univ, Dept Cardiol, Sch Med, Tokyo, Japan
Hambrecht, R:
Bremer Inst Heart & Circulat Res, Klin Links Weser, Bremen, Germany
Vranckx, P:
Shonan Kamakura Gen Hosp, Div Cardiol & Catheterizat Labs, Kamakura, Kanagawa, Japan
Jin, JM:
Daiichi Sankyo, Basking Ridge, NJ USA
Boersma, E:
Erasmus Univ, Dept Cardiol, Thoraxctr, Med Ctr, Rotterdam, Netherlands
Rodes-Cabau, J:
Jessa Hosp, Dept Cardiol, Hasselt, Belgium
Ohlmann, P:
Laval Univ, Quebec Heart & Lung Inst, Quebec City, PQ, Canada
Capranzano, P:
Univ Hosp Strasbourg, Div Cardiovasc Med, Strasbourg, France
Univ Catania, Div Cardiol, Policlin Hosp, Catania, Italy
Kim, HS:
Seoul Natl Univ Hosp, Dept Internal Med, Cardiovasc Ctr, Seoul, South Korea
Pilgrim, T:
Univ Bern, Dept Cardiol, Bern, Switzerland
Anderson, R:
Univ Hosp Wales, Dept Cardiol, Cardiff, Wales
Baber, U:
Univ Oklahoma Hlth Sci Ctr, Cardiol Sect, Oklahoma City, OK USA
Duggal, A:
Daiichi Sankyo, Basking Ridge, NJ USA
Laeis, P:
Asklepios Klin St Georg, Dept Cardiol, Hamburg, Germany
Lanz, H:
Asklepios Klin St Georg, Dept Cardiol, Hamburg, Germany
Chen, C:
Daiichi Sankyo, Basking Ridge, NJ USA
Valgimigli, M:
Univ Italian Switzerland, Cardioctr Ticino Inst, Dept Biomed Sci, Lugano, Switzerland
Veltkamp, R:
Daiichi Sankyo Europe, Munich, Germany
Alfried Krupp Hosp, Dept Neurol, Essen, Germany
Imperial Coll London, Div Brain Sci, London, England
Saito, S:
Keio Univ, Dept Cardiol, Sch Med, Tokyo, Japan
Dangas, GD:
Univ Hosp Heidelberg, Dept Neurol, Heidelberg, Germany
Natl & Kapodistrian Univ Athens, Sch Med, Athens, Greece
Asmarats L.:
Institut d’Investigació Biomèdica Sant Pau (IIB SANT PAU), Sant Quintí 77-79, 08041 Barcelona, Spain
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