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Title: | Edoxaban Versus standard of care and their effects on clinical outcomes in patients having undergone Transcatheter Aortic Valve Implantation in Atrial Fibrillation-Rationale and design of the ENVISAGE-TAVI AF trial | Authors: | Van Mieghem, Nicolas M. Unverdorben, Martin Valgimigli, Marco Mehran, Roxana Boersma, Eric Baber, Usinan Hengstenberg, Christian Shi, Minggao Chen, Cathy Saito, Shigeru Veltkamp, Roland VRANCKX, Pascal Dangas, George D. |
Issue Date: | 2018 | Publisher: | MOSBY-ELSEVIER | Source: | AMERICAN HEART JOURNAL, 205, p. 63-69 | Abstract: | Transcatheter aortic valve implantation, also called transcatheter aortic valve replacement (TAVR), is the treatment of choice for patients with severe aortic stenosis and intermediate to high operative risk. A significant portion of TAVR patients have atrial fibrillation (AF) requiring chronic oral anticoagulation. In moderate-to high-risk AF patients, the direct factor Xa inhibitor edoxaban is noninferior to vitamin K antagonists (VKAs) for prevention of stroke or systemic embolism with less bleeding and cardiovascular deaths. ENVISAGE-TAVI AF (NCT02943785) is a multinational, multicenter, prospective, randomized, openlabel, blinded end point evaluation study comparing edoxaban to VKA-based therapy in approximately 1,400 patients with an indication for chronic oral anticoagulation after successful transfemoral TAVR. The coprimary end points are to assess the differential effects of the 2 treatments (a) on net adverse clinical events (the composite of all-cause death, myocardial infarction, ischemic stroke, systemic thromboembolism, valve thrombosis, and major bleeding events) and (b) on major bleeding. Twelve hours to 5 days after successful TAVR, patients will be randomized to 60 mg daily oral edoxaban or any VKA (international normalized ratio: 2.0-3.0 or 1.6-2.6 [numbers inclusive] in Japan if age >= 70 years). Antiplatelet therapy may be administered per physician's discretion. Randomization will be stratified by edoxaban dose reduction (per local label). Treatment duration will be up to 36 months. The study is powered (80%) to detect noninferiority (margin for the hazard ratio: 1.38) for the composite primary end points, followed by superiority testing. | Notes: | [Van Mieghem, Nicolas M.] Erasmus MC, Dept Cardiol, Thoraxctr, Rotterdam, Netherlands. [Unverdorben, Martin; Chen, Cathy] Daiichi Sankyo Inc, Global Med Affairs, Basking Ridge, NJ USA. [Valgimigli, Marco] Inselspital Bern, Swiss Cardiovasc Ctr, Bern, Switzerland. [Mehran, Roxana; Baber, Usinan; Dangas, George D.] Mt Sinai Hosp, Zena & Michael A Wiener Cardiovasc Inst, New York, NY 10029 USA. [Boersma, Eric; Hengstenberg, Christian] Med Univ Vienna, Dept Internal Med 2, Div Cardiol, Vienna, Austria. [Shi, Minggao] Daiichi Sankyo Pharma Dev, Biostat, Basking Ridge, NJ USA. [Saito, Shigeru] Shonan Kamakura Gen Hosp, Dept Cardiovasc Med, Kanagawa, Japan. [Veltkamp, Roland] Imperial Coll, London, England. [Veltkamp, Roland] Afried Krupp Krankenhaus, Dept Neurol, Essen, Germany. [Vranckx, Pascal] Hartctr Hasselt, Hasselt, Belgium. | Keywords: | Cardiac & Cardiovascular Systems | Document URI: | http://hdl.handle.net/1942/28840 | ISSN: | 0002-8703 | e-ISSN: | 1097-6744 | DOI: | 10.1016/j.ahj.2018.07.006 | ISI #: | 000451727200007 | Rights: | 2018 Published by Elsevier Inc. | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
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