Edoxaban vs. Vitamin K Antagonist for Atrial Fibrillation After Transcatheter Aortic Valve Replacement in Japanese Patients - A Subanalysis of the ENVISAGE-TAVI AF Trial

Yusuke Watanabe, Kentaro Hayashida, Masanori Yamamoto, Futoshi Yamanaka, Kazumasa Yamasaki, Toru Naganuma, Yohei Ohno, Masahiro Yamawaki, Nobuyuki Morioka, Kazuki Mizutani, Norio Tada, Hiroshi Ueno, Hidetaka Nishina, Masaki Izumo, Yoshifumi Nakajima, Kenji Ando, Kensuke Takagi, Tetsuya Kimura, Kumiko Sugio, George DangasNicolas M. Van Mieghem, Christian Hengstenberg, Cathy Chen, James Jin, Martin Unverdorben, Shigeru Saito

Research output: Contribution to journalArticleAcademicpeer-review

3 Citations (Scopus)


BACKGROUND: Japanese patients undergoing transcatheter aortic valve replacement (TAVR) are often female and have a small body size, potentially impacting bleeding risk with antithrombotic therapy. Outcomes of direct oral anticoagulant use in these patients with atrial fibrillation (AF) need to be clarified.Methods and Results: This prespecified analysis included Japanese patients from ENVISAGE-TAVI AF, a prospective, randomized, open-label, adjudicator-masked trial that compared treatment with edoxaban and vitamin K antagonists (VKAs) in patients with AF after TAVR. The primary efficacy and safety outcomes were net adverse clinical events (NACE; composite of all-cause death, myocardial infarction, ischemic stroke, systemic embolic event, valve thrombosis, and International Society on Thrombosis and Haemostasis [ISTH]-defined major bleeding) and ISTH-defined major bleeding, respectively. Intention-to-treat (ITT) and on-treatment analyses were performed. Overall, 159 Japanese patients were enrolled (edoxaban group: 82, VKA group: 77) and followed for on average 483 days. Mean patient age was 83.8 years; 52.2% were female. In the ITT analysis, NACE rates were 10.9%/year with edoxaban and 12.5%/year with VKA (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.38-1.90); major bleeding occurred in 8.9%/year and 7.3%/year, respectively (HR, 1.17; 95% CI, 0.45-3.05). In edoxaban- and VKA-treated patients, rates of ischemic stroke were 1.8%/year and 1.0%/year, respectively; fatal bleeding rates were 0.9%/year and 2.0 %/year. On-treatment results were similar to ITT. CONCLUSIONS: In Japanese patients with AF after successful TAVR, edoxaban and VKA treatment have similar safety and efficacy profiles.

Original languageEnglish
Pages (from-to)1756-1763
Number of pages8
JournalCirculation journal : official journal of the Japanese Circulation Society
Issue number11
Publication statusPublished - 25 Oct 2022

Bibliographical note

Funding Information:
The authors thank all the OCEAN-SHD investigators. Medical writing and editorial assistance were provided by Margaret Van Horn, PhD, CMPP, of AlphaBioCom, LLC (King of Prussia, PA, USA), and funded by Daiichi Sankyo, Inc.

Publisher Copyright:
© 2022 Japanese Circulation Society. All rights reserved.


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