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Rationale and design of the ADAPT-TAVR trial: a randomised comparison of edoxaban and dual antiplatelet therapy for prevention of leaflet thrombosis and cerebral embolisation after transcatheter aortic valve replacement

Authors
  • Park, Hanbit1
  • Kang, Do-Yoon1
  • Ahn, Jung-Min1
  • Kim, Kyung Won1, 1
  • Wong, Anthony Y T2
  • Lam, Simon C C2
  • Yin, Wei-Hsian3
  • Wei, Jeng3
  • Lee, Yung-Tsai4
  • Kao, Hsien-Li4
  • Lin, Mao-Shin4
  • Ko, Tsung-Yu5
  • Kim, Won-Jang6
  • Kang, Se Hun6
  • Ko, Euihong1
  • Kim, Dae-Hee1
  • Koo, Hyun Jung1
  • Yang, Dong Hyun1
  • Kang, Joon-Won1
  • Jung, Seung Chai1
  • And 4 more
  • 1 Asan Medical Center, Songpa-gu, Seoul, The Republic of Korea , Songpa-gu
  • 2 Queen Mary Hospital, Pok Fu Lam, Hong Kong , Pok Fu Lam (Hong Kong SAR China)
  • 3 Cheng Hsin General Hospital, Taipei, Taiwan , Taipei
  • 4 National Taiwan University Hospital, Taipei, Taiwan , Taipei
  • 5 Hsin-Chu Branch, National Taiwan University Hospital, Hsin-Chu, Taiwan , Hsin-Chu
  • 6 CHA Bundang Medical Center, Seongnam, Gyeonggi-do, The Republic of Korea , Seongnam
Type
Published Article
Journal
BMJ Open
Publisher
BMJ
Publication Date
Jan 05, 2021
Volume
11
Issue
1
Identifiers
DOI: 10.1136/bmjopen-2020-042587
PMID: 33402409
PMCID: PMC7786793
Source
PubMed Central
Keywords
Disciplines
  • 1506
  • 1683
License
Green

Abstract

Introduction Optimal antithrombotic strategy following transcatheter aortic valve replacement (TAVR) is still unknown. We hypothesised that the direct factor Xa inhibitor edoxaban can potentially prevent subclinical leaflet thrombosis and cerebral embolisation compared with conventional dual antiplatelet therapy (DAPT) in patients undergoing TAVR. Methods and analysis The ADAPT-TAVR trial is an international, multicentre, randomised, open-label, superiority trial comparing edoxaban-based strategy and DAPT strategy in patients without an indication for oral anticoagulation who underwent successful TAVR. A total of 220 patients are randomised (1:1 ratio), 1–7 days after successful TAVR, to receive either edoxaban (60 mg daily or 30 mg daily if patients had dose-reduction criteria) or DAPT using aspirin (100 mg daily) plus clopidogrel (75 mg daily) for 6 months. The primary endpoint was an incidence of leaflet thrombosis on four-dimensional, volume-rendered cardiac CT imaging at 6 months post-TAVR. The key secondary endpoints were the number of new lesions and new lesion volume on brain diffusion-weighted MRI and the changes in neurological and neurocognitive function assessment between immediate post-TAVR and 6 months of study drug administration. Detailed clinical information on thromboembolic and bleeding events were also assessed. Ethics and dissemination Ethic approval has been obtained from the Ethics Committee/Institutional Review Board of Asan Medical Center (approval number: 2017–1317) and this trial is also approved by National Institute of Food and Drug Safety Evaluation of Republic of Korea (approval number: 31511). Results of this study will be disseminated in scientific publication in reputed journals. Trial registration number NCT03284827 .

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