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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

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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.
Author(s)
강도윤강세훈강준원고의홍구현정김경원김대희김원장박덕우박승정박한빛안정민양동훈윤성철이재홍정승채Anthony Y T WongHsien-Li KaoJeng WeiMao-Shin LinSimon C C LamTsung-Yu KoWei-Hsian YinYung-Tsai Lee
Issued Date
2021
Type
Article
Keyword
15061683adult cardiologyAngioplastyAnticoagulantsAortic Valve - diagnostic imagingAortic Valve - surgeryAortic Valve Stenosis - surgeryAspirin Brain researchCardiac arrhythmiaCardiovascular MedicineClinical outcomes ConsortiaCoronary vesselsCreatinineEmbolismsEmbolizationHeartHumansNonsteroidal anti-inflammatory drugsPatientsPlatelet Aggregation Inhibitors - adverse effectsPreventionProsthesesPyridinesRepublic of KoreaRisk Factors StrokeThiazolesThromboembolismThrombosisThrombosis - prevention & control Transcatheter Aortic Valve Replacement - adverse effectsTreatment Outcomevalvular heart disease
DOI
10.1136/bmjopen-2020-042587
URI
https://oak.ulsan.ac.kr/handle/2021.oak/7200
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_doaj_primary_oai_doaj_org_article_c956e72ab2174242997b045a5d087da5&context=PC&vid=ULSAN&lang=ko_KR&search_scope=default_scope&adaptor=primo_central_multiple_fe&tab=default_tab&query=any,contains,Rationale%20and%20design%20of%20the%20ADAPT-TAVR%20trial:%20a%20randomised%20comparison%20of%20edoxaban%20and%20dual%20antiplatelet%20therapy%20for%20prevention%20of%20leaflet%20thrombosis%20and%20cerebral%20embolisation%20after%20transcatheter%20aortic%20valve%20replacement&offset=0&pcAvailability=true
Publisher
BMJ OPEN
Location
미국
Language
영어
ISSN
2044-6055
Citation Volume
11
Citation Number
1
Citation Start Page
0
Citation End Page
0
Appears in Collections:
Medicine > Medicine
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