Dataset Information

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.

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.

SUBMITTER: Park H

PROVIDER: S-EPMC7786793 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

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.

Park Hanbit H Kang Do-Yoon DY Ahn Jung-Min JM Kim Kyung Won KW Wong Anthony Y T AYT Lam Simon C C SCC Yin Wei-Hsian WH Wei Jeng J Lee Yung-Tsai YT Kao Hsien-Li HL Lin Mao-Shin MS Ko Tsung-Yu TY Kim Won-Jang WJ Kang Se Hun SH Ko Euihong E Kim Dae-Hee DH Koo Hyun Jung HJ Yang Dong Hyun DH Kang Joon-Won JW Jung Seung Chai SC Lee Jae-Hong JH Yun Sung-Cheol SC Park Seung-Jung SJ Park Duk-Woo DW

BMJ open 20210105 1

<h4>Introduction</h4>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.<h4>Methods and analysis</h4>The ADAPT-TAVR trial is an international, multicentre, randomised, open-label, superiority trial comparing edoxaba ...[more]

PMID: 33402409

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Project description:Transcatheter mitral valve replacement (TMVR) is currently being investigated as a procedural alternative to surgical mitral valve repair or replacement (SMVR). Early data from first-in-man trials with current devices suggest that TMVR is technically feasible but carries a high mortality. This is substantially different from the early success transcatheter aortic valve replacement (TAVR) has seen and is related to complexities of the mitral valve anatomy, differences in pathology that require mitral valve replacement as well as the impact that mitral valve replacement has on physiology and cardiac function, irrespective of the modality by which the mitral valve is replaced. Importantly, in the case of TAVR, a less invasive method is offered to accomplish the same as the traditional surgical intervention. On the other hand, valve replacement is not the recommended treatment option for the majority of mitral valve disease, and in fact is avoided whenever possible during surgery given the shortened life expectancy and increased morbidity with mitral valve replacement. Another distinction between TAVR and TMVR is the etiology and natural progression of the underlying disease and driving factors for intervention that are vastly different between aortic and mitral valve disease. The primary aortic disease treated has been aortic stenosis, which has several etiologic factors that cause a similar physiologic dysfunction and risk. Aortic valve replacement leads to improved survival and quality of life. The primary mitral valve disease targeted is regurgitation, which occurs as a primary valve defect and as a secondary consequence of ventricular dysfunction. Primary mitral regurgitation is treated by valve repair with excellent long-term outcomes. Secondary regurgitation has poor long-term outcomes with current commonly used repair techniques and limited data exists showing that correction of the regurgitation improves survival. Adoption of TMVR will require overcoming the anatomic challenges as well as generating data that supports improved survival and/or quality of life.

Dataset Information

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.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

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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