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Edoxaban Versus Dual Antiplatelet Therapy for Leaflet Thrombosis and Cerebral Thromboembolism After TAVR: The ADAPT-TAVR Randomized Clinical Trial

Authors :
Duk-Woo, Park
Jung-Min, Ahn
Do-Yoon, Kang
Kyung Won, Kim
Hyun Jung, Koo
Dong Hyun, Yang
Seung Chai, Jung
Byungjun, Kim
Yiu Tung Anthony, Wong
Cheung Chi Simon, Lam
Wei-Hsian, Yin
Jeng, Wei
Yung-Tsai, Lee
Hsien-Li, Kao
Mao-Shin, Lin
Tsung-Yu, Ko
Won-Jang, Kim
Se Hun, Kang
Sung-Cheol, Yun
Seung-Ah, Lee
Euihong, Ko
Hanbit, Park
Dae-Hee, Kim
Joon-Won, Kang
Jae-Hong, Lee
Seung-Jung, Park
Source :
Circulation. 146:466-479
Publication Year :
2022
Publisher :
Ovid Technologies (Wolters Kluwer Health), 2022.

Abstract

Background: It is unknown whether the direct oral anticoagulant edoxaban can reduce leaflet thrombosis and the accompanying cerebral thromboembolic risk after transcatheter aortic valve replacement. In addition, the causal relationship of subclinical leaflet thrombosis with cerebral thromboembolism and neurological or neurocognitive dysfunction remains unclear. Methods: We conducted a multicenter, open-label randomized trial comparing edoxaban with dual antiplatelet therapy (aspirin plus clopidogrel) in patients who had undergone successful transcatheter aortic valve replacement and did not have an indication for anticoagulation. The primary end point was an incidence of leaflet thrombosis on 4-dimensional computed tomography at 6 months. Key secondary end points were the number and volume of new cerebral lesions on brain magnetic resonance imaging and the serial changes of neurological and neurocognitive function between 6 months and immediately after transcatheter aortic valve replacement. Results: A total of 229 patients were included in the final intention-to-treat population. There was a trend toward a lower incidence of leaflet thrombosis in the edoxaban group compared with the dual antiplatelet therapy group (9.8% versus 18.4%; absolute difference, −8.5% [95% CI, −17.8% to 0.8%]; P =0.076). The percentage of patients with new cerebral lesions on brain magnetic resonance imaging (edoxaban versus dual antiplatelet therapy, 25.0% versus 20.2%; difference, 4.8%; 95% CI, −6.4% to 16.0%) and median total new lesion number and volume were not different between the 2 groups. In addition, the percentages of patients with worsening of neurological and neurocognitive function were not different between the groups. The incidence of any or major bleeding events was not different between the 2 groups. We found no significant association between the presence or extent of leaflet thrombosis with new cerebral lesions and a change of neurological or neurocognitive function. Conclusions: In patients without an indication for long-term anticoagulation after successful transcatheter aortic valve replacement, the incidence of leaflet thrombosis was numerically lower with edoxaban than with dual antiplatelet therapy, but this was not statistically significant. The effects on new cerebral thromboembolism and neurological or neurocognitive function were also not different between the 2 groups. Because the study was underpowered, the results should be considered hypothesis generating, highlighting the need for further research. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03284827.

Details

ISSN :
15244539 and 00097322
Volume :
146
Database :
OpenAIRE
Journal :
Circulation
Accession number :
edsair.doi.dedup.....6374312e723a7bfcf5ce2e845f386e63