Leaflet Thickening and Motion After Transcatheter Aortic Valve Replacement: Design and Rationale of the Rotterdam Edoxaban Trial

Autor: Maarten P. van Wiechen, Ikram el Azzouzi, Wiebe G. Knol, Rik Adrichem, Thijmen W. Hokken, Joris F. Ooms, Marjo J. de Ronde-Tillmans, Joost Daemen, Peter P. de Jaegere, Alexander Hirsch, Ricardo P.J. Budde, Nicolas M. Van Mieghem
Přispěvatelé: Cardiology, Cardiothoracic Surgery, Radiology & Nuclear Medicine
Rok vydání: 2022
Předmět:
Zdroj: Cardiovascular Revascularization Medicine, 44, 67-70. Elsevier Inc.
ISSN: 1553-8389
Popis: Background: Multislice computed tomography (MSCT) may reveal hypo-attenuated leaflet thickening (HALT) and/or reduced leaflet motion (RELM) in approximately 15 % of patients after transcatheter aortic valve replacement (TAVR). These supposedly thrombogenic phenomena may be associated with neurological events and increased transprosthetic gradients. It is unclear whether oral anticoagulant therapy -specifically a factor Xa inhibitor- could affect the incidence of HALT/RELM. Study design: The Rotterdam EDOXaban (REDOX) trial is an investigator-initiated, single-center, prospective registry in which 100 patients with no formal indication for oral anticoagulant drugs or dual antiplatelet therapy, will receive a 3-month treatment with edoxaban, followed by a MSCT to detect HALT/RELM. The primary endpoint is the incidence of HALT at 3-months follow-up. Secondary endpoints include the incidence of RELM at 3 months; change in transprosthetic gradients at 1 year and the clinical composite endpoint of all-cause death, myocardial infarction (MI), ischemic stroke, systemic thromboembolism, valve thrombosis and major bleeding (International Society on Thrombosis and Hemostasis [ISTH] definition) at 1 year follow up. The study is powered to demonstrate with 90 % statistical power and a 0.025 alpha a 4 % incidence of HALT with edoxaban as compared to the expected 15 % rate with an antiplatelet regimen and will enroll 100 patients to account for loss of follow-up or CT-drop out. Conclusion: The REDOX trial will investigate the short-term effect of an Xa-inhibitor on the incidence of HALT after TAVR. (ClinicalTrials.gov Identifier: NCT04171726).
Databáze: OpenAIRE
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