AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation

Summary

ACASA-TAVI is a pragmatic randomized controlled trial assessing the value of anticoagulation therapy versus the standard antiplatelet therapy after transcatheter aortic valve implantation in patients with aortic stenosis. The trial will assess the efficacy of direct oral anticoagulation (DOAC) therapy compared to the standard single antiplatelet therapy to prevent degeneration of the valve and its safety in co-primary endpoints with blinded endpoint adjudication. The effect of DOAC therapy on hard clinical outcomes will be assessed during long-term follow-up.

Timeline

Start

2021-12-04

Primary completion

2026-06-05

Completion

2026-06-05

Publications

• Background VARC-3 WRITING COMMITTEE; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J. 2021 May 14;42(19):1825-1857. doi: 10.1093/eurheartj/ehaa799.
• Dodgson CS, Beitnes JO, Klove SF, Herstad J, Opdahl A, Undseth R, Eek CH, Broch K, Gullestad L, Aaberge L, Lunde K, Bendz B, Lie OH. An investigator-sponsored pragmatic randomized controlled trial of AntiCoagulation vs AcetylSalicylic Acid after Transcatheter Aortic Valve Implantation: Rationale and design of ACASA-TAVI. Am Heart J. 2023 Nov;265:225-232. doi: 10.1016/j.ahj.2023.08.010. Epub 2023 Aug 25.

Drugs

Indications