ACASA-TAVI
AntiCoagulation versus AcetylSalicylic Acid after Transcatheter Aortic Valve Implantation
Patient / Population Intervention / Exposition Vergleich Endpunkt
In 360 patients after TAVI without an indication for anticoagulation, 12 months of a factor Xa inhibitor was compared with aspirin on leaflet thrombosis on CT and a safety composite at 12 months.
N
360
Design
investigator-sponsored, pragmatic, multicentre (Oslo and Bergen, Norway), prospective randomised open-label blinded-endpoint (PROBE) all-comers trial; 1:1 anti-factor Xa DOAC monotherapy vs aspirin; co-primary endpoints at 12 months; long-term follow-up to 5 and 10 years
Endpunkt
co-primary: (1) incidence of hypo-attenuated leaflet thickening (HALT) on 4-dimensional cardiac CT at 12 months; (2) safety composite of VARC-3 bleeding, thromboembolic events (myocardial infarction, stroke) and all-cause death at 12 months