Rationale for Early Discontinuation of Aspirin After Transcatheter Aortic Valve Implantation: Design of the SOLOTAVI Randomized Trial

Trans-aortic valve implantation (TAVI) has become the first line treatment of aortic stenosis, a condition predominantly affecting elderly patients. In absence of a specific indication for antithrombotic therapy, lifetime aspirin is recommended after TAVI while it may be discontinued 3 months after bioprosthetic surgical valve replacement. Primary prevention, using aspirin compared to placebo among elderly patients is associated with an increased risk of major bleeding and no reduction rates of thrombotic events. Hence, there is a gap of knowledge on whether aspirin should be continued >3 months after TAVI. SOLOTAVI is a multicenter, open label, blinded endpoint assessment, 1:1 randomized, non-inferiority trial comparing aspirin discontinuation 3 months after TAVI (experimental) to long-term therapy (control). Adult patients with successful transfemoral TAVI for symptomatic aortic stenosis and no indication or contraindication for long-term antithrombotic therapy will be enrolled. Randomization is stratified on center and valve type. The primary endpoint is the 12-month composite of all cause death, myocardial infarction, stroke, and non-procedure-related major or disabling bleeding. A hierarchical analysis is performed for the primary and 3 principal secondary endpoints. The sample size is computed for demonstrating the non-inferiority of the experimental strategy compared with the control strategy, with a conservative non-inferiority margin of 6.5%. A total of 1400 patients will be enrolled. The SOLOTAVI trial will assess the non-inferiority of a 3-month duration of aspirin compared to the long-term therapy after successful transfemoral TAVI in terms of thrombotic and bleeding events. NCT06518317 clinicaltrials.org.