Short Versus Long Antiplatelet Therapy After TAVI

INTRODUCTION AND RATIONALE Aortic stenosis (AS) is the most common heart valve disease requiring intervention among elderly patients. Surgical aortic valve replacement which was the only curative treatment of AS has been challenged during the past decade by the trans-aortic valve implantation (TAVI) which is becoming the first line treatment of such condition. Antithrombotic therapy after TAVI remains a matter of debate. In patients with no indication for antiplatelet therapy, aspirin alone is recommended for lifetime. However, after bioprosthetic surgical valve replacement, aspirin is to be discontinued 3 months after surgery and there is no evidence that it should be continued in patients after TAVI with no other indication for such therapy (more than half of low risk and a third of intermediate risk TAVI patients). Aspirin as compared to placebo in the setting of primary prevention is associated with a 38% relative risk increase of major bleeding in elderly patients with no benefit in terms of mortality or cardiovascular events. Hence there is a major gap of knowledge on whether aspirin is beneficial or harmful if continued more than 3 months as recommended after successful TAVI in absence of another indication, as most such patients are elderly and at high bleeding risk. STUDY POPULATION Adult patients with successful transfemoral TAVI for symptomatic aortic stenosis with no indication for long term antiplatelet or anticoagulant therapy. This represents approximately 30% of the TAVI patient population. STUDY DESIGN Multicenter, open label, blinded endpoint assessment, randomized non-inferiority trial nested in an ongoing prospective nationwide registry RANDOMIZATION All potentially eligible patients will be included after successful TAVI at hospital discharge to be randomized to receive the experimental or control strategy. Randomization will be performed at hospital discharge (visit 0) after revision of inclusion/exclusion criteria. Randomization will be stratified by center and type of valve (balloon expandable or self-expandable). A hierarchical test procedure will be used for the analysis of the endpoints. A hierarchical test procedure will be used for the analysis of the primary and principal secondary endpoints. EXPERIMENTAL ARM Single antiplatelet therapy 75 to 100 mg aspirin for 3 months after TAVI followed by aspirin discontinuation CONTROL ARM Long term (lifetime) single antiplatelet therapy75 to 100 mg aspirin therapy after TAVI PRIMARY END POINT Net clinical benefit defined by the composite of all cause death, myocardial infarction, ischemic or hemorrhagic stroke and major or disabling bleeding assessed at 12 months follow-up NUMBER OF PATIENTS TO BE INCLUDED 1400 (700 in each group)