Single Versus Dual Antiplatelet Therapy Following TAVR: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Transcatheter aortic valve replacement (TAVR) has known a considerable expansion worldwide in the last decade for the treatment of severe and symptomatic aortic valve stenosis. Patients undergoing TAVR are at high risk of ischemic and bleeding events strongly correlated with mortality. The required antithrombotic treatment following the bioprosthestic device implantation remains an unsolved issue with current international guidelines being based on expert consensus without robust evidence-based data. Dual antiplatelet therapy (DAPT) with low-dose aspirin and clopidogrel for up to 6 months is currently recommended in patients with no indication for chronic oral anticoagulation, although associated with a significant incremental risk of bleeding complications and bringing no significant reduction of ischemic events. In accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analysis) guidelines, we performed a PROSPERO-registered (CRD42020168886) systematic review of the literature including any randomized controlled trials (RCTs) comparing single antiplatelet therapy (SAPT) with DAPT in patients undergoing TAVR, with no indication for chronic oral anticoagulation.

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A sensitivity analysis excluding the largest trial (i.e., POPular TAVI cohort A) provided consistent results regarding each safety and efficacy endpoint and the composite endpoint. The present findings are subject to the inherent limitations of the included RCTs, including open-label design and discrepancies in the delay for initiation and duration of clopidogrel and events ascertainment. In conclusion, the present updated meta-analysis suggests that, following TAVR in patients without an indication for chronic oral anticoagulation, SAPT compared with DAPT is associated with a significant reduction of bleeding complications without a significant offset regarding ischemic events. Of note, the ongoing Anti-thrombotic Strategy After trans-aortic Valve Implantation for Aortic Stenosis (ATLANTIS - NCT02664649) trial will evaluate the use of apixaban compared with SAPT or DAPT in this population.