Comparison of left atrial appendage closure and oral anticoagulation after catheter ablation for atrial fibrillation: concomitant and sequential cohorts of the OPTION randomized controlled trial

Abstract Introduction/Objectives Guidelines recommend continuation of anticoagulation following atrial fibrillation (AF) ablation in patients at high risk for stroke. Left atrial appendage closure (LAAC) has not been well-studied for routine use post ablation. LAAC can be performed in separate procedures with cardiac ablation (sequentially) or concomitantly in the same operative session. In this prespecified subanalysis of the OPTION trial, timing of ablation relative to LAAC will be evaluated. Methods OPTION is a multicenter, prospective randomized clinical trial. Patients with AF and an elevated CHA2DS2-VASc score undergoing catheter ablation were randomly assigned (1:1) to catheter-based LAAC versus oral anticoagulation. Patients underwent an AF catheter ablation procedure between 90 and 180 days prior to randomization (sequential) or were planning to have catheter ablation within 10 days of randomization (concomitant). The primary safety endpoint was non-procedural major or clinically-relevant non-major bleeding. The primary efficacy endpoint was the composite of all-cause death, stroke, or systemic embolism at 36 months. The secondary endpoint was major bleeding through 36 months, including procedural bleeding. Results A total of 1600 patients with a mean age (±SD) of 70±8 years, and a CHA2DS2-VASc score of 3.5±1.3 were randomized to anticoagulation. LAAC (n=803) was performed concomitantly with (n=328; 41%) or sequentially after (n=475; 59%) AF ablation. In the control arm (n=797), AF ablation was concomitant with randomization in 41% of patients (n=326) or sequential in 59% (n=471). Generally, patients in the sequential cohort had more clinical comorbidities. Clinical outcomes at 3 years will be available at the time of the presentation. Conclusions This subanalysis of OPTION will examine whether LAAC is a reasonable alternative to contemporary OAC after sequential or concomitant AF ablation in patients currently guideline recommended to stay on oral anticoagulation.