Outcomes of left atrial appendage closure vs oral anticoagulation after catheter ablation among patients with higher and lower stroke risk: A subanalysis of the OPTION clinical trial

Background: The OPTION trial demonstrated that, after atrial fibrillation ablation, left atrial appendage closure (LAAC) reduced nonprocedural bleeding and was noninferior to oral anticoagulation (OAC) with respect to death, stroke, or systemic embolism. Objective: This study aimed to evaluate event rates in relation to patients' baseline stroke risk. Methods: The primary safety endpoint was nonprocedural major or clinically relevant nonmajor bleeding, and the primary efficacy endpoint was a composite of death, stroke, or systemic embolism, measured at 3 years. Patients were stratified based on a CHA2DS2-VASc score of ≥4 vs ≤3. Results: The trial enrolled 1600 patients aged 70 ± 8 years, with 738 and 862 patients having CHA2DS2-VASc scores of ≥4 and ≤3, respectively. The primary efficacy outcome was similar for the OAC and LAAC arms both among patients with a CHA2DS2-VASc score of ≥4 (9.4% vs 7.8%; P = .37) and those with a CHA2DS2-VASc score of ≤3 (2.7% vs 3.3%; P = .59). Patients with a CHA2DS2-VASc score of ≤3 had an annual risk of ischemic stroke of 0.3% with LAAC and 0.1% with OAC (P = .19). Bleeding was more frequent with OAC for CHA2DS2-VASc scores of ≥4 (18.4% vs 11.5%; P < .01) and ≤3 (17.9% vs 6.0%; P < .01). Conclusion: After ablation of atrial fibrillation, the rates of cardiovascular events are low among individuals with a CHA2DS2-VASc score of ≤3 who were treated with either LAAC or OAC, and their annual risk of ischemic stroke is ≤0.3% with either treatment. Bleeding risk with OAC is similar for patients with high and low CHA2DS2-VASc and significantly lower with LAAC for both groups.