Percutaneous left atrial appendage closure following catheter ablation therapy of atrial fibrillation: outcomes stratified by bleeding risk - a sub-analysis of the OPTION study.

AIMS: Concerns have been raised over the safety and necessity of continuing oral anticoagulation (OAC) in patients following catheter ablation for atrial fibrillation (AF). OPTION demonstrated the safety and efficacy of left atrial appendage closure (LAAC) in a post-ablation population. We sought to analyse the impact of baseline bleeding risk, per HAS-BLED scores, on the outcomes for patients in a pre-specified sub-analysis.

METHODS AND

RESULTS

Patients with AF and high stroke risk undergoing catheter ablation were randomly assigned to LAAC vs. OAC in OPTION and were stratified by HAS-BLED score: 0, 1, 2, ≥3. OPTION enrolled 1600 patients (CHA2DS2-VASc score: 3.5 ± 1.3; HAS-BLED score: 1.2 ± 0.8); randomized 1:1 to ablation/LAAC or ablation/OAC. Primary effectiveness (all-cause death/stroke/systemic embolism) and safety (bleeding composite) endpoints were directionally similar in HAS-BLED subgroups; both thromboembolic and bleeding event rates were higher in patients with increasing HAS-BLED score. A significant reduction in primary safety bleeding events was noted in favour of LAAC across HAS-BLED subgroups, with more striking reductions noted for lower HAS-BLED scores of 0 (n = 265; hazard ratio: 0.25; 95% confidence interval: 0.20, 0.50) and 1 (n = 890; hazard ratio: 0.41, 95% confidence interval: 0.27-0.61).

CONCLUSION

Regardless of bleeding risk, LAAC is comparable to OAC in stroke protection while demonstrating greater freedom from bleeding in a post-ablation AF population, even in patients with low HAS-BLED scores. The OPTION study highlights an opportunity to mitigate future bleeding risk with a strategy of LAAC after ablation in patients deemed at high risk of stroke according to clinical guidelines.

TRIAL REGISTRATION NUMBER: NCT03795298.