Key result
LAAC cuts bleeding ~75% vs OAC in post-ablation AF patients with zero HAS-BLED scores.
Why the study?
Concerns exist regarding the safety and necessity of continuing oral anticoagulation after AF catheter ablation, prompting analysis of how baseline bleeding risk affects outcomes with LAAC versus OAC.
Does left atrial appendage closure reduce bleeding or thromboembolic events compared to oral anticoagulation in patients with atrial fibrillation undergoing catheter ablation, stratified by baseline bleeding risk?
RCT (n=1,600)
1:1
Does left atrial appendage closure reduce bleeding or thromboembolic events compared to oral anticoagulation in patients with atrial fibrillation undergoing catheter ablation, stratified by baseline bleeding risk?
Left atrial appendage closure after atrial fibrillation ablation significantly reduces bleeding events compared to continued oral anticoagulation, even in patients with low baseline bleeding risk.
LAAC reduces bleeding versus OAC post-ablation AF even in HAS-BLED 0 patients; extends RCT evidence across bleeding-risk strata.
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.
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Phillips et al. (2026) conducted an RCT in Atrial fibrillation (n=1,600). Left atrial appendage closure vs. Oral anticoagulation was evaluated on Primary safety (bleeding composite) in HAS-BLED score of 0 subgroup (HR 0.25, 95% CI 0.20-0.50). Left atrial appendage closure reduced bleeding events compared to oral anticoagulation in post-ablation AF patients, including those with HAS-BLED scores of 0 (HR 0.25; 95% CI 0.20-0.50).
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