Percutaneous left atrial appendage closure following catheter ablation therapy of atrial fibrillation: outcomes stratified by bleeding risk - a sub-analysis of the OPTION study.
Phillips K, Nair D, et al. • Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology • 2026
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.
Key Findings
Results
LAAC demonstrated a significant reduction in primary safety bleeding events compared to OAC across all HAS-BLED subgroups in post-ablation AF patients.
Reductions in bleeding events were observed across all HAS-BLED score subgroups (0, 1, 2, ≥3)
For HAS-BLED score of 0 (n=265): hazard ratio 0.25, 95% CI: 0.20–0.50
For HAS-BLED score of 1 (n=890): hazard ratio 0.41, 95% CI: 0.27–0.61
More striking reductions in bleeding were noted for lower HAS-BLED scores of 0 and 1
Results
Primary effectiveness outcomes (all-cause death, stroke, systemic embolism) were directionally similar between LAAC and OAC across all HAS-BLED subgroups.
LAAC was comparable to OAC in stroke protection regardless of baseline bleeding risk
Both thromboembolic and bleeding event rates were higher in patients with increasing HAS-BLED score
The primary effectiveness endpoint included all-cause death, stroke, and systemic embolism
Results were consistent across HAS-BLED subgroups: 0, 1, 2, and ≥3
Methods
The OPTION trial enrolled 1600 patients with AF and high stroke risk undergoing catheter ablation, randomized 1:1 to ablation/LAAC or ablation/OAC.
Total enrollment: 1600 patients
Mean CHA2DS2-VASc score: 3.5 ± 1.3
Mean HAS-BLED score: 1.2 ± 0.8
Patients were randomized 1:1 to ablation/LAAC or ablation/OAC
Stratification was by HAS-BLED score categories: 0, 1, 2, and ≥3
Results
Both thromboembolic and bleeding event rates increased with higher HAS-BLED scores in the study population.
This pattern was observed across all four HAS-BLED subgroups (0, 1, 2, ≥3)
The finding confirms HAS-BLED score as a predictor of both bleeding and thromboembolic risk in this population
The trend was consistent in both the LAAC and OAC treatment arms
Discussion
LAAC after catheter ablation presents an opportunity to mitigate future bleeding risk even in patients with low baseline bleeding risk scores.
The bleeding benefit of LAAC was present even in patients with HAS-BLED scores of 0 and 1, who are typically considered low bleeding risk
The largest HAS-BLED subgroup was score of 1 (n=890), which showed a hazard ratio of 0.41 for bleeding
This sub-analysis was pre-specified within the OPTION study (NCT03795298)
Authors conclude LAAC highlights 'an opportunity to mitigate future bleeding risk' in guideline-defined high stroke risk patients
What This Means
This research examined whether a small device implanted in the heart (left atrial appendage closure, or LAAC) might be better than blood thinners (oral anticoagulation, OAC) for preventing strokes after a heart rhythm procedure called catheter ablation in patients with atrial fibrillation (AF). The study analyzed data from 1,600 patients in the OPTION trial, grouping them by their bleeding risk level using a standard scoring tool called HAS-BLED. Patients were randomly assigned to receive either LAAC or continue on blood thinners after their ablation procedure.
The study found that LAAC was just as effective as blood thinners at preventing strokes and other clot-related events, regardless of patients' baseline bleeding risk. More notably, LAAC led to significantly fewer bleeding events across all risk groups, including patients who were considered low bleeding risk (HAS-BLED scores of 0 and 1). The reduction in bleeding was particularly pronounced in these lower-risk groups, with patients at the lowest risk (score of 0) showing a 75% lower hazard of bleeding with LAAC compared to blood thinners.
This research suggests that LAAC after catheter ablation may offer a meaningful way to reduce the long-term burden of bleeding associated with blood thinners, even in patients who are not typically considered high bleeding risk. These findings may be relevant for clinicians and patients considering how to manage stroke prevention after AF ablation, particularly since the bleeding benefit appeared across the full spectrum of bleeding risk profiles studied.
Phillips K, Nair D, Boersma L, Doshi R, Healey J, Jaber W, et al.. (2026). Percutaneous left atrial appendage closure following catheter ablation therapy of atrial fibrillation: outcomes stratified by bleeding risk - a sub-analysis of the OPTION study.. Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology. https://doi.org/10.1093/europace/euag093