OPTION LAAC
(2025)Objective
Does left atrial appendage closure (LAAC) after atrial fibrillation (AF) ablation reduce bleeding risk compared to long-term oral anticoagulation, while maintaining comparable efficacy
Study Summary
Intervention
Catheter-based left atrial appendage closure (WATCHMAN FLX device) vs. continued oral anticoagulation following AF ablation.
Inclusion Criteria
Patients with AF undergoing ablation and CHA₂DS₂-VASc ≥2 (men) or ≥3 (women), randomized within 90–180 days after or up to 10 days before ablation. Excluded if LVEF ≤30%.
Study Design
Arms: Left Atrial Appendage Closure vs. Oral Anticoagulation
Patients per Arm: LAAC: 803, Anticoagulation: 797
Outcome
Bottom Line
Among patients who underwent catheter-based atrial fibrillation ablation, left atrial appendage closure was associated with a lower risk of non-procedure-related major or clinically relevant nonmajor bleeding than oral anticoagulation and was noninferior to oral anticoagulation with respect to a composite of death from any cause, stroke, or systemic embolism at 36 months.
Major Points
- The OPTION trial was an international randomized trial involving 1600 patients with atrial fibrillation who had an elevated CHA2DS2-VASc score and underwent catheter ablation.
- Patients were randomly assigned 1:1 to undergo left atrial appendage closure or receive oral anticoagulation.
- The primary safety end point (non-procedure-related major bleeding or clinically relevant nonmajor bleeding) occurred in 65 patients (8.5%) in the LAA closure group and 137 patients (18.1%) in the anticoagulation group (P<0.001 for superiority).
- The primary efficacy end point (composite of death from any cause, stroke, or systemic embolism) occurred in 41 patients (5.3%) in the LAA closure group and 44 patients (5.8%) in the anticoagulation group (P<0.001 for noninferiority).
- The secondary end point (major bleeding, including procedure-related bleeding) occurred in 3.9% in the LAA closure group and 5.0% in the anticoagulation group (P<0.001 for noninferiority).
- Complications related to the appendage closure device or procedure occurred in 23 patients.
Study Design
- Study Type
- Multicenter, randomized clinical trial
- Blinding
- Blinded outcome assessment by an independent clinical events committee and independent core laboratory staff.
- Sample Size
- 1600
- Follow-up
- 36 months
- Centers
- 106
Primary Outcome
Definition: Composite of death from any cause, stroke, or systemic embolism at 36 months.
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| 44 (5.8%) | 41 (5.3%) | - | <0.001 for noninferiority |
Limitations & Criticisms
- Open-label design, which may have influenced differences in crossover rates, although outcomes were evaluated by clinicians who were unaware of the treatment assignments.
- The enrolled population predominantly represented the Han Chinese population, so the generalizability of the results to other populations may be limited owing to the differences in stroke mechanisms.
- There was some imbalance in stroke mechanisms between trial groups, with a slightly lower proportion of large-artery atherosclerosis in the alteplase group than in the standard treatment group.
- The trial excluded patients with a left ventricular ejection fraction of 30% or less, so results may not be applicable to these patients.
- The open-label design could have led patients in the anticoagulation group to seek medical attention more frequently for bleeding events.
- The low incidence of ischemic stroke in both groups and the low number of symptomatic intracranial hemorrhage events limited statistical power for these specific outcomes.
Citation
N Engl J Med 2025;392:1277-87.