← Back

OPTION LAAC

Left Atrial Appendage Closure after Ablation for Atrial Fibrillation

Share Share Copied! Compare

Year of Publication: 2025

Authors: O.M. Wazni, W.I. Saliba, D.G. Nair, ..., for the OPTION Trial Investigators*

Journal: The New England Journal of Medicine

Citation: N Engl J Med 2025;392:1277-87.

Link: https://www.nejm.org/doi/full/10.1056/NEJMoa2408308

PDF: https://pure.amsterdamumc.nl/ws/files/14...ibrillation.pdf

Clinical Question

Does left atrial appendage closure safely decrease the risk of bleeding associated with oral anticoagulants while maintaining a low risk of stroke among patients with atrial fibrillation who have undergone catheter ablation and are at moderate or high risk for stroke?

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.

      

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

Centers: 106

Follow-up Duration: 36 months

Inclusion Criteria

Patients 18 years of age or older.
Atrial fibrillation.
CHA2DS2-VASc score of at least 2 for men or at least 3 for women.
Underwent catheter ablation (performed 90 to 180 days before randomization or scheduled within 10 days after randomization).

Exclusion Criteria

CHA2DS2-VASc score less than 2 for men or less than 3 for women.
Patients with a left ventricular ejection fraction of 30% or less.
Patients with contraindications to oral anticoagulation or LAA closure.
Patients with life expectancy <12 months.

Arms

Field	Left atrial appendage closure (WATCHMAN FLX)	Control
Intervention	Catheter-based left atrial appendage closure with the WATCHMAN FLX device after AF ablation.	Continued oral anticoagulation after AF ablation.
Duration	Long-term follow-up	Long-term follow-up

Outcomes

Outcome	Type	Control	Intervention	HR / OR / RR	P-value
Composite of death from any cause, stroke, or systemic embolism at 36 months.	Primary	44 (5.8%)	41 (5.3%)	0.50%	<0.001 for noninferiority

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.

Funding

Boston Scientific

Based on: OPTION LAAC (The New England Journal of Medicine, 2025)