OPTION
Trial question
Is LAA closure noninferior to oral anticoagulation therapy in patients who underwent catheter-based AF ablation?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
34.0% female
66.0% male
N = 1600
1600 patients (547 female, 1053 male).
Inclusion criteria: patients who underwent catheter-based AF ablation.
Key exclusion criteria: requirement of long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction; unsuitable for chronic anticoagulation and/or aspirin therapy due to bleeding risk, allergy, or other reasons; stroke or TIA within 60 days before randomization; MI within 90 days of randomization.
Interventions
N=803 LAA closure (LAA closure with the Watchman FLX™ device).
N=797 anticoagulation (oral anticoagulation therapy).
Primary outcome
Death from any cause, stroke, or systemic embolism at 36 months
5.3%
5.8%
5.8 %
4.3 %
2.9 %
1.4 %
0.0 %
Left atrial appendage
closure
Anticoagulation
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in death from any cause, stroke, or systemic embolism at 36 months (5.3% vs. 5.8%; HR 0.91, 95% CI 0.59 to 1.39).
Secondary outcomes
Significant decrease in the rate of major bleeding, including procedure-related bleeding, through 36 months (3.9% vs. 5%; HR 0.77, 95% CI 0.48 to 1.24).
No significant difference in death from any cause at 36 months (3.8% vs. 4.5%; HR 0.83, 95% CI 0.51 to 1.36).
No significant difference in stroke or systemic embolism at 36 months (1.8% vs. 2.1%; HR 0.85, 95% CI 0.42 to 1.75).
Safety outcomes
Significant difference in non-procedure-related major bleeding or clinically relevant nonmajor bleeding (8.5% vs. 18.1%).
Conclusion
In patients who underwent catheter-based AF ablation, LAA closure was noninferior to anticoagulation with respect to death from any cause, stroke, or systemic embolism at 36 months.
Reference
Oussama M Wazni, Walid I Saliba, Devi G Nair et al. Left Atrial Appendage Closure after Ablation for Atrial Fibrillation. N Engl J Med. 2024 Nov 16. Online ahead of print.
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