- Question
- Can left atrial appendage closure replace oral anticoagulation in patients with atrial fibrillation who have undergone catheter ablation, reducing bleeding without losing efficacy?
- Design
- International, randomized (1:1), open-label (no masking) trial of 1600 patients, funded by Boston Scientific. The main follow-up was 36 months.
- Population
- Patients with atrial fibrillation and an elevated CHA2DS2-VASc score (≥2 in men and ≥3 in women) who underwent catheter ablation. Mean age was 69.6 years, 34.1% were women, and the mean CHA2DS2-VASc score was 3.5.
- Intervention
- Left atrial appendage closure with the WATCHMAN FLX device, with a modified post-implant drug regimen (803 patients).
- Control
- Market-approved oral anticoagulation, used per labeling for stroke prevention in atrial fibrillation throughout the trial (797 patients).
- Primary outcome
- Safety (superiority): non-procedure-related major bleeding or clinically relevant nonmajor bleeding. Efficacy (noninferiority): composite of death from any cause, stroke, or systemic embolism at 36 months.
- Results
- At 36 months, the primary safety event occurred in 8.5% of the device group and 18.1% of the anticoagulation group (P<0.001 for superiority). The primary efficacy event occurred in 5.3% and 5.8%, respectively (P<0.001 for noninferiority). Major bleeding, including procedure-related bleeding, was 3.9% versus 5.0% (P<0.001 for noninferiority).
- Safety
- Complications related to the closure device or procedure occurred in 23 patients.
- Conclusion
- After atrial fibrillation ablation, appendage closure reduced non-procedure-related bleeding compared with oral anticoagulation and was noninferior for the composite of death, stroke, or systemic embolism.
- Why it matters
- It offers a mechanical alternative to long-term anticoagulation in patients at elevated stroke risk after ablation, with less bleeding, and supports reconsidering indefinite anticoagulation in this setting.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026