Arrhythmias & electrophysiologyRandomised controlled trial
Left Atrial Appendage Closure after Ablation for Atrial Fibrillation
- Randomised controlled trial
- international
- non-inferiority (primary efficacy end point)
- superiority (primary safety end point)
Authors' conclusion
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.
Study context
- Population
- Patients with AF and elevated CHA2DS2-VASc score (≥2 in men, ≥3 in women) who underwent catheter ablation
- Participants
- 1,600 patients
- Comparison
- Left atrial appendage closure vs OAC after AF ablation
- Devicen = 803
- Anticoagulationn = 797reference
- Primary endpoint
- Primary safety: non-procedure-related major or clinically relevant nonmajor bleeding (superiority); primary efficacy: death from any cause, stroke or systemic embolism (noninferiority)
- Follow-up
- 36 months
Primary result
As reported in the abstract
| Group | Primary safety end point | Primary efficacy end point |
|---|---|---|
| Device | 65 (8.5%) | 41 (5.3%) |
| Anticoagulation | 137 (18.1%) | 44 (5.8%) |
- Device vs Anticoagulation: P < 0.001 — primary safety end point; superiority
- Device vs Anticoagulation: P < 0.001 — primary efficacy end point; noninferiority
Secondary outcomes
Major bleeding, including procedure-related bleeding · through 36 months · noninferiority
P < 0.001
Safety
- Complications related to the closure device or procedure
- 23 · events
Original publication
Left Atrial Appendage Closure after Ablation for Atrial Fibrillation. N Engl J Med. Published 16 November 2024. doi:10.1056/nejmoa2408308
Summarised from the published abstract; every number is checked against it