Arrhythmias & electrophysiologyRandomised controlled trial
Left Atrial Appendage Closure or Anticoagulation for Atrial Fibrillation
- Randomised controlled trial
- ongoing
- prospective
- international
- non-inferiority
Authors' conclusion
Among patients with atrial fibrillation who were candidates for anticoagulation, device-based left atrial appendage closure was noninferior to NOAC therapy with respect to a composite of death from cardiovascular causes, stroke, or systemic embolism and was superior to NOAC therapy for non-procedure-related bleeding at 3 years.
Study context
- Population
- Patients with AF who were suitable candidates for anticoagulation
- Participants
- 3,000 patients
- Comparison
- Device-based LAAO vs NOAC therapy
- Devicen = 1,499
- Anticoagulationn = 1,501reference
- Primary endpoint
- Composite of:
- CV death
- Stroke
- Systemic embolism (non-inferiority, margin 4.8 percentage points)
- Follow-up
- 3 years
Primary result
CV death, stroke or systemic embolism
Difference
0.9 percentage points
95% CI −0.8 to 2.6
P < 0.001 for non-inferiority
Events by treatment group
Device vs Anticoagulation
difference 0.9 percentage points (95% CI −0.8 to 2.6); P for non-inferiority < 0.001
Non-inferiority margin 4.8 as printed, not drawn
As reported in the abstract
Safety
| Outcome | Device | Anticoagulation | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Non-procedure-related bleeding (primary safety end point) · 3 years · Kaplan-Meier estimates | 10.9% | 19.0% | 0.55 (0.45–0.67) | P for superiority < 0.001 | |
| 0.512Hazard ratio (log scale) |
Original publication
Left Atrial Appendage Closure or Anticoagulation for Atrial Fibrillation. N Engl J Med. Published 28 March 2026. doi:10.1056/nejmoa2517213
Summarised from the published abstract; every number is checked against it