Arrhythmias & electrophysiology
Antithrombotic Therapy After Left Atrial Appendage Occlusion: The SIMPLAAFY Randomized Clinical Trial
Authors' conclusion
Both reduced-dose NOACs and aspirin alone were noninferior to DAPT for 6-month outcomes after uncomplicated LAAC.
Study context
- Population
- Patients with nonvalvular atrial fibrillation who underwent successful left atrial appendage closure (LAAC) and were eligible for all 3 regimenspatients randomized
- Participants
- 1,857 patients
- Comparison
- Reduced-dose non-vitamin K oral anticoagulants (NOACs) or aspirin alone vs dual antiplatelet therapy (DAPT) (noninferiority)
- DAPTn = 624reference
- Reduced-dose NOACn = 620
- Aspirin alonen = 613
- Primary endpoint
- Composite of:
- All-cause death
- Stroke
- Systemic embolism
- Major bleeding
- Follow-up
- 6-month
Methodological detailsrandomized, allocated 1:1:1, 87 US investigational sites
- Randomized
- Allocated 1:1:1
- 87 US investigational sites
Primary result
As reported in the abstract
Each group vs DAPTRisk ratio (95% CI)
Reduced-dose NOAC
0.75(0.48–1.18)
Aspirin alone
0.49(0.29–0.82)
Each group vs DAPTRisk difference, percentage points (97.5% CI)P value
Reduced-dose NOAC
−1.7(upper bound, 1.2)
P < 0.001 for noninferiorityAspirin alone
−3.5(upper bound, −0.8)
P < 0.001 for noninferiorityFurther findings
Cohort characteristics
- Mean age (SD, 8)
- 76 years
- Female
- 42.9%
- Mean CHA 2 DS 2 -VASc score (SD, 1.3)
- 4.2
- Paroxysmal atrial fibrillation
- 68.0%
Safety
Major bleeding · Exploratory without multiplicity adjustment
Clinically relevant nonmajor bleeding · Exploratory without multiplicity adjustment
Device-related thrombus · 45-day · Exploratory without multiplicity adjustment
Original publication
Antithrombotic Therapy After Left Atrial Appendage Occlusion: The SIMPLAAFY Randomized Clinical Trial. JAMA. Published 2 November 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →