Arrhythmias & electrophysiologyRandomised controlled trial
Apixaban for Stroke Prevention in Subclinical Atrial Fibrillation
- Randomised controlled trial
- double-blind
- double-dummy
Trial medication discontinued and anticoagulation started if subclinical AF >24 hours or clinical AF developed
Authors' conclusion
Among patients with subclinical atrial fibrillation, apixaban resulted in a lower risk of stroke or systemic embolism than aspirin but a higher risk of major bleeding.
Study context
- Population
- Patients with subclinical AF lasting 6 minutes to 24 hours
- Participants
- 4,012 patients
- Comparison
- Apixaban vs aspirin
- Primary endpoint
- Stroke or systemic embolism
- Follow-up
- Mean 3.5±1.8 years
Primary result
As reported in the abstract
Hazard ratio
0.63
95% CI 0.45–0.88
P = 0.007
Events by treatment group
Apixaban
0.78% per patient-year
55 events
Aspirin
1.24% per patient-year
86 events
Apixaban vs Aspirin
HR 0.63 (95% CI 0.45–0.88); P = 0.007
Safety
per patient-year
| Outcome | Apixaban | Aspirin | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Major bleeding (primary safety outcome) · on-treatment | 1.71% | 0.94% | 1.80 (1.26–2.57) | P = 0.001 | |
| 0.20.5125Hazard ratio (log scale) |
events
| Outcome | Apixaban | Aspirin | Estimate | P value |
|---|---|---|---|---|
| Fatal bleeding | 5 | 8 |
Original publication
Apixaban for Stroke Prevention in Subclinical Atrial Fibrillation. N Engl J Med. Published 12 November 2023. doi:10.1056/nejmoa2310234
Summarised from the published abstract; every number is checked against it