Arrhythmias & electrophysiologyRandomised controlled trial
Therapy for Atrial Fibrillation in Patients with Drug-Eluting Stents
- Randomised controlled trial
- multicentre
- open-label
- non-inferiority
Authors' conclusion
Among patients with atrial fibrillation who had undergone implantation of a drug-eluting stent at least 1 year earlier, NOAC monotherapy was noninferior to combination therapy for net adverse clinical events.
Study context
- Population
- Patients with AF and drug-eluting stent implanted at least 1 year earlier, South Korea
- Participants
- 960 patients
- Comparison
- NOAC monotherapy vs NOAC plus clopidogrel
- Monotherapyn = 482
- Combination therapyn = 478reference
- Primary endpoint
- Net adverse clinical events:
- All-cause death
- MI
- Stent thrombosis
- Stroke
- Systemic embolism
- Major or clinically relevant nonmajor bleeding
- Follow-up
- 12 months
Primary result
As reported in the abstract
Monotherapy vs Combination therapyAbsolute difference, percentage points (95.2% CI)P value
noninferiority
−7.6(−11.9 to −3.3)
P < 0.001Non-inferiority margin 3 as printed, not drawn
Monotherapy vs Combination therapyHazard ratio (95.2% CI)P value
superiority
0.54(0.37–0.77)
P < 0.001Non-inferiority margin 3 as printed, not drawn
Safety
| Outcome | Monotherapy | Combination therapy | HR (95% CI) | |
|---|---|---|---|---|
| Major or clinically relevant nonmajor bleeding | 5.2% | 13.2% | 0.38 (0.24–0.60) | |
| 0.20.5125Hazard ratio (log scale) |
Original publication
Therapy for Atrial Fibrillation in Patients with Drug-Eluting Stents. N Engl J Med. Published 8 November 2025. doi:10.1056/nejmoa2512091
Summarised from the published abstract; every number is checked against it