Arrhythmias & electrophysiologyRandomised controlled trial
Edoxaban Antithrombotic Therapy for Atrial Fibrillation and Stable Coronary Artery Disease
- Randomised controlled trial
- multicentre
- open-label
- adjudicator-masked
- 18 sites in South Korea
Authors' conclusion
In patients with atrial fibrillation and stable coronary artery disease, edoxaban monotherapy led to a lower risk of a composite of death from any cause, myocardial infarction, stroke, systemic embolism, unplanned urgent revascularization, or major bleeding or clinically relevant nonmajor bleeding at 12 months than dual antithrombotic therapy.
Study context
- Population
- Patients with AF and stable CAD (previously treated with revascularization or managed medically)
- Participants
- 524 vs 516
- Comparison
- Edoxaban monotherapy vs dual antithrombotic therapy
- Edoxaban monotherapyn = 524
- Dual antithrombotic therapyn = 516reference
- Primary endpoint
- Composite of:
- All-cause death
- MI
- Stroke
- Systemic embolism
- Unplanned urgent revascularization
- Major or clinically relevant nonmajor bleeding
- Follow-up
- 12 months
Primary result
As reported in the abstract
Hazard ratio
0.44
95% CI 0.30–0.65
P < 0.001
Events by treatment group
Edoxaban monotherapy vs Dual antithrombotic therapy
HR 0.44 (95% CI 0.30–0.65); P < 0.001
Secondary outcomes
Major ischemic events · 12 months
- Cumulative incidence appeared similar in the trial groups
Safety
| Outcome | Edoxaban monotherapy | Dual antithrombotic therapy | HR (95% CI) | |
|---|---|---|---|---|
| Major or clinically relevant nonmajor bleeding · Kaplan-Meier estimates | 4.7% | 14.2% | 0.34 (0.22–0.53) | |
| 0.20.5125Hazard ratio (log scale) |
Original publication
Edoxaban Antithrombotic Therapy for Atrial Fibrillation and Stable Coronary Artery Disease. N Engl J Med. Published 1 September 2024. doi:10.1056/nejmoa2407362
Summarised from the published abstract; every number is checked against it