Arrhythmias & electrophysiologyRandomised controlled trial
Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes
- Randomised controlled trial
- event-driven
- double-blind
- double-dummy
- terminated early
Authors' conclusion
Among patients with AHREs detected by implantable devices, anticoagulation with edoxaban did not significantly reduce the incidence of a composite of cardiovascular death, stroke, or systemic embolism as compared with placebo, but it led to a higher incidence of a composite of death or major bleeding. The incidence of stroke was low in both groups.
Study context
- Population
- Patients ≥65 years with device-detected atrial high-rate episodes (AHREs) ≥6 minutes and ≥1 additional stroke risk factor, without ECG-documented AFanalysis population
- Participants
- 2,536 patients
- Comparison
- Edoxaban vs placebo
- Edoxabann = 1,270
- Placebon = 1,266reference
- Primary endpoint
- Composite of:
- CV death
- Stroke
- Systemic embolism (time-to-event)
Primary result
As reported in the abstract
median follow-up 21 months
Hazard ratio
0.81
95% CI 0.60–1.08
P = 0.15
Events by treatment group
Edoxaban
3.2% per patient-year
83 of 1270
Placebo
4.0% per patient-year
101 of 1266
Edoxaban vs Placebo
HR 0.81 (95% CI 0.60–1.08); P = 0.15
Further findings
per patient-year
| Outcome | Edoxaban | Placebo | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Composite of death from any cause or major bleeding | 5.9% | 4.5% | 1.31 (1.02–1.67) | P = 0.03 | |
| 0.512Hazard ratio (log scale) |
Stroke
- Incidence approximately 1% per patient-year in both groups
ECG-diagnosed AF
- ECG-diagnosed AF developed (all patients)
- 462 of 2536 (18.2% total, 8.7% per patient-year)
Original publication
Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes. N Engl J Med. Published 25 August 2023. doi:10.1056/nejmoa2303062
Summarised from the published abstract; every number is checked against it