- Question
- Does anticoagulation with edoxaban in patients with device-detected atrial high-rate episodes (AHREs), without ECG-documented atrial fibrillation, reduce major cardiovascular events?
- Design
- Event-driven, double-blind, double-dummy randomized trial with 1:1 allocation. The analysis population was 2536 patients. It was terminated early at a median follow-up of 21 months because of safety concerns and an informal futility assessment.
- Population
- Patients aged 65 years or older with AHREs lasting at least 6 minutes detected by implanted cardiac devices and at least one additional stroke risk factor. Mean age was 78 years, 37.4% were women, and the median AHRE duration was 2.8 hours.
- Intervention
- Edoxaban at the dose approved for stroke prevention in non-valvular atrial fibrillation, with dose reduction based on renal function or low body weight.
- Control
- Placebo (with aspirin 100 mg according to each patient's indication), using a double-dummy design to maintain blinding.
- Primary outcome
- Composite of cardiovascular death, stroke, or systemic embolism, analyzed as time to first event. The safety outcome was a composite of death from any cause or major bleeding.
- Results
- The primary outcome occurred in 83 patients (3.2% per patient-year) with edoxaban and 101 (4.0% per patient-year) with placebo (HR 0.81; 95% CI 0.60 to 1.08; P = 0.15). The incidence of stroke was approximately 1% per patient-year in both groups.
- Safety
- The composite of death from any cause or major bleeding was more frequent with edoxaban: 149 patients (5.9% per patient-year) versus 114 (4.5% per patient-year) (HR 1.31; 95% CI 1.02 to 1.67; P = 0.03).
- Conclusion
- In patients with device-detected AHREs, edoxaban did not significantly reduce the composite of cardiovascular death, stroke, or systemic embolism compared with placebo, and it increased the composite of death or major bleeding.
- Why it matters
- It showed that isolated AHREs do not by themselves justify routine initiation of anticoagulation, given the low stroke risk observed and the higher bleeding risk, prompting a reassessment of how these findings are managed.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 7, 2026