NOAH-AFNET 6
Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High-Rate Episodes
Patient / Population Intervention / Exposure Comparison Outcome
In 2,536 patients with device-detected atrial high-rate episodes, edoxaban did not reduce cardiovascular death, stroke, or systemic embolism compared with placebo.
N
2,536
Design
Double-blind placebo-controlled RCT, terminated early
Endpoint
Composite of cardiovascular death, stroke, or systemic embolism
Relevance
2
Result3.2%/patient-yr vs 4.0%/patient-yr (HR 0.81, 95% CI 0.60-1.08); neutral. Death or major bleeding increased with edoxaban (HR 1.31, 95% CI 1.02-1.67).
Kirchhof P, et al. N Engl J Med. 2023;389(13):1167-1179. 10.1056/NEJMoa2303062
Discussion & critique
Stopped early for safety with a low event rate, so a small benefit cannot be fully excluded. Suggests anticoagulation of short atrial high-rate episodes causes net harm without documented AF.