Rationale: Stroke risk is higher in pacemaker patients with AHRE than in those without, but the available data also show that stroke risk in patients with AHRE is lower than in patients with atrial fibrillation. Furthermore, only a minority of patients with AHRE will develop AF, many strokes occur without a temporal relation to AHRE, and AHRE can reflect other arrhythmias than AF or artefacts. An adequately powered controlled trial of oral anticoagulation in patients with AHRE is needed.
Design: The NOAH – AFNET 6 (Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes) trial tests whether oral anticoagulation with edoxaban is superior to prevent the primary efficacy outcome of stroke or cardiovascular death compared to aspirin or no antithrombotic therapy based on evidence-based indications. The primary safety outcome will be major bleeding. NOAH – AFNET 6 will randomise 3400 patients with AHRE, but without documented AF, aged 65 or older with at least one other stroke risk factor, to oral anticoagulation therapy (edoxaban) or no anticoagulation. All patients will be followed until the end of this investigator-driven, prospective, parallel-group, randomised, event-driven, double-blind, multi-centre phase IIIb trial. Patients will be censored when they develop atrial fibrillation and offered open label anticoagulation. The sponsor is the Atrial Fibrillation NETwork (AFNET). The trial is supported by the DZHK (German Centre for Cardiovascular Research), by the BMBF (German Ministry of Education and Research) and by Daiichi Sankyo Europe.
Conclusion: NOAH – AFNET 6 will provide robust information on the effect of oral anticoagulation in patients with atrial high rate episodes detected by implanted devices.
- AF burden
- Atrial fibrillation
- atrial high rate episodes
- stroke prevention