May 3, 2017Open Access
Probing oral anticoagulation in patients with atrial high rate episodes: Rationale and design of the Non–vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes (NOAH–AFNET 6) trial
Key Result
The NOAH-AFNET 6 trial will randomize 3,400 patients with atrial high rate episodes to test whether edoxaban is superior to aspirin or no therapy for preventing stroke or cardiovascular death.
Study Design
Type
RCT (n=3,400)
Blinding
Double-blind
Randomization
Randomized
Multicenter
Yes
Structured PICO
Does edoxaban reduce stroke or cardiovascular death in patients aged ≥65 years with atrial high rate episodes and at least 1 other stroke risk factor?
P
Population
3,400 patients with atrial high rate episodes (AHRE) detected by implanted devices, without documented AF, aged ≥65 years with at least 1 other stroke risk factor
I
Intervention
Oral anticoagulation therapy (edoxaban)
C
Comparator
Aspirin or no antithrombotic therapy based on evidence-based indications
O
Outcome
Composite of stroke or cardiovascular deathcomposite
The NOAH-AFNET 6 trial is designed to determine whether oral anticoagulation with edoxaban is superior to aspirin or no antithrombotic therapy in preventing stroke or cardiovascular death in patients with device-detected atrial high rate episodes.
Abstract
Oral anticoagulation prevents ischemic strokes in patients with atrial fibrillation (AF). Early detection of AF and subsequent initiation of oral anticoagulation help to prevent strokes in AF patients. Implanted cardiac pacemakers and defibrillators allow seamless detection of atrial high rate episodes (AHRE), but the best antithrombotic therapy in patients with AHRE is not known. 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 AF. 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 artifacts. An adequately powered controlled trial of oral anticoagulation in patients with AHRE is needed. DESIGN: The Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes (NOAH-AFNET 6 ) trial tests whether oral anticoagulation with edoxaban is superior to prevent the primary efficacy outcome of stroke or cardiovascular death compared with aspirin or no antithrombotic therapy based on evidence-based indications. The primary safety outcome will be major bleeding. NOAH-AFNET 6 will randomize 3,400 patients with AHRE, but without documented AF, aged ≥65 years with at least 1 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, randomized, event-driven, double-blind, multicenter phase IIIb trial. Patients will be censored when they develop AF 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), the BMBF (German Ministry of Education and Research), and 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.