Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in Atrial Fibrillation (BRAIN-AF): Methods and Design.

BACKGROUND: Compelling evidence showing a link between atrial fibrillation (AF) and cognitive decline and dementia is accumulating. METHODS: Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in Atrial Fibrillation (BRAIN-AF) is a prospective, multicentric, double-blind, randomized-controlled trial, recruiting patients with nonvalvular AF and a low risk of stroke. Patients with a high risk of bleeding will be excluded from the study. Participants will be randomized to receive either rivaroxaban (15 mg daily) or standard of care (placebo in patients without vascular disease or acetylsalicylic acid 100 mg daily in patients with vascular disease). RESULTS: The primary outcome is the composite of stroke, transient ischemic attack, and cognitive decline (defined by a decrease in the Montreal Cognitive Assessment score ≥ 3 at any follow-up visit after baseline). Approximately 3250 patients will be enrolled in approximately 130 clinical sites until 609 adjudicated primary outcome events have occurred. CONCLUSIONS: BRAIN-AF determines whether oral anticoagulation therapy with rivaroxaban compared with standard of care reduces the risk of stroke, transient ischemic attack, or cognitive decline in patients with nonvalvular AF and a low risk of stroke.

Impact of atrial antitachycardia pacing and atrial pace prevention therapies on atrial fibrillation burden over long-term follow-up.

AIMS: Selective atrial pacing algorithms have been developed for prevention of atrial tachycardia/atrial fibrillation (AT/AF). Although short-term studies have shown modest to minimal incremental benefit of these algorithms compared with conventional dual-chamber (DDD/R) pacing for prevention of AT/AF, the long-term effects of these algorithms are unknown. Accordingly, we compared atrial antitachycardia pacing (ATP) therapy and combined atrial ATP and atrial pace prevention (ATP + Prevention) algorithms to conventional DDD/R pacing for prevention of AT/AF over long-term follow-up. METHODS AND RESULTS: Seventy-one patients with AT/AF following pacemaker insertion were randomized to DDD/R pacing, DDD/R plus ATP pacing, or DDD/R plus ATP and prevention pacing and followed for 3 years. Atrial tachycardia/AF burden and an AF symptom scale were compared over time between groups. Atrial tachycardia/AF burden remained stable over 3 years in the DDD/R and ATP + Prevention groups. Atrial tachycardia/AF burden increased significantly over time in the ATP group. Patients not on class I or III antiarrhythmic drug therapy were more likely to experience an increase in AT/AF burden over time. CONCLUSION: Atrial ATP and atrial ATP in combination with atrial pace prevention algorithms do not suppress AT/AF over long-term follow-up compared with DDD/R pacing.

Atrial Fibrillation in the Elderly.

Atrial fibrillation is a common cardiac arrhythmia affecting up to 5% of people over the age of 65 years. The elderly are less well able to withstand the hemodynamic stress of new-onset and rapid atrial fibrillation. Advancing age is a predisposing factor for atrial fibrillation itself and for its complications. The main adverse outcomes caused by atrial fibrillation include peripheral embolic events, particularly stroke and left ventricular dysfunction. Sinus rhythm is of special importance in the elderly as it may be the main way to reduce the thromboembolic risks of atrial fibrillation. When sinus rhythm cannot be restored and maintained, control of heart rate by pharmacologic or other means has advantage in itself. The long-term benefits of aspirin and warfarin in patients with chronic nonvalvular atrial fibrillation have been demonstrated by recent trials. However, these benefits do not universally extend to patients above the age of 75 years, and thoughtful individualized antithrombotic treatment is needed for the elderly patient with atrial fibrillation.