Acute cardioversion vs a wait-and-see approach for recent-onset symptomatic atrial fibrillation in the emergency department: Rationale and design of the randomized ACWAS trial

作者：Elton Dudink; Brigitte Essers; Wouter Holvoet; Bob Weijs; Justin Luermans; Hemanth Ramanna; Anho Liem; Jurren van Opstal; Lukas Dekker; Vincent van Dijk; Timo Lenderink; Otto Kamp; Lennert Kulker; Rienstra Michiel; Bas Kietselaer; Marco Alings; Jos Widdershoven; Joan Meeder; Martin Prins; van Gelder Isabelle C; Harry Crijns^*

来源：American Heart Journal, 2017, 183: 49-53.

DOI：10.1016/j.ahj.2016.09.009

Background Current standard of care for patients with recent-onset atrial fibrillation (AF) in the emergency department aims at urgent restoration of sinus rhythm, although paroxysmal AF is a condition that resolves spontaneously within 24 hours in more than 70% of the cases. A wait-and-see approach with rate-control medication only and when needed cardioversion within 48 hours of onset of symptoms is hypothesized to be noninferior, safe, and cost-effective as compared with current standard of care and to lead to a higher quality of life.
Design The ACWAS trial (NCT02248753) is an investigator-initiated, randomized, controlled, 2-arm noninferiority trial that compares a wait-and-see approach to the standard of care. Consenting adults with recent-onset symptomatic AF in the emergency department without urgent need for cardioversion are eligible for participation. A total of 437 patients will be randomized to either standard care (pharmacologic or electrical cardioversion) or the wait-and-see approach, consisting of symptom reduction through rate control medication until spontaneous conversion is achieved, with the possibility of cardioversion within 48 hours after onset of symptoms. Primary end point is the presence of sinus rhythm on 12-lead electrocardiogram at 4 weeks; main secondary outcomes are adverse events, total medical and societal costs, quality of life, and cost-effectiveness for 1 year.
Conclusions The ACWAS trial aims at providing evidence for the use of a wait-and-see approach for patients with recent-onset symptomatic AF in the emergency department.

• 出版日期2017-1