TY - JOUR
T1 - Acute cardioversion vs a wait-and-see approach for recent-onset symptomatic atrial fibrillation in the emergency department
T2 - Rationale and design of the randomized ACWAS trial
AU - Elton, Dudink
AU - Brigitte, Essers
AU - Wouter, Holvoet
AU - Bob, Weijs
AU - Justin, Luermans
AU - Hemanth, Ramanna
AU - Anho, Liem
AU - Jurren, van Opstal
AU - Lukas, Dekker
AU - Vincent, van Dijk
AU - Timo, Lenderink
AU - Otto, Kamp
AU - Lennert, Kulker
AU - Rienstra, Michiel
AU - Kietselaer, B.
AU - Marco, Alings
AU - Jos, Widdershoven
AU - Joan, Meeder
AU - Martin, Prins
AU - van Gelder, Isabelle C.
AU - Harry, Crijns
PY - 2017/1
Y1 - 2017/1
N2 - 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.
AB - 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.
KW - RHYTHM CONTROL
KW - FLUTTER
U2 - 10.1016/j.ahj.2016.09.009
DO - 10.1016/j.ahj.2016.09.009
M3 - Article
C2 - 27979041
SN - 0002-8703
VL - 183
SP - 49
EP - 53
JO - American Heart Journal
JF - American Heart Journal
ER -