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 - 18/04/17

Doi : 10.1016/j.ahj.2016.09.009

Elton Dudink, MD ^a, Brigitte Essers, MSc ^b, Wouter Holvoet, MD ^a,^c, Bob Weijs, MD, PhD ^a,^c, Justin Luermans, MD, PhD ^a, Hemanth Ramanna, MD, PhD ^d, Anho Liem, MD, PhD ^e, Jurren van Opstal, MD, PhD ^f, Lukas Dekker, MD, PhD ^g, Vincent van Dijk, MD, PhD ^h, Timo Lenderink, MD, PhD ⁱ, Otto Kamp, MD, PhD ^j, Lennert Kulker, MSc ^k, Michiel Rienstra, MD, PhD ^l, Bas Kietselaer, MD, PhD ^a, Marco Alings, MD, PhD ^m, Jos Widdershoven, MD, PhD ⁿ, Joan Meeder, MD, PhD ^c, Martin Prins, MD, PhD ^b, Isabelle van Gelder, MD, PhD ^l, Harry Crijns, MD, PhD ^a,^{^⁎}
^a Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht, Maastricht, the Netherlands
^b Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, the Netherlands
^c Department of Cardiology, VieCuri Medical Center, Venlo, the Netherlands
^d Department of Cardiology, Haga Teaching Hospital, The Hague, the Netherlands
^e Department of Cardiology, Sint Franciscus Hospital, Rotterdam, the Netherlands
^f Department of Cardiology, Medisch Spectrum Twente, Enschede, the Netherlands
^g Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands
^h Department of Cardiology, St Antonius Hospital, Nieuwegein, the Netherlands
ⁱ Department of Cardiology, Zuyderland Medical Center, Heerlen, the Netherlands
^j Department of Cardiology, VU University Medical Center, Amsterdam, the Netherlands
^k Department of Cardiology, Alrijne Hospital, Leiderdorp, the Netherlands
^l Department of Cardiology, University Medical Center Groningen, Groningen, the Netherlands
^m Department of Cardiology, Amphia Hospital, Breda, the Netherlands
ⁿ Department of Cardiology, Elisabeth—TweeSteden Hospital, Tilburg, the Netherlands

^⁎Reprint requests: H. J. G. M. Crijns, Department of Cardiology, Maastricht University Medical Center, PO Box 5800, 6202 AZ, Maastricht, the Netherlands.Department of CardiologyMaastricht University Medical CenterPO Box 5800Maastricht6202 AZthe Netherlands

Abstract

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.

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Plan

	RCT No. NCT02248753.
	This trial is funded by a grant of Netherlands Organization for Health Research and Development – Health Care Efficiency Research program (Grant No. 837002524). No additional extramural funding was used to support this work.

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Vol 183

P. 49-53 - janvier 2017 Retour au numéro

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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 - 18/04/17

Abstract

Background

Design

Conclusions

Plan

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