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(Circulation. 2008;117:1518-1525.)
© 2008 American Heart Association, Inc.

Arrhythmia/Electrophysiology

Vernakalant Hydrochloride for Rapid Conversion of Atrial Fibrillation

A Phase 3, Randomized, Placebo-Controlled Trial

Denis Roy, MD; Craig M. Pratt, MD; Christian Torp-Pedersen, MD; D. George Wyse, MD, PhD; Egon Toft, MD; Steen Juul-Moller, MD; Tonny Nielsen, MD; S. Lind Rasmussen, MD; Ian G. Stiell, MD; Benoit Coutu, MD; John H. Ip, MD; Edward L.C. Pritchett, MD; A. John Camm, MD, for the Atrial Arrhythmia Conversion Trial Investigators

From the Montreal Heart Institute, University of Montreal, Montreal, Quebec, Canada (D.R.); Department of Cardiology, Methodist DeBakey Heart Center, Methodist Hospital Research Institute, Houston, Tex (C.M.P.); Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark (C.T.-P.); Libin Cardiovascular Institute of Alberta, Calgary, Alberta, Canada (D.G.W.); Department for Health Science and Technology, Aalborg University, and Department of Cardiology, Aalborg Hospital, Aalborg, Denmark (E.T.); Universitetssjukhuset I Malmo, Malmo, Sweden (S.J.-M.); Centralsygehuset Esbjerg Varde, Esbjerg, Denmark (T.N.); Hvidovre Hospital, Hvidovre, Denmark (S.L.R.); Department of Emergency Medicine, University of Ottawa, Ottawa, Ontario, Canada (I.G.S.); Notre-Dame Hospital, Montreal, Quebec, Canada (B.C.); Thoracic and Cardiovascular Institute, Lansing, Mich (J.H.I.); Duke University, Durham, NC (E.L.C.P.); and St George’s Hospital, London, UK (A.J.C.).

Reprint requests to Dr Denis Roy, Montreal Heart Institute, 5000 Belanger St, Montreal, Quebec H1T 1C8, Canada. E-mail d_roy{at}icm-mhi.com

Received June 28, 2007; accepted January 4, 2008.

Background— The present study assessed the efficacy and safety of vernakalant hydrochloride (RSD1235), a novel compound, for the conversion of atrial fibrillation (AF).

Methods and Results— Patients were randomized in a 2:1 ratio to receive vernakalant or placebo and were stratified by AF duration of 3 hours to 7 days (short duration) and 8 to 45 days (long duration). A first infusion of placebo or vernakalant (3 mg/kg) was given for 10 minutes, followed by a second infusion of placebo or vernakalant (2 mg/kg) 15 minutes later if AF was not terminated. The primary end point was conversion of AF to sinus rhythm for at least 1 minute within 90 minutes of the start of drug infusion in the short-duration AF group. A total of 336 patients were randomized and received treatment (short duration, n=220; long duration, n=116). Of the 145 vernakalant patients, 75 (51.7%) in the short-duration AF group converted to sinus rhythm (median time, 11 minutes) compared with 3 of the 75 placebo patients (4.0%; P<0.001). Overall, in the short- and long-duration AF groups, 83 of the 221 vernakalant patients (37.6%) experienced termination of AF compared with 3 of the 115 placebo patients (2.6%; P<0.001). Transient dysgeusia and sneezing were the most common side effects in vernakalant-treated patients. Four vernakalant-related serious adverse events (hypotension [2 events], complete atrioventricular block, and cardiogenic shock) occurred in 3 patients.

Conclusion— Vernakalant demonstrated rapid conversion of short-duration AF and was well tolerated.

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CLINICAL PERSPECTIVE

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Clinical Summaries
Circulation 2008 117: 1499. [Full Text]