Published Online
on October 2, 2009

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Original Article

Vernakalant Hydrochloride for the Rapid Conversion of Atrial Fibrillation Following Cardiac Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial

Peter R. Kowey^1,10; Paul Dorian²; L.Brent Mitchell³; Craig M. Pratt⁴; Denis Roy⁵; Peter J. Schwartz⁶; Jerzy Sadowski⁷; Dorota Sobczyk⁷; Andrzej Bochenek⁸ and Egon Toft⁹

¹ Lankenau Hospital & Institute of Medical Research, Wynnewood, PA;
² St. Michael's Hospital & University of Toronto, Toronto, Ontario, Canada;
³ Libin Cardio Inst of Alberta, Calgary Health Region & Univ of Calgary, Calgary, Alberta, Canada;
⁴ Baylor College of Medicine & The Methodist Hospital, Houston, TX;
⁵ Montreal Heart Institute & Université de Montréal, Montreal, Quebec, Canada;
⁶ University of Pavia & Fondazione IRCCS Policlinico San Matteo, Pavia, Italy;
⁷ Jagiellonian University, Krakow, Poland;
⁸ Medical University of Silesia, Katowice, Poland;
⁹ Aalborg University & Aalborg University Hospital, Aalborg, Denmark

^* Corresponding author; email: koweyp{at}mlhs.org

Background—Postoperative atrial arrhythmias are common and are associated with considerable morbidity. This study was designed to evaluate the efficacy and safety of vernakalant for the conversion of atrial fibrillation (AF) or atrial flutter (AFL) following cardiac surgery.

Methods and Results—This was a prospective, randomized, double-blind, placebo-controlled trial of vernakalant for the conversion of AF or AFL following coronary artery bypass graft, valvular surgery, or both. Patients were randomized 2:1 to receive a 10-minute infusion of vernakalant 3 mg/kg or placebo. If AF or AFL was present after a 15-minute observation period, then a second 10-minute infusion of vernakalant 2 mg/kg or placebo was given. The primary endpoint was the conversion of post-cardiac surgery AF or AFL to sinus rhythm (SR) within 90 minutes of dosing. In patients with AF, 47 of 100 (47%) patients who received vernakalant converted to SR compared with 7 of 50 (14%) patients who received placebo (P<.001). The median time to conversion was 12 minutes. Vernakalant was not effective in converting postoperative AFL to SR. Two serious adverse events occurred within 24 hours of vernakalant administration (hypotension and complete atrioventricular block). There were no cases of torsades de pointes, sustained ventricular tachycardia, or ventricular fibrillation. There were no deaths.

Conclusions—Vernakalant was safe and effective in the rapid conversion of AF to SR in patients who developed AF post-cardiac surgery.

Clinical Trial Registration—http://www.clinicaltrials.gov/ct/show/NCT00125320?order=3, NCT00125320

Key Words: antiarrhythmia agents • atrial flutter • antiarrhythmic drugs • atrial fibrillation • cardiac surgery