• Circ Arrhythm Electrophysiol · Dec 2009

    Randomized Controlled Trial Multicenter Study

    Vernakalant hydrochloride for the rapid conversion of atrial fibrillation after cardiac surgery: a randomized, double-blind, placebo-controlled trial.

    • Peter R Kowey, Paul Dorian, L Brent Mitchell, Craig M Pratt, Denis Roy, Peter J Schwartz, Jerzy Sadowski, Dorota Sobczyk, Andrzej Bochenek, Egon Toft, and Atrial Arrhythmia Conversion Trial Investigators.
    • Division of Cardiovascular Disease, Lankenau Hospital and Institute of Medical Research, Wynnewood, PA 19096, USA. KoweyPR@MLHHeart.org
    • Circ Arrhythm Electrophysiol. 2009 Dec 1;2(6):652-9.

    BackgroundPostoperative 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) after cardiac surgery.Methods And ResultsThis was a prospective, randomized, double-blind, placebo-controlled trial of vernakalant for the conversion of AF or AFL after coronary artery bypass graft, valvular surgery, or both. Patients were randomly assigned 2:1 to receive a 10-minute infusion of 3 mg/kg vernakalant or placebo. If AF or AFL was present after a 15-minute observation period, then a second 10-minute infusion of 2 mg/kg vernakalant or placebo was given. The primary end point was the conversion of postcardiac surgery AF or AFL to sinus rhythm within 90 minutes of dosing. In patients with AF, 47 of 100 (47%) who received vernakalant converted to SR compared with 7 of 50 (14%) patients who received placebo (P<0.001). The median time to conversion was 12 minutes. Vernakalant was not effective in converting postoperative AFL to sinus rhythm. 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.ConclusionsVernakalant was safe and effective in the rapid conversion of AF to sinus rhythm in patients who had AF after cardiac surgery.Clinical Trial Registrationclinicaltrials.gov. Identifier: NCT00125320.

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