1. Vernakalant hydrochloride for the rapid conversion of atrial fibrillation after cardiac surgery: a randomized, double-blind, placebo-controlled trial.
- Author
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Kowey PR, Dorian P, Mitchell LB, Pratt CM, Roy D, Schwartz PJ, Sadowski J, Sobczyk D, Bochenek A, and Toft E
- Subjects
- Aged, Anisoles adverse effects, Anti-Arrhythmia Agents adverse effects, Argentina, Atrial Fibrillation etiology, Atrial Fibrillation physiopathology, Atrial Flutter etiology, Atrial Flutter physiopathology, Double-Blind Method, Electrocardiography, Europe, Female, Humans, India, Infusions, Intravenous, Male, Middle Aged, North America, Prospective Studies, Pyrrolidines adverse effects, Time Factors, Treatment Outcome, Anisoles administration & dosage, Anti-Arrhythmia Agents administration & dosage, Atrial Fibrillation drug therapy, Atrial Flutter drug therapy, Coronary Artery Bypass adverse effects, Heart Valve Prosthesis Implantation adverse effects, Pyrrolidines administration & dosage
- Abstract
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) after cardiac surgery., Methods and Results: This 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., Conclusions: Vernakalant was safe and effective in the rapid conversion of AF to sinus rhythm in patients who had AF after cardiac surgery., Clinical Trial Registration: clinicaltrials.gov. Identifier: NCT00125320.
- Published
- 2009
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