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


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.


BACKGROUND
clinicaltrials.gov. Identifier: NCT00125320.
Kowey
Peter R
PR
Division of Cardiovascular Disease, Lankenau Hospital and Institute of Medical Research, Wynnewood, PA 19096, USA. KoweyPR@MLHHeart.org
Dorian
Paul
P
Mitchell
L Brent
LB
Pratt
Craig M
CM
Roy
Denis
D
Schwartz
Peter J
PJ
Sadowski
Jerzy
J
Sobczyk
Dorota
D
Bochenek
Andrzej
A
Toft
Egon
E
D000368:Aged; D000840:Anisoles / Q000008:administration & dosage* / Q000009:adverse effects; D000889:Anti-Arrhythmia Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001118:Argentina; D001281:Atrial Fibrillation / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D001282:Atrial Flutter / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D001026:Coronary Artery Bypass / Q000009:adverse effects*; D004311:Double-Blind Method; D004562:Electrocardiography; D005060:Europe; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects*; D006801:Humans; D007194:India; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009656:North America; D011446:Prospective Studies; D011759:Pyrrolidines / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome
D000840:Anisoles; D000889:Anti-Arrhythmia Agents; D011759:Pyrrolidines; C524581:vernakalant