Document Detail


Vernakalant hydrochloride for the rapid conversion of atrial fibrillation after cardiac surgery: a randomized, double-blind, placebo-controlled trial.
MedLine Citation:
PMID:  19948506     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Peter R Kowey; Paul Dorian; L Brent Mitchell; Craig M Pratt; Denis Roy; Peter J Schwartz; Jerzy Sadowski; Dorota Sobczyk; Andrzej Bochenek; Egon Toft;
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Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Circulation. Arrhythmia and electrophysiology     Volume:  2     ISSN:  1941-3084     ISO Abbreviation:  Circ Arrhythm Electrophysiol     Publication Date:  2009 Dec 
Date Detail:
Created Date:  2009-12-16     Completed Date:  2010-01-07     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101474365     Medline TA:  Circ Arrhythm Electrophysiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  652-9     Citation Subset:  IM    
Affiliation:
Division of Cardiovascular Disease, Lankenau Hospital and Institute of Medical Research, Wynnewood, PA 19096, USA. KoweyPR@MLHHeart.org
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00125320
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MeSH Terms
Descriptor/Qualifier:
Aged
Anisoles / administration & dosage*,  adverse effects
Anti-Arrhythmia Agents / administration & dosage*,  adverse effects
Argentina
Atrial Fibrillation / drug therapy*,  etiology,  physiopathology
Atrial Flutter / drug therapy*,  etiology,  physiopathology
Coronary Artery Bypass / adverse effects*
Double-Blind Method
Electrocardiography
Europe
Female
Heart Valve Prosthesis Implantation / adverse effects*
Humans
India
Infusions, Intravenous
Male
Middle Aged
North America
Prospective Studies
Pyrrolidines / administration & dosage*,  adverse effects
Time Factors
Treatment Outcome
Chemical
Reg. No./Substance:
0/Anisoles; 0/Anti-Arrhythmia Agents; 0/Pyrrolidines; 0/vernakalant
Investigator
Investigator/Affiliation:
P Dorian / ; P Kowey / ; L B Mitchell / ; C Pratt / ; D Roy / ; P Schwartz / ; E Toft / ; J Camm / ; D DeMets / ; L Køber / ; J Y Le Heuzey / ; A Waldo / ; K Egstrup / ; L Erhardt / ; M Hamer / ; E Pritchett / ; Blumberg / ; Figal / ; Giniger / ; Lolo / ; Rabinovich / ; Basta / ; Connolly / ; Coutu / ; Dorian / ; Green / ; Mitchell / ; Phaneuf / ; Talajic / ; Aggestrup / ; Andersen / ; Jorgensen / ; Olsen / ; Kler / ; Kumar / ; Mahant / ; Nair / ; Rajan / ; Rane / ; Rani / ; Gerometta / ; Iliceto / ; Minzioni / ; Schwartz / ; Banach / ; Bochenek / ; Sadowski / ; Stepinska / ; Zembala / ; Boylan / ; Ferdinand / ; Gellman / ; Ip / ; Levy / ; Lowe / ; Niazi / ; Pollak / ; Roth / ; Vidaillet /

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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