CLINICAL RESEARCH: ATRIAL FIBRILLATION
The efficacy of azimilide in the treatment of atrial fibrillation in the presence of left ventricular systolic dysfunction
Results from the Azimilide Postinfarct Survival Evaluation (ALIVE) trial
Craig M. Pratt, MD, FACC*,*,
Steven N. Singh, MD, FACC ,
Hussein R. Al-Khalidi, PhD ,
Jose M. Brum, MD,
Michael J. Holroyde, PhD,
Stephen R. Marcello, MD, FACC,
Peter J. Schwartz, MD, FACC ,
A. John Camm, MD, FACC|| ALIVE Investigators
* The Methodist DeBakey Heart Center and Department of Medicine, Section of Cardiology, Baylor College of Medicine, Houston, Texas, USA
Department of Cardiology, Veterans Affairs Medical Center, Washington, DC, USA
Procter & Gamble Pharmaceuticals, Cincinnati, Ohio, USA
Department of Cardiology, Policlinico S. Matteo, IRRCS and University of Pavia, Italy
|| Department of Cardiology, St. George's Hospital, London, United Kingdom
Manuscript received June 23, 2003;
revised manuscript received October 1, 2003,
accepted October 20, 2003.
* Reprint requests and correspondence: Dr. Craig M. Pratt, Baylor College of Medicine, 6565 Fannin Street, F1001, Houston, Texas 77030, USA.
cpratt{at}bcm.tmc.edu
Presented as an abstract at the 75th Annual American Heart Association's Scientific Sessions, November 2002.
OBJECTIVES: The purpose of this study was to assess the effect of oral azimilide dihydrochloride (AZ) 100 mg versus placebo on the onset, termination, and prevalence of atrial fibrillation (AF) in a subpopulation of patients in the Azimilide Postinfarct Survival Evaluation (ALIVE) trial.
BACKGROUND: Previous clinical trials have demonstrated the antiarrhythmic effects of AZ in patients with AF. Azimilide was investigated for its effects on mortality in patients with depressed left ventricular (LV) function after recent myocardial infarction (MI) and in a subpopulation of patients with AF.
METHODS: A total of 3,381 post-MI patients with depressed LV function were enrolled in this randomized, placebo-controlled, double-blind study of AZ 100 mg on all-cause mortality. A total of 93 patients had AF on the baseline 12-lead electrocardiogram (ECG). An additional 27 patients developed AF after initially being in sinus rhythm at randomization. These patients were identified through 12-lead ECGs obtained during routine visits at week 2, months 1, 4, 8, and 12.
RESULTS: Patients with AF at baseline had a higher mortality than those without AF (p = 0.0006). Among AF patients, there was no difference in mortality between AZ patients and placebo patients (p = 0.82). Fewer AZ patients developed AF than placebo patients (p = 0.04). More AZ patients than placebo patients converted to sinus rhythm, but this difference did not achieve statistical significance (p = 0.076). Over one-year follow-up, more AZ patients were in sinus rhythm than placebo patients (p = 0.04).
CONCLUSIONS: Azimilide was safe and effective AF therapy in patients with depressed LV function after an MI.
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Abbreviations and Acronyms
| | AF | = atrial fibrillation | | ALIVE | = Azimilide Postinfarct Survival Evaluation | | AZ | = azimilide dihydrochloride | | CHF-STAT | = Survival Trial of Antiarrhythmic Therapy in Congestive Heart Failure | | CI | = confidence interval | | DIAMOND | = Danish Investigators of Arrhythmia and Mortality on Dofetilide trial | | HR | = hazard ratio | | LV | = left ventricle/left ventricular | | LVEF | = left ventricular ejection fraction | | MI | = myocardial infarction | | NYHA | = New York Heart Association |
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