Amiodarone in Patients with Congestive Heart Failure and Asymptomatic Ventricular Arrhythmia

doi:10.1056/NEJM199507133330201

Volume 333:77-82		July 13, 1995		Number 2

Amiodarone in Patients with Congestive Heart Failure and Asymptomatic Ventricular Arrhythmia

Steven N. Singh, Ross D. Fletcher, Susan Gross Fisher, Bramah N. Singh, H. Daniel Lewis, Prakash C. Deedwania, Barry M. Massie, Cindy Colling, Diane Lazzeri, for The Survival Trial of Antiarrhythmic Therapy in Congestive Heart Failure

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ABSTRACT

Background Asymptomatic ventricular arrhythmias in patientswith congestive heart failure are associated with increasedrates of overall mortality and sudden death. Amiodarone is nowused widely to prevent ventricular tachycardia and fibrillation.We conducted a trial to determine whether amiodarone can reduceoverall mortality in patients with congestive heart failureand asymptomatic ventricular arrhythmias.

Methods We used a double-blind, placebo-controlled protocolin which 674 patients with symptoms of congestive heart failure,cardiac enlargement, 10 or more premature ventricular contractionsper hour, and a left ventricular ejection fraction of 40 percentor less were randomly assigned to receive amiodarone (336 patients)or placebo (338 patients). The primary end point was overallmortality, and the median follow-up was 45 months (range, 0to 54).

Results There was no significant difference in overall mortalitybetween the two treatment groups (P = 0.6). The two-year actuarialsurvival rate was 69.4 percent (95 percent confidence interval,64.2 to 74.6) for the patients in the amiodarone group and 70.8percent (95 percent confidence interval, 65.7 to 75.9) for thosein the placebo group. At two years, the rate of sudden deathwas 15 percent in the amiodarone group and 19 percent in theplacebo group (P = 0.43). There was a trend toward a reductionin overall mortality among the patients with nonischemic cardiomyopathywho received amiodarone (P = 0.07). Amiodarone was significantlymore effective in suppressing ventricular arrhythmias and increasedthe left ventricular ejection fraction by 42 percent at twoyears.

Conclusions Although amiodarone was effective in suppressingventricular arrhythmias and improving ventricular function,it did not reduce the incidence of sudden death or prolong survivalamong patients with heart failure, except for a trend towardreduced mortality among those with nonischemic cardiomyopathy.

Source Information

From the Department of Cardiology, Veterans Affairs Medical Center, Washington, D.C. (S.N.S., R.D.F., D.L.); Veterans Affairs Cooperative Studies Coordinating Center, Hines, Ill., and Loyola University Medical Center, Maywood, Ill. (S.G.F.); the Department of Cardiology, Wadsworth Veterans Affairs Medical Center, Los Angeles (B.N.S.); the Department of Cardiology, Veterans Affairs Medical Center, Kansas City, Mo. (H.D.L.); the Department of Cardiology, Veterans Affairs Medical Center, Fresno, Calif. (P.C.D.); the Department of Cardiology, Veterans Affairs Medical Center, San Francisco (B.M.M.); and the Cooperative Studies Program, Veterans Affairs Medical Center, Albuquerque, N.M. (C.C.).

Address reprint requests to Dr. Singh at the Division of Cardiology, Veterans Affairs Medical Center 1E301, 50 Irving St., NW, Washington, DC 20422.

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