Amiodarone or an Implantable Cardioverter-Defibrillator for Congestive Heart Failure

doi:10.1056/NEJMoa043399

A correction has been published: N Engl J Med 2005;352(20):2146.

Volume 352:225-237		January 20, 2005		Number 3

Amiodarone or an Implantable Cardioverter–Defibrillator for Congestive Heart Failure

Gust H. Bardy, M.D., Kerry L. Lee, Ph.D., Daniel B. Mark, M.D., Jeanne E. Poole, M.D., Douglas L. Packer, M.D., Robin Boineau, M.D., Michael Domanski, M.D., Charles Troutman, R.N., Jill Anderson, R.N., George Johnson, B.S.E.E., Steven E. McNulty, M.S., Nancy Clapp-Channing, R.N., M.P.H., Linda D. Davidson-Ray, M.A., Elizabeth S. Fraulo, R.N., Daniel P. Fishbein, M.D., Richard M. Luceri, M.D., John H. Ip, M.D., for the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators

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ABSTRACT

Background Sudden death from cardiac causes remains a leadingcause of death among patients with congestive heart failure(CHF). Treatment with amiodarone or an implantable cardioverter–defibrillator(ICD) has been proposed to improve the prognosis in such patients.

Methods We randomly assigned 2521 patients with New York HeartAssociation (NYHA) class II or III CHF and a left ventricularejection fraction (LVEF) of 35 percent or less to conventionaltherapy for CHF plus placebo (847 patients), conventional therapyplus amiodarone (845 patients), or conventional therapy plusa conservatively programmed, shock-only, single-lead ICD (829patients). Placebo and amiodarone were administered in a double-blindfashion. The primary end point was death from any cause.

Results The median LVEF in patients was 25 percent; 70 percentwere in NYHA class II, and 30 percent were in class III CHF.The cause of CHF was ischemic in 52 percent and nonischemicin 48 percent. The median follow-up was 45.5 months. There were244 deaths (29 percent) in the placebo group, 240 (28 percent)in the amiodarone group, and 182 (22 percent) in the ICD group.As compared with placebo, amiodarone was associated with a similarrisk of death (hazard ratio, 1.06; 97.5 percent confidence interval,0.86 to 1.30; P=0.53) and ICD therapy was associated with adecreased risk of death of 23 percent (0.77; 97.5 percent confidenceinterval, 0.62 to 0.96; P=0.007) and an absolute decrease inmortality of 7.2 percentage points after five years in the overallpopulation. Results did not vary according to either ischemicor nonischemic causes of CHF, but they did vary according tothe NYHA class.

Conclusions In patients with NYHA class II or III CHF and LVEFof 35 percent or less, amiodarone has no favorable effect onsurvival, whereas single-lead, shock-only ICD therapy reducesoverall mortality by 23 percent.

Source Information

From the Seattle Institute for Cardiac Research (G.H.B., C.T., J.A., G.J.) and the University of Washington, Seattle (J.E.P., D.P.F.); Duke University, Durham, N.C. (K.L.L., D.B.M., S.E.M., N.C.-C., L.D.D.-R., E.S.F.); the Mayo Clinic, Rochester, Minn. (D.L.P.), the National Heart, Lung, and Blood Institute, Bethesda, Md. (R.B., M.D.), Florida Arrhythmia Consultants, Fort Lauderdale, Fla. (R.M.L.), and Ingham Medical Center, Lansing, Mich. (J.H.I.).

Address reprint requests to Dr. Bardy at the Seattle Institute for Cardiac Research, 7900 East Greenlake Dr. North, No. 300, Seattle, WA 98103, or at gbardy{at}sicr.org.

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Implantable Cardioverter–Defibrillators
Mack M. J., Nash I., van Veldhuisen D. J., Voors A. A., Patwala A., Schlosshan D., Williams S. G., Bardy G. H., Lee K. L., Mark D. B., Kadish A. H., McClellan M. B., Tunis S. R.
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N Engl J Med 2005; 352:2022-2025, May 12, 2005. Correspondence

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