Prophylactic Defibrillator Implantation in Patients with Nonischemic Dilated Cardiomyopathy
Alan Kadish, M.D., Alan Dyer, Ph.D., James P. Daubert, M.D., Rebecca Quigg, M.D., N.A. Mark Estes, M.D., Kelley P. Anderson, M.D., Hugh Calkins, M.D., David Hoch, M.D., Jeffrey Goldberger, M.D., Alaa Shalaby, M.D., William E. Sanders, M.D., Andi Schaechter, B.S.N., R.N., Joseph H. Levine, M.D., for the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Investigators
Background Patients with nonischemic dilated cardiomyopathyare at substantial risk for sudden death from cardiac causes.However, the value of prophylactic implantation of an implantablecardioverterdefibrillator (ICD) to prevent sudden deathin such patients is unknown.
Methods We enrolled 458 patients with nonischemic dilated cardiomyopathy,a left ventricular ejection fraction of less than 36 percent,and premature ventricular complexes or nonsustained ventriculartachycardia. A total of 229 patients were randomly assignedto receive standard medical therapy, and 229 to receive standardmedical therapy plus a single-chamber ICD.
Results Patients were followed for a mean (±SD) of 29.0±14.4months. The mean left ventricular ejection fraction was 21 percent.The vast majority of patients were treated with angiotensin-convertingenzyme(ACE) inhibitors (86 percent) and beta-blockers (85 percent).There were 68 deaths: 28 in the ICD group, as compared with40 in the standard-therapy group (hazard ratio, 0.65; 95 percentconfidence interval, 0.40 to 1.06; P=0.08). The mortality rateat two years was 14.1 percent in the standard-therapy group(annual mortality rate, 7 percent) and 7.9 percent in the ICDgroup. There were 17 sudden deaths from arrhythmia: 3 in theICD group, as compared with 14 in the standard-therapy group(hazard ratio, 0.20; 95 percent confidence interval, 0.06 to0.71; P=0.006).
Conclusions In patients with severe, nonischemic dilated cardiomyopathywho were treated with ACE inhibitors and beta-blockers, theimplantation of a cardioverterdefibrillator significantlyreduced the risk of sudden death from arrhythmia and was associatedwith a nonsignificant reduction in the risk of death from anycause.
Source Information
From the Clinical Cardiology Trials Office, Division of Cardiology, Department of Medicine, Northwestern University Medical School, Chicago (A.K., A.D., R.Q., J.G., A. Schaechter); the University of Rochester Medical Center, Rochester, N.Y. (J.P.D.); New England Medical Center, Boston (N.A.M.E.); Marshfield Clinic, Marshfield, Wisc. (K.P.A.); Johns Hopkins Hospital, Baltimore (H.C.); St. Francis Hospital, Roslyn, N.Y. (D.H., J.H.L.); the University of North Carolina at Chapel Hill, Chapel Hill (W.E.S.); and the Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (A. Shalaby).
Address reprint requests to Dr. Kadish at 251 E. Huron, Feinberg 8-536, Chicago, IL 60611, or at a-kadish{at}northwestern.edu.
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