- Comment in:
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ACP J Club. 2004 Nov-Dec;141(3):61.
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N Engl J Med. 2004 May 20;350(21):2126-8.
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N Engl J Med. 2004 May 20;350(21):2193-5.
Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy.
Kadish A,
Dyer A,
Daubert JP,
Quigg R,
Estes NA,
Anderson KP,
Calkins H,
Hoch D,
Goldberger J,
Shalaby A,
Sanders WE,
Schaechter A,
Levine JH;
Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Investigators.
Clinical Cardiology Trials Office, Division of Cardiology, Department of Medicine, Northwestern University Medical School, Chicago, USA. a-kadish@northwestern.edu
BACKGROUND: Patients with nonischemic dilated cardiomyopathy are at substantial risk for sudden death from cardiac causes. However, the value of prophylactic implantation of an implantable cardioverter-defibrillator (ICD) to prevent sudden death in 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 ventricular tachycardia. A total of 229 patients were randomly assigned to receive standard medical therapy, and 229 to receive standard medical therapy plus a single-chamber ICD. RESULTS: Patients were followed for a mean (+/-SD) of 29.0+/-14.4 months. The mean left ventricular ejection fraction was 21 percent. The vast majority of patients were treated with angiotensin-converting-enzyme (ACE) inhibitors (86 percent) and beta-blockers (85 percent). There were 68 deaths: 28 in the ICD group, as compared with 40 in the standard-therapy group (hazard ratio, 0.65; 95 percent confidence interval, 0.40 to 1.06; P=0.08). The mortality rate at two years was 14.1 percent in the standard-therapy group (annual mortality rate, 7 percent) and 7.9 percent in the ICD group. There were 17 sudden deaths from arrhythmia: 3 in the ICD group, as compared with 14 in the standard-therapy group (hazard ratio, 0.20; 95 percent confidence interval, 0.06 to 0.71; P=0.006). CONCLUSIONS: In patients with severe, nonischemic dilated cardiomyopathy who were treated with ACE inhibitors and beta-blockers, the implantation of a cardioverter-defibrillator significantly reduced the risk of sudden death from arrhythmia and was associated with a nonsignificant reduction in the risk of death from any cause. Copyright 2004 Massachusetts Medical Society
PMID: 15152060 [PubMed - indexed for MEDLINE]