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J Am Coll Cardiol, 2006; 47:2477-2482, doi:10.1016/j.jacc.2005.11.090
(Published online 25 May 2006). © 2006 by the American College of Cardiology Foundation |
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* Clinical Trials Unit, Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, the Division of Cardiology, Feinberg School of Medicine, Chicago, Illinois
University of North Carolina, Chapel Hill, North Carolina
Marshfield Clinic, Marshfield, Wisconsin
Heart Center, St. Francis Hospital, Roslyn, New York.
Manuscript received August 10, 2005; revised manuscript received October 12, 2005, accepted November 8, 2005.
* Reprint requests and correspondence: Dr. Alan H. Kadish, 251 East Huron Street, Feinberg Pavilion, Suite 8-536, Chicago, Illinois 60611. (Email: a-kadish{at}northwestern.edu).
OBJECTIVES: This study sought to determine whether the time from diagnosis to randomization was related to outcome in a clinical trial of implantable cardioverter-defibrillator (ICD) insertion in nonischemic cardiomyopathy.
BACKGROUND: Whether the duration of nonischemic cardiomyopathy is related to arrhythmic risk and the possible benefit of ICD insertion is unknown.
METHODS: The Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation (DEFINITE) trial randomized 458 patients with nonischemic dilated cardiomyopathy and a left ventricular ejection fraction <36% to receive standard medical therapy with or without an ICD. Patients were randomized regardless of the duration of known cardiomyopathy as long as a reversible cause of left ventricular dysfunction was not present. Patients were divided into recently and remotely diagnosed nonischemic cardiomyopathy groups based on the time from diagnosis of cardiomyopathy to randomization. To categorize patients, cut points of three and nine months were used.
RESULTS: Patients with recently diagnosed cardiomyopathy who received an ICD had better survival than those treated with standard therapy at both cut points. This difference in survival was significant at three months (p < 0.05) and was borderline significant at nine months (p = 0.058). Patients with remotely diagnosed cardiomyopathy did not have a significant survival benefit with ICD insertion, but there were no significant differences between ICD benefit in the recent and remote diagnosis groups (p = 0.17 and 0.25).
CONCLUSIONS: Patients who have a recent cardiomyopathy diagnosis do not have any less ICD benefit than those with a remote diagnosis. Thus, ICD therapy should be considered in such patients as soon as they are identified as long as a reversible cause of left ventricular dysfunction is excluded.
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