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DEFibrillators In Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE)

  • Published:
Cardiac Electrophysiology Review

Abstract

The DEFibrillators In Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) was a multi-center, randomized, investigator-initiated trial. Patients enrolled in the trial had non-ischemic cardiomyopathy (LVEF ≤35%), a history of symptomatic heart failure and spontaneous arrhythmia (>10 PVCs/hr or non-sustained ventricular tachycardia defined as 3 to 15 beats at a rate of >120 bpm) on Holter monitor or telemetry within the past 6 months. All patients received standard oral medical therapy for heart failure including angiotensin converting enzyme inhibitors and beta-blockers. Patients were randomized to implantable cardioverter defibrillator (ICD) versus no ICD. Patients were followed for 2 to 3 years. The primary endpoint was total mortality. Quality of life and pharmacoeconomics analysis was also performed. A registry tracked patients who met basic inclusion criteria but were not randomized. We estimated an annual total mortality of 15% at 2 years in the treatment arm that did not receive an ICD. The ICD was expected to reduce mortality by 50%. Approximately 229 patients were required in each treatment group. Forty-five centers were included in this trial that was designed to last an estimated 4 years. Enrollment was projected to occur over 2 1/2 years with a post enrollment follow-up of 1 1/2 years.

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Authors and Affiliations

  1. Division of Cardiology, Department of Medicine, Northwestern University Medical School, Chicago, IL, USA

    Andi Schaechter & Alan H. Kadish

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  1. Andi Schaechter
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  2. Alan H. Kadish
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Schaechter, A., Kadish, A.H. DEFibrillators In Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE). Card Electrophysiol Rev 7, 457–462 (2003). https://doi.org/10.1023/B:CEPR.0000023162.45506.c4

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  • DOI: https://doi.org/10.1023/B:CEPR.0000023162.45506.c4

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