DEFibrillators In Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE)

Area of Science:

• Cardiology
• Clinical Trials
• Medical Devices

Background:

• Non-ischemic cardiomyopathy (NICM) with reduced ejection fraction (
• Standard medical therapy for heart failure may not sufficiently mitigate sudden cardiac death risk in these patients.

Purpose of the Study:

• To evaluate the efficacy of implantable cardioverter defibrillators (ICDs) in reducing total mortality in patients with NICM.
• To assess the impact of ICDs on quality of life and healthcare costs in this population.

Main Methods:

• The DEFibrillators In Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) trial was a multi-center, randomized study.
• Patients with NICM, symptomatic heart failure, and documented arrhythmias were randomized to ICD or no ICD, alongside standard medical therapy.
• Follow-up was for 2-3 years, with total mortality as the primary endpoint.

Main Results:

• An estimated annual mortality of 15% at 2 years was projected for the no-ICD arm.
• ICDs were anticipated to reduce mortality by 50% in the target population.
• The study required approximately 229 patients per group for adequate statistical power.

Conclusions:

• ICDs represent a potential life-saving intervention for select patients with non-ischemic cardiomyopathy and high-risk arrhythmias.
• Further analysis of quality of life and pharmacoeconomics is crucial for comprehensive treatment evaluation.