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DEFibrillators In Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE)
Andi Schaechter1, Alan H Kadish,
1Division of Cardiology, Department of Medicine, Northwestern University Medical School, Chicago, IL, USA.
The DEFINITE trial evaluated implantable cardioverter defibrillators (ICDs) for non-ischemic cardiomyopathy. ICDs are expected to significantly reduce mortality in high-risk heart failure patients.
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.
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