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Amiodarone versus Implantable Defibrillator (AMIOVIRT): background, rationale, design, methods, results and
Mevan Wijetunga1, S Adam Strickberger,
1Division of Cardiology, Washington Hospital Center, Washington, DC, USA.
Cardiac Electrophysiology Review
|April 9, 2004
Summary
Amiodarone and implantable cardioverter-defibrillators (ICDs) showed similar survival benefits for non-ischemic dilated cardiomyopathy patients. Amiodarone trended towards better arrhythmia-free survival and lower costs, but quality of life was comparable.
Area of Science:
- Cardiology
- Electrophysiology
- Pharmacology
Background:
- Non-ischemic dilated cardiomyopathy (NIDCM) increases sudden cardiac death risk.
- The efficacy of implantable cardioverter-defibrillator (ICD) therapy for primary prevention in asymptomatic NIDCM patients remains unclear.
- Amiodarone offers potential survival benefits in NIDCM.
Purpose of the Study:
- To compare amiodarone versus ICD therapy in NIDCM patients with asymptomatic non-sustained ventricular tachycardia (NSVT) and LVEF ≤0.35.
- To evaluate differences in total mortality, arrhythmia-free survival, quality of life, and healthcare costs.
Main Methods:
- The Amiodarone versus Implantable Defibrillator (AMIOVIRT) study randomized 103 NIDCM patients to amiodarone (52) or ICD (51).
- The study was stopped early due to a futility stopping rule at the first interim analysis.
- Outcomes assessed included survival rates, arrhythmia occurrence, quality of life, and medical costs.
Main Results:
- No significant difference in 1- and 3-year survival rates between amiodarone and ICD groups (90% vs. 96% at 1 year; 87% vs. 88% at 3 years).
- A trend towards improved arrhythmia-free survival (p=0.1) and significantly lower medical costs (p=0.1) in the amiodarone group.
- Quality of life measures were not significantly different between groups at one year (p=0.1).
Conclusions:
- Amiodarone and ICD therapy demonstrated comparable survival rates in this NIDCM patient cohort.
- Amiodarone may offer advantages in arrhythmia control and cost-effectiveness, warranting further investigation.
- The study was limited by early termination due to futility.