Clinical research
Amiodarone versus implantable cardioverter-defibrillator:randomized trial in patients with nonischemicdilated cardiomyopathy and asymptomaticnonsustained ventricular tachycardia—AMIOVIRT

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Abstract

Objectives

The purpose of this multicenter randomized trial was to compare total mortality during therapy with amiodarone or an implantable cardioverter-defibrillator (ICD) in patients with nonischemic dilated cardiomyopathy (NIDCM) and nonsustained ventricular tachycardia (NSVT).

Background

Whether an ICD reduces mortality more than amiodarone in patients with NIDCM and NSVT is unknown.

Methods

One hundred three patients with NIDCM, left ventricular ejection fraction ≤0.35, and asymptomatic NSVT were randomized to receive either amiodarone or an ICD. The primary end point was total mortality. Secondary end points included arrhythmia-free survival, quality of life, and costs.

Results

The study was stopped when the prospective stopping rule for futility was reached. The percent of patients surviving at one year (90% vs. 96%) and three years (88% vs. 87%) in the amiodarone and ICD groups, respectively, were not statistically different (p = 0.8). Quality of life was also similar with each therapy (p = NS). There was a trend with amiodarone, as compared to the ICD, towards improved arrhythmia-free survival (p = 0.1) and lower costs during the first year of therapy ($8,879 vs. $22,039, p = 0.1).

Conclusions

Mortality and quality of life in patients with NIDCM and NSVT treated with amiodarone or an ICD are not statistically different. There is a trend towards a more beneficial cost profile and improved arrhythmia-free survival with amiodarone therapy.

Abbreviations

CAD
coronary artery disease
ICD
implantable cardioverter-defibrillator
NIDCM
nonischemic dilated cardiomyopathy
NSVT
nonsustained ventricular tachycardia
SCD
sudden cardiac death
VF
ventricular fibrillation
VT
ventricular tachycardia

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This project was supported in part by an unrestricted research grant from the Guidant Corporation.