CLINICAL RESEARCH
Amiodarone versus implantable cardioverter-defibrillator:randomized trial in patients with nonischemicdilated cardiomyopathy and asymptomaticnonsustained ventricular tachycardiaAMIOVIRT
S. Adam Strickberger, MD, FACC*,*,
John D. Hummel, MD, FACC ,
Thomas G. Bartlett, MD, FACC ,
Howard I. Frumin, MD, FACC ,
Claudio D. Schuger, MD, FACC||,
Scott L. Beau, MD, FACC¶,
Cynthia Bitar, RN#,
Fred Morady, MD, FACC# AMIOVIRT Investigators
* Washington Hospital Center, Washington, DC, USA
Mid-Ohio Cardiology Consultants, Columbus, Ohio, USA
Northwest Ohio Cardiology Consultants, Toledo, Ohio, USA
Northpointe Heart Center, Berkley, Michigan, USA
|| Henry Ford Hospital, Detroit, Michigan, USA
¶ Blandford Physician Center, Little Rock, Arkansas, USA
# University of Michigan, Ann Arbor, Michigan, USA
Manuscript received July 1, 2002;
revised manuscript received December 10, 2002,
accepted January 9, 2003.
* Reprint requests and correspondence: Dr. S. Adam Strickberger, Washington Hospital Center, 110 Irving Street, NW, #5A-12, Washington, DC 20010-3455, USA. strickberger{at}medstar.net
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.
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Abbreviations and Acronyms
| | 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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