Amiodarone versus implantable cardioverter-defibrillator:randomized trial in patients with nonischemic dilated cardiomyopathy and asymptomatic nonsustained ventricular tachycardia--AMIOVIRT.
OBJECTIVE
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 < or =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 US dollars vs. $22,039 US dollars, 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.
Strickberger
S Adam
SA
Washington Hospital Center, 110 Irving Street NW, #5A-12, Washington, DC 20010-3455, USA. strickberger@medstar.net
Hummel
John D
JD
Bartlett
Thomas G
TG
Frumin
Howard I
HI
Schuger
Claudio D
CD
Beau
Scott L
SL
Bitar
Cynthia
C
Morady
Fred
F
D000638:Amiodarone / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D000889:Anti-Arrhythmia Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D002311:Cardiomyopathy, Dilated / Q000150:complications* / Q000191:economics / Q000401:mortality; D003365:Costs and Cost Analysis; D017147:Defibrillators, Implantable / Q000009:adverse effects / Q000191:economics; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D015996:Survival Rate; D017180:Tachycardia, Ventricular / Q000150:complications / Q000191:economics / Q000401:mortality / Q000517:prevention & control*
D000889:Anti-Arrhythmia Agents; D000638:Amiodarone