Title of Trial
AMIOVIRT Trial (Amiodarone Versus Implantable Cardioverter-Defibrillator: Randomized Trial in Patients With Nonischemic Dilated Cardiomyopathy and Asymptomatic Nonsustained Ventricular Tachycardia)

Date and Location of Presentation
AHA 2000

Date and Citation of Primary Publication(s) or References
Journal of the American College of Cardiology 2003 May 21;41(10):1707-12

Purpose of the Trial
Nonischemic dilated cardiomyopathy patients with asymptomatic non-sustained VT are at high risk for sudden cardiac death. The efficacies of two treatment modalities, amiodarone and the ICD, in preventing sudden cardiac death in this patient population are compared.

Study Categories
ICD, SCD, Antiarrhythmic Drug

Patient Population
Non-ischemic dilated cardiomyopathy

Inclusion Criteria
Non-ischemic dilated cardiomyopathy; LVEF < 35%; asymptomatic NSVT; NYHA I, II, III; age > 18 yrs

Exclusion Criteria
Syncope; pregnancy; a contraindication to amiodarone or defibrillator therapy; concomitant therapy with a Class I antiarrhythmic drug

Study Design
Prospective, randomized, multicenter study

Primary Endpoint
Total mortality

Secondary Endpoints
SCD, non-SCD, non-cardiac death, syncope, arrhythmia-free survival, quality of life, and cost

Baseline Characteristics
Number of patients: 103
Mean Age: 60 ± 12 years (amio); 58 ± 11 yrs (ICD)
Gender: % female; 26% (amio); 33% (ICD)
Other characteristics
LVEF=0.23 ± 0.08 (amio), 0.22 ± 0.10 (ICD); NYHA Class II or III = 87% (amio), 80% (ICD); mean amiodarone dosage=303 ± 93mg/day

Years Follow-up:  2.0 ± 1.3 yrs

Results
Trial was terminated early because of the lack of a difference in mortality between the amiodarone and the ICD arms. The survival rates at 1 and 3 years were similar for the amiodarone and the ICD groups (90% vs 96% at 1 yr; 87% vs 88% at 3 yrs; p=0.8). There was no statistical difference in arrhythmia-free survival rates at 1 and 3 yrs between the amiodarone & the ICD groups (p=0.1). Quality of life assessment was similar for both groups. The total cost of medical care in the first year was 60% less with amiodarone (p=0.1).

Conclusion
In patients with NIDCM, LVEF < 0.35, and asymptomatic NSVT the total mortality rate at 3 years is similar whether they are treated with amiodarone or an ICD.

Sponsor
Pacesetter INC, Getz Brothers proprietary limited (Sydney Australia)

Trial Status: Completed

Review written by Sung Chun, M.D.