Title of Trial
Defibrillator in Acute Myocardial Infarction Trial

Date and Location of Presentation
March 8, 2004, American College of Cardiology Scientific Sessions

Purpose of the Trial
To determine if ICD improves survival in patients with acute myocardial infarction, ejection fraction less than or equal to 35%, and abnormal heart rate variability.

Study Categories
ICD and Sudden Cardiac Death

Patient Population
Patients with acute myocardial infarction, abnormal left ventricular function, and abnormal heart rate variability.

Inclusion Criteria
Myocardial infarction within 6-40 days, EF < 0.35, Abnormal Holter monitor heart rate variability with SDNN < 70ms or 24 hour mean RR < 750ms.

Exclusion Criteria
NYHA CHF Class IV, non-cardiac illness with expected survival < 2 years, CABG or 3V PTCA since MI, ICD indication

Study Design
Randomized multicenter trial. Randomization to 1) Optimal medical therapy, 2) Optimal medical therapy and ICD.

Primary Endpoint(s)
All-cause mortality

Secondary Endpoint(s)
Arrhythmic Death; Quality of Life assessment

Baseline Characteristics
Patient number: 674
Mean Age: 62 years
Other characteristics: EF: 27.9% ICD; 28.5% Control

Follow-up: 2.5 years

Results
No significant difference in survival in patients treated with ICD and compared to no ICD (7.5% vs. 6.9% all-cause mortality, hazard ratio 1.08, p=0.66). A significant reduction in arrhythmic death (1.5% ICD group vs. 3.5% no ICD group, hazard ratio 0.42, p=0.009) but increase in non arrhythmic death in ICD group compared to no ICD group (6.1% vs. 3.5%, hazard ratio 1.75, p=0.016).

Sponsor
National Institutes of Health; St. Jude

Trial Status: Completed

Review written by Paul J. Wang, MD