DINAMIT
Trial question
What is the role of ICD therapy in patients with acute MI who had reduced LV function and impaired cardiac autonomic function?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
24.0% female
76.0% male
N = 674
674 patients (160 female, 514 male).
Inclusion criteria: patients with acute MI who had reduced LV function and impaired cardiac autonomic function.
Key exclusion criteria: congestive HF; noncardiac disease that limited life expectancy; name on a waiting list for a heart transplant; current, ongoing ICD therapy; prior implantation of a permanent pacemaker; requirement for an ICD.
Interventions
N=332 implantation of a cardioverter-defibrillator (plus standard medical therapy).
N=342 standard medical therapy alone (no ICD).
Primary outcome
Incidence of death from any cause
7.5% / y
6.9% / y
7.5 % / y
5.6 % / y
3.8 % / y
1.9 % / y
0.0 % / y
Implantation of a
cardioverter-defibrillator
Standard medical therapy
alone
No significant
difference ↔
No significant difference in the incidence of death from any cause (7.5% / y vs. 6.9% / y; HR 1.08, 95% CI 0.76 to 1.55).
Secondary outcomes
Significant decrease in the incidence of death due to arrhythmia (1.5% / y vs. 3.5% / y; HR 0.42, 95% CI 0.22 to 0.83).
Significant increase in the incidence of death from nonarrhythmic causes (6.1% / y vs. 3.5% / y; HR 1.75, 95% CI 1.11 to 2.76).
Conclusion
In patients with acute MI who had reduced LV function and impaired cardiac autonomic function, implantation of a cardioverter-defibrillator was not superior to standard medical therapy alone with respect to the incidence of death from any cause.
Reference
Hohnloser SH, Kuck KH, Dorian P et al. Prophylactic use of an implantable cardioverter-defibrillator after acute myocardial infarction. N Engl J Med. 2004 Dec 9;351(24):2481-8.
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