DEFINITE
Trial question
What is the role of prophylactic implantation of an ICD in patients with nonischemic dilated cardiomyopathy?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
29.0% female
71.0% male
N = 458
458 patients (132 female, 326 male).
Inclusion criteria: patients with nonischemic dilated cardiomyopathy, an LVEF < 36%, and premature ventricular complexes or nonsustained VT.
Key exclusion criteria: NYHA class IV congestive HF, had permanent pacemakers, in whom cardiac transplantation appeared to be imminent, familial cardiomyopathy associated with sudden death, and acute myocarditis or congenital heart disease.
Interventions
N=229 implantation of a cardioverter-defibrillator (plus standard medical therapy).
N=229 standard medical therapy alone (ACE inhibitors and β-blockers, in addition to digoxin and diuretics if necessary).
Primary outcome
Sudden death from arrhythmia
3
14
14.0
10.5
7.0
3.5
0.0
Implantation of a
cardioverter-defibrillator
Standard medical therapy
alone
Significant
decrease ▼
Significant decrease in sudden death from arrhythmia (3 vs. 14; HR 0.2, 95% CI 0.06 to 0.71).
Secondary outcomes
No significant difference in death (28 vs. 40; HR 0.65, 95% CI 0.4 to 1.06).
Conclusion
In patients with nonischemic dilated cardiomyopathy, an LVEF < 36%, and premature ventricular complexes or nonsustained VT, implantation of a cardioverter-defibrillator was superior to standard medical therapy alone with respect to sudden death from arrhythmia.
Reference
Kadish A, Dyer A, Daubert JP et al. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med. 2004 May 20;350(21):2151-8.
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