DANISH
Trial question
What is the role of prophylactic ICD in patients with symptomatic systolic HF not caused by coronary artery disease?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
28.0% female
72.0% male
N = 1116
1116 patients (307 female, 809 male).
Inclusion criteria: patients with symptomatic systolic HF (LVEF ≤ 35%) not caused by coronary artery disease.
Key exclusion criteria: permanent AF with a resting HR > 100 beats/min or renal failure that was being treated with dialysis.
Interventions
N=556 ICD (ICD or a CRT pacemaker or CRT defibrillator).
N=560 control (usual clinical care).
Primary outcome
Rate of all-cause death at a median follow-up of 67.6 months
21.6%
23.4%
23.4 %
17.5 %
11.7 %
5.8 %
0.0 %
Implantable
cardioverter-defibrillator
Control
No significant
difference ↔
No significant difference in the rate of all-cause death at a median follow-up of 67.6 months (21.6% vs. 23.4%; HR 0.87, 95% CI 0.68 to 1.12).
Secondary outcomes
Significant decrease in SCD (4.3% vs. 8.2%; HR 0.5, 95% CI 0.31 to 0.82).
Safety outcomes
No significant differences in device infections (4.9% vs. 3.6%, p=0.29).
Significant differences in risk of device infection, among patients who were not receiving CRT (5.1% vs. 0.8%, p = 0.006; HR 6.35, 95% CI 1.38-58.87).
Conclusion
In patients with symptomatic systolic HF (LVEF ≤ 35%) not caused by coronary artery disease, ICD was not superior to control with respect to the rate of all-cause death at a median follow-up of 67.6 months.
Reference
Kober L, Thune JJ, Nielsen JC et al. Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure. N Engl J Med. 2016 Sep 29;375(13):1221-30.
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