6/28/23, 1:14 AM DANISH Pathway Feedback Search Clinical Topics Home Studies DANISH DANISH Disease Disease Heart failure Ventricular arrhythmias 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 N = 1116 72.0% male 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 https://web.pathway.md/studies/recNwOrWTIay47g9I 1/2 6/28/23, 1:14 AM DANISH Pathway Rate of all-cause death at a median follow-up of 67.6 months 23.4 % 23.4 21.6 17.5 % 11.7 % 5.8 % No significant difference 0.0 % Implantable cardioverter-defibrillator Control 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 sudden cardiac death (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. Open reference URL https://web.pathway.md/studies/recNwOrWTIay47g9I 2/2