Key result
ICD implantation fails to reduce all-cause mortality versus usual care in non-ischemic HFrEF.
Why the study?
Patients with HF and COPD may face increased risks of competing non-arrhythmic causes of death, and the effect of ICD implantation according to baseline COPD status over extended follow-up required examination.
Does primary-prevention ICD implantation reduce all-cause mortality in patients with non-ischemic HFrEF, and is this effect modified by baseline COPD status?
RCT (n=1,116)
Does primary-prevention ICD implantation reduce all-cause mortality in patients with non-ischemic HFrEF, and is this effect modified by baseline COPD status?
Effect estimate: HR 0.89 (95% CI 0.74-1.08)
In an extended 9.5-year follow-up of the DANISH trial, primary-prevention ICDs reduced sudden cardiovascular death but not all-cause mortality in non-ischemic HFrEF, regardless of baseline COPD status.
Primary-prevention ICDs confer no all-cause mortality benefit in non-ischaemic HFrEF regardless of COPD; confirms consensus from prior RCTs and extends follow-up.
Background Patients with heart failure (HF) and chronic obstructive pulmonary disease (COPD) generally have a greater symptom burden and worse clinical outcomes than those with HF without COPD. Patients with HF and COPD may therefore have an increased risk of competing causes of death to arrhythmic death. In the Danish Study to Assess the Efficacy of Implantable Cardioverter Defibrillators (ICDs) in Patients with Non-ischaemic Systolic HF on Mortality (DANISH) trial, ICD implantation did not provide an overall survival benefit in patients with non-ischaemic HF with reduced ejection fraction (HFrEF). Purpose Adding four years of additional follow-up to the DANISH trial, we examined the effect of ICD implantation according to COPD status at baseline. Methods In the DANISH trial, 1,116 patients with non-ischaemic HFrEF were randomised to receive an ICD (N=556, ICD group) or usual clinical care (N=560, control group). The primary outcome was death from any cause. Outcomes were analysed according to COPD status at baseline. Results Data on COPD status were available for 1,104 patients, and 135 patients (12%) had COPD. During a median follow-up of 9.5 years, compared with usual clinical care, ICD implantation did not reduce the rate of death from any cause (HR 0.89 [95% CI, 0.74-1.08]), and the results were independent of COPD status at baseline (no COPD: HR 0.97 [95% CI, 0.79-1.20]; COPD: HR 0.72 [95% CI, 0.42-1.21]; P for interaction, 0.21). Similarly, ICD implantation did not reduce the rate of cardiovascular death (overall: HR 0.87 [95% CI, 0.70-1.09]; no COPD: HR 0.97 [95% CI, 0.76-1.24]; COPD: HR 0.66 [95% CI, 0.34-1.28]; P for interaction, 0.15). Finally, baseline COPD status did not modify the beneficial effects of ICD implantation on sudden cardiovascular death (overall: HR 0.60 [95% CI, 0.40-0.92]; no COPD: HR 0.62 [95% CI, 0.39-0.99]; COPD: HR 0.55 [95% CI, 0.18-1.65]; P for interaction, 0.77). See Figure for results. Conclusions In an extended follow-up study of the DANISH trial, primary-prevention ICD implantation did not reduce all-cause mortality, but it did reduce sudden cardiovascular death, in patients with non-ischaemic HFrEF regardless of COPD status at baseline.
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Yafasova et al. (2025) conducted an RCT in non-ischaemic heart failure with reduced ejection fraction (HFrEF) (n=1,116). Implantable Cardioverter Defibrillator (ICD) vs. usual clinical care was evaluated on death from any cause (HR 0.89, 95% CI 0.74-1.08). ICD implantation did not reduce the rate of death from any cause compared with usual clinical care in patients with non-ischaemic HFrEF (HR 0.89; 95% CI 0.74-1.08), regardless of COPD status.
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