Cardiac resynchronisation therapy and implantable cardioverter-defibrillator in non-ischaemic systolic heart failure: extended follow-up of the DANISH trial

Abstract

Abstract Background In the Danish Study to Assess the Efficacy of Implantable Cardioverter-Defibrillators [ICDs] in Patients with Non-ischaemic Systolic Heart Failure on Mortality (DANISH) trial, ICD implantation did not provide an overall survival benefit in patients with non-ischaemic systolic heart failure. A high proportion of patients in the DANISH trial received a cardiac resynchronisation therapy (CRT) device, which improves the prognosis in patients with heart failure. Therefore, it is of interest to examine whether the effect of ICD implantation in patients with non-ischaemic systolic heart failure is modified by CRT. Purpose Adding 4 years of additional follow-up to the DANISH trial, we examined the effect of ICD implantation according to status with respect to CRT implantation at baseline. Methods In the DANISH trial, 556 patients with non-ischaemic systolic heart failure were randomised to receive an ICD and 560 to receive usual clinical care (control). Patients fulfilling indications for a CRT device received a CRT-defibrillator (if randomised to ICD arm) or CRT-pacemaker (if randomised to control arm). In the ICD group, 322 patients (57.9%) received a CRT device; in the control group, 323 patients (57.7%) received a CRT device. In this extended follow-up study, patients were followed until May 18, 2020. The primary outcome was death from any cause; secondary outcomes were cardiovascular death and sudden cardiovascular death. Results During a median follow-up of 9.5 years, the ICD group did not have significantly lower all-cause mortality compared with the control group (hazard ratio [HR] 0.89 [95% CI, 0.74–1.08]). The results were independent of whether the patient received a CRT device at randomisation (patients with a CRT device: HR 0.92 [95% CI, 0.72–1.18]; patients without a CRT device: HR 0.86 [95% CI, 0.64–1.14]; P for interaction, 0.72). Similarly, ICD implantation did not reduce rates of cardiovascular death overall (HR 0.87 [95% CI, 0.70–1.09]), and this association was not modified by CRT (patients with a CRT device: HR 0.89 [95% CI, 0.66–1.19]; patients without a CRT device: HR 0.85 [95% CI, 0.60–1.20]; P for interaction, 0.86). The ICD group had significantly lower rates of sudden cardiovascular death in the overall population (HR, 0.60 [95% CI, 0.40–0.92]), and this association was not modified by CRT (patients with a CRT device: HR 0.69 [95% CI, 0.40–1.21]; patients without a CRT device: HR 0.51 [95% CI, 0.26–0.97]; P for interaction, 0.47). See Figure 1 for all results. Conclusions In this extended follow-up study of the DANISH trial, the effect of ICD implantation in patients with non-ischaemic systolic heart failure was not modified by CRT. Funding Acknowledgement Type of funding sources: Foundation. Main funding source(s): The DANISH trial was supported by unrestricted grants from Medtronic, St Jude Medical, Tryg Fonden, and the Danish Heart Foundation. No further funding was obtained for this follow-up study.