Key result
ICD therapy did not significantly reduce all-cause mortality in patients with diabetes and non-ischaemic systolic heart failure (HR 0.92; 95% CI 0.57-1.50), with no significant interaction by diabetes status (Pinteraction=0.60).
Why the study?
ICD implantation reduces sudden cardiac death but not all-cause death in non-ischaemic systolic heart failure, but whether diabetes affects ICD treatment effects is unclear.
Does implantable cardioverter-defibrillator (ICD) implantation reduce all-cause death, cardiovascular death, and sudden cardiac death in patients with diabetes and non-ischaemic systolic heart failure?
RCT (n=1,116)
Does implantable cardioverter-defibrillator (ICD) implantation reduce all-cause death, cardiovascular death, and sudden cardiac death in patients with diabetes and non-ischaemic systolic heart failure?
Effect estimate: HR 0.92 (95% CI 0.57-1.50)
p-value: p=0.60
In patients with non-ischaemic systolic heart failure, the presence of diabetes does not significantly modify the treatment effect of ICD therapy on mortality outcomes, though the analysis may be underpowered.
ICD should not yet change practice in diabetic non-ischaemic systolic HF; leaves open mortality benefit in larger cohorts.
AIMS: Implantable cardioverter-defibrillator (ICD) implantation reduce the risk of sudden cardiac death, but not all-cause death in patients with non-ischaemic systolic heart failure (HF). Whether co-existence of diabetes affects ICD treatment effects is unclear. METHODS AND RESULTS: We examined the effect of ICD implantation on risk of all-cause death, cardiovascular death, and sudden cardiac death (SCD) according to diabetes status at baseline in the Danish Study to Assess the Efficacy of ICDs in Patients with Non-ischaemic Systolic Heart Failure on Mortality (DANISH) trial. Outcomes were analysed by use of cumulative incidence curves and Cox regressions models. Of the 1116 patients enrolled, 211 (19%) had diabetes at baseline. Patients with diabetes were more obese, had worse kidney function and more were in New York Heart Association Class III/IV. The risk of device infections and other complications in the ICD group was similar among patients with and without diabetes (6.1% vs. 4.6% P = 0.54). Irrespective of treatment group, diabetes was associated with higher risk of all-cause death, cardiovascular death, and SCD. The treatment effect of ICD in patients with diabetes vs. patients without diabetes was hazard ratio (HR) = 0.92 (0.57-1.50) vs. HR = 0.85 (0.63-1.13); Pinteraction = 0.60 for all-cause mortality, HR = 0.99 (0.58-1.70) vs. HR = 0.70 (0.48-1.01); Pinteraction = 0.25 for cardiovascular death, and HR = 0.81 (0.35-1.88) vs. HR = 0.40 (0.22-0.76); Pinteraction = 0.16 for sudden cardiac death. CONCLUSION: Among patients with non-ischaemic systolic HF, diabetes was associated with higher incidence of all-cause mortality, primarily driven by cardiovascular mortality including SCD. Treatment effect of ICD therapy was not significantly modified by diabetes which might be due to lack of power.
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Rørth et al. (2019) conducted an RCT in non-ischaemic systolic heart failure (n=1,116). Implantable cardioverter-defibrillator (ICD) vs. Control (no ICD) was evaluated on all-cause mortality (HR 0.92, 95% CI 0.57-1.50, p=0.60). ICD therapy did not significantly reduce all-cause mortality in patients with diabetes and non-ischaemic systolic heart failure (HR 0.92; 95% CI 0.57-1.50), with no significant interaction by diabetes status (Pinteraction=0.60).
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