Heart failure & cardiomyopathiesSecondary analysis

New York Heart Association Functional Class and Implantable Cardioverter-Defibrillator in Non-Ischaemic Heart Failure with Reduced Ejection Fraction: Extended Follow-Up of the DANISH Trial

Eur J Heart FailPublished

  • Secondary analysis of the DANISH randomised trial
  • extended follow-up
  • subgroup analysis by New York Heart Association (NYHA) class

Authors' conclusion

In patients with non-ischaemic HFrEF, ICD implantation, compared with usual care, did not reduce the overall mortality rate, but it did reduce sudden cardiovascular death, regardless of baseline NYHA class.

Study context

Population
Patients with non-ischaemic heart failure with reduced ejection fraction (HFrEF)
Participants
1,116 patients
Comparison
Implantable cardioverter-defibrillator (ICD) implantation vs usual care, by NYHA class
Primary endpoint
All-cause mortality
Follow-up
Median 9.5 years

Primary result

As reported in the abstract

All-cause mortality, by NYHA class
ICD vs Usual careHR
all participants
0.89(95% CI 0.74–1.08)
NYHA class II
0.85(CI 0.64–1.13)
NYHA class III/IV
0.89(CI 0.69–1.14)

Further findings

OutcomeValuesHR
CV death, by NYHA class — ICD vs Usual care · all participants0.87 (95% CI 0.70–1.09)
CV death, by NYHA class — ICD vs Usual care · NYHA class II0.78 (CI 0.54–1.12)
CV death, by NYHA class — ICD vs Usual care · NYHA class III/IV0.89 (CI 0.67–1.19)
Sudden CV death, by NYHA class — ICD vs Usual care · all participants0.60 (95% CI 0.40–0.92)
Sudden CV death, by NYHA class — ICD vs Usual care · NYHA class II0.73 (CI 0.40–1.36)
Sudden CV death, by NYHA class — ICD vs Usual care · NYHA class III/IV0.52 (CI 0.29–0.94)
NYHA class III/IV vs II (prognosis) — NYHA III/IV vs NYHA II · all-cause mortality1.52 (95% CI 1.20–1.93)
NYHA class III/IV vs II (prognosis) — NYHA III/IV vs NYHA II · CV death1.95 (CI 1.47–2.60)
OutcomeValuesEstimate
Baseline NYHA class distributionNYHA II 53.5% · NYHA III 45.3% · NYHA IV 1.3%
  • CV death, by NYHA class: interaction P = 0.58
  • Sudden CV death, by NYHA class: interaction P = 0.39

Original publication

New York Heart Association Functional Class and Implantable Cardioverter-Defibrillator in Non-Ischaemic Heart Failure with Reduced Ejection Fraction: Extended Follow-Up of the DANISH Trial. Eur J Heart Fail. Published 11 May 2024. doi:10.1002/ejhf.3239

Summarised from the published abstract; every number is checked against it