Heart failure & cardiomyopathies

Heart failure, peripheral artery disease, and dapagliflozin: a patient-level meta-analysis of DAPA-HF and DELIVER

Eur Heart JPublished Patient-level pooled meta-analysis of the DAPA-HF and DELIVER randomised trials

An erratum to this article was published (Eur Heart J, 1 Aug 2023 ↗)

Authors' conclusion

The risk of worsening HF or cardiovascular death was higher in patients with PAD, as was the risk of amputation. The benefits of dapagliflozin were consistent in patients with and without PAD, and dapagliflozin did not increase the risk of amputation.

Study context

Population
Patients with heart failure (HF) with reduced, mildly reduced or preserved EF, with or without PADPAD history available for 11,005
Participants
11,007 patients
Comparison
Dapagliflozin vs placebo, by PAD status
Outcome
Composite of:
  • Worsening HF
  • CV death
Follow-up
Median 22 months (IQR 17-30)
Methodological detailssubgroup analysis by PAD
  • Subgroup analysis by PAD

Pooled result

As reported in the abstract

Worsening HF or CV death, by PAD status (subgroups)
Dapagliflozin vs PlaceboHazard ratio (95% CI)
PAD
0.71(0.54–0.94)
No PAD
0.80(0.73–0.88)

Further pooled results

Per 100 person-years

OutcomePADNo PADAdjusted HR (95% CI)
Primary outcome rate, PADvs no PAD (per 100 person-years)15.1 (95% CI 13.1–17.3)10.6 (95% CI 10.2–11.1)1.23 (1.06–1.43)
  • Primary outcome rate, PAD vs no PAD (per 100 person-years): PAD in 809 of 11 005 (7.4%)

Safety

Amputation, by PAD status · value = PAD subgroup

No PAD

  • Amputation, by PAD status: interaction P = 1.00

Amputation, by PAD status

Amputations not more common with dapagliflozin irrespective of PAD status; infection rather than ischaemia main trigger

Original publication

Heart failure, peripheral artery disease, and dapagliflozin: a patient-level meta-analysis of DAPA-HF and DELIVER. Eur Heart J. Published 23 May 2023. doi:10.1093/eurheartj/ehad276

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