Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction – The DELIVER Trial

Presented at the ESC congress 2022 by: Prof. Scott Solomon, MD - Boston, MA, USA

Introduction and methods

DELIVER was a randomized, double-blind, placebo-controlled trial that investigated the efficacy and safety of dapagliflozin in patients with mildly reduced or preserved ejection fraction. Patients aged ≥40 years, NYHA class II-IV, LVEF >40%, structural heart disease and elevated natriuretic peptides were eligible. Special about DELIVER is that it enrolled both ambulatory and (recently) hospitalized patients and patients with previously reduced ejection fraction that had improved to >40%. A total of 6263 patients were randomized to receive either dapagliflozin, 10 mg once daily (n=3131) or placebo (n=3132). The primary composite endpoint was CV death, HF hospitalization or urgent HF visit. Median follow-up was 2.3 years.

Main results

• Dapagliflozin reduced the risk of the primary composite endpoint of CV death, HF hospitalization or urgent HF visit, compared to placebo (HR 0.82, 95% CI 0.73-0.92, P=0.0008, NNT=32).
• There was no evidence of attenuation of treatment benefit in patients with LVEF ≥60%. Results also did not vary between patients who were enrolled during or within 30 days of a HF hospitalization or later. The treatment effect was also similar in patients who had improved EF (prior EF ≤ 40%) and patients who had an EF consistently above 40%.
• The HRs of the components of the primary endpoint were HR 0.79 (95% CI 0.69-0.91) for worsening HF (HF hospitalization or urgent HF visit) and HR 0.88 (5% CI 0.74-1.05) for CV death.
• Key secondary outcomes of total HF hospitalizations and CV death (rate ratio 0.77, 95% CI 0.67-0.89), and total symptom burden (mean difference in KCCQ TSS 2.4, 95% CI 1.6-3.2) were also reduced.
• Safety outcomes were similar in the two treatment arms.

Conclusion

Dapagliflozin reduced risk of CV death or worsening HF in patients with HFmrEF or HFpEF, with no attenuation of treatment benefit in patients with the highest EF. Dapagliflozin was as effective in ambulatory and hospitalized patients and among patients with a prior EF ≤ 40% that had improved to >40%.

Prof. Solomon said: “these findings suggest that SGLT2i therapy should be foundational therapy in heart failure irrespective of ejection fraction”

-Our reporting is based on the information provided at the ESC Congress-

Watch a video about the DELIVER trial The results of this study were simultaneously published in N Engl J Med.