The DELIVER trial evaluated the effectiveness of dapagliflozin in reducing the risk of time to first worsening heart failure (HF) event or cardiovascular death in patients with HF with mildly reduced or preserved ejection fraction (EF). In this prespecified analysis, the objective was to assess the impact of dapagliflozin on total (i.e., first and recurrent) HF events and cardiovascular death in this population.
The study enrolled participants from August 2018 to December 2020, and data were analyzed from August to October 2022. The participants were randomly assigned to receive either dapagliflozin, 10 mg, once daily, or a matching placebo. The outcome measured was the total episodes of worsening HF (hospitalization for HF or urgent HF visit requiring intravenous HF therapies) and cardiovascular death.
Of the 6263 included patients, 2747 (43.9%) were women, and the mean (SD) age was 71.7 (9.6) years. The study found that dapagliflozin reduced the rate of total HF events (first and subsequent HF hospitalizations and urgent HF visits) and cardiovascular death, regardless of patient characteristics, including EF. The rate ratio for total HF events and cardiovascular death for dapagliflozin compared with placebo was 0.77 (95% CI, 0.67-0.89; P < .001) in the LWYY model, and 0.72 (95% CI, 0.65-0.81; P < .001) in the joint frailty model.
Patients with more HF events had features of more severe HF, such as higher N-terminal pro–B-type natriuretic peptide level, worse kidney function, more prior HF hospitalizations, and longer duration of HF, although EF was similar to those with no HF events. The results were similar for total HF hospitalizations (without urgent HF visits) and cardiovascular death and in all subgroups, including those defined by EF.
In summary, the DELIVER trial found that dapagliflozin reduced the rate of total HF events and cardiovascular death in patients with HF with mildly reduced or preserved EF, regardless of patient characteristics, including EF. The study used the proportional rates approach of Lin, Wei, Yang, and Ying (LWYY) and a joint frailty model to examine the effect of dapagliflozin on total HF events and cardiovascular death. The results were consistent across all subgroups, including those defined by EF.
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