Key result
Empagliflozin cuts CV death or worsening heart failure events ~24% vs. placebo in HFpEF.
Why the study?
The study was conducted to report data from EMPEROR-Preserved according to the prespecified endpoint definitions of the DELIVER trial.
Does empagliflozin reduce the composite of cardiovascular death, HF hospitalizations, or urgent HF visits in patients with heart failure with preserved ejection fraction when using DELIVER-like endpoint definitions?
RCT (n=5,988)
Double-blind
Randomized
Yes
Does empagliflozin reduce the composite of cardiovascular death, HF hospitalizations, or urgent HF visits in patients with heart failure with preserved ejection fraction when using DELIVER-like endpoint definitions?
Applying DELIVER trial endpoint definitions to the EMPEROR-Preserved trial modestly altered the findings, with the composite renal endpoint becoming statistically significant in patients with EF <60%.
Harmonized endpoints confirm empagliflozin efficacy in HFpEF; leaves open renal outcome effects in broader EF ranges.
AIMS: To report data from EMPEROR-Preserved according to prespecified endpoints of DELIVER. METHODS AND RESULTS: In order to assess the impact of DELIVER-like definition on EMPEROR-Preserved outcomes, the following differences were reconciled: (1) the primary outcome in DELIVER added urgent heart failure (HF) visits to cardiovascular death or HF hospitalizations; (2) the EMPEROR-Preserved trial did not require documentation of physical findings or laboratory tests for confirming a HF hospitalization and it included events of 12-24 h if intensification of treatment was not only oral diuretics; (3) DELIVER excluded undetermined causes of deaths from the primary endpoint; (4) the composite renal endpoint in DELIVER included a sustained ≥50% decline in estimated glomerular filtration rate and incorporated renal death; and (5) DELIVER will assess outcomes in the overall population and in patients with ejection fraction (EF) <60% separately. Using the endpoint definitions from DELIVER, the primary outcome overall occurred in 13.1% in the empagliflozin and 16.8% in the placebo group (hazard ratio [HR] 0.76, 95% confidence interval [CI] 0.67-0.87; p < 0.0001). The relative risk reduction (RRR) changed from 21% to 24% when urgent HF visits were added, and undetermined death was eliminated. Compared to overall population RRR of 24%, it was 28% in patients with EF <60%. Death from cardiovascular causes excluding undetermined causes occurred in 6.2% in the empagliflozin and in 7.1% in the placebo group (HR 0.88, 95% CI 0.73-1.07). The RRR for the composite renal endpoint changed from 22% in the overall population (HR 0.78, 95% CI 0.54-1.13) to 40% when patients with EF <60% were assessed (p = 0.037). CONCLUSION: Findings from EMPEROR-Preserved were modestly altered when analysed using cardiovascular trial endpoint definitions of the DELIVER trial. For the composite renal endpoint, the effect of empagliflozin became statistically significant in patients with EF <60% using the DELIVER definition.
No takes yet. Share an insight, caveat, or question.
Anker et al. (2022) conducted an RCT in Heart failure with preserved ejection fraction (HFpEF) (n=5,988). Empagliflozin vs. Placebo was evaluated on Composite of cardiovascular death or worsening HF events (hospitalization for HF or urgent HF visit requiring intravenous therapy) using DELIVER definitions (HR 0.76, 95% CI 0.67-0.87, p=<0.0001). Using DELIVER trial endpoint definitions, empagliflozin significantly reduced the risk of cardiovascular death or worsening heart failure events by 24% (HR 0.76) compared to placebo in HFpEF.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: