Eur J Heart Fail. 2022 May 23. doi: 10.1002/ejhf.2558. Online ahead of print.
ABSTRACT
AIMS: To report data from EMPEROR-Preserved according to prespecified endpoints of DELIVER.
METHODS AND RESULTS: To assess the impact of DELIVER-like definition on EMPEROR-Preserved outcomes, the following differences were reconciled: 1) primary outcome in DELIVER added urgent HF visits to cardiovascular death or HF hospitalizations; 2) 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 hours if intensification of treatment was not only oral diuretics; 3) DELIVER excluded undetermined causes of deaths from primary endpoint; 4) The composite renal endpoint in DELIVER included a sustained reduction of ≥50% eGFR and incorporated renal death; and 5): DELIVER will assess outcomes in the total population and in 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 (HR 0.76 [0.67, 0.87]; P<0.001). 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 [0.73, 1.07]). The RRR for the renal endpoint (changed from 22% in the overall population (HR 0.78; 95% CI, 0.54 to 1.13) to 40% when patients with EF <60% were assessed (P=0.037).
CONCLUSION: Findings from the EMPEROR-Preserved were modestly altered when analyzed using cardiovascular trial endpoint definitions of the DELIVER trial. For the composite renal endpoint, the effect of empagliflozin became statistically significant in patients with LVEF <60% using the DELIVER definition.
PMID:35604680 | DOI:10.1002/ejhf.2558
