Heart failure & cardiomyopathies
Comparison of Investigator-Reported and Centrally Adjudicated Heart Failure Outcomes in the EMPEROR-Reduced Trial
Authors' conclusion
Investigator adjudication is an alternative to a CEC with similar accuracy and faster event accumulation. The use of granular (SCTI) criteria did not improve trial performance.
Study context
- Population
- Patients with chronic heart failure (HF) with reduced ejection fraction in the EMPEROR-Reduced trial
- Comparison
- Investigator-reported vs centrally adjudicated HF outcomes
- Primary endpoint
- Treatment effect on primary composite outcome:
- First HHF
- CV mortality
Primary result
As reported in the abstract
Primary composite outcome
| Group | HR for treatment effect |
|---|---|
| IR | 0.75 [95% CI: 0.66-0.85] |
| Clinical Events Committee (CEC) | 0.75 [95% CI: 0.65-0.86] |
HR for treatment effect
IR0.75 [95% CI: 0.66-0.85]
Clinical Events Committee (CEC)0.75 [95% CI: 0.65-0.86]
- CEC confirmed IR events for primary outcome
- 76.3%
- CEC confirmed IR CV mortality events
- 89.1%
- CEC confirmed IR hospitalization for heart failure (HHF) events
- 73.7%
Further findings
Prognosis after first HHF (all-cause mortality and CV mortality)
- Did not differ between IR or CEC
- IR primary HHF with different CEC primary cause had highest subsequent fatal event rate
SCTI criteria
- Full SCTI criteria present in CEC HHFs, with similar treatment effect to non-SCTI
- 90%
Time to protocol target number of primary events (841)
Months
- IR reached target earlier than CEC
- 3
- IR reached target earlier than CEC with full SCTI criteria
- 4
Original publication
Comparison of Investigator-Reported and Centrally Adjudicated Heart Failure Outcomes in the EMPEROR-Reduced Trial. JACC Heart Fail. Published 1 February 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →