Portal de investigação
Comparison of Investigator-Reported and Centrally Adjudicated Heart Failure Outcomes in the EMPEROR-Reduced Trial
Data de publicação:
Data Ahead of Print:
Autores da FMUP
Participantes de fora da FMUP
- Carson, P
- Teerlink, JR
- Komajda, M
- Anand, I
- Anker, SD
- Butler, J
- Doehner, W
- Filippatos, G
- Haass, M
- Miller, A
- Pehrson, S
- Pocock, SJ
- Schnaidt, S
- Schnee, JM
- Zannad, F
- Packer, M
Unidades de investigação
Abstract
BACKGROUND There is limited published information on outcome adjudication in heart failure (HF). OBJECTIVES The authors sought to compare investigator reports (IRs) to a Clinical Events Committee (CEC) and the impact of SCTI (Standardized Clinical Trial Initiative) criteria.METHODS In the EMPEROR-Reduced trial, the authors compared IRs to the CEC for concordance; treatment effect on primary composite outcome events; and the components first event hospitalization primarily for HF or cardiovascular mortality (CVM), prognosis after hospitalization for heart failure (HHF), total HHFs, and trial duration with and without SCTI criteria.RESULTS The CEC confirmed 76.3% of IR events for the primary outcome (CVM: 89.1%; HHF: 73.7%). The HR for treatment effect did not differ between adjudication methods for the primary outcome (IR: 0.75 [95% CI: 0.66-0.85]; CEC: 0.75 [95% CI: 0.65-0.86]), its components, or total HHFs. The prognosis after first HHF for all-cause mortality and CVM also did not differ between IR or CEC. Interestingly, IR primary HHF with different CEC primary cause had the highest subsequent fatal event rate. Full SCTI criteria were present in 90% of CEC HHFs-with a similar treatment effect to non-SCTI. The IR primary event reached the protocol target number (841) 3 months earlier than CEC (4 months with full SCTI criteria). CONCLUSIONS 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. Finally, our data suggest that consideration be given to broadening the HHF definition to include "for or with" worsening disease. (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Reduced Ejection Fraction [EMPEROR-Reduced]; NCT03057977)(c) 2023 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Dados da publicação
- ISSN/ISSNe:
- 2213-1787, 2213-1779
- Tipo:
- Article
- Páginas:
- 407-417
- Link para outro recurso:
- www.scopus.com
JACC-HEART FAILURE Elsevier BV
Citações Recebidas na Web of Science: 1
Citações Recebidas na Scopus: 9
Documentos
- Não há documentos
Filiações
Keywords
- adjudication; empagliflozin; heart failure; investigator
Financiamento
Proyectos asociados
Dapagliflozin, Spironolactone or Both for HFpEF (SOGALDI-PEF) - NCT05676684
Investigador Principal: João Pedro Melo Marques Pinho Ferreira
Ensaio Clínico Académico (SOGALDI-PEF) . AstraZeneca . 2022
Citar a publicação
Carson P,Teerlink JR,Komajda M,Anand I,Anker SD,Butler J,Doehner W,Ferreira JP,Filippatos G,Haass M,Miller A,Pehrson S,Pocock SJ,Schnaidt S,Schnee JM,Zannad F,Packer M. Comparison of Investigator-Reported and Centrally Adjudicated Heart Failure Outcomes in the EMPEROR-Reduced Trial. JACC Heart Fail. 2023. 11. (4):p. 407-417. IF:13,000. (1).
