Comparison of Investigator-Reported and Centrally Adjudicated Heart Failure Outcomes in the EMPEROR-Reduced Trial.

Autor:	Carson P; Rehoboth Beach, Delaware, USA. Electronic address: petercarson@mac.com., Teerlink JR; University of California San Francisco Medical Center, San Francisco, California, USA., Komajda M; Institut de Cardiologie, Boulevard de Hôpital, Paris, France., Anand I; University of Minnesota Medical School, Minneapolis, Minnesota, USA; Veterans Affairs Medical Center, La Jolla, California, USA., Anker SD; Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research partner site, Berlin, Germany; Charité Universitätsmedizin Berlin, Berlin, Germany; Institute of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland., Butler J; Baylor Scott and White Health, Dallas, Texas, USA; University of Mississippi School of Medicine, Jackson, Mississippi, USA., Doehner W; Charite Universitätsmedizin Berlin Campus Virchow-Medical Center, Berlin, Germany., Ferreira JP; Université de Lorraine, Nancy, France., Filippatos G; National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens, Greece., Haass M; Theresienkrankenhaus, Mannheim, Germany., Miller A; University of Florida Health, Jacksonville, Florida, USA., Pehrson S; University Hospital Rigshospitalet, Blegdamsvej, Copenhagen, Denmark., Pocock SJ; London School of Hygiene and Tropical Medicine, London, United Kingdom., Schnaidt S; Boehringer Ingelheim Pharma GmbH and Co KG, Biberach, Germany., Schnee JM; Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut, USA., Zannad F; Université de Lorraine, Nancy, France., Packer M; Baylor Heart and Vascular Institute, Dallas, Texas, USA; Imperial College, London, United Kingdom.
Jazyk:	angličtina
Zdroj:	JACC. Heart failure [JACC Heart Fail] 2023 Apr; Vol. 11 (4), pp. 407-417. Date of Electronic Publication: 2023 Feb 01.
DOI:	10.1016/j.jchf.2022.11.017
Abstrakt:	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). Competing Interests: Funding Support and Author Disclosures The EMPEROR-Reduced trial was funded by the Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance. Dr Carson has received consulting fees from Boehringer Ingelheim and IQVIA related to work on the Clinical Events Committee during the conduct of the study. Dr Teerlink has received research support and/or has been a consultant for Amgen, AstraZeneca, Bayer AG, Boehringer Ingelheim, Bristol Myers Squibb, Cytokinetics, Medtronic, Merck, Novartis, Servier, and Windtree Therapeutics. Dr Komajda has received consulting fees from Boehringer Ingelheim related to work on the Clinical Events Committee during the conduct of the study and personal fees from Novartis, Servier, Amgen, Sanofi, Bayer, AstraZeneca, Lilly, and Torrent. Dr Anand has received consulting fees from Boehringer Ingelheim related to work on the Clinical Events Committee during the conduct of the study and personal fees from Novartis, Servier, Amgen, Sanofi, Bayer, AstraZeneca, Lilly, and Torrent. Dr Anker has received grants and personal fees from Vifor International and Abbott Vascular; personal fees from AstraZeneca, Bayer, Brahms, Boehringer Ingelheim, Cardiac Dimensions, Novartis, Occlutech, Servier, and Vifor International; and is a Trial Executive Committee member of the Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance (trial sponsor). Dr Butler has received consulting fees from Boehringer Ingelheim, Cardior, CVRx, Foundry, G3 Pharma, Imbria, Impulse Dynamics, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Merck, Novartis, Novo Nordisk, Relypsa, Roche, Sanofi, Sequana Medical, VWave Ltd, and Vifor; and is a Trial Executive Committee member of the Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance (trial sponsor). Dr Doehner has received consulting fees from Boehringer Ingelheim related to work on the Clinical Events Committee during the conduct of the study; personal fees from Aimediq, Bayer, Boehringer Ingelheim, Medtronic, Pfizer, Sanofi-Aventis, Sphingotec, Vifor Pharma; and research support from the European Union (Horizon2020), German ministry of Education and Research, German Center for Cardiovascular Research, Vifor Pharma, and ZS Pharma. Dr Ferreira has received consulting fees from Boehringer Ingelheim and is a Trial Executive Committee member of Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance (trial sponsor). Dr Filippatos has received lecture fees and/or committee member contributions in clinical trials sponsored by Bayer, Medtronic, Vifor, Servier, Novartis, and Amgen; research support from the European Union; and is a Trial Executive Committee member of the Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance (trial sponsor). Dr Haass has received consulting fees from Boehringer Ingelheim related to work on the Clinical Events Committee during the conduct of the study. Dr Miller has received consulting fees from Abbott, Boehringer Ingelheim, Respicardia, CVRx, Pfizer, and AbbVie. Dr Pehrson has received consulting fees and/or lecture fees from Boehringer Ingelheim, GlaxoSmithKline, Celgene, Bristol Myers Squibb, Bayer, and Johnson & Johnson. Dr Pocock has received consulting fees and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from Boehringer Ingelheim; and is a Trial Executive Committee member of Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance (trial sponsor). Mr Schnaidt and Dr Schnee are employees of Boehringer Ingelheim. Dr Zannad has recently received Steering Committee or Advisory Board fees from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Cardior, CVRx, Janssen, Livanova, Merck, Mundipharma, Novartis, Novo Nordisk, and Vifor Fresenius; and is a Trial Executive Committee member of the Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance (trial sponsor). Dr Packer has received consulting fees from AbbVie, Actavis, Amgen, Amarin, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Casana, CSL Behring, Cytokinetics, Johnson & Johnson, Eli Lilly and Company, Moderna, Novartis, ParatusRx, Pfizer, Relypsa, Salamandra, Synthetic Biologics, and Theravance; and is a Trial Executive Committee member of Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance (trial sponsor). (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
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