Key Points
• Source: JACC Heart Failure
• Conclusion: “In this study, the investigators had a similar accuracy in detecting treatment effect and HHF [first event hospitalization primarily for heart failure] events with comparable risk of fatal outcome compared to the CEC [Clinical Events Committee]—but with more rapid accumulation of primary outcome events. This suggests little benefit provided by a central adjudication process. Our data also indicate that the recently emerging approach of requiring granular criteria for an HF event definition is unnecessary, because this did not improve accuracy and may delay the accumulation of events to complete a trial.”
• In the current adjudication of the EMPORER-Reduced HF trial, U.S. and international researchers found that there was high concordance between CEC-adjudicated and investigator-reported events for CV death. Conversely, there was discordance in nearly one-quarter of HHF events
• Cause-specific events such as CV death and HHF in HF trials should be optimally assessed, per the researchers. HF patients often present with various comorbidities, which makes pinpointing the primary cause of death or hospitalization difficult.
• “Although there is interest in defining endpoints, including a recent focus on specific criteria for HHF, there have been few publications on the actual adjudication process itself, which includes the important question of whether the adjudication should be done on the data provided by investigator report or by a central adjudication committee,” the authors wrote.
• Limitations of the current study include variations in criteria for admission and care at various centers across the world and differences in clinical judgment with regard to HHF.