An updated chapter on the high bleeding risk (HBR) patient

The PCR-EAPCI Textbook

Summary

Patients at high bleeding risk (HBR) comprise a growing subgroup of patients undergoing PCI. Nonetheless, such patients have historically been excluded from or under-represented in clinical trials in PCI patients. Moreover, completed and ongoing trials aiming to enrol HBR patients use heterogeneous definitions of HBR, limiting the interpretation and comparison of results. To address this issue, the Academic Research Consortium for high bleeding risk (ARC-HBR) proposed a standardised definition of HBR patients intended for use in trials of HBR patients undergoing PCI.

Using a cut-off of BARC 3-5 bleeding of ≥4% or intracranial haemorrhage of ≥1% at one year to denote major bleeding, a list of binary major and minor HBR criteria were created based on consensus and review of the available evidence. The criteria are pragmatic, objective, and comprehensive to both trialists, physicians and patients.

The definition is intended to provide consistency in defining the HBR population for clinical trials, to complement regulatory review and ultimately, clinical decision-making. The proposed ARC-HBR consensus definition represents the first pragmatic approach to a consistent definition of HBR in clinical trials evaluating safety and effectiveness of devices and drug regimens for patients undergoing PCI. It is hoped that use of the ARC-HBR definitions and trial design considerations may facilitate faster access to safer devices, drugs and optimal care for this vulnerable patient population.

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