Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention

Area of Science:

• Cardiology
• Clinical Trials
• Medical Device Regulation

Background:

• Lack of standardized definition for high bleeding risk (HBR) in percutaneous coronary intervention (PCI) hinders clinical trials and decision-making.
• HBR patient identification and management are critical for PCI procedures.

Purpose of the Study:

• To develop a consensus definition for patients at high bleeding risk undergoing PCI.
• To provide consistency for clinical trial design, data interpretation, and regulatory review.

Main Methods:

• Convened the Academic Research Consortium for High Bleeding Risk (ARC-HBR), comprising international experts, regulatory authorities, and industry observers.
• Held two consensus meetings in April 2018 (Washington, DC) and October 2018 (Paris, France).
• Reviewed available evidence to establish a pragmatic definition of HBR.

Main Results:

• Developed a consensus definition for patients at high bleeding risk undergoing PCI.
• The definition aims to standardize HBR patient identification in clinical trials.

Conclusions:

• The proposed ARC-HBR consensus definition offers a pragmatic approach to consistently identify HBR patients.
• This definition will enhance clinical trial consistency, aid decision-making, and support regulatory review for PCI interventions.