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Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the
Philip Urban1,2, Roxana Mehran3, Roisin Colleran4
1La Tour Hospital, Geneva, Switzerland.
Insights
Standardizing the definition of high bleeding risk is crucial for percutaneous coronary intervention trials. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) developed a consensus definition for better patient identification and management.
Area of Science:
- Cardiology
- Clinical Trials
- Medical Device Regulation
Background:
- Standardized definitions are lacking for identifying patients at high bleeding risk undergoing percutaneous coronary intervention (PCI).
- This lack of standardization hinders clinical trial design, data interpretation, and decision-making for PCI procedures.
- Consistent identification of high bleeding risk patients is essential for evaluating new therapies.
Purpose of the Study:
- To develop a consensus definition for patients at high bleeding risk (HBR) undergoing PCI.
- To provide a standardized definition for use in clinical trials and regulatory reviews.
- To improve clinical decision-making for HBR patients undergoing PCI.
Main Methods:
- Convened the Academic Research Consortium for High Bleeding Risk (ARC-HBR), comprising international experts, regulatory authorities, and industry representatives.
- Conducted two consensus meetings in April 2018 (Washington, DC) and October 2018 (Paris, France).
- Reviewed available evidence to establish a pragmatic definition of high bleeding risk.
Main Results:
- Developed a consensus definition for patients at high bleeding risk (HBR) undergoing PCI.
- The definition aims to standardize patient selection for clinical trials.
- This provides a consistent framework for evaluating PCI devices and drug regimens in HBR populations.
Conclusions:
- The proposed ARC-HBR definition offers the first pragmatic approach to consistently identify high bleeding risk patients in PCI trials.
- This consensus definition will aid in trial design, data interpretation, and regulatory review.
- Implementation of this definition is expected to enhance the evaluation of safety and effectiveness of PCI interventions in high-risk populations.
Abstract:
Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision-making. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities, and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention-related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention.
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