Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk

TLDR

High bleeding risk in patients undergoing percutaneous coronary intervention is poorly defined, limiting trial design, data interpretation, and clinical decision‑making, and the Academic Research Consortium for High Bleeding Risk (ARC‑HBR) was formed to address this gap. The ARC‑HBR definition aims to standardize high‑bleeding‑risk classification for clinical trials, clinical decision‑making, and regulatory review. The consortium convened two meetings in 2018, organized by the Cardiovascular European Research Center and attended by FDA, PMDA, and industry observers, to review evidence and develop a consensus definition. The resulting ARC‑HBR consensus document is the first pragmatic, consistent definition of high bleeding risk for trials assessing the safety and effectiveness of devices and drug regimens in percutaneous coronary intervention.

Abstract

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.