Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk
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 Cons...
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Published in: | European heart journal 2019-08, Vol.40 (31), p.2632-2653 |
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Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
Format: | Article |
Language: | eng |
Subjects: | |
Online Access: | Get full text |
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Summary: | 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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ISSN: | 0195-668X 1522-9645 1522-9645 |