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

Philip Urban 1 Roxana Mehran 2 Roisin Colleran 3 Dominick Angiolillo 4 Robert Byrne 3 Davide Capodanno 5 Thomas Cuisset 6, 7 Donald Cutlip 8 Pedro Eerdmans 9 John Eikelboom 10 Andrew Farb 11 C Michael Gibson 8 John Gregson 12 Michael Haude 13 Stefan James 14 Hyo-Soo Kim 15 Takeshi Kimura 16 Akihide Konishi 17 John Laschinger 11 Martin Leon 18 P Magee 11 Yoshiaki Mitsutake 17 Darren Mylotte 19 Stuart Pocock 12 Matthew Price 20 Sunil Rao 21 Ernest Spitzer 22 Norman Stockbridge 11 Marco Valgimigli 23 Olivier Varenne 24 Ute Windhoevel 25 Robert Yeh 26 Mitchell Krucoff 21 Marie-Claude Morice 27
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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Philip Urban, Roxana Mehran, Roisin Colleran, Dominick Angiolillo, Robert Byrne, et al.. Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk. European Heart Journal, Oxford University Press (OUP): Policy B, 2019, 40 (31), pp.2632-2653. ⟨10.1093/eurheartj/ehz372⟩. ⟨hal-02542151⟩

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