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

Urban, Philip; Mehran, Roxana; Colleran, Roisin; Angiolillo, Dominick J; Byrne, Robert A; Capodanno, Davide; Cuisset, Thomas; Cutlip, Donald; Eerdmans, Pedro; Eikelboom, John; Farb, Andrew; Gibson, C Michael; Gregson, John; Haude, Michael; James, Stefan K; Kim, Hyo-Soo; Kimura, Takeshi; Konishi, Akihide; Laschinger, John; Leon, Martin B; ... (2019). 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, 40(31), pp. 2632-2653. Oxford University Press 10.1093/eurheartj/ehz372

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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.

Item Type:

Journal Article (Review Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Valgimigli, Marco

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1522-9645

Publisher:

Oxford University Press

Language:

English

Submitter:

Amanda Valle

Date Deposited:

08 Aug 2019 07:39

Last Modified:

23 Oct 2019 03:36

Publisher DOI:

10.1093/eurheartj/ehz372

PubMed ID:

31116395

Uncontrolled Keywords:

clinical trial protocols as topic hemorrhage percutaneous coronary intervention

BORIS DOI:

10.7892/boris.132406

URI:

https://boris.unibe.ch/id/eprint/132406

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