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Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention.

Publication ,  Journal Article
Urban, P; Mehran, R; Colleran, R; Angiolillo, DJ; Byrne, RA; Capodanno, D; Cuisset, T; Cutlip, D; Eerdmans, P; Eikelboom, J; Farb, A; Haude, M ...
Published in: Circulation
July 16, 2019

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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Published In

Circulation

DOI

EISSN

1524-4539

Publication Date

July 16, 2019

Volume

140

Issue

3

Start / End Page

240 / 261

Location

United States

Related Subject Headings

  • Risk Assessment
  • Percutaneous Coronary Intervention
  • Paris
  • Humans
  • Hemorrhage
  • District of Columbia
  • Consensus
  • Congresses as Topic
  • Cardiovascular System & Hematology
  • Anticoagulants
 

Citation

APA
Chicago
ICMJE
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Urban, P., Mehran, R., Colleran, R., Angiolillo, D. J., Byrne, R. A., Capodanno, D., … Morice, M.-C. (2019). Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention. Circulation, 140(3), 240–261. https://doi.org/10.1161/CIRCULATIONAHA.119.040167
Urban, Philip, Roxana Mehran, Roisin Colleran, Dominick J. Angiolillo, Robert A. Byrne, Davide Capodanno, Thomas Cuisset, et al. “Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention.Circulation 140, no. 3 (July 16, 2019): 240–61. https://doi.org/10.1161/CIRCULATIONAHA.119.040167.
Urban P, Mehran R, Colleran R, Angiolillo DJ, Byrne RA, Capodanno D, et al. Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention. Circulation. 2019 Jul 16;140(3):240–61.
Urban, Philip, et al. “Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention.Circulation, vol. 140, no. 3, July 2019, pp. 240–61. Pubmed, doi:10.1161/CIRCULATIONAHA.119.040167.
Urban P, Mehran R, Colleran R, Angiolillo DJ, Byrne RA, Capodanno D, Cuisset T, Cutlip D, Eerdmans P, Eikelboom J, Farb A, Gibson CM, Gregson J, Haude M, James SK, Kim H-S, Kimura T, Konishi A, Laschinger J, Leon MB, Magee PFA, Mitsutake Y, Mylotte D, Pocock S, Price MJ, Rao SV, Spitzer E, Stockbridge N, Valgimigli M, Varenne O, Windhoevel U, Yeh RW, Krucoff MW, Morice M-C. Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention. Circulation. 2019 Jul 16;140(3):240–261.

Published In

Circulation

DOI

EISSN

1524-4539

Publication Date

July 16, 2019

Volume

140

Issue

3

Start / End Page

240 / 261

Location

United States

Related Subject Headings

  • Risk Assessment
  • Percutaneous Coronary Intervention
  • Paris
  • Humans
  • Hemorrhage
  • District of Columbia
  • Consensus
  • Congresses as Topic
  • Cardiovascular System & Hematology
  • Anticoagulants