Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention.
Journal article

Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention.

  • Urban P La Tour Hospital, Geneva, Switzerland (P.U.).
  • Mehran R Icahn School of Medicine at Mount Sinai, New York, NY (R.M.).
  • Colleran R Deutsches Herzzentrum München, Technische Universität München, Germany (R.C., R.A.B.).
  • Angiolillo DJ Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).
  • Byrne RA Deutsches Herzzentrum München, Technische Universität München, Munich, Germany (R.A.B.).
  • Capodanno D Cardio-Thoracic-Vascular Department, Centro Alte Specialità e Trapianti (D. Capodanno), Catania, Italy.
  • Cuisset T Département de Cardiologie, Centre Hospitalier Universitaire Timone and Inserm, Inra, Centre de recherche en cardiovasculaire et nutrition, Faculté de Médecine, Aix-Marseille Université, Marseille, France (T.C.).
  • Cutlip D Cardiology Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (D. Cutlip).
  • Eerdmans P Head of the Notified Body, DEKRA Certification B.V. (P.E.).
  • Eikelboom J Department of Medicine, McMaster University, Hamilton, Canada (J.E.).
  • Farb A US Food and Drug Administration, Silver Spring, MD (A.F., J.L., P.F.A.M., N.S.).
  • Gibson CM Baim Institute for Clinical Research, Brookline, MA (C.M.G.).
  • Gregson J London School of Hygiene and Tropical Medicine, UK (J.G., S.P.).
  • Haude M Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Germany (M.H.).
  • James SK Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Sweden (S.K.J.).
  • Kim HS Cardiovascular Center, Seoul National University Hospital, Korea (H.-S.K.).
  • Kimura T Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Japan (T.K.).
  • Konishi A Office of Medical Devices 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan (A.K., Y.M.).
  • Laschinger J US Food and Drug Administration, Silver Spring, MD (A.F., J.L., P.F.A.M., N.S.).
  • Leon MB Columbia University Medical Center, New York, NY (M.B.L.).
  • Magee PFA US Food and Drug Administration, Silver Spring, MD (A.F., J.L., P.F.A.M., N.S.).
  • Mitsutake Y Office of Medical Devices 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan (A.K., Y.M.).
  • Mylotte D University Hospital and National University of Ireland, Galway (D.M.).
  • Pocock S London School of Hygiene and Tropical Medicine, UK (J.G., S.P.).
  • Price MJ Scripps Clinic, La Jolla, CA (M.J.P.).
  • Rao SV Duke Clinical Research Institute, Durham, NC (S.V.R., M.W.K.).
  • Spitzer E Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands (E.S.).
  • Stockbridge N US Food and Drug Administration, Silver Spring, MD (A.F., J.L., P.F.A.M., N.S.).
  • Valgimigli M Department of Cardiology, Inselspital, University of Bern, Switzerland (M.V.).
  • Varenne O Service de Cardiologie, Hôpital Cochin, Assistance publique - hôpitaux de Paris, Paris, France (O.V.).
  • Windhoevel U Cardiovascular European Research Center, Massy, France (P.U., U.W., M.-C.M.).
  • Yeh RW Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y.).
  • Krucoff MW Duke Clinical Research Institute, Durham, NC (S.V.R., M.W.K.).
  • Morice MC Cardiovascular European Research Center, Massy, France (P.U., U.W., M.-C.M.).
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  • 2019-05-23
Published in:
  • Circulation. - 2019
English 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.
Language
  • English
Open access status
hybrid
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Persistent URL
https://sonar.rero.ch/global/documents/58178
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