Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention

Philip Urban^{1

2}, Roxana Mehran³, Roisin Colleran⁴, Dominick J Angiolillo⁵, Robert A Byrne⁶, Davide Capodanno^{7

8}, Thomas Cuisset⁹, Donald Cutlip¹⁰, Pedro Eerdmans¹¹, John Eikelboom¹², Andrew Farb¹³, C Michael Gibson^{14

15}, John Gregson¹⁶, Michael Haude¹⁷, Stefan K James¹⁸, Hyo-Soo Kim¹⁹, Takeshi Kimura²⁰, Akihide Konishi²¹, John Laschinger¹³, Martin B Leon^{22

23}, P F Adrian Magee¹³, Yoshiaki Mitsutake²¹, Darren Mylotte²⁴, Stuart Pocock¹⁶, Matthew J Price²⁵, Sunil V Rao²⁶, Ernest Spitzer^{27

28}, Norman Stockbridge¹³, Marco Valgimigli²⁹, Olivier Varenne^{30

31}, Ute Windhoevel², Robert W Yeh³², Mitchell W Krucoff^{26

33}, Marie-Claude Morice²

Affiliations

¹ La Tour Hospital, Geneva, Switzerland (P.U.).
² Cardiovascular European Research Center, Massy, France (P.U., U.W., M.-C.M.).
³ Icahn School of Medicine at Mount Sinai, New York, NY (R.M.).
⁴ Deutsches Herzzentrum München, Technische Universität München, Germany (R.C., R.A.B.).
⁵ Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).
⁶ Deutsches Herzzentrum München, Technische Universität München, Munich, Germany (R.A.B.).
⁷ Cardio-Thoracic-Vascular Department, Centro Alte Specialità e Trapianti (D. Capodanno), Catania, Italy.
⁸ Azienda Ospedaliero Universitario "Vittorio Emanuele-Policlinico," University of Catania, Italy (D. Capodanno).
⁹ 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.).
¹⁰ Cardiology Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (D. Cutlip).
¹¹ Head of the Notified Body, DEKRA Certification B.V. (P.E.).
¹² Department of Medicine, McMaster University, Hamilton, Canada (J.E.).
¹³ US Food and Drug Administration, Silver Spring, MD (A.F., J.L., P.F.A.M., N.S.).
¹⁴ Baim Institute for Clinical Research, Brookline, MA (C.M.G.).
¹⁵ Harvard Medical School, Boston, MA (C.M.G.).
¹⁶ London School of Hygiene and Tropical Medicine, UK (J.G., S.P.).
¹⁷ Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Germany (M.H.).
¹⁸ Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Sweden (S.K.J.).
¹⁹ Cardiovascular Center, Seoul National University Hospital, Korea (H.-S.K.).
²⁰ Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Japan (T.K.).
²¹ Office of Medical Devices 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan (A.K., Y.M.).
²² Columbia University Medical Center, New York, NY (M.B.L.).
²³ Cardiovascular Research Foundation, New York, NY (M.B.L.).
²⁴ University Hospital and National University of Ireland, Galway (D.M.).
²⁵ Scripps Clinic, La Jolla, CA (M.J.P.).
²⁶ Duke Clinical Research Institute, Durham, NC (S.V.R., M.W.K.).
²⁷ Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands (E.S.).
²⁸ Cardialysis, Clinical Trial Management and Core Laboratories, Rotterdam, the Netherlands (E.S.).
²⁹ Department of Cardiology, Inselspital, University of Bern, Switzerland (M.V.).
³⁰ Service de Cardiologie, Hôpital Cochin, Assistance publique - hôpitaux de Paris, Paris, France (O.V.).
³¹ Université Paris Descartes, Sorbonne Paris-Cité, France (O.V.).
³² Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y.).
³³ Duke University Medical Center, Durham, NC (M.W.K.).

PMID: 31116032
PMCID: PMC6636810
DOI: 10.1161/CIRCULATIONAHA.119.040167

Review

Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention

Philip Urban et al. Circulation. 2019.

. 2019 Jul 16;140(3):240-261.

doi: 10.1161/CIRCULATIONAHA.119.040167. Epub 2019 May 22.

Authors

Affiliations

¹ La Tour Hospital, Geneva, Switzerland (P.U.).
² Cardiovascular European Research Center, Massy, France (P.U., U.W., M.-C.M.).
³ Icahn School of Medicine at Mount Sinai, New York, NY (R.M.).
⁴ Deutsches Herzzentrum München, Technische Universität München, Germany (R.C., R.A.B.).
⁵ Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).
⁶ Deutsches Herzzentrum München, Technische Universität München, Munich, Germany (R.A.B.).
⁷ Cardio-Thoracic-Vascular Department, Centro Alte Specialità e Trapianti (D. Capodanno), Catania, Italy.
⁸ Azienda Ospedaliero Universitario "Vittorio Emanuele-Policlinico," University of Catania, Italy (D. Capodanno).
⁹ 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.).
¹⁰ Cardiology Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (D. Cutlip).
¹¹ Head of the Notified Body, DEKRA Certification B.V. (P.E.).
¹² Department of Medicine, McMaster University, Hamilton, Canada (J.E.).
¹³ US Food and Drug Administration, Silver Spring, MD (A.F., J.L., P.F.A.M., N.S.).
¹⁴ Baim Institute for Clinical Research, Brookline, MA (C.M.G.).
¹⁵ Harvard Medical School, Boston, MA (C.M.G.).
¹⁶ London School of Hygiene and Tropical Medicine, UK (J.G., S.P.).
¹⁷ Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Germany (M.H.).
¹⁸ Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Sweden (S.K.J.).
¹⁹ Cardiovascular Center, Seoul National University Hospital, Korea (H.-S.K.).
²⁰ Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Japan (T.K.).
²¹ Office of Medical Devices 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan (A.K., Y.M.).
²² Columbia University Medical Center, New York, NY (M.B.L.).
²³ Cardiovascular Research Foundation, New York, NY (M.B.L.).
²⁴ University Hospital and National University of Ireland, Galway (D.M.).
²⁵ Scripps Clinic, La Jolla, CA (M.J.P.).
²⁶ Duke Clinical Research Institute, Durham, NC (S.V.R., M.W.K.).
²⁷ Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands (E.S.).
²⁸ Cardialysis, Clinical Trial Management and Core Laboratories, Rotterdam, the Netherlands (E.S.).
²⁹ Department of Cardiology, Inselspital, University of Bern, Switzerland (M.V.).
³⁰ Service de Cardiologie, Hôpital Cochin, Assistance publique - hôpitaux de Paris, Paris, France (O.V.).
³¹ Université Paris Descartes, Sorbonne Paris-Cité, France (O.V.).
³² Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y.).
³³ Duke University Medical Center, Durham, NC (M.W.K.).

PMID: 31116032
PMCID: PMC6636810
DOI: 10.1161/CIRCULATIONAHA.119.040167

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.

Keywords: clinical trial protocols as topic; hemorrhage; percutaneous coronary intervention.

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References

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Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention

Affiliations

Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention

Authors

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