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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

Urban, Philip (author)
La Tour Hosp, Geneva, Switzerland;Cardiovasc European Res Ctr, Massy, France
Mehran, Roxana (author)
Icahn Sch Med Mt Sinai, New York, NY 10029 USA
Colleran, Roisin (author)
Tech Univ Munich, Deutsch Herzzentrum Munchen, Munich, Germany
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Angiolillo, Dominick J. (author)
Univ Florida, Coll Med, Div Cardiol, Jacksonville, FL USA
Byrne, Robert A. (author)
Tech Univ Munich, Deutsch Herzzentrum Munchen, Munich, Germany
Capodanno, Davide (author)
Ctr Alte Special & Trapianti, Cardiothoracvasc Dept, Catania, Italy;Univ Catania, Azienda Osped Univ Vittorio Emanuele Policlin, Catania, Italy
Cuisset, Thomas (author)
Aix Marseille Univ, Fac Med, CHU Timone, Dept Cardiol, Marseille, France;Aix Marseille Univ, Fac Med, INSERM, Inra,Ctr Rech Cardiovasc & Nutr, Marseille, France
Cutlip, Donald (author)
Harvard Med Sch, Cardiol Div, Beth Israel Deaconess Med Ctr, Boston, MA 02115 USA
Eerdmans, Pedro (author)
DEKRA Certificat BV, Notified Body, Hamilton, ON, Canada
Eikelboom, John (author)
McMaster Univ, Dept Med, Hamilton, ON, Canada
Farb, Andrew (author)
US FDA, Silver Spring, MD USA
Gibson, C. Michael (author)
Harvard Med Sch, Boston, MA 02115 USA;Baim Inst Clin Res, Brookline, MA USA
Gregson, John (author)
London Sch Hyg & Trop Med, London, England
Haude, Michael (author)
Lukaskrankenhaus GmbH, Stadt Kliniken Neuss, Neuss, Germany
James, Stefan, 1964- (author)
Uppsala universitet,Kardiologi,Uppsala kliniska forskningscentrum (UCR)
Kim, Hyo-Soo (author)
Seoul Natl Univ Hosp, Cardiovasc Ctr, Seoul, South Korea
Kimura, Takeshi (author)
Kyoto Univ, Dept Cardiovasc Med, Grad Sch Med, Kyoto, Japan
Konishi, Akihide (author)
Pharmaceut & Med Devices Agcy, Off Med Devices 1, Tokyo, Japan
Laschinger, John (author)
US FDA, Silver Spring, MD USA
Leon, Martin B. (author)
Columbia Univ, Med Ctr, New York, NY USA;Cardiovasc Res Fdn, New York, NY USA
Magee, Pf Adrian (author)
US FDA, Silver Spring, MD USA
Mitsutake, Yoshiaki (author)
Pharmaceut & Med Devices Agcy, Off Med Devices 1, Tokyo, Japan
Mylotte, Darren (author)
Univ Hosp, Galway, Ireland;Natl Univ Ireland, Galway, Ireland
Ls, Stuart Pocock (author)
London Sch Hyg & Trop Med, London, England
Price, Matthew J. (author)
Scripps Clin, La Jolla, CA USA
Rao, Sunil, V (author)
Duke Clin Res Inst, Durham, NC USA
Spitzer, Ernest (author)
Erasmus Univ, Thoraxctr, Med Ctr, Rotterdam, Netherlands;Clin Trial Management & Core Labs, Cardialysis, Rotterdam, Netherlands
Stockbridge, Norman (author)
US FDA, Silver Spring, MD USA
Valgimigli, Marco (author)
Univ Bern, Dept Cardiol, Inselspital, Bern, Switzerland
Varenne, Olivier (author)
Hop Cochin, AP HP, Serv Cardiol, Paris, France;Univ Paris 05, Sorbonne Paris Cite, Paris, France
Windhoevel, Ute (author)
Cardiovasc European Res Ctr, Massy, France
Yeh, Robert W. (author)
Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA
Krucoff, Mitchell W. (author)
Duke Clin Res Inst, Durham, NC USA;Duke Univ, Med Ctr, Durham, NC USA
Morice, Marie-Claude (author)
Cardiovasc European Res Ctr, Massy, France
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 (creator_code:org_t)
2019-05-22
2019
English.
In: European Heart Journal. - : Oxford University Press (OUP). - 0195-668X .- 1522-9645. ; 40:31, s. 2632-2653
Related links:
https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
https://academic.oup...
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  • Journal article (peer-reviewed)
Abstract Subject headings
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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.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Kardiologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)

Keyword

clinical trial protocols as topic
hemorrhage
percutaneous coronary intervention

Publication and Content Type

ref (subject category)
art (subject category)

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