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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

      review-article
      1 , 2 , 3 , 4 , 5 , 4 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 12 , 21 , 22 , 12 , 20 , 23 , 15 , 24 , 25 , 26 , 27 , 12 , 28 , 29 , 30 , 2 , 31 , 25 , 32 , 2
      European Heart Journal
      Oxford University Press
      clinical trial protocols as topic, hemorrhage, percutaneous coronary intervention

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          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.

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          Most cited references121

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          Transection of the oesophagus for bleeding oesophageal varices.

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            Transfusion strategies for acute upper gastrointestinal bleeding.

            The hemoglobin threshold for transfusion of red cells in patients with acute gastrointestinal bleeding is controversial. We compared the efficacy and safety of a restrictive transfusion strategy with those of a liberal transfusion strategy. We enrolled 921 patients with severe acute upper gastrointestinal bleeding and randomly assigned 461 of them to a restrictive strategy (transfusion when the hemoglobin level fell below 7 g per deciliter) and 460 to a liberal strategy (transfusion when the hemoglobin fell below 9 g per deciliter). Randomization was stratified according to the presence or absence of liver cirrhosis. A total of 225 patients assigned to the restrictive strategy (51%), as compared with 61 assigned to the liberal strategy (14%), did not receive transfusions (P<0.001) [corrected].The probability of survival at 6 weeks was higher in the restrictive-strategy group than in the liberal-strategy group (95% vs. 91%; hazard ratio for death with restrictive strategy, 0.55; 95% confidence interval [CI], 0.33 to 0.92; P=0.02). Further bleeding occurred in 10% of the patients in the restrictive-strategy group as compared with 16% of the patients in the liberal-strategy group (P=0.01), and adverse events occurred in 40% as compared with 48% (P=0.02). The probability of survival was slightly higher with the restrictive strategy than with the liberal strategy in the subgroup of patients who had bleeding associated with a peptic ulcer (hazard ratio, 0.70; 95% CI, 0.26 to 1.25) and was significantly higher in the subgroup of patients with cirrhosis and Child-Pugh class A or B disease (hazard ratio, 0.30; 95% CI, 0.11 to 0.85), but not in those with cirrhosis and Child-Pugh class C disease (hazard ratio, 1.04; 95% CI, 0.45 to 2.37). Within the first 5 days, the portal-pressure gradient increased significantly in patients assigned to the liberal strategy (P=0.03) but not in those assigned to the restrictive strategy. As compared with a liberal transfusion strategy, a restrictive strategy significantly improved outcomes in patients with acute upper gastrointestinal bleeding. (Funded by Fundació Investigació Sant Pau; ClinicalTrials.gov number, NCT00414713.).
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              Derivation and validation of the predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score: a pooled analysis of individual-patient datasets from clinical trials

              Dual antiplatelet therapy (DAPT) with aspirin plus a P2Y12 inhibitor prevents ischaemic events after coronary stenting, but increases bleeding. Guidelines support weighting bleeding risk before the selection of treatment duration, but no standardised tool exists for this purpose.
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                Author and article information

                Journal
                Eur Heart J
                Eur. Heart J
                eurheartj
                European Heart Journal
                Oxford University Press
                0195-668X
                1522-9645
                14 August 2019
                22 May 2019
                22 May 2019
                : 40
                : 31 , Focus Issue on Interventional Cardiology
                : 2632-2653
                Affiliations
                [1 ]La Tour Hospital, Geneva, Switzerland
                [2 ]Cardiovascular European Research Center, Massy, France
                [3 ]Icahn School of Medicine at Mount Sinai, New York, NY
                [4 ]Deutsches Herzzentrum München, Technische Universität München, Germany
                [5 ]Division of Cardiology, University of Florida College of Medicine, Jacksonville
                [6 ]Cardio-Thoracic-Vascular Department, Centro Alte Specialità e Trapianti, Catania, Italy
                [7 ]Azienda Ospedaliero Universitario “Vittorio Emanuele-Policlinico,” University of Catania, Italy
                [8 ]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
                [9 ]Cardiology Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA
                [10 ]Head of the Notified Body, DEKRA Certification B.V
                [11 ]Department of Medicine, McMaster University, Hamilton, Canada
                [12 ]US Food and Drug Administration, Silver Spring, MD
                [13 ]Harvard Medical School, Boston, MA
                [14 ]Baim Institute for Clinical Research, Brookline, MA
                [15 ]London School of Hygiene and Tropical Medicine, UK
                [16 ]Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Germany
                [17 ]Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Sweden
                [18 ]Cardiovascular Center, Seoul National University Hospital, Korea
                [19 ]Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Japan
                [20 ]Office of Medical Devices 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
                [21 ]Columbia University Medical Center, New York, NY
                [22 ]Cardiovascular Research Foundation, New York, NY
                [23 ]University Hospital and National University of Ireland, Galway
                [24 ]Scripps Clinic, La Jolla, CA
                [25 ]Duke Clinical Research Institute, Durham, NC
                [26 ]Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands
                [27 ]Cardialysis, Clinical Trial Management and Core Laboratories, Rotterdam, the Netherlands
                [28 ]Department of Cardiology, Inselspital, University of Bern, Switzerland
                [29 ]Service de Cardiologie, Hôpital Cochin, Assistance publique - hôpitaux de Paris, Paris, France
                [30 ]Université Paris Descartes, Sorbonne Paris-Cité, France
                [31 ]Beth Israel Deaconess Medical Center, Boston, MA
                [32 ]Duke University Medical Center, Durham, NC
                Author notes
                Correspondence: Philip Urban, MD, Hôpital de la Tour, 1 Ave Maillard, 1217 Geneva, Switzerland. Email: philip.urban@ 123456latour.ch
                Article
                ehz372
                10.1093/eurheartj/ehz372
                6736433
                31116395
                bc9c343c-212a-4149-a815-5d278e5bb3d9
                © 2019 The Authors. The European Heart Journal is published on behalf of the European Society of Cardiology, Inc., by Oxford University Press. This is an open access article under the terms of the Creative Commons Attribution Non-Commercial-NoDerivs License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited, the use is non-commercial, and no modifications or adaptations are made.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution NonCommercial-NoDerivs License ( http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

                History
                Page count
                Pages: 22
                Funding
                Funded by: Abbott Vascular 10.13039/100011949
                Funded by: Alvimedica
                Funded by: Amgen 10.13039/100002429
                Funded by: AstraZeneca 10.13039/100004325
                Funded by: Biosensors 10.13039/501100008877
                Funded by: Biotronik 10.13039/501100005035
                Funded by: Boston Scientific 10.13039/100008497
                Funded by: Celonova
                Funded by: Chiesi 10.13039/100007560
                Funded by: Cordis 10.13039/100006479
                Funded by: Daiichi Sankyo
                Funded by: Edwards Lifesciences 10.13039/100006520
                Funded by: Janssen
                Funded by: Medinol
                Funded by: Medtronic 10.13039/100004374
                Funded by: Orbusneich
                Funded by: Portola
                Funded by: Sanofi 10.13039/100004339
                Funded by: Sinomed
                Funded by: Sahajanand Medical Technologies
                Funded by: Terumo 10.13039/501100008645
                Categories
                Current Opinion

                Cardiovascular Medicine
                clinical trial protocols as topic,hemorrhage,percutaneous coronary intervention

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