Evidence map›Paper›PMID 31116032›Full record

ReviewCirculation2019

Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention.

Philip Urban, Roxana Mehran, Roisin Colleran, Dominick J Angiolillo, Robert A Byrne, Davide Capodanno, Thomas Cuisset, Donald Cutlip, Pedro Eerdmans, John Eikelboom and 24 more

3 registry-linked trialsAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Circulation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 290 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
290citing papers in PubMed, 7 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04885816 naterminatednot on this mapstarted 2021, after this paper: background citation

Drug-Eluting Balloon Versus Drug-eluting Stent On de Novo coRonary Artery Disease in Patients With High Bleeding Risk

TypeinterventionalSponsorInstituto Nacional de Cardiologia Ignacio ChavezRan2021 to 2021Enrolled5ConditionsHigh Bleeding Risk, Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)ArmsDrug Eluting Balloon (DEB), Drug Eluting Stents (DES)
NCT05240781 naunknown statusnot on this mapstarted 2021, after this paper: background citation

Zotarolimus Eluting Stent Versus Sirolimus Eluting Stent in High Bleeding Risk Angioplasty

TypeinterventionalSponsorInstituto Nacional de Cardiologia Ignacio ChavezRan2021 to 2025Enrolled280ConditionsHigh Bleeding Risk, Coronary Artery Disease, Percutaneous Coronary InterventionArmsZotarolimus eluting stent, Sirolimus eluting stent
NCT05631769 phase4active not recruitingnot on this mapstarted 2020, after this paper: background citation

Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases - DAPT Duration According the Bleeding Risk

TypeinterventionalSponsorSeoul National University HospitalRan2020 to 2027Enrolled4,900ConditionsCoronary Artery Disease, Acute Myocardial Infarction, Stable AnginaArmsDual antiplatelet agent duration
3 · Its place in the literature

Who cites it

290 citing papers in PubMed, 7 syntheses or guidelines pooled it.

  1. Pooled it
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  8. Trial
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  10. One-month dual antiplatelet therapy followed by prasugrel monotherapy at a reduced dose: the 4D-ACS randomised trial.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025
    Trial
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  19. Bleeding risk differences after TAVR according to the ARC-HBR criteria: insights from SCOPE 2.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2022
    Trial
  20. Impact of one-month DAPT followed by aspirin monotherapy in patients undergoing percutaneous coronary intervention according to clinical presentation: a post hoc analysis of the randomised One-Month DAPT trial.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2022
    Trial

230 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

34 authors.

Philip UrbanLa Tour Hospital, Geneva, Switzerland (P.U.).
Roxana MehranIcahn School of Medicine at Mount Sinai, New York, NY (R.M.).
Roisin ColleranDeutsches Herzzentrum München, Technische Universität München, Germany (R.C., R.A.B.).
Dominick J AngiolilloDivision of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).
Robert A ByrneDeutsches Herzzentrum München, Technische Universität München, Munich, Germany (R.A.B.).
Davide CapodannoCardio-Thoracic-Vascular Department, Centro Alte Specialità e Trapianti (D. Capodanno), Catania, Italy.
Thomas CuissetDépartement 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.).
Donald CutlipCardiology Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (D. Cutlip).
Pedro EerdmansHead of the Notified Body, DEKRA Certification B.V. (P.E.).
John EikelboomDepartment of Medicine, McMaster University, Hamilton, Canada (J.E.).
Andrew FarbUS Food and Drug Administration, Silver Spring, MD (A.F., J.L., P.F.A.M., N.S.).
C Michael GibsonBaim Institute for Clinical Research, Brookline, MA (C.M.G.).
John GregsonLondon School of Hygiene and Tropical Medicine, UK (J.G., S.P.).
Michael HaudeStädtische Kliniken Neuss, Lukaskrankenhaus GmbH, Germany (M.H.).
Stefan K JamesDepartment of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Sweden (S.K.J.).
Hyo-Soo KimCardiovascular Center, Seoul National University Hospital, Korea (H.-S.K.).
Takeshi KimuraDepartment of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Japan (T.K.).
Akihide KonishiOffice of Medical Devices 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan (A.K., Y.M.).
John LaschingerUS Food and Drug Administration, Silver Spring, MD (A.F., J.L., P.F.A.M., N.S.).
Martin B LeonColumbia University Medical Center, New York, NY (M.B.L.).
P F Adrian MageeUS Food and Drug Administration, Silver Spring, MD (A.F., J.L., P.F.A.M., N.S.).
Yoshiaki MitsutakeOffice of Medical Devices 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan (A.K., Y.M.).
Darren MylotteUniversity Hospital and National University of Ireland, Galway (D.M.).
Stuart PocockLondon School of Hygiene and Tropical Medicine, UK (J.G., S.P.).
Matthew J PriceScripps Clinic, La Jolla, CA (M.J.P.).
Sunil V RaoDuke Clinical Research Institute, Durham, NC (S.V.R., M.W.K.).
Ernest SpitzerThoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands (E.S.).
Norman StockbridgeUS Food and Drug Administration, Silver Spring, MD (A.F., J.L., P.F.A.M., N.S.).
Marco ValgimigliDepartment of Cardiology, Inselspital, University of Bern, Switzerland (M.V.).
Olivier VarenneService de Cardiologie, Hôpital Cochin, Assistance publique - hôpitaux de Paris, Paris, France (O.V.).
Ute WindhoevelCardiovascular European Research Center, Massy, France (P.U., U.W., M.-C.M.).
Robert W YehBeth Israel Deaconess Medical Center, Boston, MA (R.W.Y.).
Mitchell W KrucoffDuke Clinical Research Institute, Durham, NC (S.V.R., M.W.K.).
Marie-Claude MoriceCardiovascular European Research Center, Massy, France (P.U., U.W., M.-C.M.).

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Congresses as TopicConsensusAnticoagulantsDistrict of ColumbiaHemorrhageHumansParisPercutaneous Coronary InterventionRisk AssessmentAnticoagulantsclinical trial protocols as topichemorrhagepercutaneous coronary intervention

Identifiers

PMID31116032
PMCPMC6636810

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.