Evidence map›Paper›PMID 31116395›Full record

ArticleEuropean heart journal2019

Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk.

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

4 registry-linked trialsAbstract readConsensus Statement
PubMed Full text at PMC Publisher
In one paragraph

Article in European heart journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 263 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
263citing papers in PubMed, 8 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.

NCT04360720 phase3completednot on this mapstarted 2020, after this paper: background citation

PercutaNEOus Coronary Intervention Followed by Monotherapy INstead of Dual Antiplatelet Therapy in the SETting of Acute Coronary Syndromes: The NEO-MINDSET Trial

TypeinterventionalSponsorHospital Israelita Albert EinsteinRan2020 to 2024Enrolled3,410ConditionsAcute Coronary SyndromeArmsAntiplatelet Monotherapy
NCT04580602 completednot on this mapstarted 2020, after this paper: background citation

Correlation Between Bleeding Complication and Treatment Failure on P2Y12 Inhibitors and Its Predictions Based on Cipherome's Pharmacogenomic Technology

TypeobservationalSponsorCipherome, Inc.Ran2020 to 2022Enrolled200ConditionsStent Thrombosis, Ischemic Stroke, Myocardial Infarction, Acute Coronary Syndrome
NCT05698732 recruitingnot on this mapstarted 2023, after this paper: background citation

Coroflex® ISAR NEO Coronary Stent System Post-Market Clinical Follow-up Study

TypeobservationalSponsorFundación EPICRan2023 to 2027Enrolled3,000ConditionsCoronary Artery Disease (CAD), Ischemic Heart DiseaseArmsCoroflex® ISAR NEO coronary stent system
NCT06665919 nacompletednot on this mapstarted 2023, after this paper: background citation

Randomized Controlled Trial for Evaluating CYP2C19 Allele Genotype-guided Clopidogrel Treatment Outcomes in Real-world Practice After the ePCI

TypeinterventionalSponsorVistamedi Ltd.Ran2023 to 2025Enrolled283ConditionsCoronary Artery Disease, Clopidogrel Resistance, Coronary Thrombosis, Adverse Cardiac EventsArmsCYP2C19 Genotype-Guided Clopidogrel Treatment, CYP2C19 Genotype Guided Antiplatelet Treatment Alternative to Clopidogrel, The Conventional Clopidogrel Treatment
3 · Its place in the literature

Who cites it

263 citing papers in PubMed, 8 syntheses or guidelines pooled it.

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  3. Prasugrel in the management of acute coronary syndromes: a systematic review.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2026
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203 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.
Roxana MehranIcahn School of Medicine at Mount Sinai, New York, NY.
Roisin ColleranDeutsches Herzzentrum München, Technische Universität München, Germany.
Dominick J AngiolilloDivision of Cardiology, University of Florida College of Medicine, Jacksonville.
Robert A ByrneDeutsches Herzzentrum München, Technische Universität München, Germany.
Davide CapodannoCardio-Thoracic-Vascular Department, Centro Alte Specialità e Trapianti, 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.
Donald CutlipCardiology Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.
Pedro EerdmansHead of the Notified Body, DEKRA Certification B.V.
John EikelboomDepartment of Medicine, McMaster University, Hamilton, Canada.
Andrew FarbUS Food and Drug Administration, Silver Spring, MD.
C Michael GibsonHarvard Medical School, Boston, MA.
John GregsonLondon School of Hygiene and Tropical Medicine, UK.
Michael HaudeStädtische Kliniken Neuss, Lukaskrankenhaus GmbH, Germany.
Stefan K JamesDepartment of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Sweden.
Hyo-Soo KimCardiovascular Center, Seoul National University Hospital, Korea.
Takeshi KimuraDepartment of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Japan.
Akihide KonishiOffice of Medical Devices 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
John LaschingerUS Food and Drug Administration, Silver Spring, MD.
Martin B LeonColumbia University Medical Center, New York, NY.
P F Adrian MageeUS Food and Drug Administration, Silver Spring, MD.
Yoshiaki MitsutakeOffice of Medical Devices 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Darren MylotteUniversity Hospital and National University of Ireland, Galway.
Stuart PocockLondon School of Hygiene and Tropical Medicine, UK.
Matthew J PriceScripps Clinic, La Jolla, CA.
Sunil V RaoDuke Clinical Research Institute, Durham, NC.
Ernest SpitzerThoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands.
Norman StockbridgeUS Food and Drug Administration, Silver Spring, MD.
Marco ValgimigliDepartment of Cardiology, Inselspital, University of Bern, Switzerland.
Olivier VarenneService de Cardiologie, Hôpital Cochin, Assistance publique - hôpitaux de Paris, Paris, France.
Ute WindhoevelCardiovascular European Research Center, Massy, France.
Robert W YehBeth Israel Deaconess Medical Center, Boston, MA.
Mitchell W KrucoffDuke Clinical Research Institute, Durham, NC.
Marie-Claude MoriceCardiovascular European Research Center, Massy, France.

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

Acute Coronary SyndromeAgedAged, 80 and overAnemiaAsiaClinical Decision-MakingClinical Trials as TopicDrug-Eluting StentsDrug MonitoringDual Anti-Platelet TherapyEuropeFibrosisFrailtyHemorrhageHumansHypertension, PortalMetalsclinical trial protocols as topichemorrhagepercutaneous coronary intervention

Identifiers

PMID31116395
PMCPMC6736433

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.