Evidence map›Paper›PMID 33066794›Full record

Observational studyCardiovascular diabetology2020

Ticagrelor monotherapy in patients with concomitant diabetes mellitus and chronic kidney disease: a post hoc analysis of the GLOBAL LEADERS trial.

Chao Gao, Mariusz Tomaniak, Kuniaki Takahashi, Hideyuki Kawashima, Rutao Wang, Hironori Hara, Masafumi Ono, Gilles Montalescot, Scot Garg, Michael Haude and 10 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Cardiovascular diabetology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01813435 (GLOBAL LEADERS), which is not on this map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
1.9field-weighted citation impact, top 12% of its field
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.

NCT01813435 phase3completednot on this map

GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation

TypeinterventionalSponsorECRI bvRan2013 to 2018Enrolled15,991ConditionsCoronary Artery Disease (CAD)ArmsTicagrelor, Acetylsalicylic Acid, Clopidogrel
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 3 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Antiplatelet agents for chronic kidney disease.The Cochrane database of systematic reviews · 2022
    Pooled it
  4. Trial
  5. Ticagrelor-based antiplatelet therapy after percutaneous coronary intervention in chronic coronary syndrome.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025
    Article
  6. Article
  7. Article
  8. Review
  9. Review
  10. Updates on New Therapies for Patients with CKD.Kidney international reports · 2024
    Review
  11. Impact of chronic kidney disease and diabetes on clinical outcomes in women undergoing PCI.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023
    Review
  12. P2YNature reviews. Cardiology · 2022
    Review
  13. Observational
  14. Article
  15. Review
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

20 authors at 14 institutions in 10 countries.

Chao GaoDepartment of Cardiology, Xijing hospital, Xi'an, China.
Mariusz TomaniakFirst Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.
Kuniaki TakahashiAmsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Hideyuki KawashimaAmsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Rutao WangDepartment of Cardiology, Xijing hospital, Xi'an, China.
Hironori HaraAmsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Masafumi OnoAmsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Gilles MontalescotSorbonne University, ACTION Study Group, Institute of Cardiology, Pitié-Salpêtrière Hospital, Paris, France.
Scot GargDepartment of Cardiology, Royal Blackburn Hospital, Blackburn, UK.
Michael HaudeDepartment of Cardiology, Rheinland Klinikum Neuss, Lukaskrankenhaus, Neuss, Germany.
Ton SlagboomOLVG, Amsterdam, Netherlands.
Pascal VranckxDepartment of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium.
Marco ValgimigliDepartment of Cardiology, Bern University Hospital, Bern, Switzerland.
Stephan WindeckerDepartment of Cardiology, Bern University Hospital, Bern, Switzerland.
Robert-Jan van GeunsDepartment of Cardiology, Radboud University, Nijmegen, The Netherlands.
Christian HammKerckhoff Heart Center, Bad Nauheim, Germany.
Philippe Gabriel StegFACT, French Alliance for Cardiovascular Trials, Paris, France.
Yoshinobu OnumaDepartment of Cardiology, National University of Ireland Galway, Galway, Ireland.
Dominick J AngiolilloDivision of Cardiology, University of Florida College of Medicine, Jacksonville, FL, USA.
Patrick W SerruysDepartment of Cardiology, National University of Ireland Galway, Galway, Ireland. patrick.w.j.c.serruys@gmail.com.ORCID 0000-0002-0390-8060
Ollscoil na Gaillimhe – University of Galway · IERadboud University Nijmegen · NLUniversity Hospital of Bern · CHAmsterdam University Medical Centers · NLAssistance Publique – Hôpitaux de Paris · FRJessa Hospital · BEKerckhoff Klinik · DELukaskrankenhaus · DEMedical University of Warsaw · PLNational University of Ireland · IEOLVG · NLRoyal Blackburn Teaching Hospital · GBSorbonne Université · FRUniversity of Florida · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with both diabetes mellitus (DM) and chronic kidney disease (CKD) are a subpopulation characterized by ultrahigh ischemic and bleeding risk after percutaneous coronary intervention. There are limited data on the impact of ticagrelor monotherapy among these patients.

methodsIn this post hoc analysis of the GLOBAL-LEADERS trial, the treatment effects of the experimental (one-month dual-antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) versus the reference regimen (12-month DAPT followed by 12-month aspirin alone) were analyzed according to DM/CKD status. The primary endpoint was a composite endpoint of all-cause death or new Q-wave myocardial infarction at 2-years. The patient-oriented composite endpoint (POCE) was defined as the composite of all-cause death, any stroke, site-reported MI and any revascularization, whereas net adverse clinical events (NACE) combined POCE with BARC type 3 or 5 bleeding events.

resultsAt 2 years, the DM + /CKD + patients had significantly higher incidences of the primary endpoint (9.5% versus 3.1%, adjusted HR 2.16; 95% CI [1.66-2.80], p < 0.001), BARC type 3 or 5 bleeding events, stroke, site-reported myocardial infraction, all revascularization, POCE, and NACE, compared with the DM-/CKD- patients. Among the DM + /CKD + patients, after adjustment, there were no significant differences in the primary endpoints between the experimental and reference regimen; however, the experimental regimen was associated with lower rates of POCE (20.6% versus 25.9%, HR 0.74; 95% CI [0.55-0.99], p = 0.043, p

conclusionAmong patients with both DM and CKD, ticagrelor monotherapy was not associated with lower rates of all-cause death or new Q-wave, or major bleeding complications; however, it was associated with lower rates of POCE and NACE. These findings should be interpreted as hypothesis-generating. CLINICAL

trial registrationClinicalTrials.gov (NCT01813435).

Indexed as

Diabetes MellitusPercutaneous Coronary InterventionRenal Insufficiency, ChronicAgedAged, 80 and overAsiaAustraliaBrazilCanadaCoronary Artery DiseaseDrug-Eluting StentsEuropeFemaleHemorrhageHumansIncidencePlatelet Aggregation InhibitorsTicagrelorAspirin-free antiplatelet strategiesChronic kidney diseaseDAPTDiabetes mellitusPercutaneous coronary interventionTicagrelor

Identifiers

PMID33066794
PMCPMC7568378
OpenAlexW3093077614

What OpenQuestion holds

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LicenceCC BY
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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.