Impact of renal function on clinical outcomes after PCI in ACS and stable CAD patients treated with ticagrelor: a prespecified analysis of the GLOBAL LEADERS randomized clinical trial.


Journal

Clinical research in cardiology : official journal of the German Cardiac Society
ISSN: 1861-0692
Titre abrégé: Clin Res Cardiol
Pays: Germany
ID NLM: 101264123

Informations de publication

Date de publication:
Jul 2020
Historique:
received: 08 09 2019
accepted: 28 11 2019
pubmed: 12 1 2020
medline: 13 5 2021
entrez: 12 1 2020
Statut: ppublish

Résumé

Impaired renal function (IRF) is associated with increased risks of both ischemic and bleeding events. Ticagrelor has been shown to provide greater absolute reduction in ischemic risk following acute coronary syndrome (ACS) in those with versus without IRF. A pre-specified sub-analysis of the randomized GLOBAL LEADERS trial (n = 15,991) comparing the experimental strategy of 23-month ticagrelor monotherapy (after 1-month ticagrelor and aspirin dual anti-platelet therapy [DAPT]) with 12-month DAPT followed by 12-month aspirin after percutaneous coronary intervention (PCI) in ACS and stable coronary artery disease (CAD) patients stratified according to IRF (glomerular filtration rate < 60 ml/min/1.73 m At 2 years, patients with IRF (n = 2171) had a higher rate of the primary endpoint (all-cause mortality or centrally adjudicated, new Q-wave myocardial infarction [MI](hazard ratio [HR] 1.64, 95% confidence interval [CI] 1.35-1.98, p IRF negatively impacted long-term prognosis after PCI. There were no differential treatment effects found with regard to all-cause death or new Q-wave MI after PCI in patients with IRF treated with ticagrelor monotherapy. The trial has been registered with ClinicalTrials.gov, number NCT01813435.

Sections du résumé

BACKGROUND BACKGROUND
Impaired renal function (IRF) is associated with increased risks of both ischemic and bleeding events. Ticagrelor has been shown to provide greater absolute reduction in ischemic risk following acute coronary syndrome (ACS) in those with versus without IRF.
METHODS METHODS
A pre-specified sub-analysis of the randomized GLOBAL LEADERS trial (n = 15,991) comparing the experimental strategy of 23-month ticagrelor monotherapy (after 1-month ticagrelor and aspirin dual anti-platelet therapy [DAPT]) with 12-month DAPT followed by 12-month aspirin after percutaneous coronary intervention (PCI) in ACS and stable coronary artery disease (CAD) patients stratified according to IRF (glomerular filtration rate < 60 ml/min/1.73 m
RESULTS RESULTS
At 2 years, patients with IRF (n = 2171) had a higher rate of the primary endpoint (all-cause mortality or centrally adjudicated, new Q-wave myocardial infarction [MI](hazard ratio [HR] 1.64, 95% confidence interval [CI] 1.35-1.98, p
CONCLUSIONS CONCLUSIONS
IRF negatively impacted long-term prognosis after PCI. There were no differential treatment effects found with regard to all-cause death or new Q-wave MI after PCI in patients with IRF treated with ticagrelor monotherapy.
CLINICAL TRIAL REGISTRATION BACKGROUND
The trial has been registered with ClinicalTrials.gov, number NCT01813435.

Identifiants

pubmed: 31925529
doi: 10.1007/s00392-019-01586-9
pii: 10.1007/s00392-019-01586-9
doi:

Substances chimiques

Platelet Aggregation Inhibitors 0
Ticagrelor GLH0314RVC

Banques de données

ClinicalTrials.gov
['NCT01813435']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

930-943

Auteurs

Mariusz Tomaniak (M)

Department of Cardiology, Erasmus University Medical Centre, Erasmus University, Rotterdam, The Netherlands.
First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.

Ply Chichareon (P)

Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.

Dominika Klimczak-Tomaniak (D)

Department of Immunology, Transplantation and Internal Medicine, Department of Cardiology, Hypertension and Internal Medicine, Medical University of Warsaw, Warsaw, Poland.

Kuniaki Takahashi (K)

Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.

Norihiro Kogame (N)

Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.

Rodrigo Modolo (R)

Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Department of Internal Medicine, Cardiology Division, University of Campinas (UNICAMP), Campinas, Brazil.

Rutao Wang (R)

Department of Cardiology, Xijing Hospital, Xi'an, China.
Department of Cardiology, Radboud University, Nijmegen, The Netherlands.

Masafumi Ono (M)

Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.

Hironori Hara (H)

Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.

Chao Gao (C)

Department of Cardiology, Xijing Hospital, Xi'an, China.
Department of Cardiology, Radboud University, Nijmegen, The Netherlands.

Hideyuki Kawashima (H)

Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.

Tessa Rademaker-Havinga (T)

Cardialysis Core Laboratories and Clinical Trial Management, Rotterdam, The Netherlands.

Scot Garg (S)

Royal Blackburn Hospital, Blackburn, UK.

Nick Curzen (N)

University Hospital Southampton NHSF, Southampton, UK.

Michael Haude (M)

Department of Cardiology, Städtische Kliniken Neuss, Neuss, Germany.

Janusz Kochman (J)

First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.

Tommaso Gori (T)

Deutsches Zentrum für Herz und Kreislauf Forschung, Standort Rhein-Main, University Medical Center Mainz, Mainz, Germany.

Gilles Montalescot (G)

Cardiology Department, ACTION Study Group, Nîmes University Hospital, Montpellier University, Nîmes, France.

Dominick J Angiolillo (DJ)

Division of Cardiology, University of Florida College of Medicine, Jacksonville, FL, USA.

Davide Capodanno (D)

Division of Cardiology, A.O.U. "Policlinico-Vittorio Emanuele", University of Catania, Catania, Italy.

Robert F Storey (RF)

Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Cardiology and Cardiothoracic Surgery Directorate, Sheffield Teaching Hospitals NHS Foundation Trust, Cardiovascular Research Unit, Centre for Biomedical Research, Northern General Hospital, Sheffield, UK.

Christian Hamm (C)

University of Giessen, Giessen, Germany.

Pascal Vranckx (P)

Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium.

Marco Valgimigli (M)

Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.

Stephan Windecker (S)

Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.

Yoshinobu Onuma (Y)

Department of Cardiology, National University of Ireland, Galway (NUIG), University Road, Galway, H91 TK33, Ireland.

Patrick W Serruys (PW)

NHLI, Imperial College London, London, UK. patrick.w.j.c.serruys@gmail.com.
Department of Cardiology, National University of Ireland, Galway (NUIG), University Road, Galway, H91 TK33, Ireland. patrick.w.j.c.serruys@gmail.com.

Richard Anderson (R)

University Hospital of Wales, Cardiff, UK.

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