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.
- Tomaniak M Department of Cardiology, Erasmus University Medical Centre, Erasmus University, Rotterdam, The Netherlands.
- Chichareon P Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
- Klimczak-Tomaniak D Department of Immunology, Transplantation and Internal Medicine, Department of Cardiology, Hypertension and Internal Medicine, Medical University of Warsaw, Warsaw, Poland.
- Takahashi K Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
- Kogame N Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
- Modolo R Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
- Wang R Department of Cardiology, Xijing Hospital, Xi'an, China.
- Ono M Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
- Hara H Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
- Gao C Department of Cardiology, Xijing Hospital, Xi'an, China.
- Kawashima H Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
- Rademaker-Havinga T Cardialysis Core Laboratories and Clinical Trial Management, Rotterdam, The Netherlands.
- Garg S Royal Blackburn Hospital, Blackburn, UK.
- Curzen N University Hospital Southampton NHSF, Southampton, UK.
- Haude M Department of Cardiology, Städtische Kliniken Neuss, Neuss, Germany.
- Kochman J First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.
- Gori T Deutsches Zentrum für Herz und Kreislauf Forschung, Standort Rhein-Main, University Medical Center Mainz, Mainz, Germany.
- Montalescot G Cardiology Department, ACTION Study Group, Nîmes University Hospital, Montpellier University, Nîmes, France.
- Angiolillo DJ Division of Cardiology, University of Florida College of Medicine, Jacksonville, FL, USA.
- Capodanno D Division of Cardiology, A.O.U. "Policlinico-Vittorio Emanuele", University of Catania, Catania, Italy.
- 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.
- Hamm C University of Giessen, Giessen, Germany.
- Vranckx P Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium.
- Valgimigli M Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.
- Windecker S Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.
- Onuma Y Department of Cardiology, National University of Ireland, Galway (NUIG), University Road, Galway, H91 TK33, Ireland.
- Serruys PW NHLI, Imperial College London, London, UK. patrick.w.j.c.serruys@gmail.com.
- Anderson R University Hospital of Wales, Cardiff, UK.
- 2020-01-12
Published in:
- Clinical research in cardiology : official journal of the German Cardiac Society. - 2020
Aspirin-free antiplatelet strategies
Chronic kidney disease
DAPT
Impaired renal function
Percutaneous coronary intervention
Ticagrelor
English
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
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 m2).
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, padj = 0.001), all-cause death, site-reported MI, all revascularization and BARC 3 or 5 type bleeding, compared with patients without IRF. Among patients with IRF, there were similar rates of the primary endpoint (HR 0.82, 95% CI 0.61-1.11, p = 0.192, pint = 0.680) and BARC 3 or 5 type bleeding (HR 1.10, 95% CI 0.71-1.71, p = 0.656, pint = 0.506) in the experimental versus the reference group. No significant interactions were seen between IRF and treatment effect for any of the secondary outcome variables. Among ACS patients with IRF, there were no between-group differences in the rates of the primary endpoint or BARC 3 or 5 type bleeding; however, the rates of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, MI, or revascularization (pint = 0.028) and net adverse clinical events (POCE and BARC 3 or 5 type bleeding) (pint = 0.045), were lower in the experimental versus the reference group. No treatment effects were found in stable CAD patients categorized according to presence of IRF.
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
The trial has been registered with ClinicalTrials.gov, number NCT01813435.
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
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 m2).
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, padj = 0.001), all-cause death, site-reported MI, all revascularization and BARC 3 or 5 type bleeding, compared with patients without IRF. Among patients with IRF, there were similar rates of the primary endpoint (HR 0.82, 95% CI 0.61-1.11, p = 0.192, pint = 0.680) and BARC 3 or 5 type bleeding (HR 1.10, 95% CI 0.71-1.71, p = 0.656, pint = 0.506) in the experimental versus the reference group. No significant interactions were seen between IRF and treatment effect for any of the secondary outcome variables. Among ACS patients with IRF, there were no between-group differences in the rates of the primary endpoint or BARC 3 or 5 type bleeding; however, the rates of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, MI, or revascularization (pint = 0.028) and net adverse clinical events (POCE and BARC 3 or 5 type bleeding) (pint = 0.045), were lower in the experimental versus the reference group. No treatment effects were found in stable CAD patients categorized according to presence of IRF.
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
The trial has been registered with ClinicalTrials.gov, number NCT01813435.
- Language
-
- English
- Open access status
- green
- Identifiers
-
- DOI 10.1007/s00392-019-01586-9
- PMID 31925529
- Persistent URL
- https://folia.unifr.ch/global/documents/157352
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