Abstract
| Original language | English |
|---|---|
| Pages (from-to) | 72-82 |
| Number of pages | 11 |
| Journal | Catheterization and cardiovascular interventions |
| Volume | 100 |
| Issue number | 1 |
| Early online date | 2022 |
| DOIs | |
| Publication status | Published - 1 Jul 2022 |
Keywords
- drug interaction
- dual antiplatelet therapy
- percutaneous coronary intervention
- proton pump inhibitor
- ticagrelor monotherapy
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In: Catheterization and cardiovascular interventions, Vol. 100, No. 1, 01.07.2022, p. 72-82.
Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - Impact of proton pump inhibitors on efficacy of antiplatelet strategies with ticagrelor or aspirin after percutaneous coronary intervention
T2 - Insights from the GLOBAL LEADERS trial
AU - Ono, Masafumi
AU - Onuma, Yoshinobu
AU - Kawashima, Hideyuki
AU - Hara, Hironori
AU - Gao, Chao
AU - Wang, Rutao
AU - O'Leary, Neil
AU - Benit, Edouard
AU - Janssens, Luc
AU - Ferrario, Maurizio
AU - Żurakowski, Aleksander
AU - Dominici, Marcello
AU - Huber, Kurt
AU - Buszman, Paweł
AU - Garg, Scot
AU - Wykrzykowska, Joanna J.
AU - Piek, Jan J.
AU - Jüni, Peter
AU - Hamm, Christian
AU - Windecker, Stephan
AU - Vranckx, Pascal
AU - Deliargyris, Efthymios N.
AU - Bhatt, Deepak L.
AU - Storey, Robert F.
AU - Valgimigli, Marco
AU - The GLOBAL LEADERS trial investigators
AU - Serruys, Patrick W.
N1 - Funding Information: The GLOBAL LEADERS trial was supported by unrestricted grants from AstraZeneca, Biosensors, and The Medicines Company. ECRI (European Cardiovascular Research Institute) was formally the sponsor of the study. GLOBAL LEADERS was sponsored by the European Clinical Research Institute, which received funding from Biosensors International, AstraZeneca, and the Medicines Company. P. J. is a Tier 1 Canada Research Chair in Clinical Epidemiology of Chronic Diseases. This study was completed, in part, with funding from the Canada Research Chairs Program. Open access funding provided by IReL. Funding Information: Dr. Hironori Hara reports a grant for studying overseas from Japanese Circulation Society and a grant from Fukuda Foundation for Medical Technology, outside the submitted work. Dr. Jan J. Piek reports personal fees and nonfinancial support from Philips/Volcano, outside the submitted work. Dr. Peter Jüni serves as unpaid member of the steering group of trials funded by Appili Therapeutics, Astra Zeneca, Biotronik, Biosensors, St. Jude Medical and The Medicines Company, has received research grants to the institution from Astra Zeneca, Biotronik, Biosensors International, Eli Lilly and The Medicines Company, and honoraria to the institution for participation in advisory boards and/or consulting from Amgen, Ava and Fresenius, but has not received personal payments by any pharmaceutical company or device manufacturer. Dr. Christian Hamm reports personal fees from AstraZeneca, outside the submitted work. Dr. Marco Valgimigli reports personal fees from Astra Zeneca, grants and personal fees from Terumo, personal fees from Alvimedica/CID, personal fees from Abbott Vascular, personal fees from Daiichi Sankyo, personal fees from Opsens, personal fees from Bayer, personal fees from CoreFLOW, personal fees from Idorsia Pharmaceuticals Ltd., personal fees from Universität Basel | Dept. Klinische Forschung, personal fees from Vifor, personal fees from Bristol Myers Squib SA, personal fees from iVascular, personal fees from Medscape, outside the submitted work. Dr. Stephan Windecker reports grants from Amgen, grants from Abbott, grants from BMS, grants from Bayer, grants from Boston Scientific, grants from Biotronik, grants from Cardinal Health, grants from CardioValve, grants from CSL Behring, grants from Daiichi Sankyo, grants from Edwards Lifesciences, grants from Johnson and Johnson, grants from Medtronic, grants from Querbet, grants from Polares, grants from Sanofi, grants from Terumo, grants from Sinomed, outside the submitted work; and Stephan Windecker serves as unpaid member of the steering/excecutive group of trials funded by Abbott, Abiomed, Amgen, BMS, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Polares, Sinomed, V‐Wave and Xeltis, but has not received personal payments by any pharmaceutical company or device manufacturer. He is also member of the steering/excecutive committee group of several investigated‐initiated trials that receive funding by industry without impact on his personal remuneration. Dr. Pascal Vranckx reports personal fees from astra zeneca, personal fees from bayer ag, personal fees from daiichi sankio, personal fees from behring cls, personal fees from terumo, outside the submitted work. Dr. Efthymios N. Deliargyris reports other from PLX Pharma, outside the submitted work. Dr. Deepak L. Bhatt reports grants from Amarin, grants from AstraZeneca, grants from Bristol‐Myers Squibb, grants from Eisai, grants from Ethicon, grants from Medtronic, grants from sanofi aventis, grants from The Medicines Company, other from FlowCo, grants and other from PLx Pharma, other from Takeda, personal fees from Duke Clinical Research Institute, personal fees from Mayo Clinic, personal fees from Population Health Research Institute, personal fees, nonfinancial support and other from American College of Cardiology, personal fees from Belvoir Publications, personal fees from Slack Publications, personal fees from WebMD, personal fees from Elsevier, other from Medscape Cardiology, other from Regado Biosciences, other from Boston VA Research Institute, personal fees and nonfinancial support from Society of Cardiovascular Patient Care, nonfinancial support from American Heart Association, personal fees from HMP Global, grants from Roche, personal fees from Harvard Clinical Research Institute (now Baim Institute for Clinical Research), other from Clinical Cardiology, personal fees from Journal of the American College of Cardiology, other from VA, grants from Pfizer, grants from Forest Laboratories/AstraZeneca, grants from Ischemix, other from St. Jude Medical (now Abbott), other from Biotronik, grants and other from Cardax, other from Boston Scientific, grants from Amgen, grants from Lilly, grants from Chiesi, grants from Ironwood, personal fees from Cleveland Clinic, personal fees from Mount Sinai School of Medicine, other from Merck, grants from Abbott, grants from Regeneron, other from Svelte, grants and other from PhaseBio, grants from Idorsia, grants from Synaptic, personal fees from TobeSoft, grants, personal fees and other from Boehringer Ingelheim, personal fees from Bayer, other from Novo Nordisk, grants from Fractyl, personal fees from Medtelligence/ReachMD, personal fees from CSL Behring, other from Cereno Scientific, grants from Afimmune, personal fees from Ferring Pharmaceuticals, other from CSI, grants from Lexicon, personal fees from MJH Life Sciences, personal fees from Level Ex, personal fees from Contego Medical, personal fees from CellProthera, personal fees from K2P, outside the submitted work. Dr. Robert F. Storey reports personal fees from Bayer, personal fees from Bristol‐Myers Squibb/Pfizer, grants and personal fees from AstraZeneca, grants and personal fees from Thromboserin, personal fees from Haemonetics, personal fees from Amgen, grants and personal fees from Glycardial Diagnostics, personal fees from Portola, personal fees from Medscape, grants and personal fees from Cytosorbents, personal fees from Intas Pharmaceuticals, outside the submitted work. Dr. Patrick W. Serruys reports personal fees from Sino Medical Sciences Technology, personal fees from Philips/Volcano, personal fees from Xeltis, outside the submitted work. The remaining authors declare no conflicts of interest. Funding Information: The GLOBAL LEADERS trial was supported by unrestricted grants from AstraZeneca, Biosensors, and The Medicines Company. ECRI (European Cardiovascular Research Institute) was formally the sponsor of the study. GLOBAL LEADERS was sponsored by the European Clinical Research Institute, which received funding from Biosensors International, AstraZeneca, and the Medicines Company. P. J. is a Tier 1 Canada Research Chair in Clinical Epidemiology of Chronic Diseases. This study was completed, in part, with funding from the Canada Research Chairs Program. Open access funding provided by IReL. Publisher Copyright: © 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.
PY - 2022/7/1
Y1 - 2022/7/1
N2 - Background: Several studies have suggested that proton pump inhibitors (PPIs) may reduce the antiplatelet effects of clopidogrel and/or aspirin, possibly leading to cardiovascular events. Aims: We aimed to investigate the association between PPI and clinical outcomes in patients treated with ticagrelor monotherapy or conventional antiplatelet therapy after percutaneous coronary intervention (PCI). Methods: This is a subanalysis of the randomized GLOBAL LEADERS trial, comparing the experimental antiplatelet arm (23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy [DAPT]) with the reference arm (12-month aspirin monotherapy following 12-month DAPT) after PCI. Patient-oriented composite endpoints (POCEs: all-cause mortality, myocardial infarction, stroke, or repeat revascularization) and its components were assessed stratified by PPI use as a time-dependent covariate in patients with the experiment or reference antiplatelet arm. Results: Among 15,839 patients, 2115 patients (13.5%) experienced POCE at 2 years. In the reference arm, the use of PPIs was independently associated with POCE (hazard ratio [HR]: 1.27; 95% confidence interval [CI]: 1.12–1.44) and its individual components, whereas it was not in the experimental arm (HR: 1.04; 95% CI: 0.92–1.19; pinteraction = 0.035). During the second-year follow-up, patients taking aspirin with PPIs had a significantly higher risk of POCE compared to those on aspirin without PPIs (HR: 1.57; 95% CI: 1.27–1.94), whereas the risk did not differ significantly irrespective of PPI in ticagrelor monotherapy group (HR: 1.03; 95% CI: 0.83–1.28; pinteraction = 0.008). Conclusions: In contrast to conventional antiplatelet strategy, there were no evidence suggesting the interaction between ticagrelor monotherapy and PPIs on increased cardiovascular events, which should be confirmed in further studies. Clinical Trial Registration: URL: https://clinicaltrials.gov.
AB - Background: Several studies have suggested that proton pump inhibitors (PPIs) may reduce the antiplatelet effects of clopidogrel and/or aspirin, possibly leading to cardiovascular events. Aims: We aimed to investigate the association between PPI and clinical outcomes in patients treated with ticagrelor monotherapy or conventional antiplatelet therapy after percutaneous coronary intervention (PCI). Methods: This is a subanalysis of the randomized GLOBAL LEADERS trial, comparing the experimental antiplatelet arm (23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy [DAPT]) with the reference arm (12-month aspirin monotherapy following 12-month DAPT) after PCI. Patient-oriented composite endpoints (POCEs: all-cause mortality, myocardial infarction, stroke, or repeat revascularization) and its components were assessed stratified by PPI use as a time-dependent covariate in patients with the experiment or reference antiplatelet arm. Results: Among 15,839 patients, 2115 patients (13.5%) experienced POCE at 2 years. In the reference arm, the use of PPIs was independently associated with POCE (hazard ratio [HR]: 1.27; 95% confidence interval [CI]: 1.12–1.44) and its individual components, whereas it was not in the experimental arm (HR: 1.04; 95% CI: 0.92–1.19; pinteraction = 0.035). During the second-year follow-up, patients taking aspirin with PPIs had a significantly higher risk of POCE compared to those on aspirin without PPIs (HR: 1.57; 95% CI: 1.27–1.94), whereas the risk did not differ significantly irrespective of PPI in ticagrelor monotherapy group (HR: 1.03; 95% CI: 0.83–1.28; pinteraction = 0.008). Conclusions: In contrast to conventional antiplatelet strategy, there were no evidence suggesting the interaction between ticagrelor monotherapy and PPIs on increased cardiovascular events, which should be confirmed in further studies. Clinical Trial Registration: URL: https://clinicaltrials.gov.
KW - drug interaction
KW - dual antiplatelet therapy
KW - percutaneous coronary intervention
KW - proton pump inhibitor
KW - ticagrelor monotherapy
UR - http://www.scopus.com/inward/record.url?scp=85131534332&partnerID=8YFLogxK
U2 - https://doi.org/10.1002/ccd.30217
DO - https://doi.org/10.1002/ccd.30217
M3 - Article
C2 - 35500171
SN - 1522-1946
VL - 100
SP - 72
EP - 82
JO - Catheterization and cardiovascular interventions
JF - Catheterization and cardiovascular interventions
IS - 1
ER -