TY - JOUR
T1 - Patient-oriented composite endpoints and net adverse clinical events with ticagrelor monotherapy following percutaneous coronary intervention
T2 - Insights from the randomised GLOBAL LEADERS trial
AU - Serruys, Patrick W.
AU - Tomaniak, Mariusz
AU - Chichareon, Ply
AU - Modolo, Rodrigo
AU - Kogame, Norihiro
AU - Takahashi, Kuniaki
AU - Chang, Chun Chin
AU - Spitzer, Ernest
AU - Walsh, Simon
AU - Adlam, David
AU - Hildick-Smith, David
AU - Édes, István
AU - Van der Harst, Pim
AU - Krackhardt, Florian
AU - Tijssen, Jan
AU - Rademaker-Havinga, Tessa
AU - Garg, Scot
AU - Steg, Philippe Gabriel
AU - Hamm, Christian
AU - Jüni, Peter
AU - Vranckx, Pascal
AU - Onuma, Yoshinobu
AU - Verheugt, Freek W.A.
N1 - Funding Information:
GLOBAL LEADERS was sponsored by the European Clinical Research Institute, which received unrestricted grants from Biosensors International, AstraZeneca, and The Medicines Company.
Funding Information:
P.W. Serruys has received personal fees from AstraZeneca, Biotronik, Cardialysis, GLG Research, Medtronic, Sino Medical Sciences Technology, Société Europa Digital & Publishing, Stentys France, Svelte Medical Systems, Philips/Volcano, St. Jude Medical, Qualimed, and Xeltis, outside the submitted work. E. Spitzer reports institutional grants from the European Cardiovascular Research Institute, during the conduct of the study. M. Tomaniak has received lecture fees from AstraZeneca. P. Chichareon has received a research grant from Biosensors. R. Modolo has received research grants from Biosensors. D. Adlam reports grants from the British Heart Foundation, grants from the NIHR Rare Diseases Translational Research Collaboration, grants and non-financial support from NIHR Leicester Biomedical Research Centre, grants from Beat SCAD, grants from Abbott Vascular, and non-financial support from AstraZeneca, during the conduct of the study. J. Tijssen reports personal fees from Cardialysis, for DSMB membership of the GLOBAL LEADERS trial during the conduct of the study. P.G. Steg reports grants and personal fees from Bayer/Janssen, Merck, Sanofi, Amarin, and Servier, personal fees from Amgen, Bristol-Myers Squibb, Boehringer-Ingelheim, Pfizer, Novartis, Regeneron, Lilly, and AstraZeneca, outside the submitted work. C. Hamm reports personal fees from AstraZeneca during the conduct of the study and personal fees from AstraZeneca outside the submitted work. P. Jüni has received research grants to the institution from AstraZeneca, Biotronik, Biosensors International, Eli Lilly and The Medicines Company, outside the submitted work, and is a Tier 1 Canada Research Chair in Clinical Epidemiology of Chronic Diseases (the GLOBAL LEADERS study was completed in part, with funding from the Canada Research Chairs Programme). P. Jüni serves as unpaid member of the steering group of trials funded by AstraZeneca, Biotronik, Biosensors, St. Jude Medical and The Medicines Company. P. Vranckx has received personal fees from AstraZeneca and The Medicines Company during the conduct of the study and personal fees from Bayer HealthCare, Terumo, and Daiichi Sankyo outside the submitted work. Y. Onuma has received consultancy fees from Abbott Vascular outside the submitted work. F. Verheugt reports personal fees from AstraZeneca during the conduct of the study. The other authors have no conflicts of interest to declare. The Guest Editor is a consultant for Edwards Lifesciences.
Publisher Copyright:
© 2019 Pensoft Publishers. All rights reserved.
PY - 2019/12
Y1 - 2019/12
N2 - Aims: The aim of this study was to evaluate the impact of 23-month ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) on the rates of patient-oriented composite endpoints (POCE) and net adverse clinical events (NACE). Methods and results: The rates of site-reported Academic Research Consortium (ARC)-2 defined POCE (all-cause death, any stroke, any myocardial infarction or any revascularisation) and NACE (POCE or bleeding type 3 or 5 according to the Bleeding ARC [BARC]) were reported up to two years by intentionto- treat principle in the randomised, multicentre, open-label GLOBAL LEADERS study comparing two antiplatelet strategies in 15,991 patients undergoing PCI. The experimental strategy consisted of aspirin with ticagrelor for one month followed by ticagrelor monotherapy for 23 months, whereas the reference treatment consisted of 12-month DAPT followed by 12-month aspirin monotherapy. At two years, POCE occurred in 1,050 (13.2%) patients in the experimental group and in 1,131 (14.2%) in the reference group (HR 0.93, 95% CI: 0.85-1.01, p=0.085). NACE occurred in 1,145 (14.4%) patients in the experimental group and in 1,237 (15.5%) patients in the reference group (HR 0.92, 95% CI: 0.85-1.00, p=0.057). In pre-specified subgroup analyses, no significant treatment-by-subgroup interactions were found for either POCE or NACE at two years. Conclusions: The experimental treatment strategy of one-month DAPT followed by 23 months of ticagrelor alone did not result in a significant reduction in the rates of site-reported POCE or NACE, when compared to the reference treatment. ClinicalTrials.gov Identifier: NCT01813435.
AB - Aims: The aim of this study was to evaluate the impact of 23-month ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) on the rates of patient-oriented composite endpoints (POCE) and net adverse clinical events (NACE). Methods and results: The rates of site-reported Academic Research Consortium (ARC)-2 defined POCE (all-cause death, any stroke, any myocardial infarction or any revascularisation) and NACE (POCE or bleeding type 3 or 5 according to the Bleeding ARC [BARC]) were reported up to two years by intentionto- treat principle in the randomised, multicentre, open-label GLOBAL LEADERS study comparing two antiplatelet strategies in 15,991 patients undergoing PCI. The experimental strategy consisted of aspirin with ticagrelor for one month followed by ticagrelor monotherapy for 23 months, whereas the reference treatment consisted of 12-month DAPT followed by 12-month aspirin monotherapy. At two years, POCE occurred in 1,050 (13.2%) patients in the experimental group and in 1,131 (14.2%) in the reference group (HR 0.93, 95% CI: 0.85-1.01, p=0.085). NACE occurred in 1,145 (14.4%) patients in the experimental group and in 1,237 (15.5%) patients in the reference group (HR 0.92, 95% CI: 0.85-1.00, p=0.057). In pre-specified subgroup analyses, no significant treatment-by-subgroup interactions were found for either POCE or NACE at two years. Conclusions: The experimental treatment strategy of one-month DAPT followed by 23 months of ticagrelor alone did not result in a significant reduction in the rates of site-reported POCE or NACE, when compared to the reference treatment. ClinicalTrials.gov Identifier: NCT01813435.
KW - ACS/NSTE-ACS
KW - Adjunctive pharmacotherapy
KW - Clinical trials
KW - Stable angina
UR - http://www.scopus.com/inward/record.url?scp=85113288421&partnerID=8YFLogxK
U2 - 10.4244/EIJ-D-19-00202
DO - 10.4244/EIJ-D-19-00202
M3 - Article
AN - SCOPUS:85113288421
SN - 1774-024X
VL - 15
SP - E1090-+
JO - EuroIntervention
JF - EuroIntervention
IS - 12
ER -