Norihiro Kogame1,2, Ply Chichareon1,3, Kenneth De Wilder4, Kuniaki Takahashi1, Rodrigo Modolo1,5, Chun Chin Chang6, Mariusz Tomaniak6, Hidenori Komiyama1, Alaide Chieffo7, Antonio Colombo8, Scot Garg9, Yves Louvard10, Peter Jüni11,12, Philippe G Steg13, Christian Hamm14, Pascal Vranckx15, Marco Valgimigli16, Stephan Windecker16, Hans-Peter Stoll17, Yoshinobu Onuma6, Luc Janssens4, Patrick W Serruys18. 1. Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands. 2. Department of Cardiology, Toho University medical center Ohashi hospital, Tokyo, Japan. 3. Faculty of Medicine, Division of Cardiology, Department of Internal Medicine, Prince of Songkla University, Songkhla, Thailand. 4. Heart Centre, Imelda Hospital Bonheiden, Bonheiden, Belgium. 5. Cardiology Division, Department of Internal Medicine, University of Campinas (UNICAMP), Campinas, Brazil. 6. Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. 7. Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy. 8. Interventional Cardiology Unit, Villa Maria Cecila Hospital GVM, Cotignola (RA), Italy. 9. Department of Cardiology, Royal Blackburn Hospital, Blackburn, UK. 10. Department of Cardiology, Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Hopital Privé Jacques Cartier, Massy, France. 11. Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Toronto, Ontario, Canada. 12. Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada. 13. French Alliance for Cardiovascular Trials (FACT), Université Paris-Diderot, Paris, France. 14. Kerckhoff Heart and Thorax Center, University of Giessen, Giessen, Germany. 15. Faculty of Medicine and Life Sciences, Jessa Ziekenhuis, the Hasselt University, Hasselt, Belgium. 16. Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland. 17. Biosensors Clinical Research, Morges, Switzerland. 18. International Centre for Circulatory Health, Imperial College London, London, UK.
Abstract
BACKGROUND: The aim of this study was to investigate the impact of ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) for bifurcation lesions. METHODS: GLOBAL LEADERS was a randomized, superiority, all-comers trial comparing 1-month DAPT with ticagrelor and aspirin followed by 23-month ticagrelor monotherapy (experimental treatment) with standard 12-month DAPT followed by 12-month aspirin monotherapy (reference treatment) in patients treated with a biolimus A9-eluting stent. The primary endpoint was a composite of all-cause death or new Q-wave myocardial infarction (MI) at 2 years. RESULTS: Among the 15,845 patients included in this subgroup analysis, 2,498 patients (15.8%) underwent PCI for at least one bifurcation lesion. The incidence of the primary endpoint was similar between the bifurcation and nonbifurcation groups (4.7 vs. 4.0%, p = .083). The experimental treatment had no significant effect on the primary endpoint according to the presence/absence of a bifurcation lesion (bifurcation: hazard ratio [HR]: 0.74, 95% confidence interval [CI]: 0.51-1.07; nonbifurcation: HR: 0.90, 95% CI: 0.76-1.07, p for interaction = .343), but was associated with significant reduction in definite or probable stent thrombosis (p for interaction = .022) and significant excess of stroke (p for interaction = .018) when compared with the reference treatment. CONCLUSIONS: After PCI for bifurcation lesions using 1-month of DAPT followed by ticagrelor monotherapy for 23 months did not demonstrate explicit benefit regarding all-cause death or new Q-wave MI as in the overall trial.
RCT Entities:
BACKGROUND: The aim of this study was to investigate the impact of ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) for bifurcation lesions. METHODS: GLOBAL LEADERS was a randomized, superiority, all-comers trial comparing 1-month DAPT with ticagrelor and aspirin followed by 23-month ticagrelor monotherapy (experimental treatment) with standard 12-month DAPT followed by 12-month aspirin monotherapy (reference treatment) in patients treated with a biolimus A9-eluting stent. The primary endpoint was a composite of all-cause death or new Q-wave myocardial infarction (MI) at 2 years. RESULTS: Among the 15,845 patients included in this subgroup analysis, 2,498 patients (15.8%) underwent PCI for at least one bifurcation lesion. The incidence of the primary endpoint was similar between the bifurcation and nonbifurcation groups (4.7 vs. 4.0%, p = .083). The experimental treatment had no significant effect on the primary endpoint according to the presence/absence of a bifurcation lesion (bifurcation: hazard ratio [HR]: 0.74, 95% confidence interval [CI]: 0.51-1.07; nonbifurcation: HR: 0.90, 95% CI: 0.76-1.07, p for interaction = .343), but was associated with significant reduction in definite or probable stent thrombosis (p for interaction = .022) and significant excess of stroke (p for interaction = .018) when compared with the reference treatment. CONCLUSIONS: After PCI for bifurcation lesions using 1-month of DAPT followed by ticagrelor monotherapy for 23 months did not demonstrate explicit benefit regarding all-cause death or new Q-wave MI as in the overall trial.
Authors: Ilias Nikolakopoulos; Evangelia Vemmou; Judit Karacsonyi; Lorenzo Azzalini; Brian A Bergmark; Yiannis S Chatzizisis; Allison B Hall; Jason Wollmuth; Kevin Croce; Hani Jneid; Bavana V Rangan; M Nicholas Burke; Emmanouil S Brilakis Journal: J Invasive Cardiol Date: 2022-01 Impact factor: 2.022