Coronary interventions

Impact of ticagrelor monotherapy on two-year clinical outcomes in patients with long stenting: a post hoc analysis of the GLOBAL LEADERS trial

EuroIntervention 2020;16:634-644. DOI: 10.4244/EIJ-D-19-00498

Kuniaki Takahashi
Kuniaki Takahashi1, MD; Ply Chichareon1,2, MD; Rodrigo Modolo1,3, MD; Norihiro Kogame1, MD; Chun Chin Chang4, MD; Mariusz Tomaniak4,5, MD; Aris Moschovitis6, MD; Nick Curzen7, BM (Hons), PhD; Michael Haude8, MD; Werner Jung9, MD; Lene Holmvang10, MD, DMSc; Scot Garg11, MD, PhD; Jan G.P. Tijssen1,12, PhD; Joanna J. Wykrzykowska1, MD, PhD; Robbert J. de Winter1, MD, PhD; Christian Hamm13, MD; Philippe Gabriel Steg14, MD; Hans-Peter Stoll15, MD; Yoshinobu Onuma16, MD, PhD; Marco Valgimigli17, MD, PhD; Pascal Vranckx18, MD, PhD; Stephan Windecker17, MD; Patrick W. Serruys16, MD, PhD
1. Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; 2. Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand; 3. Department of Internal Medicine, Cardiology Division, University of Campinas (UNICAMP), Campinas, Brazil; 4. Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands; 5. First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland; 6. Tiefenauspital, Bern, Switzerland; 7. University Hospital Southampton, Southampton, and Faculty of Medicine, University of Southampton, Southampton, United Kingdom; 8. Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany; 9. Schwarzwald-Baar Klinikum, Villingen-Schwenningen, Germany; 10. Copenhagen University Hospital – Rigshospitalet, Copenhagen, Denmark; 11. Royal Blackburn Hospital, Blackburn, United Kingdom; 12. Cardialysis B.V., Rotterdam, the Netherlands; 13. Kerckhoff Campus, University of Giessen, Bad Nauheim, Germany; 14. FACT (French Alliance for Cardiovascular Trials), Université Paris-Diderot, Paris, France; 15. Biosensors Clinical Research, Morges, Switzerland; 16. Department of Cardiology, National University of Ireland, Galway, Ireland; 17. Department of Cardiology, University of Bern, Inselspital, Bern, Switzerland; 18. Jessa Ziekenhuis, Faculty of Medicine and Life Sciences at the Hasselt University, Hasselt, Belgium

Aims: The aim of this study was to evaluate the impact of a novel antiplatelet regimen in patients with increasing total stent length (TSL).

Methods and results: This is a post hoc analysis of the GLOBAL LEADERS trial, a prospective, multicentre, open-label, randomised trial, investigating the impact of the experimental strategy (one-month dual antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) versus the reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) in patients with a Biolimus A9-eluting stent (BES). The primary endpoint was the composite of all-cause death and new Q-wave myocardial infarction (MI), and the secondary endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at two years. To investigate the association between total stent length and outcomes, groups were compared in quartiles according to TSL; the fourth quartile group was at significantly higher ischaemic risk at two years. In that stratum (TSL ≥46 mm), the experimental strategy significantly reduced the risk of the primary endpoint (hazard ratio [HR] 0.67, 95% confidence interval [CI]: 0.49-0.90; pinteraction=0.043), while demonstrating a similar risk of BARC type 3 or 5 bleeding (HR 0.99, 95% CI: 0.66-1.49; pinteraction=0.975).

Conclusions: Ticagrelor monotherapy could potentially balance ischaemic and bleeding risks, thereby achieving a net clinical benefit in patients with a TSL ≥46 mm with a BES.

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