Impact of Ticagrelor Monotherapy on Two-Year Clinical Outcomes in Patients with Long Stenting: A Post Hoc Analysis of the Global Leaders Trial
DOI: 10.4244/EIJ-D-19-00498
Kuniaki Takahashi1, ; Ply Chichareon2, ; Rodrigo Modolo3, ; Norihiro Kogame4, ; Chun Chin Chang5, ; Mariusz Tomaniak6, ; Aris Moschovitis7, ; Nick Curzen8, ; Michael Haude9, ; Werner Jung10, ; Lene Holmvang11, ; Scot Garg12, ; Jan G.P. Tijssen13, ; Joanna J. Wykrzykowska14, ; Robbert J. de Winter15, ; Christian Hamm16, ; Philippe Gabriel Steg17, ; Hans-Peter Stoll18, ; Yoshinobu Onuma19, ; Marco Valgimigli20, ; Pascal Vranckx21, ; Stephan Windecker22, ; Patrick W Serruys23, ;
1. Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. 2. Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand. 3. Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Department of Internal Medicine, Cardiology Division. University of Campinas (UNICAMP). Campinas, Brazil. 4. Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. 5. Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. 6. Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands; First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland 7. Tiefenauspital, Bern, Switzerland. 8. University Hospital Southampton, Southampton, United Kingdom & Faculty of Medicine, University of Southampton, Southampton, United Kingdom. 9. Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany. 10. Schwarzwald-Baar Klinikum, Villingen-Schwenningen, Germany. 11. Copenhagen University Hospital – Rigshospitalet, Copenhagen, Denmark. 12. Royal Blackburn Hospital, Blackburn, United Kingdom. 13. Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Cardialysis B.V., Rotterdam, Netherlands. 14. Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. 15. Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. 16. Kerckhoff Campus, University of Giessen, Bad Nauheim, Germany. 17. FACT (French Alliance for Cardiovascular Trials), Université Paris-Diderot, Paris, France 18. Biosensors Clinical Research, Morges, Switzerland. 19. Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands; Cardialysis B.V., Rotterdam, Netherlands. 20. Department of Cardiology, University of Bern, Inselspital, Bern, Switzerland. 21. Jessa Ziekenhuis, Faculty of Medicine and Life Sciences at the Hasselt University, Hasselt, Belgium. 22. Department of Cardiology, University of Bern, Inselspital, Bern, Switzerland. 23. Imperial College London, London, United Kingdom, United Kingdom
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[Aims:] 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, multi-centre, open-label, randomised trial, investigating the impact of the experimental strategy (one-month dual antiplatelet regimen [DAPT] followed by 23-month ticagrelor monotherapy) versus the reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) in patients with Biolimus A9-eluting stent (BES). The primary endpoint was the composite of the 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, and the fourth quartile group was at significantly higher ischemic risk at two years. In that stratum (TSL≥ 46mm), 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 potentially could balance ischemic and bleeding risks, thereby achieving a net clinical benefit in patients with TSL≥ 46 mm with BES.
