Patrick W. Serruys1, MD, PhD; Mariusz Tomaniak2,3, MD; Ply Chichareon4,5, MD; Rodrigo Modolo4,6, MD; Norihiro Kogame4, MD; Kuniaki Takahashi4, MD; Chun Chin Chang2, MD; Ernest Spitzer2,7, MD; Simon J. Walsh8, MD, PhD; David Adlam9, MD, PhD; David Hildick-Smith10, MD, PhD; István Édes11, MD, PhD; Pim van de Harst12, MD, PhD; Florian Krackhardt13, MD, PhD; Jan G.P. Tijssen4,7, MD, PhD; Tessa Rademaker-Havinga7, PhD; Scot Garg14, MD, PhD; Philippe Gabriel Steg15, MD, PhD; Christian Hamm16, MD, PhD; Peter Jüni17, PhD; Pascal Vranckx18, MD, PhD; Yoshinobu Onuma2,7, MD, PhD; Freek W.A. Verheugt19, MD, PhD; GLOBAL LEADERS Study Investigators
1. NHLI, Imperial College London, London, United Kingdom, United Kingdom; 2. Erasmus Medical Center, Erasmus University, Rotterdam, The Netherlands; 3. First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland; 4. Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands; 5. Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand; 6. Department of Internal Medicine, Cardiology Division, University of Campinas (UNICAMP), Campinas, Brazil; 7. Cardialysis Core Laboratories and Clinical Trial Management, Rotterdam, the Netherlands; 8. Royal Victoria Hospital, Belfast, Northern Ireland; 9. University of Leicester and University Hospitals Leicester, Leicester, United Kingdom; 10. Royal Sussex County Hospital, Brighton, United Kingdom; 11. Department of Cardiology, University of Debrecen, Hungary; 12. University of Groningen, University Medical Centre Groningen (UMCG), Groningen, the Netherlands; 13. Charité – Universitätsmedizin Berlin, Department of Internal Medicine and Cardiology, Campus Virchow-Klinikum, Berlin, Germany; 14. Royal Blackburn Hospital, Blackburn, United Kingdom; 15. FACT (French Alliance for Cardiovascular Trials), Université Paris Diderot, Hôpital Bichat, Assistance Publique - Hôpitaux de Paris, and INSERM U-1148, Paris, France; 16. University of Giessen, Giessen, and Campus Kerckhoff, Bad Nauheim, Germany; 17. Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Department of Medicine and the Institute of Health Policy, Management and Evaluation at the University of Toronto, Toronto, Canada; 18. Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium; 19. Department of Cardiology, Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, the Netherlands
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 intention-to-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