‘Ticagrelor alone vs. dual antiplatelet therapy from 1 month after drug-eluting coronary stenting among patients with STEMI’: a post hoc analysis of the randomized GLOBAL LEADERS trial

Author:

Gamal Amr S123ORCID,Hara Hironori14,Tomaniak Mariusz56ORCID,Lunardi Mattia17,Gao Chao18,Ono Masafumi14,Kawashima Hideyuki14,Jüni Peter9ORCID,Vranckx Pascal10,Windecker Stephan11ORCID,Hamm Christian12,Steg Philippe Gabriel13,Onuma Yoshinobu1,Serruys Patrick W114

Affiliation:

1. Department of Cardiology, National University of Ireland, Galway (NUIG), University Road, Galway H91 TK33, Ireland

2. Department of Cardiology, North Cumbria University Hospital NHS Trust, Newtown Road, Cumbria CA2 7HY, England, UK

3. Department of Cardiology, Zagazig University, Zagazig, Sharkia, 44519, Egypt

4. Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands

5. Department of Cardiology, Erasmus University MC, Dr. Molewaterplein 40 Street, 3015 GD Rotterdam, The Netherlands

6. First Department of Cardiology, Medical University of Warsaw, Banacha 1a Street, 02-097 Warsaw, Poland

7. Division of Cardiology, University of Verona, Piazzale Stefani 1, Verona 37100, Italy

8. Department of Cardiology, Radboud University Medical Center, Geert Grooteplein Zuid 8, 6525 GA Nijmegen, The Netherlands

9. Applied Health Research Centre, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, 30 Bond Street Toronto, Ontario M5B 1W8, Canada

10. Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Stadsomvaart 11, 3500 Hasselt, Belgium

11. Department of Cardiology, Bern University Hospital, Freiburgstrasse 4, 3010 Bern, Switzerland

12. Department of Cardiology, Campus Kerckhoff of the University of Giessen, Kerckhoff Heart and Thorax Center, Benekestrasse 2-8, 61231, Bad Nauheim, Germany

13. Université de Paris, FACT, Assistance Publique-Hôpitaux de Paris Hôpital Bichat, AP-HP, 46 rue Henri Huchard, 75018 Paris, France

14. Department of Cardiology, Imperial College London, Exhibition Road, London SW7 2BX, UK

Abstract

Abstract Aim To evaluate the efficacy and safety of ticagrelor monotherapy beyond 1 month and up to 24 months vs. standard 12-month dual antiplatelet therapy (DAPT) with aspirin and ticagrelor followed by aspirin monotherapy among ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI) in the GLOBAL LEADERS trial. Methods and results We performed a post hoc analysis of STEMI patients in the GLOBAL LEADERS trial comparing experimental ticagrelor monotherapy (1062 patients) with standard 12-month DAPT (1030 patients). We evaluated predefined primary and secondary endpoints in both treatment arms. Rates of net adverse clinical events (NACE), patient-oriented composite endpoints (POCE), and bleeding academic research consortium (BARC)-defined bleeding Type 3 or 5 were also evaluated. At 2 years, there were no significant differences in rates of primary endpoints in patients who had STEMI [0.89 (0.61–1.31)]. There were similar rates of NACE and POCE in both experimental and reference treatment groups at 2 years post-PCI [hazard ratio (HR) 0.96 (0.77–1.20) and 0.96 (0.77–1.21), respectively]. BARC 3 or 5 bleeding events were numerically less in experimental compared to reference treatment groups at 1 year [HR 0.55 (0.27–1.13)] and 2 years [0.61 (0.32–1.16)]. Conclusion Presentation with STEMI has not influenced the incidence of GLOBAL LEADERS defined primary endpoints. There were no significant differences in rates of NACE, POCE, and BARC bleeding between the two treatment groups up to 2 years of follow-up. Although these findings should be viewed as exploratory, they expand the evidence on potential safety of aspirin-free antiplatelet strategies after PCI in STEMI.

Funder

GLOBAL LEADERS

European Clinical Research Institute

Biosensors International, AstraZeneca

Medicines Company

Publisher

Oxford University Press (OUP)

Subject

Cardiology and Cardiovascular Medicine,Critical Care and Intensive Care Medicine,General Medicine

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