The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

Ticagrelor Monotherapy Beyond One Month after PCI in ACS or Stable CAD in Elderly Patients Aged Above 75 Years: a Prespecified Analysis of the Randomized GLOBAL LEADERS Trial

DOI: 10.4244/EIJ-D-19-00699

1. Department of Cardiology, Erasmus Medical Centre,Rotterdam,The Netherlands; First Department of Cardiology, Medical University of Warsaw,Warsaw,Poland
2. Amsterdam UMC, Amsterdam,The Netherlands; Division of Cardiology, Department of Internal Medicine, Prince of Songkla University,Songkhla,Thailand
3. Amsterdam UMC, Amsterdam,The Netherlands; Department of Internal Medicine, Cardiology Division, University of Campinas (UNICAMP),Campinas,Brazil
4. Amsterdam UMC, Amsterdam,The Netherlands
5. Department of Cardiology, Erasmus Medical Centre,Rotterdam,The Netherlands
6. Department of Cardiology, Erasmus Medical Centre,Rotterdam,The Netherlands; Cardialysis Core Laboratories and Clinical Trial Management,Rotterdam,The Netherlands
7. PAKS Dabrowa,Dabrowa Gornicza,Poland
8. Department of Cardiology, Erasmus Medical Centre,Rotterdam,The Netherlands; Department of Cardiology, Radboud UMC,Nijmegen,The Netherlands
9. "St. Marina" University Hospital,Varna,Bulgaria
10. Department of Cardiology, Medical Faculty, Johannes Kepler University,Linz,Austria
11. Uniklinikum Tübingen,Tübingen,Germany
12. PAKS Kozle,Kedzierzyn-Kozle,Poland
13. Clinic Hospital Barcelona,Barcelona,Spain
14. Krakowski Szpital Specjalistyczny im. Jana Pawła II,Krakow,Poland
15. Cardialysis Core Laboratories and Clinical Trial Management,Rotterdam,The Netherlands
16. Amsterdam UMC, Amsterdam,The Netherlands Cardialysis Core Laboratories and Clinical Trial; Management, Rotterdam,The Netherlands
17. Applied Health Research Centre,Li Ka Shing Knowledge Institute,St Michael’s Hospital,University of Toronto,Toronto,Canada
18. University of Giessen,Giessen,Germany
19. FACT,Université Paris Diderot,Hôpital Bichat,Assistance Publique-Hôpitaux deParis ,Paris,France
20. Department of Cardiology, Erasmus Medical Centre,Rotterdam,The Netherlands Cardialysis Core Laboratories and Clinical Trial; Management, Rotterdam,The Netherlands
21. Department of Cardiology and Critical Care Medicine,Hartcentrum Hasselt, Jessa Ziekenhuis,Hasselt,Belgium
22. Department of Cardiology, Bern University Hospital, Inselspital, University of Bern,Bern,Switzerland
23. Mount Sinai Heart, Mount Sinai Medical Centre,New York,New York,US
24. University Hospital of Wales,Cardiff,UK
25. Azienda Ospedaliera S. Maria,Terni,Italy
26. NHLI, Imperial College London, London, United Kingdom, United Kingdom
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Aims:Antiplatelet treatment in the elderly post percutaneous coronary interventions (PCI) remains a complex issue.

Methods and results:A pre-specified analysis of randomized GLOBAL LEADERS (n=15991), comparing 23-month ticagrelor monotherapy (after one month of DAPT) with the reference treatment (12-month DAPT followed by 12 months of aspirin).Among elderly patients (>75 years; n=2565), the primary endpoint (two-year all-cause mortality or new Q-wave corelab-adjudicated myocardial infarction [MI]) occurred in 7.2% and 9.4% of patients in the ticagrelor monotherapy and the reference group, respectively, (hazard ratio [HR]0.75, 95% confidence interval [CI] 0.58-0.99,p=0.041;pint=0.23); BARC-defined bleeding type 3/5 occurred in 5.2% and 4.1%, respectively (HR1.29; 95%CI0.89-1.86;p=0.180;pint=0.06). The elderly with stable CAD had a higher rate of BARC 3/5 type bleeding (HR2.05, 95%CI1.18-3.55) with ticagrelor monotherapy versus the reference treatment (pint=0.02). Elderly patients had a lower rate of definite or probable stent thrombosis (ST) with ticagrelor monotherapy (0.4%vs.1.4%,p=0.015,pint=0.01),compared with the reference group.

Conclusions:In this prespecified, exploratory analysis of the overall neutral trial, there was no differential treatment effect of ticagrelor monotherapy (after one-month dual therapy with aspirin) found in elderly patients undergoing PCI with respect to the rate of the primary endpoint of all-cause death or new Q-wave MI. The lower rate of ST in the elderly with ticagrelor monotherapy is hypothesis-generating.

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