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
Mariusz Tomaniak1; Ply Chichareon2; Rodrigo Modolo3; Kuniaki Takahashi4; Chun Chin Chang5; Norihiro Kogame4; Ernest Spitzer6; Pawel E. Buszman7; Robert-Jan van Geuns8; Veselin Valkov9; Clemens Steinwender10; Tobias Geisler11; Janusz Prokopczuk12; Manel Sabate13; Krzysztof Zmudka14; Tessa Rademaker-Havinga15; Jan G.P. Tijssen16; Peter Juni17; Christian Hamm18; P Gabriel Steg19; Yoshinobu Onuma20; Pascal Vranckx21; Marco Valgimigli22; Stephan Windecker22; Usman Baber23; Richard Anderson24; Marcello Dominici25; Patrick W Serruys26, ;
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.
