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

Coronary interventions

Ticagrelor monotherapy beyond one month after PCI in ACS or stable CAD in elderly patients: a pre-specified analysis of the GLOBAL LEADERS trial

EuroIntervention 2020;15:e1605-e1614. DOI: 10.4244/EIJ-D-19-00699

1. Department of Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands; 2. First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland; 3. Amsterdam UMC, Amsterdam, the Netherlands; 4. Division of Cardiology, Department of Internal Medicine, Prince of Songkla University, Songkhla, Thailand; 5. Department of Internal Medicine, Cardiology Division, University of Campinas (UNICAMP), Campinas, Brazil; 6. Cardialysis Core Laboratories and Clinical Trial Management, Rotterdam, the Netherlands; 7. PAKS Dabrowa, Dabrowa Gornicza, Poland; 8. 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. Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael’s Hospital, University of Toronto, Toronto, Canada; 16. University of Giessen, Giessen, Germany; 17. FACT, Université Paris Diderot, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France; 18. Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; 19. Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium; 20. Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland; 21. Mount Sinai Heart, Mount Sinai Medical Center, New York, NY, USA; 22. University Hospital of Wales, Cardiff, United Kingdom; 23. Azienda Ospedaliera S. Maria, Terni, Italy

Aims: Antiplatelet treatment in the elderly post percutaneous coronary interventions (PCI) remains a complex issue. Here we report the results of the pre-specified subgroup analysis of the GLOBAL LEADERS trial evaluating the long-term safety and cardiovascular efficacy of ticagrelor monotherapy among patients categorised according to the pre-specified cut-off value of 75 years of age.

Methods and results: This was a pre-specified analysis of the randomised GLOBAL LEADERS trial (n=15,991), 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=2,565), the primary endpoint (two-year all-cause mortality or new Q-wave core lab-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 (HR 1.29, 95% CI: 0.89-1.86; p=0.180; pint=0.06). The elderly with stable CAD had a higher rate of BARC 3/5 type bleeding (HR 2.05, 95% CI: 1.18-3.55) 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 pre-specified, 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. ClinicalTrials.gov identifier: NCT01813435

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