Anna Franzone1, MD, PhD; Eugène P. McFadden2,3, MD; Sergio Leonardi4, MD, MHS; Raffaele Piccolo1, MD, PhD; Pascal Vranckx5, MD, PhD; Patrick W. Serruys6,7, MD; Christian Hamm8, MD; Philippe Gabriel Steg9, MD; Dik Heg10, PhD; Mattia Branca10, PhD; Peter Jüni11, MD; Stephan Windecker12, MD; Marco Valgimigli12, MD, PhD; GLASSY Investigators
1. Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy; 2. Cardialysis Core Laboratories and Clinical Trial Management, Rotterdam, the Netherlands; 3. Department of Cardiology, Cork University Hospital, Cork, Ireland; 4. University of Pavia and Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy; 5. Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium; 6. Department of Cardiology, Imperial College London, London, United Kingdom; 7. Department of Cardiology, National University of Ireland, Galway, Ireland; 8. German Center for Cardiovascular Research (DZHK), partner site RheinMain, Frankfurt am Main, and Department of Cardiology, Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany; 9. Université de Paris and AP-HP, Paris, France; 10. Institute of Social and Preventive Medicine and Clinical Trials Unit, University of Bern, Bern, Switzerland; 11. Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael’s Hospital, Department of Medicine, University of Toronto, Ontario, Canada; 12. Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
Aims: The aim of this study was to investigate the effect of ticagrelor monotherapy after one-month dual antiplatelet therapy (DAPT) or conventional DAPT in patients with or without acute coronary syndrome (ACS) in the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY).
Methods and results: Risk estimates were expressed as rate ratios (RR) with 95% confidence intervals (CI). A total of 3,840 ACS and 3,745 stable ischaemic heart disease (SIHD) patients were included. At two years, rates of the co-primary efficacy endpoint, a composite of death, myocardial infarction, stroke or urgent target vessel revascularisation, were 7.94% in the experimental and 9.68% in the control group (RR 0.82, 95% CI: 0.66-1.01) among ACS patients and 6.31% in the experimental and 7.14% in the control group (RR 0.89, 95% CI: 0.69-1.13) among SIHD patients (pint=0.63). Trends for lower and higher risk of BARC 3 or 5 bleeding with the experimental strategy in ACS (2.27% vs 3.00%, RR 0.76, 95% CI: 0.51-1.12) and SIHD (2.70% vs 1.96%, RR 1.39, 95% CI: 0.91-2.12) patients, respectively, were observed with significant interaction testing (pint=0.039). A net clinical benefit endpoint, the composite of both co-primary study endpoints, favoured the experimental treatment among ACS patients only.
Conclusions: Ticagrelor monotherapy after one-month DAPT provided consistent treatment effects on ischaemic endpoints in patients with or without ACS but only the former experienced a net clinical benefit. ClinicalTrials.gov identifier: NCT03231059