Ticagrelor or aspirin 1 year after revascularisation: a landmark analysis of the GLOBAL LEADERS trial

DOI: 10.4244/EIJ-D-21-00870

Masafumi Ono
Masafumi Ono1,2, MD; Hironori Hara1,2, MD; Hideyuki Kawashima1,2, MD; Chao Gao2,3, MD; Rutao Wang2,3, MD; Joanna J. Wykrzykowska1,4, MD, PhD; Jan J. Piek1, MD, PhD; Scot Garg5, MD, PhD; Christian Hamm6, MD; Philippe Gabriel Steg7, MD; Marco Valgimigli8, MD, PhD; Stephan Windecker9, MD; Pascal Vranckx10, MD, PhD; Yoshinobu Onuma2, MD, PhD; Patrick W. Serruys2,11, MD, PhD
1. Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands; 2. Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; 3. Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands; 4. University Medical Center Groningen, Groningen, the Netherlands; 5. Department of Cardiology, Royal Blackburn Hospital, Blackburn, United Kingdom; 6. University of Giessen and Kerckhoff Heartand Thorax Center, University of Giessen, Bad Nauheim, Germany; 7. FACT (French Alliance for Cardiovascular Trials), Université de Paris, Assistance Publique-Hôpitaux de Paris, Paris, France; 8. Cardiocentro Ticino Institute, and Università della Svizzera Italiana (USI), Lugano, Switzerland; 9. Department of Cardiology, University of Bern, Inselspital, Bern, Switzerland; 10. Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium; 11. NHLI, Imperial College London, London, United Kingdom

Background: The optimal antiplatelet strategy in the second year after percutaneous coronary intervention (PCI) remains unclear.

Aims: We aimed to compare ticagrelor monotherapy with aspirin monotherapy on clinical outcomes beyond 1 year post-PCI.

Methods: This post hoc subanalysis of the open-label, all-comers, randomised GLOBAL LEADERS trial, which compared 23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT), with 12-month aspirin monotherapy following 12-month DAPT, only included patients who, at 12 months, were free from ischaemic and bleeding events, and adherent to their assigned antiplatelet therapy. The incidences of ischaemic events (all-cause death, any myocardial infarction, or any stroke) and bleeding events (Bleeding Academic Research Consortium [BARC] type 3 or 5 bleeding) during the second year (12-24 months) were compared between patients receiving either ticagrelor or aspirin monotherapy.

Results: The present analysis included 11,121 (ticagrelor monotherapy n=5,308, and aspirin monotherapy n=5,813) of the 15,991 patients enrolled in GLOBAL LEADERS. During the second year, the ischaemic composite endpoint was lower with ticagrelor monotherapy compared to aspirin monotherapy (1.9% vs 2.6%: log-rank p=0.014, adjusted hazard ratio [HR] 0.74, 95% confidence interval [CI]: 0.58-0.96; p=0.022), which was primarily driven by a reduced risk of myocardial infarction. In contrast, BARC type 3 or 5 bleeding was numerically higher with ticagrelor monotherapy (0.5% vs 0.3%: log-rank p=0.051, adjusted HR 1.89, 95% CI: 1.03-3.45; p=0.005).

Conclusions: Patients free from events at the end of the first year post-PCI and who adhered to their prescribed regimen had a reduced risk of ischaemic events compared to aspirin monotherapy in the second year post-PCI. ClinicalTrials.gov: NCT01813435

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