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OBJECTIVE: To investigate the impact of different anti-platelet strategies on outcomes after percutaneous coronary intervention (PCI) in patients with established cardiovascular disease (CVD). METHODS: GLOBAL LEADERS was a randomized, superiority, all-comers trial comparing one-month dual anti-platelet therapy (DAPT) with ticagrelor and aspirin followed by 23-month ticagrelor monotherapy (experimental treatment) with standard 12-month DAPT followed by 12-month aspirin monotherapy (reference treatment) in patients treated with a biolimus A9-eluting stent. Established CVD was defined as ≥1 prior myocardial infarction, PCI, coronary artery bypass operation, stroke, or established peripheral vascular disease. The primary endpoint was a composite of all-cause death or new Q-wave MI at 2-years. The secondary safety endpoint was BARC 3 or 5 bleeding. Exploratory secondary endpoints were the patient-orientated composite endpoint and net adverse clinical events. RESULTS: Among the 15,761 patients in this cohort were 6,693 patients (42.5%) with established CVD. Compared to those without established CVD, these patients had significantly higher rates of the primary (5.1 vs. 3.3%, HR1.59[1.36-1.86], p

Original publication




Journal article


Catheter Cardiovasc Interv

Publication Date





1369 - 1378


antiplatelet, cardiovascular disease, coronary artery disease, percutaneous coronary intervention, poly-vascular disease, Aged, Aspirin, Drug Administration Schedule, Drug-Eluting Stents, Dual Anti-Platelet Therapy, Female, Heart Disease Risk Factors, Humans, Male, Middle Aged, Myocardial Ischemia, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Prospective Studies, Purinergic P2Y Receptor Antagonists, Recurrence, Risk Assessment, Sirolimus, Ticagrelor, Time Factors, Treatment Outcome