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Impact of established cardiovascular disease on outcomes in the randomized global leaders trial
Author(s) -
Garg Scot,
Chichareon Ply,
Kogame Norihiro,
Takahashi Kuniaki,
Modolo Rodrigo,
Chang ChunChin,
Tomaniak Mariusz,
FathOrdoubadi Farzin,
Anderson Richard,
Oldroyd Keith G.,
Stables Rod H.,
Kukreja Neville,
Chowdhary Saqib,
Galasko Gavin,
Hoole Stephen,
Zaman Azfar,
Hamm Christian W.,
Steg Philippe G.,
Jüni Peter,
Valgimigli Marco,
Windecker Stephan,
Onuma Yoshinobu,
Serruys Patrick W.
Publication year - 2020
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.28649
Subject(s) - medicine , ticagrelor , clinical endpoint , percutaneous coronary intervention , myocardial infarction , conventional pci , hazard ratio , aspirin , cardiology , stroke (engine) , randomized controlled trial , coronary artery disease , stent , surgery , confidence interval , mechanical engineering , engineering
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 < .001) and secondary composite endpoints with no significant differences in bleeding. There was a nonsignificant reduction in the primary endpoint in patients with established CVD receiving the experimental treatment (4.6 vs. 5.6%, HR0.82[0.66–1.02], p = .07). When comparing patients without CVD to those with one or three territories of CVD, the hazard ratio for the primary endpoint increased in unadjusted and adjusted models. Conclusions The poorer outcomes in patients with established CVD are not mitigated by prolonged monotherapy with a potent P2Y12 inhibitor suggesting a greater need to focus on modifiable risk factors.