P2812Ischemic efficacy and bleeding safety of ticagrelor monotherapy in patients with multivessel percutaneous coronary intervention: insights from the Global Leaders trial

Abstract

Abstract Background/Introduction The optimal duration of DAPT after coronary stent implantation remains a matter of debate and a novel antiplatelet regimen without an increased risk of bleeding while maintaining an anti-ischemic efficacy is of paramount importance in patients at higher risk of ischemia. Purpose The aim of the present sub-study of the Global Leaders trial is to evaluate the efficacy and safety of the experimental antiplatelet strategy (1-month dual antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) vs. the reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) in patients with multivessel percutaneous coronary intervention (PCI). Methods The Global Leaders trial enrolled 15,991 patients treated by default with a biolimus A-9 eluting stent. The present sub-study of the trial sought to evaluate the impact of the long-term ticagrelor monotherapy on the primary endpoint (composite of all-cause death and new Q-wave myocardial infarction [MI] centrally adjudicated with the Minnesota code) at two years. In addition, the patient-oriented composite endpoint (POCE) (composite of all-cause death, any stroke, any MI, and any revascularization) and the net adverse clinical events (NACE) (composite of POCE and Bleeding Academic Research Consortium [BARC] type 3 or 5 bleeding) were also evaluated at two years. Results A total of 15,845 patients was included in this analysis, of whom 3,576 patients received multivessel PCI. At two years, the experimental strategy significantly reduced a risk of the primary endpoint (the composite of all-cause death and new Q-wave myocardial infarction [MI]) (3.05% vs. 4.85%, HR: 0.62, 95% CI: 0.44–0.88, p=0.006, Pinteraction=0.031) in patients with multivessel PCI. Similarly, the experimental treatment had a significant risk reduction in the patient-oriented composite endpoint (POCE), defined as the composite of all-cause death, any stroke, any MI, and any revascularization (13.37% vs. 16.74%, HR: 0.78, 95% CI: 0.66–0.93, p=0.005, Pinteraction=0.020) and the net adverse clinical events (NACE), defined as the composite of POCE and Bleeding Academic Research Consortium [BARC] defined bleeding type 3 or 5 (14.65% vs. 18.38%, HR: 0.78, 95% CI: 0.66–0.92, p=0.003, Pinteraction=0.014) at two years. There was no significant difference in BARC type 3 or 5 bleeding (2.44% vs. 2.65%, HR: 0.92, 95% CI: 0.61–1.39, p=0.685, Pinteraction=0.754) at two years between the two regimens. KM in patients with multivessel PCI Conclusion The present study has demonstrated the experimental antiplatelet strategy, when compared with the reference regimen, could potentially have a favourable balance between ischemic efficacy and bleeding safety in patients who underwent multivessel PCI. Acknowledgement/Funding The Global Leaders trial was supported by unrestricted grants from AstraZeneca, Biosensors, and The Medicines Company. ECRI (European Cardiovascular R