| BackgroundCoronary bifurcation lesions account for approximately 20% of all percutaneous coronary interventions(PCI),and represent a technical challenge in PCI.The treatment of bifurcation lesions is associated with low PCI successful rate,and a high incidence of adverse cardiovascular events in long-term prognosis.Due to the special hemodynamic characteristics and complex stent metal structure in the bifurcation lesions,the incidence of stent thrombosis and other adverse cardiovascular events of coronary artery bifurcation lesions after PCI is significantly higher than that of non-bifurcation lesions.Although the advances in drug-eluting stent technology and PCI strategies have improved the clinical outcomes of bifurcation PCI,the ischemic events after PCI for coronary bifurcation lesions remain still a non-negligible problem.The dual antiplatelet regimen(DAPT),which combines aspirin with one P2Y12 receptor inhibitor,is the cornerstone for the prevention of ischemic events after PCI in patients with coronary artery disease.However,to date,no studies have compared the clinical outcomes between different kinds of P2Y12 receptor inhibitors during coronary bifurcation PCI.ObjectivesFollow-up is performed to observe the effects of different P2Y12 receptor inhibitors(ticargrelor or clopidogrel)on ischemic and hemorrhagic events in patients with coronary bifurcations undergoing PCI.We also assessed the safety and efficacy of ticagrelor and clopidogrel in patients with coronary artery bifurcation lesions.MethodsWe performed a cohort study,which recruited patients with bifurcation lesions underwent PCI between June 2015 and February 2017 in Xinqiao Hospital,Chongqing,China.According to different DAPT regimens,the patients were divided into the ticagrelor group(ticagrelor plus aspirin for 1 year after PCI)and the clopidogrel group(clopidogrel plus aspirin for 1 year after PCI).We followed up the patients at different time points: 1 month,3 months,6 months and 12 months after PCI,and recorded the medication status and clinical adverse events.The primary endpoint was major adverse cardiovascular events(MACE),which consisted of cardiovascular death,recurrent myocardial infarction and stroke;Secondary endpoints included cardiovascular death,recurrent myocardial infarction stroke and stent thrombosis.The bleeding event was defined by the European Society of Hemorrhage Academic Research.Major bleeding was defined when the BARC was classified as type 3 and above.Results1.From July 2015 to February 2017,a total of 720 bifurcation patients underwent PCI at Xinqiao Hospital,of which 136 were excluded because of the exclusion criteria,and 31 patients were lost during the follow-up period.Finally,553 patients were included in the analysis,including 283 patients in the clopidogrel group(51.18%)and 270 patients in the ticargrelor group(48.82%).The proportion of true bifurcation lesions in the ticagrelor group(72.59%)was significantly higher than that in the clopidogrel group(64.66%)(P=0.045).The coronary lesions Synatx score in the ticagrelor group(21.01±8.62)was also significantly higher than that in the clopidogrel group(19.41±8.44)(P=0.028).2.The effectiveness between ticagrelor and clopidogrel.The 1-year primary endpoint events in the ticagrelor group and clopidogrel group was8.15% and 12.01%,respectively.After adjusting for confounding factors using the Cox regression model,the risk ratio(HR)and 95% confidence interval(CI)of the primary endpoint was 0.488 and 0.277-0.861(P=0.013),indicating the risk of primary endpoint event of the ticagrelor group was significantly lower than that of the clopidogrel group.Twelve patients(4.44%)suffered myocardial infarction in the ticagrelor group and 24 patients(8.48%)suffered myocardial infarction in the clopidogrel group.After adjusting for confounding factors,the risk of myocardial infarction of ticagrelor group was significantly lower than that of clopidogrel group(HR: 0.341,95% CI: 0.162-0.719,P=0.005).There were no significant differences in the risk of cardiovascular death,stroke and stent thrombosis between the ticagrelor group and clopidogrel group(cardiovascular death: HR: 0.540,95% CI: 0.146-1.999,P=0.356;stroke: HR: 0.717,95% CI: 0.241-2.512,P=0.603;stent thrombosis: 0.415,95% CI: 0.131-1.319,P=0.136).3.The safety analysis of ticagrelor and clopidogrel.The risk of all bleeding events in the ticagrelor group and clopidogrel group was 25.19% and 15.19%,respectively.The total bleeding risk in the ticagrelor group was significantly higher than that in the clopidogrel group(HR:1.791,95%CI:1.214-2.644,P=0.005).There were 8 patients(2.96%)with major bleeding in the ticagrelor group and 7 patients(2.47%)in the clopidogrel group.After the confounding factors were corrected by the Cox regression model,there was no significant difference in the risk of major bleeding between the two groups(HR: 0.972,95% CI: 0.321-2.941,P=0.960).4.In order to further correct the confounding factors,we performed a propensity score matching analysis(PSM)with a ratio of 1:1.The patients in the two groups were both 240 after PSM,the baseline data in balance between the two groups.After PSM,the primary end point event(P=0.004)and myocardial infarction(P= 0.005)were still higher in the ticagrelor group as compared to the clopidogrel group.There was no significant difference in the risk of cardiovascular death(P=0.407),stroke(P=0.159),and stent thrombosis(P=0.219)between the two groups.There was a higher risk of total bleeding in the ticagrelor group compared with the clopidogrel group(P=0.004),but no significant difference in the risk of major bleeding between the two groups(P=0.614).5.Subgroup analysis was conducted according to the Syntax score.The risk of MACE events,cardiovascular death,myocardial infarction,stroke,and stent thrombosis was higher in the high Syntax score group than in the low Syntax score group(P<0.05),and there was no significant difference in the risk of major bleeding between the two groups(P=0.154).In patients with low Syntax scores,there was no significant difference in the risk of MACE events,cardiovascular death,myocardial infarction,stroke,stent thrombosis and major bleeding between the ticagrelor subgroup and the clopidogrel subgroup(P>0.05).In patients with high Syntax scores,ticagrelor reduced the risk of MACE events(P=0.023)and myocardial infarction(P=0.014),but did not increase the risk of major bleeding as compared to clopidogrel(P=0.655).6.Subgroup analysis was conducted according to true bifurcation lesions.The risk of MACE events,myocardial infarction and stent thrombosis was higher in patients with true bifurcation lesions than in patients with non-true bifurcation lesions(P<0.05),but there was no significant difference in the risk of major bleeding between the two groups was observed(P=0.686).In patients with non-true bifurcation lesions,there was no significant difference in the risk of MACE events,cardiovascular death,myocardial infarction,stroke,stent thrombosis and major bleeding between the ticagrelor group and the clopidogrel group(P>0.05).In patients with true bifurcation lesions,ticagrelor significantly reduced the risk of MACE events(P=0.048)and myocardial infarction(P=00.035),but did not increase the risk of major bleeding in patients(P=0.426).Conclusions1.Ticagrelor is more likely to be used for patients with severe bifurcation lesions(including true bifurcation lesions and high Syntax scores)after PCI.2.For patients with bifurcation lesions PCI,ticagrelor significantly reduces the MACEs which may be driven by myocardial infarction.3.Compared with clopidogrel,ticagrelor does not increase the risk of major bleeding in patients with bifurcation lesions after PCI.4.High Syntax score is associated with high risk of ischemic events in patients with bifurcation lesions after PCI.5.In patients with high Syntax scores,ticagrelor decrease the risk of MACE events and myocardial infarction.6.The risk of MACE events,myocardial infarction and stent thrombosis in patients with true bifurcation lesions is higher than that in patients with non-true bifurcation lesions.7.In patients with true bifurcation lesions,ticagrelor reduces the risk of MACE events and myocardial infarction. |
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