Safety And Efficacy Of Long-term Dual Antiplatelet Therapy In Patients With Complex Coronary Artery Disease Treated With Percutaneous Coronary Intervention

Objective:The aims of this study were to investigate the prognosis of patients with complex coronary artery disease and treated with percutaneous coronary intervention(PCI)in the real world.Among those patients with complex coronary artery disease who were event-free at 12 months and continue DAPT in first 12 months,we want to investigate the efficacy and safety of extend dual antiplatelet therapy(DAPT)during 12-24 month.Method:Optimal anti Platelet Therapy for Chinese patients with Coronary Artery Disease(OPT-CAD)registry is a prospective,large-scale,multicenter,registered clinical study which enrolled a total of 14,032 CAD patients receiving at least one kind of antiplatelet agent in 107 Chinese centers from January 2012 to March 2014.In this study,we analyzed a total of 8347 patients treated with PCI in the OPT-CAD study to investigate the prognosis of patients with complex coronary artery disease in the real world.For this analysis,the primary endpoints was the major adverse cardiac and cerebrovascular events(MACCE)at 24 month,which was defined as cardiac death,myocardial infarction and ischemic stroke.The secondary endpoints was all-cause death,myocardial infarction,ischemic stroke and all bleeding ascertained according to the BARC(Bleeding Academic Research Consortium)definitions at 24 months.Patients with complex coronary disease who were event-free at 12 months,we divided into two group according to with or without extended DAPT during 12-24 months,and we want to investigate the efficacy and safety of extended DAPT in patients with complex coronary disease treated with PCI.The definition of complex coronary artery disease were angiography showed diffused lesions,bifurcation graft vessel lesions,thrombotic lesions,chronic total occlusion,3-vessel disease or small vessel lesions.To reduce treatment-selection bias and potential confounding factors,we performed rigorous adjustments for the baseline and lesion characteristics of the patients using their propensity scores(PSM).Result:Among 8347 patients,6136(73.5%)had at least one feature of complex coronary artery disease.Patients with complex coronary artery disease had higher rates of MACCE(5.67% vs.3.93%,log-rank P=0.002),MI(2.07% vs.0.86%,log-rank P<0.001),cardiac death(2.09% vs.1.27%,log-rank P=0.015),all cause death(2.88% vs.2.08%,log-rank P=0.045)or all bleeding(10.14% vs.8.05%,log-rank P=0.004)compared with patients without complex artery disease in 2 years follow-up.There was no significant difference between the two groups at the rate of ischemic stroke(2.20% vs.2.08%,log-rank P=0.727)or major bleeding(1.01% vs.1.18%,log-rank P=0.522).Among those with complex coronary artery disease who were event-free at 12 months,rates of MACCE(1.83% vs.2.40%,log-rank P=0.213),all cause death(0.99% vs.0.73%,log-rank P=0.354)or all bleeding(3.33% vs.2.82%,log-rank P=0.268)in12-24 months follow-up were similar between those received DAPT(2733 patients,59%)and single antiplatelet therapy(SAPT)beyond 12 months,(1917 patients,41%).Patients received extended DAPT during 12-24 months had similar rates of MI(0.66% vs.1.04%,log-rank P=0.170),cardiac death(0.62% vs.0.47%,log-rank P=0.466),and ischemic stroke(0.66% vs.1.10%,log-rank P=0.123)compared with those with SAPT but had a significantly incidence of major bleeding(0.51% vs.0.10%,log-rank P=0.018).After performing propensity-score matching for the entire population,a total of 1683 pairs of patients successfully matched.There were no significant differences in baseline clinical or lesion characteristics between the two groups for the propensity-matched subjects.There was no significant difference between the two groups in rate of MACCE(2.02% vs.2.44%,log-rank P=0.457)and other endpoint.But the rates of all bleeding and major bleeding were higher in DAPT group than SAPT group(3.74% vs.2.44%,log-rank P=0.023 and 0.59% vs.0.12%,log-rank P=0.019,respectively).Conclusion : Patients with complex artery disease treated with PCI has poor 2-yearprognosis compared with those without complex coronary artery disease.Among patients with complex artery disease who were event-free at 12 months,extended DAPT during 12-24 months does not reduce the risk of MACCE,but increase the risk of major bleeding compared with the SAPT strategy.