植入新型生物可降解涂层药物洗脱支架后应用双联抗血小板治疗冠心病合并分叉病变患者临床有效性及安全性分析  

Efficacy and safety of dual antiplatelet therapy in the treatment of coronary artery disease with bifurcation lesions at 6 and 12 months after implantation of bioabsorbable polymer drug-eluting stent system

作　　者：赵惟超 裘淼涵 李晶 范鹏 李毅 韩雅玲 ZHAO Wei-chao;QIU Miao-han;LI Jing;FAN Peng;LI Yi;HAN Ya-ling(Department of Cardiology,General Hospital of Northern Theater Command,Shenyang 110016,China)

机构地区：[1]北部战区总医院心血管内科,辽宁沈阳110016

出　　处：《临床军医杂志》2020年第5期485-488,共4页Clinical Journal of Medical Officers

基　　金：国家重点研发计划项目(2016YFC1301300);国家重点研发计划项目分课题(2016YFC1301303)。

摘　　要：目的比较植入新型生物可降解涂层药物洗脱支架(BP-DES)后应用双联抗血小板(DAPT)治疗冠心病合并分叉病变患者6个月与12个月的有效性及安全性。方法选取I-LOVE-IT 2研究中分叉病变处植入BP-DES的冠心病患者717例为研究对象。根据植入BP-DES后DAPT的时程,将患者分为6个月DAPT组(A组,n=349)与12个月DAPT组(B组,n=368)。主要终点为4年患者源性的复合终点(PoCE),包含全因死亡、心肌梗死、缺血性卒中和/或任何血运重建的复合终点。次要终点为4年的靶病变失败(包括心源性死亡、靶血管心肌梗死、症状驱动性靶病变血运重建等)、出血学术研究联合会(BARC)定义的主要出血事件(BARC 3~5型)、确定或可能的支架内血栓。所有患者均获得4年随访,分析其临床疗效及预后情况。结果两组患者4年的PoCE、靶病变血运重建、全因死亡、严重出血等发生率比较,差异无统计学意义(P>0.05)。多因素Cox回归分析显示,合并糖尿病(风险比=1.57,95%可信区间1.07~2.30)、基线SYNTAX评分(风险比=1.04,95%可信区间1.01~1.07)为4年PoCE的独立危险因素。结论植入BP-DES后应用DAPT治疗冠心病合并分叉病变患者6个月与12个月的预后无明显差异,合并糖尿病、基线SYNTAX评分为4年PoCE的独立危险因素。Objective To evaluate the efficacy and safety of dual antiplatelet therapy(DAPT)in the treatment of coronary artery disease(CAD)with bifurcation lesions at 6 and 12 months after implantation of bioabsorbable polymer drug-eluting stent system(BP-DES).Methods A total of 717 CAD patients with bifurcation lesion who were performed BP-DES implantation in the I-LOVE-IT 2 study were selected as subjects.According to the time history of DAPT after BP-DES implantation,the patients were divided into the DAPT group at 6 months(Group A,n=349)and DAPT group at 12 months(Group B,n=368).The primary endpoint was the patient-derived composite endpoint(PoCE)at 4 years,including the composite endpoint of all-cause death,myocardial infarction,ischemic stroke,and/or any revascularization.Secondary endpoints were 4 years of target lesion failure(including cardiogenic death,target vessel myocardial infarction and symptomatic target lesion revascularization),major bleeding events(bleeding academic research consortium type 3~5)as defined by the bleeding academic community,and identified or possible stent thrombosis.All patients were followed up for 4 years to analyze their clinical efficacy and prognosis.Results There was no statistically significant difference between the two groups in the incidence of PoCE,target lesion revascularization,all-cause death and severe bleeding at 4 years(P>0.05).Multivariate Cox regression analysis showed that combined diabetes(risk ratio 1.57,95%CI:1.07~2.30)and baseline SYNTAX score(risk ratio 1.04,95%CI:1.01~1.07)were independent risk factors for PoCE at 4 years.Conclusion After the implantation of BP-DES,there is no significant difference in the prognosis between 6 months and 12 months after the implantation of DAPT in the treatment of patients with CAD complicated with bifurcation lesions.The patients with diabetes and the baseline SYNTAX score are independent risk factors for 4 years of PoCE.

关 键 词：分叉病变 经皮冠状动脉介入治疗 生物可降解涂层药物洗脱支架 双联抗血小板治疗 预后 

分 类 号：R541.4[医药卫生—心血管疾病]