冠状动脉药物洗脱支架类型对再狭窄患者远期预后的影响  

Long-term Effects of Drug-eluting Stent Type on Outcomes in Patients with Coronary Artery Disease and In-stent Restenosis

作　　者：马元良 姚懿[2] 尹春琳[1] 徐娜[2] 唐晓芳[2] 贾斯达 张策[2] 宋莹[2] 许晶晶[2] 赵雪燕[2] 宋雷[2] 陈珏[2] 杨跃进[2] 乔树宾[2] 高润霖[2] 徐波[2] 袁晋青[2] 高立建[2] MA Yuan-liang;YAO Yi;YIN Chun-lin;XU Na;TANG Xiao-fang;JIA Si-da;ZHANG Ce;SONG Ying;XU Jing-jing;ZHAO Xue-yan;SONG Lei;CHEN Jue;YANG Yue-jin;QIAO Shu-bin;GAO Run-lin;XU Bo;YUAN Jin-qing;AO Li-jian(Department of Cardiology,Xuanwu Hospital,Capital Medical University,Beijing 100053,China;National Clinical Research Center for Cardiovascular Diseases,State Key Laboratory of Cardiovascular Disease,Center for Coronary Heart Disease,Fuwai Hospital,National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100037,China)

机构地区：[1]首都医科大学宣武医院心脏内科,北京市100053 [2]中国医学科学院北京协和医学院国家心血管病中心阜外医院冠心病诊疗中心心血管疾病国家临床医学研究中心心血管疾病国家重点实验室,北京市100037

出　　处：《中国分子心脏病学杂志》2022年第1期4462-4469,共8页Molecular Cardiology of China

摘　　要：目的 在支架内再狭窄(in-stent restenosis,ISR)患者中,比较第二代药物洗脱支架(second generation drug-eluting stent,G2-DES)和涂层可降解药物洗脱支架(biodegradable polymer drug-eluting stent,BP-DES)的有效性和安全性。方法 连续纳入了2013年全年于阜外医院行经皮冠状动脉介入术(percutaneous coronary intervention,PCI)治疗的10 724例患者,最终入选254例置入G2-DES和47例置入BP-DES的ISR患者。随访时间2年,有效性终点为主要不良心脑血管事件(major adverse cardiovascular and cerebrovascular event,MACCE),包括靶血管相关心肌梗死(target vessel-related myocardial infarction,TV-MI)、靶血管血运重建(target vessel revascularization,TVR)、心源性死亡和卒中;安全性终点为支架血栓。比较了两组间终点事件以及生存率的差异,采用多因素Cox法检测终点事件的危险因素。结果 两组患者在基线资料、冠状动脉病变、介入操作方面的变量无统计学意义差异,G2-DES组的替罗非班应用率低于BP-DES组(14.2%vs31.9%,P=0.003)。2年随访发现G2-DES组和BP-DES组之间的MACCE发生率无统计学意义差异(10.2%vs 12.8%,P=0.608),且MACCE各组分发生率大致相似(P> 0.05),支架血栓发生率无统计学意义差异(2.0%vs 4.3%,P=0.300)。两组患者在各终点方面的生存率均未见统计学意义差异(P> 0.05),多因素Cox分析显示支架类型不是MACCE或支架血栓的独立危险因素(P值均> 0.05)。结论对于ISR患者,在G2-DES与BP-DES之间有效性终点与安全性终点的发生率无明显差异,支架类型对患者生存率无显著影响、且不是患者预后的影响因素。Objective To compare the efficacy and safety between second generation drug-eluting stent(G2-DES) and biodegradable polymer drug-eluting stent(BP-DES) in patients with coronary artery disease and in-stent restenosis(ISR).Methods Totally 10 724 consecutive patients were enrolled who received percutaneous coronary intervention(PCI) in Fuwai Hospital during 2013,and finally 254 patients with G2-DES and 47 patients with BP-DES who had ISR were included.The follow-up period was 2 years.The efficacy endpoint was major adverse cardiovascular and cerebrovascular event(MACCE)including target vessel-related myocardial infarction(TV-MI),target vessel revascularization(TVR),cardiogenic death and stroke,and the safety endpoint was intra-stent thrombosis.The differences on the percentage of endpoint events and eventfree survival rates were compared between the 2 groups.Multi-factorial Cox proportional hazard regression model was applied to identify the independent risk factor of endpoint events.Results Between the G2-DES and BP-DES groups,the variables were not statistically different concerning baseline material,degree of coronary artery disease or interventional procedure,and the application rate of tirofiban was lower in the G2-DES group compared with the BP-DES group(14.2% vs 31.9%,P = 0.003).Based on 2-year follow-up,there were no difference on the incidences of MAACE(10.2% vs 12.8%,P =0.608) or its components(P > 0.05) between the G2-DES and BP-DES groups,while there were neither significant difference on the incidence of intra-stent thrombosis(2.0% vs 4.3%,P = 0.300).The event-free survival rates were similar between the G2-DES and BP-DES groups(P > 0.05),and multi-factorial Cox analysis showed that the type of stent was not an independent risk factor for MACCE or intra-stent thrombosis(P > 0.05).Conclusion The efficacy and safety index were not significant different between G2-DES and BP-DES groups in patients with ISR.Moreover the type of stent did not influence the survival rates between the G2-DES and BP-DES groups,

关 键 词：冠心病 支架内再狭窄 经皮冠状动脉介入术 预后 支架血栓 

分 类 号：R541.4[医药卫生—心血管疾病]