急性冠脉综合征患者植入国产药物支架的长期疗效和安全性分析  

Long-term efficacy and safety of domestic drug-eluting stents in patients with acute coronary syndrom

作　　者：姚海木[1] 孙同文[2] 张晓娟[2] 万有栋[2] 付新[1] 沈德良[1] 张金盈[1] 李凌[1] 

机构地区：[1]郑州大学第一附属医院心内科,郑州450052 [2]郑州大学第一附属医院综合ICU,郑州450052

出　　处：《中华急诊医学杂志》2015年第1期62-67,共6页Chinese Journal of Emergency Medicine

基　　金：国家自然科学基金（81370364）;河南省医学科技攻关计划（20120307、201203035）;河南省省部共建项目（201301005）;河南省高校科技创新人才专项基金（2012HASTIT001）;河南省科技成果转化项目（122102310584）;河南省卫生科技创新人才工程专项基金

摘　　要：目的探讨急性冠脉综合征（acute coronary syndrome，ACS）患者植入国产药物洗脱支架（DES）的长期疗效和安全性。方法选取自2009年7月至2010年12月所有在郑州大学第一附属医院心内科成功行经皮冠状动脉介入治疗（pereutaneous coronary intervention，PCI）的ACS患者。排除标准：植入金属裸支架或混合植入支架（同时植入国产和进口DES）。收集患者临床及介入相关资料，采用门诊、电话和查阅再次住院病历的方法进行随访，记录主要心脏不良事件（MACE）的发生情况。按植入支架的不同分为国产DES组和进口DES组。数据变量应用独立t检验或秩和检验，分类数据的比较用χ^2检验或精确概率计算。采用多因素Logistic逐步回归判断ACS患者PCI术后预后危险因素，KaplanMeier生存曲线比较植入不同支架患者PCI后生存率。以P〈0．05为差异具有统计学意义。结果（1）共入选患者1683例，成功随访1558例（随访率92．6％），随访时间（29．1±5．9）个月。发生主要心脏不良事件130例（8．3％），其中心源性死亡32例（2．1％），再发心肌梗死16例（1％），血运重建94例（6％）。（2）两组间全因死亡、心源性死亡、再发心肌梗死、再次血运重建、支架内再狭窄、支架内血栓形成和MACE发生率均差异无统计学意义（P〉0．05）。（3）多因素logistic逐步回归分析显示：糖尿病（OR=1．75，95％CI：1．09—2．82，P=0．021）、处理血管数（OR=2．16，95％CI：1．22～3．83，P=0．09）和处理左主干病变（OR=9．47，95％CI：2．96～30．26，P=0．01）是发生MACE的独立预测因子；左室射血分数〈40％是支架内血栓形成的独立预测因子（OR=1．34，95％CI：1．13～1．86，P=0．014）。（4）Kaplan—Meier生存曲线分析显示，两组间累积生存率和无事件生存率均差异无统计学意义（P〉0．05）。结论ACS患者植入国产DES�Objective To investigate the long term efficacy and safety of domestic drug-eluting stents （DES） in patients with acute coronary syndrome （ACS） following percutaneous coronary intervention （PCI）. Methods AU patients with ACS treated with successful PCI from July 2009 to December 2010 were included in this study. Patients were excluded from analysis if they were implanted with bare metal stents or different kinds of stents （domestic and imported DES ） simultaneously. Clinical, laboratory, angiographic and procedural data were collected. Chnical follow-up was done through patient visits, telephone interview, and medical record review and adverse cardiac events were recorded. The patients were divided into two groups according to different stents implanted： domestic DES and imported DES. Comparisons between continuous variables were made using the Student t-test or Wilcoxon rank-sum test.Categorical data were tested using χ^2 test or the Fisher exact test. Multivariate logistic regression analysis was performed to identify- independent predictors of events. Cumulative survival curves were constructed using the Kaplan-Meier method and comparisons made using log-rank tests. All statistical analyses were performed using SPSS 17.0 software, and a two-tailed P value of 〈 0. 05 was considered statistically significant. Results （1） There were 1683 patients enrolled in the analysis and 1558 （92. 6% ） of them were successfully followed-up. Mean follow-up time was （29.1 ±5.9） months. There were 130 （8.3%） cases subjected to major adverse cardiovascular events （MACE） , including 32 （2. 1% ） cases with cardiac death, 16 （1%） cases with re-myocardial infarction, and 94 （6%） cases with revascularization. （2） The rates of all cause death, cardiac death, re-infarction, revascularization, in-stent restenosis, in-stent thrombosis and MACE were not significantly different between the two groups （ all P 〉 0. 05 ）. （ 3 ） Multivariate logistic regression revealed that di

关 键 词：急性冠脉综合征 经皮冠状动脉介入术 药物洗脱支架 心脏不良事件 

分 类 号：R541.4[医药卫生—心血管疾病]