不同时期中国非ST段抬高型急性冠状动脉综合征患者临床特征与预后

Clinical characteristics and prognosis comparison of Chinese non ST-segment elevation acute coronary syndrome patients in two different time periods

目的 比较分析不同时期中国非ST段抬高型急性冠状动脉综合征（NSTE-ACS）患者的临床特征、治疗方式及预后,了解时代变化对患者人群特点和治疗效果的影响.方法 两组病例来自不同时期的两个国际大规模NSTE-ACS临床试验中所有接受冠状动脉造影的中国患者.共入选1 473例NSTE-ACS患者,其中749例来自1999年4月至2000年12月我国38个中心开展的组织评估缺血综合征策略登记（OASIS）研究（OASIS组）;另724例者来自2007年4月至2008年6月我国24个中心参与的对比NSTE-ACS治疗的国际随机研究（TIMACS组）.随访时间均为患者入选之日起的180 d.比较其临床特征、治疗方式及预后.结果 与OASIS组比较,TIMACS组的患者年龄较大[（64.2±10.1）岁比（58.7±10.2）岁],男性比例较少[66.3％（480/724）比74.4％（557/749）],入院时血压较低,有较多的既往介入治疗史[9.4％（68/724）比6.4％（48/749）]、卒中史]8.8％ （64/724）比5.1％（38/749）]、高血压史[62.8％ （455/724）比56.6％（424/749）]和糖尿病史[23.3％（169/724）比16.2％（121/749）]的患者,而冠心病史]37.4％（271/724）比59.1％（443/749）]和心肌梗死史[12.0％（87/724）比27.6％ （207/749）]的患者所占比例较低（P均＜0.05）.住院期间TIMACS组PCI治疗比例较高[74.9％（524/724）比49.3％（369/749）,P＜0.001].住院期间,出院带药和180 d随访时TIMACS研究在冠心病二级预防药物[β受体阻滞剂、血管紧张素转换酶抑制剂和（或）血管紧张素Ⅱ受体拮抗剂（ACEI/ARB）、调脂药等]应用比例及患者的依从性明显高于OASIS组（P均＜0.05）.180 d随访时TIMACS组联合终点事件发生率明显低于OASIS组[13.3％（96/724）比25.2％（189/749）,P＜0.001],特别是顽固性心绞痛[5.2％（38/724）比22.6％（169/749）,P＜0.001]明显减少.应用Cox回归模型对基线水平和住院期间相关治疗进行校正后,TIMACS组发生联合终点事件（HR =0.39,95％CI：0.29～0.53,P＜0.001）和顽固性心绞痛或心绞痛再入院事件（HR =0.17,95％CI：0.11 ～0.25,P＜0.001）的风险降低.结论 TIMACS研究的患者在PCI治疗、冠心病二级预防等方面优于OASIS研究,180 d随访的联合终点事件发生明显少于后者.提示随着国内外指南的更新和临床诊治水平的提高,中国在NSTE-ACS治疗方面有明显的进步.

Objective To compare the clinical characteristics,treatment methods and outcomes in Chinese non ST-segment elevation acute coronary syndrome （NSTE-ACS） patients from two large clinical trials in different time periods.Methods All Chinese NSTE-ACS patients from two large International clinical trials （OASIS Registry and TIMACS） underwent coronary artery angiography after first admission were recruited in our analysis.The follow-up time was 180 days.A total of 1 473 NSTE-ACS patients were recruited in this analysis,in which 749 from Organization to Assess Strategies for Ischemic Syndromes （OASIS REISTRY） that completed in 38 centers in China from April 1999 to December 2000,and the rest 724 patients from The Timing of Intervention in Acute Coronary Syndromes （TIMACS） trial in 24 centers in China performed from April 2007 to June 2008.Results Compared to OASIS patients,TIMACS group were older （（64.2 ± 10.1） years old vs.（58.7 ± 10.2） years old）,and fewer male patients （66.3％ （480/724） vs.74.4％ （557/749））,lower blood pressure at admission,and more histories of previous PCI （9.4％ （68/724 vs.6.4％ （48/749））,stroke （8.8％ （64/724） vs.5.1％ （38/749））,hypertension （62.8％ （455/724） vs.56.6％ （424/749）） and diabetes （23.3％ （169/724） vs.16.2％ （121/749））,lower histories of coronary artery disease （37.4％ （271/724） vs.59.1％ （443/749）） and myocardial infarction （12.0％ （87/724） vs.27.6％ （207/749）） （all P ＜ 0.05）.After admission,comparing to OASIS group,TIMACS patients had significant higher PCI proportion （74.9％ （524/724） vs.49.3％ （369/749）,P ＜ 0.001）.In addition,for secondary prevention,TIMACS patients had significant higher standard medication treatment proportion during hospitalization,at discharge and at 180 days follow up than OASIS group （P ＜ 0.05 for β-blocker,ACEI/ARB and lipid lowering drugs） and higher compliance rate.The combined primary outcome event rate at 180 days was much lower in TIMACS than in OASIS patients （13.3％ （96/724） vs.25.2％ （189/749）,P ＜0.001） mostly due to the reduction on the refractory angina （5.2％ （38/724） vs.22.6％ （169/749）,P ＜ 0.001）.Results of COX regression model adjusted for baseline levels and treatment during hospitalization showed that the incidence rate of combination endpoint （HR =0.39,95％ CI：0.29-0.53,P ＜ 0.001） and refractory ischemia/angina rehospitalization （HR =0.17,95％ CI：0.11-0.25,P ＜ 0.001） were both lower in TIMACS patients than in OASIS patients.Conclusion PCI procedure and secondary prevention medication administration are more often applied in TIMACS patients than in OASIS group,which is related to less integrated incidence of primary outcomes reflecting progress in Chinese medical care for non ST elevated acute coronary syndrome patients according to the updated guidelines.