雷帕霉素洗脱支架与金属裸支架治疗冠心病慢性完全闭塞病变临床效果的 Meta 分析

摘要

目的：评价雷帕霉素洗脱支架（SES）与金属裸支架（BMS）治疗冠心病慢性完全闭塞（CTO）病变的临床效果。方法计算机联网检索 PubMed、Cochrane Central Register of Controlled Trials、中国知网（CNKI）等全文数据库，筛选2000—2014年公开发表的关于 SES 与 BMS 治疗冠心病 CTO 病变临床效果的随机对照试验（RCT），SES组置入 SES，BMS 组置入 BMS。对文献质量进行严格评价后，对符合要求的 RCT 进行资料提取并采用 RevMan 5.0软件进行 Meta 分析。比较 SES 组和 BMS 组患者主要不良心血管事件（MACEs）发生率、全因死亡率、心肌梗死（MI）发生率、支架内血栓形成（IST）发生率、靶病变血运重建（TLR）发生率、靶血管血运重建（TVR）发生率。结果共纳入5项符合标准的 RCT，纳入患者总数为1001例，其中 SES 组为501例、BMS 组为500例。Meta 分析结果显示：两组患者全因死亡率〔RR =1.55，95% CI（0.68，3.54），P =0.30〕、MI 发生率〔RR =0.63，95% CI（0.35，1.14）， P =0.13〕、IST 发生率〔RR =1.81，95% CI（0.61，5.34），P =0.28〕比较，差异无统计学意义。SES 组患者 MACEs发生率〔RR =0.31，95% CI（0.23，0.42），P ﹤0.00001〕、TLR 发生率〔RR =0.16，95% CI（0.11，0.25），P ﹤0.00001〕、TVR 发生率〔RR =0.28，95% CI（0.21，0.38），P ﹤0.00001〕低于 BMS 组。结论基于现有文献证据，采用 SES 治疗的冠心病 CTO 病变患者 MACEs 发生率、TLR 发生率、TVR 发生率低于采用 BMS 治疗者，但全因死亡率、MI 发生率、IST 发生率间无差异，SES 可作为临床治疗冠心病 CTO 病变的首选。%Objective To evaluate the clinical effect in treating chronic totally occluded lesion of patients with coronary heart disease between sirolimus - eluting stent( SES) and bare - metal stent( BMS). Methods A research was carried on PubMed,Cochrane Central Register of Controlled Trials and CNKI by computer,to screen publicly published RCTs about clinical effect in treating chronic totally occluded lesion of patients with coronary heart disease between SES and BMS from 2000 to 2014,thereinto patients of SES group received SES,patients of BMS group received BMS. The involved literatures were strictly evaluated,and related data was extracted,RevMan 5. 0 software was used to carry out the meta - analysis. Incidence of MACEs,all - cause mortality,incidence of myocardial infarction,incidence of intra - stent thrombosis(IST),incidence of target lesion revascularization(TLR) and incidence of target vascular reconstruction( TVR) were compared between the two groups. Results A total of 5 RCTs were involved,including 1 001 patients(501 patients in SES group,500 patients in BMS group). Meta - analysis showed that,no statistically significant differences of all - cause mortality〔 RR = 1. 55,95% CI (0. 68,3. 54),P = 0. 30〕,incidence of myocardial infarction〔RR = 0. 63,95% CI(0. 35,1. 14),P = 0. 13〕,incidence of IST〔RR = 1. 81,95% CI(0. 61,5. 34),P = 0. 28〕between the two groups;incidence of MACEs〔RR = 0. 31,95% CI (0. 23,0. 42),P ﹤ 0. 000 01〕,incidence of TLR〔RR = 0. 16,95% CI(0. 11,0. 25),P ﹤ 0. 000 01〕 and incidence of TVR〔RR = 0. 28,95% CI(0. 21,0. 38),P ﹤ 0. 000 01〕of SES group were statistically significantly lower than those of BMS group. Conclusion Based on now available literature evidences,the incidence of MACEs,incidence of TLR and incidence of TVR of patients with coronary heart disease complicated with chronic totally occluded lesion that treated by SES are significantly lower than those patients treated by BMS,but all - cause mortality,incidence of myocardial infarction and incidence of IST showed no significant differences,SES can be served as the first choice on clinic.