裸支架与药物洗脱支架腔内置入术治疗膝下动脉缺血性疾病疗效的Meta分析

Efficacy of Bare-Metal Stent and Drug-Eluting Stent in Endovascular Treatment of Infrapopliteal Arterial Occlusive Disease:A Meta-Analysis

目的采用Meta分析的方法评价药物洗脱支架（drug clutingstent，DES）和金属裸支架（bare metal stent，BMs）腔内置人术治疗膝下动脉缺血性疾病的疗效及安全性。方法计算机检索国内外数据库中关于DES和BMS腔内置人术治疗膝下动脉缺血性疾病的相关随机对照试验（RCT），按照纳入标准和排除标准进行文献筛选和质量评价后，采用RevMan5．2软件进行Meta分析。比较2组患者的术后1年再狭窄率、术后1年支架通畅率、术后保肢率、术后死亡率及术后靶血管血运重建率。结果共纳入了6个研究，包括572例膝下动脉缺血性疾病患者，其中DES组302例，BMS组270例。Meta分析结果显示：2组患者的术后1年支架通畅率比较差异有统计学意义（OR=I．64，95％CI：1．35～1．98，P〈0．0001），DES组较高；术后1年再狭窄率（OR=0．19，95％CI：0．12～0．30，P〈0．0001）和靶血管血运重建率（OR=0．09，95％CI：0．02～0．32，P=-0．0002）比较差异均有统计学意义，DES组均较低；而2组患者的术后死亡率（OR=0．98，95％CI：0．58～1．65，P=0．9400）与保肢率（OR=I．29，95％CI：0．58～2．86，P=0．5300）比较差异均无统计学意义。结论与BMS腔内置入术治疗膝下动脉缺血性疾病相比较，DES腔内置人术可显著提高术后1年支架通畅率，明显降低术后1年再狭窄率和降低靶血管血运重建率。

Objective To evaluate the efficacy and safety ofendovascular implantation of bare-metal stent （BMS） and endovascular implantation of drug-eluting stent （DES） in treatment of infrapopliteal arterial occlusive disease by using Meta-analysis. Methods Randomized controlled trial about endovascular implantation of BMS and endovascular impl- antation of DES in treatment of infrapopliteal arterial occlusive disease were searched in domestic and international data- bases, literature screening in accordance with inclusion criteria and exclusion criteria was taken firstly, and then quality assessment was performed. Comparison of 1-year restenosis rate, 1-year patency rate, incidence of limb salvage, morta- lity, and 1-year target lesion revascularization rate after operation between BMS group and DES group were performed by using RevMan 5.2 software for Meta-analysis. Results Six literatures included 572 cases who suffered from infrapo- pliteal arterial occlusive disease were included at all, including 302 cases in DES group and 270 cases in BMS group. The results of Meta-analysis showed that, compared with BMS group, 1-year patency rate after operation in DES group was higher （OR=I. 64, 95% C1： 1.35-1.98, P〈0. 000 1）, but 1-year restenosis rate （OR=0. 19, 95% CI： 0. 12-0. 30, P〈 0. 000 1） and 1-year target lesion revascularization rate after operation （OR=0. 09, 95% CI： 0. 02-0. 32, P=-0. 000 2） were both lower. There were no significance difference between the BMS group and DES group on incidence of postoperative limb salvage （OR=I. 29, 95% CI： 0. 58-2.86, P=0. 530 0） and postoperative mortality （OR=0. 98, 95% CI： 0. 58-1.65, P=-0. 940 0）. Conelusion Compared with endovascular implantation ofBMS, endovascular implan- tation of DES can increase the 1-year patency rate and reduce 1-year restenosis rate or 1-year target lesion revasculariza- tion rate after operation for infrapopliteal arterial occlusive disease.