Ding Yong, Zhou Min, Wang Yonggang, Cai Liang, Shi Zhenyu
Department of Vascular Surgery, Zhongshan Hospital, Institute of Vascular Surgery, Fudan University, Shanghai, China.
Department of Vascular Surgery, Souzhou Municipal Hospital, Suzhou City, China.
Ann Vasc Surg. 2018 Jul;50:96-105. doi: 10.1016/j.avsg.2017.12.003. Epub 2018 Mar 4.
This study aimed to perform a systematic review and meta-analysis of current evidence comparing the drug-eluting stent (DES) with the bare-metal stent (BMS) in the treatment of femoropopliteal artery disease (FPAD).
All relevant articles reporting the results of DES versus BMS implantation in FPAD were systematically searched in MEDLINE, EMBASE, and Cochrane database. Randomized controlled trial (RCT), cohort, and retrospective study were all included. The efficacy end points included late lumen loss (LLL), binary restenosis, primary patency rate, freedom from target lesion revascularization (TLR), and stent fracture. Related data of the follow-up outcomes were extracted and pooled. For each end point, odds ratios (ORs) and 95% confidence intervals (CIs) were calculated.
A total of 9 studies with 776 patients were included in this meta-analysis. There was no statistically significant difference between the DES and BMS groups in terms of LLL at 6 months (standard mean difference = -0.37, P = 0.07); binary restenosis at 6, 12, and 24 months (OR = 0.44, P = 0.20; OR = 0.75, P = 0.74; and OR = 0.62, P = 0.36; respectively); primary patency rate at 6, 12, and 24 months (OR = 1.18, P = 0.73; OR = 1.43, P = 0.70; OR = 1.25, P = 0.68, respectively); freedom from TLR at 12 months (OR = 1.13, P = 0.79); and stent fracture at 6 months (OR = 1.67, P = 0.38). A sensitivity analysis demonstrated that there was a significant benefit in the DES group over the BMS group in binary restenosis at 6 months (OR = 0.22, P = 0.008) after excluding a retrospective study, whereas no significant difference was observed when eliminating any other study. A subgroup analysis did not reveal any significant difference between a subgroup (sirolimus-eluting stent or paclitaxel-eluting stent) and the BMS group in FPAD.
According to current evidence, DES was not superior to BMS in the treatment of FPAD. Further larger RCTs are needed to provide more evidence in the comparison between DES and BMS for FPAD.
本研究旨在对目前比较药物洗脱支架（DES）与裸金属支架（BMS）治疗股腘动脉疾病（FPAD）的证据进行系统评价和荟萃分析。
在MEDLINE、EMBASE和Cochrane数据库中系统检索所有报告DES与BMS植入治疗FPAD结果的相关文章。纳入随机对照试验（RCT）、队列研究和回顾性研究。疗效终点包括晚期管腔丢失（LLL）、二元再狭窄、原发性通畅率、无靶病变血运重建（TLR）和支架断裂。提取并汇总随访结果的相关数据。对于每个终点，计算比值比（OR）和95%置信区间（CI）。
本荟萃分析共纳入9项研究，776例患者。DES组和BMS组在6个月时的LLL（标准均差=-0.37，P=0.07）；6、12和24个月时的二元再狭窄（OR分别为0.44，P=0.20；OR=0.75，P=0.74；OR=0.62，P=0.36）；6、12和24个月时的原发性通畅率（OR分别为1.18，P=0.73；OR=1.43，P=0.70；OR=1.25，P=0.68）；12个月时无TLR（OR=1.13，P=0.79）；以及6个月时的支架断裂（OR=1.67，P=0.38）方面，差异均无统计学意义。敏感性分析表明，排除一项回顾性研究后，DES组在6个月时的二元再狭窄方面比BMS组有显著优势（OR=0.22，P=0.008），而排除任何其他研究时未观察到显著差异。亚组分析未显示在FPAD中，亚组（西罗莫司洗脱支架或紫杉醇洗脱支架）与BMS组之间有任何显著差异。
根据目前的证据，DES在治疗FPAD方面并不优于BMS。需要进一步开展更大规模的RCT，以提供更多关于DES与BMS治疗FPAD比较的证据。
