Zhang Jianbin, Xu Xiaojie, Kong Jie, Xu Rongwei, Fan Xueqiang, Chen Jie, Zheng Xia, Ma Bo, Sun Mingsheng, Ye Zhidong, Liu Peng
1 Department of Cardiovascular Surgery, China-Japan Friendship Hospital, Beijing, China.
2 Graduate School of Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.
Vasc Endovascular Surg. 2017 Feb;51(2):72-83. doi: 10.1177/1538574416689426. Epub 2017 Jan 19.
Drug-eluting balloon (DEB) and drug-eluting stent (DES) have been proposed for the treatment of infrapopliteal artery disease. We performed a systematic review and meta-analysis of the current available studies investigating outcomes of DEB and DES in the treatment of infrapopliteal artery disease.
Multiple databases were systematically searched to identify studies investigating the outcomes of DEB and DES in the treatment of patients with infrapopliteal artery disease. The quality of studies was assessed by Cochrane Collaboration method. The demographic data, risk factors, outcomes, and antiplatelet strategy were extracted.
Nine studies were identified with 707 and 606 patients in DEB/DES and standard percutaneous balloon angioplasty (PTA)/bare metal stenting (BMS) group, respectively. The risk of target lesion revascularization (TLR; odds ratio [OR] = 0.38, 95% confidence interval [CI]: 0.23-0.63, P < .01), restenosis rate (OR = 0.30, 95% CI: 0.18-0.50, P < .01), and amputation rate (OR = 0.49, 95% CI: 0.29-0.83, P < .01) significantly decreased in the DES group. The overall survival (OR = 0.86, 95% CI: 0.56-1.32, P = .50) was similar in DES and standard PTA/BMS group; TLR (OR = 0.59, 95% CI: 0.32-1.09, P = .09), restenosis rate (OR = 0.49, 95% CI: 0.11-2.14, P = .35), amputation rate (OR = 1.32, 95% CI: 0.51-3.40, P = .57), and overall survival (OR = 1.40, 95% CI: 0.72-2.71, P = .32) were similar in DEB and standard PTA group.
The present meta-analysis suggests that compared with standard PTA/BMS, DES may decrease the risk of clinically driven TLR, restenosis rate, and amputation rate without any impact on mortality. However, DEB has no obvious advantage in the treatment of infrapopliteal disease. Due to the limitations of our study, more randomized controlled trials, especially those for DEB, are necessary.
药物洗脱球囊（DEB）和药物洗脱支架（DES）已被用于治疗腘下动脉疾病。我们对目前关于DEB和DES治疗腘下动脉疾病疗效的现有研究进行了系统评价和荟萃分析。
系统检索多个数据库，以确定关于DEB和DES治疗腘下动脉疾病患者疗效的研究。采用Cochrane协作方法评估研究质量。提取人口统计学数据、危险因素、疗效和抗血小板策略。
共纳入9项研究，DEB/DES组和标准经皮球囊血管成形术（PTA）/裸金属支架置入术（BMS）组分别有707例和606例患者。DES组靶病变血运重建（TLR）风险（比值比[OR]=0.38，95%置信区间[CI]：0.23-0.63，P<.01）、再狭窄率（OR=0.30，95%CI：0.18-0.50，P<.01）和截肢率（OR=0.49，95%CI：0.29-0.83，P<.01）显著降低。DES组与标准PTA/BMS组的总生存率（OR=0.86，95%CI：0.56-1.32，P=.50）相似；DEB组与标准PTA组的TLR（OR=0.59，95%CI：0.32-1.09，P=.09）、再狭窄率（OR=0.49，95%CI：0.11-2.14，P=.35）、截肢率（OR=1.32，95%CI：0.51-3.40，P=.57）和总生存率（OR=1.40，95%CI：0.72-2.71，P=.32）相似。
本荟萃分析表明，与标准PTA/BMS相比，DES可降低临床驱动的TLR风险、再狭窄率和截肢率，且对死亡率无影响。然而，DEB在治疗腘下疾病方面无明显优势。由于本研究存在局限性，需要更多的随机对照试验，尤其是针对DEB的试验。
