比较紫杉醇药物球囊与金属裸支架治疗下肢动脉硬化闭塞症的对照临床研究

Comparative Clinical Study of Paclitaxel Drug Balloon and Bare Metal Stent in the Treatment of Lower Extremity Arteriosclerosis Obliterans

摘要: 目的：观察药物涂层球囊(drug-coated balloon, DCB)与金属裸支架( bare metal stent, BMS)治疗下肢动脉硬化闭塞症(ASO)长段病变的疗效。方法：笔者通过选取2016年12月至2019年12月青岛大学附属医院血管外科接受介入治疗的老年下肢ASO患者，共73条患肢(病变长度 ≥ 20 cm)。每条患肢在选择合适的手术入路后使用普通球囊预扩张，然后选取符合靶病变的药物涂层球囊(DCB)或金属裸支架(BMS)植入，其中接受DCB治疗(包括单纯DCB和DCB + 短支架植入)的有36条患肢(DCB组)，接受BMS治疗的有37条患肢(BMS组)。观察术后1个月、3个月、6个月、9个月、12个月血管通畅率及靶病变血管再重建率，期间无患者死亡、截肢。采用SPSS 22.0软件进行统计分析。根据数据类型，组间比较采用t检验或χ²检验。结果：73条患肢均获得技术成功，且随访率为100%。观察2组患肢术后12个月血管通畅率及靶病变重建率。结果：DCB组的术后12月靶病变通畅率为86.1%，BMS组的通畅率86.4%，差异无统计学意义(P > 0.05)，但是DCB组术后12月的临床驱动的靶病变重建率更低(DCB: 11.1% VS BMS: 48.6%)，差异有统计学意义(P < 0.05)。结论：药物涂层球囊在治疗下肢动脉硬化闭塞症(病变长度 ≥ 20 cm)与金属裸支架在近期疗效上无显著差异，但相较于金属裸支架植入，药物涂层球囊有更少的术后管腔丢失，更低的血管再重建率。

Abstract: Objective: To observe the efficacy of drug-coated balloon (DCB) and bare metal stent (BMS) in the treatment of long-segment lesions of lower extremity arteriosclerosis obliterans (ASO). Methods: The author selected 73 elderly patients with lower extremity ASO (lesion length ≥ 20 cm) who underwent interventional treatment in the Department of Vascular Surgery, Qingdao University Affiliated Hospital from December 2016 to December 2019. After selecting the appropriate surgical approach, each affected limb is predilated with a common balloon, and then a drug-coated balloon (DCB) or bare metal stent (BMS) that meets the target lesion is selected for implantation, and DCB treatment (including simple DCB and DCB + short stent implantation) had 36 affected limbs (DCB group), and 37 affected limbs (BMS group) received BMS treatment. The primary vascular patency rate and target lesion vascular remodeling rate were observed at 1 month, 3 months, 6 months, 9 months, and 12 months postoperatively. During this period, no patients died or had amputations. We use SPSS 22.0 software for statistical analysis. According to the data type, the t test or the χ² test is used for comparison between groups. Results: All 73 affected limbs were technically successful, and the follow-up rate was 100%. The primary vascular patency rate and target lesion reconstruction rate were observed in the two groups at 12 months postoperatively. Results: In DCB group, the patency rate of target lesion was 86.1% 12 months after operation, and the patency rate of target lesion in the BMS group was 86.4%. The difference was not statistically significant (P > 0.05). However, the clinical driven target lesion reconstruction rate was lower in DCB group 12 months after surgery (DCB: 11.1% VS BMS: 48.6%), and the difference was statistically significant (P < 0.05). Conclusion: There is no significant difference between drug-coated balloons in the treatment of lower extremity arteriosclerosis obliterans (lesion length ≥ 20 cm) and bare metal stents in the short-term efficacy, but compared with bare metal stent implantation, drug-coated balloons have less. The postoperative lumen is lost, and the rate of vascular reconstruction is lower.