药物球囊治疗股腘动脉硬化闭塞症的临床研究

Drug-coated balloon treatment for femoropopliteal arteriosclerosis occlusion

摘要:

目的 评估药物涂层球囊(DCB)治疗股腘动脉硬化闭塞的有效性及安全性。方法 回顾性分析2016年6月至2017年5月哈尔滨医科大学附属第一医院血管外科及群力分院血管外科行球囊治疗的股腘动脉病变患者162例(Rutherford 2~4级)。其中采用DCB治疗的患者102例(DCB组),采用普通球囊即经皮腔内血管成形术(PTA)治疗的患者60例(PTA组)。患者在术后30 d、6个月和12个月后于我院复诊并对其进行随访。收集2组患者一般资料,观察患者疗效终点和安全终点。采用SPSS 19.0软件对数据进行分析。根据数据类型,组间比较采用独立样本t检验、χ²检验(Pearson χ² 或四表格校正公式)或Wilcoxon符号秩和检验。结果 2组患者一般资料差异无统计学意义(P＞0.05),但男性、有吸烟史患者比例均＞50%。2组患者病变特点及手术相关指标差异均无统计学意义(P＞0.05)。随访12个月后,与PTA组患者比较,DCB组一期通畅率[76.5%(78/102) vs 56.7%(34/60),P=0.008]和踝肱指数[(0.89±0.14) vs(0.82±0.20),P=0.027]显著升高,靶病变血运重建(TLR)比例显著降低[5.9%(6/102) vs 27.1%(16/60),P＜0.001],差异有统计学意义,但2组患者在提高步行受损问卷(WIQ)[22.3(8.0,9.4) vs 21.4(5.4,7.7)分,P=0.403]、手术成功比例[100%(102/102) vs 100%(60/60),P=1.000]方面差异无统计学意义。DCB组1例男性患者因严重慢性阻塞性肺疾病伴严重肺感染于随访6个月后死亡,PTA组1例糖尿病患者于随访6个月后因足外伤后感染严重行膝下截肢术；但2组患者安全终点事件及主要不良事件发生率差异均无统计学意义(P＞0.05)。结论 DCB治疗初发性股腘动脉硬化闭塞效果明显优于PTA,安全性不劣于PTA。

Abstract:

Objective To assess the efficacy and safety of drug-coated balloon (DCB) treatment for femoralpopliteal arteriosclerosis occlusion.Methods A retrospective analysis was conducted of 162 patients treated in our hospital from June 2016 to May 2017 with femoralpopliteal artery disease (Rutherford 2-4). The patients were classified as DCB group (n=102) treated with DCB and PTA group (n=60) with percutaneous transluminal angioplasty (PTA). The patients were followed up and evaluated at 30 days, 6 months and 12 months after operation. Basic information was collected, and efficacy endpoints and safety endpoints were analyzed for both groups. SPSS statistics 19.0 was used for data analysis, and independent samples t test, Chi-square test (Pearson Chi-square or four-fold contingency table) or Wilcoxon signed-rank test were used for comparison. Results No significant difference between the 2 groups was observed in the basic data, but the male and the smokers in both groups accounted for above 50%. There was no significant difference between the 2 groups (P>0.05) in the characteristics of lesion and operation-associated variables. At 12 months follow-up, DCB group had a significantly greater increase than the PTA group in the primary patency rate [76.5%(78/102) vs 56.7%(34/60),P=0.008] and ankle brachial index (ABI) [(0.89±0.14) vs (0.82±0.20), P=0.027] and a significantly greater decrease in the ratio of target lesion revascularization (TLR) [5.9%(6/102) vs 27.1%(16/60), P<0.001]. However, the DCB group did not differ significantly than the PTA group in improved walking impairment questionnaire (WIQ) score [22.3(8.0,9.4) vs 21.4(5.4,7.7),P=0.403] and success rate of operation [100%(102/102) vs 100%(60/60), P=1.000]. One man in DCB group died of severe chronic obstructive pulmonary disease with severe pulmonary infection after 6 months′ follow-up, and one diabetic patient in PTA group underwent lower knee amputation for severe infection following foot trauma also after 6 months′ follow-up, but there was no significant difference between 2 groups in the incidence of safety endpoints and main adverse events (P>0.05). Conclusion DCB shows superior outcomes over PTA in the treatment of de novo femoropopliteal arteriosclerosis occlusion with comparable safety.