The demand for endovascular therapy is increasing in an aging society, but the problem of restenosis in the chronic phase has not been resolved in femoropopliteal occlusive disease. Few studies have compared drug-coated balloon (DCB) and scaffold devices in chronic total occlusion (CTO) of the superficial femoral artery (SFA). This study aimed to compare DCBs with scaffold in patients with CTO of the SFA. This was a single-center, retrospective study. From June 2018 to December 2019, we compared 31 patients and 33 limbs treated with DCBs and 44 patients and 45 limbs treated with a stent or stent-graft (scaffold) for SFA CTO. The primary endpoint was 12-month primary patency. The secondary endpoints were 12-month freedom from clinically driven target lesion revascularization (CD-TLR) and 12-month freedom from re-occlusion. The DCBs were performed using an intravascular ultrasound (IVUS)-guided approach or a non-loop wire technique. Baseline characteristics were similar between the groups. An intraluminal approach was performed to use all DCBs. The bailout stent rate was 0% in the DCB group. Kaplan–Meier analysis showed that rates of 12-month primary patency tended to be higher in the DCB than in the scaffold group (92.7 vs. 76.6%, p = 0.073) and that freedom from CD-TLR also did not differ significantly between the two groups (96.8 vs. 86.3%, p = 0.17). Kaplan–Meier analysis also showed that the 12-month freedom from re-occlusion rate was significantly less in the Scaffold than in the DCB group (96.8 vs. 79.3%, p = 0.045). Therefore, we concluded that in treatment for CTO of the SFA, a DCB with intraluminal angioplasty without bailout stenting was less re-occlusion compared with scaffold.

老龄化社会对血管内治疗的需求日益增加，但股腘动脉闭塞性疾病的慢性期再狭窄问题仍未得到解决。很少有研究比较药物涂层球囊 (DCB) 和支架装置在股浅动脉 (SFA) 慢性完全闭塞 (CTO) 中的作用。本研究旨在比较 DCB 与支架在 SFA 的 CTO 患者中的作用。这是一项单中心的回顾性研究。从 2018 年 6 月至 2019 年 12 月，我们比较了 31 名患者和 33 名肢体接受 DCB 治疗，以及 44 名患者和 45 名肢体接受了支架或支架移植物（支架）治疗的 SFA CTO。主要终点是 12 个月的主要通畅率。次要终点是 12 个月免于临床驱动的靶病变血运重建 (CD-TLR) 和 12 个月免于再闭塞。DCB 是使用血管内超声 (IVUS) 引导的方法或非环线技术进行的。各组之间的基线特征相似。进行腔内方法以使用所有 DCB。DCB 组的救助支架率为 0%。Kaplan-Meier 分析显示，DCB 的 12 个月初次通畅率往往高于支架组（92.7% 对 76.6%，p  = 0.073），并且两组之间无 CD-TLR 的情况也没有显着差异（96.8 对 86.3%，p  = 0.17）。Kaplan-Meier 分析还显示，支架组 12 个月的再闭塞率明显低于 DCB 组（96.8% 对 79.3%，p  = 0.045）。因此，我们得出的结论是，在 SFA 的 CTO 治疗中，与支架相比，采用腔内血管成形术的 DCB 与支架相比，再闭塞较少。