Efficacy and Safety Differences between Domestic Paclitaxel Drug-Coated Balloons and Metal Bare Stents in the Treatment of ASO of Femoral-Popliteal Arteries Type IIA-C.

Abstract

The aim in this study was to investigate the efficacy and safety of domestic paclitaxel-coated balloon (DCB) and bare metal stent (BMS) in the treatment of Transatlantic Cooperative Organization Consensus II (ASC II) types A–C femoral-popliteal arteriosclerosis obliterans (ASO). A total of 103 patients with ASC II A–C femoropopliteal ASO, who received treatment in our hospital from March 2020 to March 2021, were retrospectively selected and divided into the DCB group (n = 56) and BMS group (n = 47), according to treatment methods. The general clinical data and surgical results were compared between the two groups. The patients were followed up, and the primary patency rate, restenosis rate, freedom from target lesion revascularization (f-TLR), and limb preservation rate were recorded. The liver and kidney functions before and after operation and the occurrence of major postoperative adverse events were recorded. The operation was successful in both groups. The minimum diameter of the DCB group was smaller than that of the BMS group after treatment (P < 0.05). At 6 and 12 months after operation, the Rutherford classification decreased and ABI index increased in both groups (P < 0.05), but there was no significant difference (P > 0.05). At 6 and 12 months after surgery, f-TLR was significantly higher in the DCB group than in the BMS group (P < 0.05); at 12 months after surgery, the restenosis rate was lower in the DCB group than in the BMS group (P < 0.05). There was no significant difference in the primary patency rate and limb preservation rate at 6 and 12 months after operation between the two groups (P > 0.05). Before and after operation, there was no significant difference in liver and kidney function between the two groups (P > 0.05). Within 12 months after surgery, 1 patient in the DCB group developed puncture site hematoma 3 days after surgery, and 1 patient in the BMS group developed acute thrombosis 1 day after surgery, and no intervention-related deaths occurred. Domestic paclitaxel DCB can achieve better f-TLR and lower restenosis rate than BMS in the treatment of type II A–C femoral-popliteal artery ASO. Short-term and medium-term efficacy and safety are comparable to BMS.