Efficacy and safety of drug-coated balloon versus non-drug-coated balloon combined with bare metal stent implantation in treatment of patients with occlusions of the superficial femoral artery: a retrospective study in clinical practice.

ABSTRACT

OBJECTIVE: To assess the efficacy and safety of drug-coated balloon and non-drug-coated balloon combined with bare metal stent implantation for the treatment of patients with occlusions of the superficial femoral artery. METHODS: In this retrospective study, 83 patients with occlusions of the superficial femoral artery were included. Among them, 41 patients received paclitaxel drug coated balloon treatment combined with bare metal stent implantation treatment (experimental group), the remaining 42 received non-drug-coated balloon treatment (control group). Patients were followed up at 1, 6, and 12 months after surgery. The primary clinical assessments, including ankle brachial index (ABI), RutherFord grade, Doppler ultrasound, or CT angiography (CTA), were used to observe the patency of target vessels, perioperative and postoperative complications. RESULTS: All the diseased vessels were successfully opened. There were no serious intraoperative complications such as vascular rupture or acute thrombosis. There was no significant difference in ankle brachial index, RutherFord grade, and total score between the two groups at one month and six months after operation (P>0.05). There was no significant difference in mortality, amputation rate, or thrombosis between the two groups (P>0.05). Twelve months after the operation, the ankle brachial index, Rutherford grade and total score of the experimental group were better than those of the control group (P<0.05). There was no significant difference in mortality, amputation rate, or thrombosis between the two groups (P>0.05). CONCLUSION: Paclitaxel coated balloon is safe and effective in the treatment of superficial femoral arteriosclerosis occlusion. It can significantly improve the ABI and Rutherford grades of patients, and it had a higher patency rate and lower reconstruction rate, but it may affect the healing ability of foot ulcer.