Clinical follow-up study of paclitaxel-coated balloon in the treatment of symptomatic lower extremity arteriosclerosis obliterans

Abstract

Objective To investigate the clinical effect of paclitaxel coated balloon in the treatment of symptomatic lower extremity arteriosclerosis obliterans. Methods From January 2016 to April 2017, 64 patients with symptomatic lower limb arteriosclerosis obliterans (ASO) of femoral and popliteal artery stenosis admitted to Chongming Branch Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine were selected as the research subjects.According to the principle of randomization, they were divided into two groups, 32 cases in each group.In the drug-coated group, ordinary balloon was pre-expanded, and then paclitaxel drug-coated balloon was used to expand.If there were still retraction and stenosis of diseased vessels, which affected the blood flow of lower limbs, remedial stents were implanted.Bare stent group used a slightly smaller balloon to pre-expand superficial femoral artery and then release the stent.After one year follow-up, the changes of ankle-brachial index (ABI), restenosis rate of target lesion vessels, Rutherford grading changes, clinical drive target vessel revascularization rate, perioperative period, death rate of patients during follow-up period, amputation rate and complication rate were observed. Results There were no amputations or deaths in the whole group during the perioperative period and follow-up.The incidence of complications in the drug-coated group was 3.1% (1/32), significantly lower than that in the bare stent group 18.8% (6/32) (χ2=4.010, P=0.045). Before treatment, the ABI of patients in drug-coated group and bare stent group at 6 months and 12 months after treatment were significantly different (Finter-group=7.028, Pinter-group=0.024, Fintra-group=219.028, Pintra-group=0.000, Finteraction=350.028, Pinteraction=0.000), and ABI of the two groups at 12 months after treatment were (0.73±0.11) and (0.68±0.09), respectively, the difference was statistically significant (t=1.990, P=0.025). Six months after operation, the restenosis rates of target lesions in the two groups were 9.4%(3/32) and 15.6%(5/32), respectively, with no significant difference (χ2=0.571, P=0.450); The restenosis rate of bare stent group was 37.5%(12/32) 12 months after operation, which was significantly higher than that of drug-coated group by 15.6%(5/32) (χ2=3.925, P=0.048). Clinical observation results showed that 12 months after operation, the target-lesion revascularization (TLR) of the drug-coated group was 3.1% (1/32) and that of the bare stent group was 9.4% (3/32), with no significant difference.Rutherford grading was improved in both groups(χ2=1.067, P>0.05). Conclusion Paclitaxel drug-coated balloon is safe and effective in the treatment of symptomatic lower limb arteriosclerosis obliterans, which is worthy of clinical application. Key words: Arterial occlusion of the lower limb; Drug-coated balloon; Paclitaxel; Restenosis; Ankle brachial index