Comparison of the efficacy of drug-eluting balloon for de novo lesions and in-stent restenosis lesions of the femoropopliteal arteries

Abstract

ObjectiveTo compare the efficacy of drug-eluting balloons for de novo and in-stent restenosis (ISR) for lesions of the femoropopliteal arteries during 12-month follow-up. Materials and methodsA retrospective analysis of 66 patients was performed. These patients had lower extremity atherosclerosis obliterans and were treated with drug-eluting balloons from June 2016 to June 2017. All the lesions were femoropopliteal, including 47 de novo lesions and 19 ISR lesions. Clinical results were followed up at 6 months and 12 months postoperatively. The primary patency rate, target lesion revascularization, Rutherford classification, ankle-brachial index, amputation rate and mortality were compared between the two groups. ResultsAll the 66 patients underwent the treatment of femoropopliteal artery lesions with unilateral limbs. The surgical success rates were 100%. No adverse events such as acute ischemia or amputation occurred in the hospital. There was no difference between the two groups' Rutherford classification and the ankle-brachial index at the 6-month follow-up (p > 0.05). At the 12-month follow-up, the de novo group's Rutherford classification was lower than the ISR group (p = 0.026), and the ankle-brachial index of the ISR group was lower (0.66 ± 0.033 vs 0.52 ± 0.056, p = 0.036). There was no difference between the patency rate of the de novo group and the ISR group (93.6% vs 84.2%, p = 0.229) at the 6-month follow-up. However, the ISR group patency rate was lower at the 12-month follow-up (63.2% vs 85.1%, p = 0.048). As for revascularization there was no significant difference between the two groups at the 6-month follow-up (4.2% vs 10.5%, p = 0.334), but a higher rate occurred in the ISR group at the 12-month follow-up (26.3% vs 6.4%, p = 0.025). There were no significant differences in the mortality or amputation rate between the two groups (p > 0.05). ConclusionsDrug-eluting balloons were effective in treating both de novo lesions and ISR lesions in the atherosclerotic femoropopliteal artery, but the 12-month follow-up results of ISR lesions were less favorable than the de novo lesions.