Efficacy Analysis of Drug-Coated Balloons in the Treatment of Ultra-Long Segment Lesions of Femoral Popliteal Artery

Abstract

PurposeTo evaluate the mid-term clinical efficacy of paclitaxel drug-coated balloons (DCBs) in the treatment of femoral artery Transatlantic Inter-Society Consensus (TASC) grades C/D lesions. MethodsThe clinical data of 73 cases with TASC grades C/D lesions of femoral artery treated with paclitaxel DCBs at the Department of Vascular Surgery, the First Hospital of Fujian Medical University from August 2016 to January 2020 were retrospectively analyzed. The primary endpoint was primary patency rate. The secondary endpoints were freedom from re-intervention, Rutherford classification, ankle branch index (ABI), amputation events, and all-cause death. ResultsA total of 73 cases of limb lesions received endoluminal treatment. The mean age of the patients including 49 males and 24 females was (72.66±11.1) years, with an initial Rutherford classification of 2-5 and an ABI of 0.4±0.1. The mean Rutherford classification was 3.70±0.95. The mean lesion length was (25.75±9.67) cm, including 61.64% chronic occlusive lesions and 27.39% stenotic lesions, the remaining 10.97% were mixed lesions, containing multiple segments of stenosis and CTO lesions. 43.8% of the lesions were associated with severe calcification. Stent implantation rate was 8%. Overall mortality at follow-up was 4% at 1 year and 8% at 2 years,and no amputations seen. The ABI was 0.83±0.07 at 1-year follow-up and 0.78±0.05 at 2-year follow-up. The Kaplan-Meier survival curve predicted 1-year phase I patency rate was 75.3%±5% and the 2-year patency rate was 63.3%±5.7%. Freedom from TLR was 78.4±4.9% at 1 year and 69.2%±3.6% at 2 years. Logistic regression analysis showed that diabetes mellitus, severe calcification, chronic renal insufficiency and restenosis were the significant factors affecting the patency of target lesions. ConclusionPaclitaxel DCBs in the treatment of femoral artery with TASC grades C/D lesions can achieve relatively satisfactory mid-term clinical safety and efficacy results, provided there is an acceptable result on completion angiogram.