Drug-coated vs uncoated balloon angioplasty in the treatment of femoropopliteal arterial lesions

Abstract

Background Inspite of immediate technical success, neointimal hyperplasia and restenosis remain the Achilles heel of endovascular interventions. Drug-coated balloons (DCBs) have shown promising outcomes regarding anti-restenotic efficacy in management of femoro-popliteal arterial lesions compared to uncoated balloon. Objectives To evaluate the efficacy of the paclitaxel-coated balloon versus uncoated balloon angioplasty in treatment of femoropopliteal lesions regarding primary patency and restenosis at 12 months. Patients and Methods Between Sept 2017 and Sept 2019, this prospective randomized study was performed at Menoufia University hospitals. Sixty patients suffering symptomatic lower limb ischemia (Rutherford category 3 to 5) were randomly assigned into group A (30 patients) that were treated by DCB angioplasty, and group B (30 patients) that were treated by uncoated balloon (UCB) angioplasty. The primary patency, mean diameter restenosis, and binary restenosis (≥50% diameter stenosis) of the treated lesions at 12 months were collected and analyzed. Results Baseline characteristics were comparable in both groups. The 12-month mean diameter restenosis was significantly lower in DCB group than UCB group (27.8±35.2% vs. 44.9±33.8% respectively, P Conclusions Treatment of symptomatic femoro-popliteal disease with paclitaxel coated balloon angioplasty is associated with superior anti-restenotic efficacy that provides a better primary patency rate compared to uncoated balloon angioplasty at 12 months.