Inhibition of Restenosis in Femoropopliteal Arteries

Abstract

Background— The success of percutaneous intervention in peripheral arterial disease is limited by restenosis. The aim of the present pilot study was to evaluate a novel method of local drug delivery. Methods and Results— This randomized multicenter study with blinded reading enrolled 87 patients in Rutherford class 1 to 4 with occlusion or hemodynamically relevant stenosis, restenosis, or in-stent restenosis of femoropopliteal arteries. Treatment was performed by either conventional uncoated or paclitaxel-coated balloon catheters. The primary end point was late lumen loss at 6 months. Secondary end points included restenosis rate, ankle brachial index, Rutherford class, target lesion revascularization, and tolerance up to >18 months. Before intervention, there were no significant differences in lesion characteristics such as reference diameter (5.3±1.1 versus 5.2±1.0 mm), degree of stenosis (84±11% versus 84±16%), proportion of restenotic lesions (36% versus 33%), and mean lesion length (5.7 cm [0.8 to 22.6 cm] versus 6.1 cm [0.9 to 19.3 cm]) between treatment groups. The 6-month follow-up angiography performed in 31 of 45 and 34 of 42 patients showed less late lumen loss in the coated balloon group (0.5±1.1 versus 1.0±1.1 mm; P =0.031). The number of target lesion revascularizations was lower in the paclitaxel-coated balloon group than in control subjects (3 of 45 versus 14 of 42 patients; P =0.002). Improvement in Rutherford class was greater in the coated balloon group ( P =0.045), whereas the improvement in ankle brachial index was not different. The difference in target lesion revascularizations between treatment groups was maintained up to >18 months. No adverse events were assessed as related to balloon coating. Conclusions— In this pilot trial, paclitaxel balloon coating caused no obvious adverse events and reduced restenosis in patients undergoing angioplasty of femoropopliteal arteries.

An Overview of Optimal Endovascular Strategy in Treating the Femoropopliteal Artery: Mechanical, Biological, and Procedural Factors

“…At 24 months, the rates increased to 52 and 15%, respectively. In addition, Werk et al 53 reported the results of the femoral paclitaxel trial in 87 patients. Patients were randomized 1:1 to control PTA versus iopromide-paclitaxel coated balloon.…”

“…At 24 months, the rates increased to 52 and 15%, respectively. In addition, Werk et al 53 Mechanical, Biological, and Procedural Factors in Treating the Femoropopliteal Artery Shammas 3 This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.…”

Calcium Burden Assessment and Impact on Drug-Eluting Balloons in Peripheral Arterial Disease

“…Several trials and studies have reported their efficacy to reduce restenosis rate for the treatment of femoro-popliteal and below-the-knee lesions [13][14][15][16][17][18][19][20].…”

Current Trends and outcomes: Endovascular Management in Arteriosclerosis Obliterans (ASO) of Lower Limb Vessels

“…In prospective clinical trials In relatively small CLI patient cohorts, tibial vessel drug-eluting balloon (DEB) angioplasty significantly reduced restenosis rates and late lumen loss (LLL) at 3, 6, and 12 months [68,69] Although these angiographic assessments were not core lab adjudicated, there is a growing perception that the clinical results of DEB tibial angioplasty mirror the clinical experience in the superficial femoral artery. [70,71,72,73] Ankle-brachial index (ABI) test is recommended screening test for early diagnosis of PAD in patients with signs and symptoms of lower extremity ischemia. An ABI <0.9 with values from 0.91 to 1.0, consider as borderline abnormal.…”