The use of paclitaxel-coated angioplasty balloons during percutaneous treatment of femoropopliteal disease is associated with significant reductions in late lumen loss and target-lesion revascularization, according to a small, multi-center trial published in the Feb. 14 issue of the New England Journal of Medicine.
Gunnar Tepe, MD, Eberhard-Karls University in Tübingen, Germany, and colleagues, investigated the use of paclitaxel-coated angioplasty balloons and paclitaxel dissolved in the angiographic contrast medium during angioplasty of the leg because previous clinical trials have failed to prove their efficacy in peripheral arteries
The investigators randomly assigned 154 patients with stenosis or occlusion of a femoropopliteal artery to treatment with standard balloon catheters coated with paclitaxel, uncoated balloons with paclitaxel dissolved in the contrast medium or uncoated balloons without paclitaxel (control). The primary end point was late lumen loss at six months.
Late lumen loss was reduced by more than 75% with paclitaxel-coated balloons, according to researchers.
The mean age of the patients was 68 years, 24% were smokers, and 49% had diabetes, the researchers reported. Of the 154 patients, 27% of the lesions were total occlusions, and 36% were restenotic lesions, and the mean lesion length was 7.4 cm, the authors said.
The researchers said that there were no significant differences in baseline characteristics between the groups and no adverse events attributable to the paclitaxel-coated balloons. At six months, the investigators reported that the mean late lumen loss was 1.7 mm in the control group, as compared with 0.4 mm in the group treated with paclitaxel-coated balloons and 2.2 mm in the group treated with paclitaxel in the contrast medium.
The rate of revascularization of target lesions at six months was 20 of 54 (37%) in the control group, 2 of 48 (4%) in the group treated with paclitaxel-coated balloons, and 15 of 52 (29%) in the group treated with paclitaxel in the contrast medium; at 24 months, the rates increased to 28 of 54 (52%), 7 of 48 (15%), and 21 of 52 (40%), respectively, according to the researchers.
During the first six months post-treatment, the authors reported that five patients died and four had major amputations. The authors attributed the deaths and amputations to the overall high risk of the study population that included 25 patients with critical limb ischemia.
The trial was a preliminary study, limited in scope and observation period, the authors wrote. “Additional and larger trials will be necessary to provide definitive evidence of benefit,” they added.
However, the “use of paclitaxel-coated balloon catheters significantly lowered the incidence of restenosis at six months and the rate of target-lesion revascularization at six, 12, and 24 months," the authors wrote.