No additional benefit from laser in balloon angioplasty of the superficial femoral artery

Objectives: To evaluate the efficacy of the addition of plaque ablation by hot-lip laser to balloon angioplasty. Design: Prospective randomised clinical trial. Materials and methods: Patients with either occlusion or >50% diameter stenosis less than 3cm in length in the superficial femoral artery, and with two or three calf vessel run-off were eligible and randomised to receive either balloon angioplasty alone or with laser assistance. Treatment failure in follow-up was defined as reocclusion or recurrence of greater than 50% stenosis at the site of angioplasty. Results: Ninety limbs (82 patients) were entered into the study. Forty-four patients had mild claudication, 32 move severe symptoms and 6 rest pain or ulceration. More patients with diabetes (5 of 5, p = 0.04, Fisher's exact test) and occlusions (16 of 22, p < 0.05, χ²) were randomised to the laser group. Initial technical success was obtained in all lesions. The median duration of follow-up was 1 year. Failure occurred in 40 limbs during follow-up. Three segments, all with initial occlusions and undergoing laser angioplasty re-occluded within 2 days, one requiring immediate thrombectomy. Another 20 limbs underwent further intervention. Overall success (± S.D.) (Kaplan-Meier) at 1 year was 67% (± 5%) and at 2 years 43% (± 7%). Only increased age, initial occlusion, female sex, and not smoking were significantly (p < 0.05, Cox's proportional hazards) associated with failure; on multivariate analysis, age and occlusion were the best independent predictors. There was no significant difference (p > 0.05) in outcome between limbs undergoing laser assisted balloon angioplasty and balloon alone either overall or within the stenosis or occlusion subgroups. Conclusions: This study found no significant benefit was gained by the addition of laser to balloon angioplasty and that the long term success was modest for lesions considered to be suitable for angioplasty.