NO ADDITIONAL BENEFIT FROM LASER IN BALLOON ANGIOPLASTY OF THE SUPERFICIAL FEMORAL-ARTERY

Objectives: To evaluate the efficacy of the addition of plaque ablatio n by hot-tip laser to balloon angioplasty. Design: Prospective randomi sed clinical trial. Materials and methods: Patients with either occlus ion ol >50% diameter stenosis less than 3cm in length in the superfici al femoral artery, and with two or. three calf vessel run-off were eli gible and randomised to receive either balloon angioplasty alone or wi th laser assistance, Treatment failure in follow-tip was defined as re occlusion or recurrence of greater than 50% stenosis at the site of an gioplasty. Results: Ninety limbs (82 patients) were entered into the s tudy. Forty-four patients had mild claudication, 32 more severe sympto ms 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, ch i(2)) 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 wi th initial occlusions and undergoing laser angioplasty re-occluded wit hin 2 days, one requiring immediate thrombectomy. Another 20 limbs und erwent 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 significantl y (p < 0.05, Cox's proportional hazards) associated with failure; on m ultivariate analysis, age and occlusion were the best independent pred ictors. There was no significant difference (p > 0.05) in outcome betw een limbs undergoing laser assisted balloon angioplasty and balloon al one either overall or within the stenosis or occlusion subgroups. Conc lusions: This study found no significant benefit was gained by the add ition of laser to balloon angioplasty and that the long term success w as modest for lesions considered to be suitable for angioplasty.