Efficacy of Polidocanol Foam versus Liquid in Sclerotherapy of the Great Saphenous Vein: A Multicentre Randomised Controlled Trial with a 2-year Follow-up

Abstract

Objective To compare the relative efficacy of polidocanol (Aetoxisclerol ®, Kreussler, Germany) when used as a foam or liquid in the treatment of saphenous incompetence. Materials and methods Multicentre, prospective, randomised controlled trial conducted in patients with incompetence of the great saphenous vein (GSV) with a truncal diameter of 4–8 mm. The great saphenous vein was injected using a single injection 2–2.5 ml of either 3% polidocanol or sclerosant foam containing one-fifth 3% polidocanol to four-fifths air (DSS technique). Clinical assessments and duplex ultrasound scanning were performed after 3 weeks and then every 6 months for 2 years. No re-injection was performed irrespective of the immediate result. The main outcome measure was elimination of GSV reflux. Results Ninety-five patients participated in the study, 47 were randomised to the foam sclerosant group and 48 to the liquid group. No significant difference between the 2 groups was found regarding sex, age, height, weight and saphenous vein diameter. At 3 weeks, complete elimination of reflux was obtained in 17 of the 48 patients (35%) who received liquid sclerotherapy, versus 40 of the 47 subjects (85%) in the foam group ( p < 0.001, Chi squared). The incidence of immediate venous spasm and the length of the sclerotic reaction, occlusion measured by echography, were significantly greater in the foam group. There was no difference in the incidence of ecchymosis, inflammatory reactions or other side effects. Follow-up of 6, 12, 18 and 24 months confirms our early results published in 2003. In total only 5 patients were lost to follow-up at 2 years (all of them were in foam group). These patients were included in the final outcome analysis as treatment failures (success rates at 2 years: 53% in foam group and 12% in liquid group). Conclusion The sclerosant foam used in this study was more than twice as effective as the liquid from which the foam was prepared.