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Comparison of 1% and 3% polidocanol foam in ultrasound guided sclerotherapy of the great saphenous vein: a randomised, double-blind trial with 2 year-follow-up. "The 3/1 Study".

Hamel-Desnos C, Ouvry P, Benigni JP, Boitelle G, Schadeck M, Desnos P, Allaert FA

Société Française de Phlébologie, 46 rue Saint-Lambert, 75015 Paris, France. claudine@desnos.eu

OBJECTIVES: To compare 1% and 3% POL foam in treating the great saphenous vein (GSV) by ultrasound guided sclerotherapy. DESIGN: Multicentre, prospective, randomised, double-blind trial with 2 year-follow-up. PATIENTS AND METHODS: 148 patients with GSV reflux (saphenous trunk diameter 4-8 mm) were randomised to undergo ultrasound guided foam sclerotherapy using either 1% or 3% POL foam in a single session. Foam production was standardised using a sterile disposable syringe kit including sterile air and the Turbofoam machine. Duplex ultrasonography was used to assess the outcome at 3 weeks, 6 months, 1 year, 18 months and 2 years. The main criterion of success was the disappearance of the venous reflux. The length of occlusion of the vein (only measured at 3 week-echography assessment) was a secondary criterion. Side effects were assessed. RESULTS: 74 patients were included in each group. The mean volume of foam injected was 4.4 ml for the 3% group and 4.6 ml for the 1% group. After 3 weeks, reflux was abolished in 96% (71 patients) of the 3% group and 88% (68 patients) of the 1% group (NS). The mean occlusion length of the vein was 38 cm for the 3% group and 34 for the 1% group (NS). After 2-years, reflux was absent in 69% of the 3% group and 68% of the 1% group (NS). 14 patients were lost to follow-up at 2 years. CONCLUSION: This study demonstrates equivalent efficacy for 1% POL and 3% POL foam in sclerotherapy of the GSV where the trunk is less than 8 mm in diameter. These data obtained two years of follow-up confirm our previously reported 6 month-follow-up data published in 2005.

Published 13 November 2007 in Eur J Vasc Endovasc Surg, 34(6): 723-9; discussion 730.
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