Outcomes and side effects of duplex-guided sclerotherapy in the treatment of great saphenous veins with 1% versus 3% polidocanol foam: results of a randomized controlled trial with 1-year follow-up

Abstract

Background: Eighty subjects were treated with either 1 or 3% polidocanol foam to compare the efficacy and adverse sequelae of each concentration of polidocanol foam.

Objective: The objective was to compare the effects of two different concentrations of polidocanol foam.

Material and methods: During a 6-month period, we treated 80 consecutive patients with primary incompetent great saphenous veins in combination with saphenofemoral junction incompetence. These patients were treated with foam of either 1 or 3% polidocanol. Duplex analyses were made before treatment and in follow-up visits to determine the presence or absence of reflux.

Results: After 1 year, there was a clinically relevant difference in percentage of patients with occlusion of the treated great saphenous vein between both groups: 69.5% in the 1% foam group versus 80.1% in the 3% foam group; however, this difference was not statistically significant (p=.249). After 1 year of follow-up, patients in the 3% polidocanol group noticed a larger cosmetic improvement than patients in the 1% group.

Conclusions: In the treatment of primary incompetent greater saphenous veins, 3% polidocanol foam seems to be more effective than 1% polidocanol foam. The side effects were approximately similar in both groups.