A multicenter, randomized, placebo-controlled study to evaluate the efficacy and safety of varithena® (Polidocanol endovenous microfoam 1%) for symptomatic, visible varicose veins with saphenofemoral junction incompetence

Abstract

Objectives: A randomized, placebo-controlled, multicenter study was conducted to evaluate the safety and efficacy of polidocanol endovenous microfoam (1%, Varithena™ [polidocanol injectable foam], BTG International Ltd.). Methods: Patients (n=77) with symptomatic, visible varicose veins were randomized to treatment with either Varithena 1% or placebo. Results: Varithena provided greater mean changes from Baseline in patient-reported assessments of symptoms (e.g., heaviness, achiness, swelling, throbbing, itching [HASTI™] score 30.7 points vs 16.7 points, p=0.0009, primary endpoint; and modified Venous Insufficiency Epidemiological and Economic Study-Quality-of-Life/Symptoms [m-VEINESQOL/ Sym; p<0.001]), physician-assessed VCSS, and physician- and patient-assessed appearance compared with placebo. The HASTI score correlated highly with the modified-VEINES-QOL/Sym and Chronic Venous Insufficiency Questionnaire-2 scores (r=0.7 to>0.9, p≤0.001). Adverse events included contusion, incision-site hematoma, and limb discomfort. Venous thrombus adverse events were reported as mild and generally resolved without sequelae. Conclusions: Varithena provided significantly greater symptom relief and improvement in leg appearance compared with placebo. Adverse events were generally mild and transient. (www.clinicaltrials.gov [NCT00758420]).