Ultrasound-guided Sclerotherapy of the Great Saphenous Vein With 1% vs. 3% Polidocanol Foam: A Multicentre Double-Blind Randomised Trial With 3-year Follow-Up

Eur J Vasc Endovasc Surg. 2010 Jun;39(6):779-86. doi: 10.1016/j.ejvs.2010.01.022. Epub 2010 Mar 4.

Abstract

Objectives: The aim of this study was to compare the efficacy and side effects of ultrasound-guided foam sclerotherapy of the great saphenous vein using 1% and 3% polidocanol foam with a 3-year follow-up.

Design: A multicentre prospective double-blind randomised clinical trial comparing the efficacy of 1% vs. 3% polidocanol sclerosant foam.

Materials and methods: Patients with incompetence of the great saphenous vein (GSV) in CEAP clinical classes C2-5 (CEAP, Clinical-Etiology-Anatomy-Pathophysiology), with or without incompetence of the sapheno-femoral junction, were included. The Turbofoam method was used to create 1% and 3% polidocanol foam, which was injected into the GSV under ultrasound guidance, with a volume not exceeding 10 ml. Further foam sclerotherapy was carried out at 6 weeks, 3 and 6 months if required to abolish persistent venous reflux. The main outcome measure was the absence of saphenous reflux as assessed by ultrasound imaging at 6 months, 1, 2 and 3 years. Clinical severity (Venous Clinical Severity score (VCSS)) and quality of life (the Chronic Venous Insufficiency Questionnaire (CIVIQ)) scores were assessed.

Results: A total of 143 patients were included; 1% group men = 18, women = 55, 3% group men = 19, women = 51. The abolition of venous reflux was: 1% group, 69% and 3% group, 85% at 6 months; 1% group, 79% and 3% group, 78% at 3 years (including additional injections at 6 months). Three asymptomatic thrombo-embolic events (2%) occurred. Local side effects (principally pigmentation and matting) were 9% in the 3% group and 6% in the 1% group at 3 years (N.S.). Clinical severity and quality of life scores improved by more than 20% at 6 months in both the groups, with no difference between the groups.

Conclusions: This is the first randomised clinical trial of ultrasound-guided foam sclerotherapy which is a 3-year follow-up and shows equivalent efficacy of 1% and 3% sclerosant foam.

Clinical trial registration number: 2006-07-05.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Injections, Intravenous
  • Male
  • Middle Aged
  • Polidocanol
  • Polyethylene Glycols / administration & dosage*
  • Prospective Studies
  • Saphenous Vein / diagnostic imaging*
  • Sclerosing Solutions / administration & dosage*
  • Sclerotherapy / methods*
  • Time Factors
  • Tissue Adhesives
  • Treatment Outcome
  • Ultrasonography, Doppler, Color / methods*
  • Venous Insufficiency / diagnostic imaging
  • Venous Insufficiency / therapy*

Substances

  • Sclerosing Solutions
  • Tissue Adhesives
  • Polidocanol
  • Polyethylene Glycols