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.
OBJECTIVE
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.


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


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.


BACKGROUND
2006-07-05.
Blaise
S
S
Department of Vascular Medicine, Grenoble University Hospital, France. SBlaise@chu-grenoble.fr
Bosson
J L
JL
Diamand
J M
JM
D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D000077423:Polidocanol; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011446:Prospective Studies; D012501:Saphenous Vein / Q000000981:diagnostic imaging*; D012597:Sclerosing Solutions / Q000008:administration & dosage*; D015911:Sclerotherapy / Q000379:methods*; D013997:Time Factors; D014014:Tissue Adhesives; D016896:Treatment Outcome; D018615:Ultrasonography, Doppler, Color / Q000379:methods*; D014689:Venous Insufficiency / Q000000981:diagnostic imaging / Q000628:therapy*
D012597:Sclerosing Solutions; D014014:Tissue Adhesives; D000077423:Polidocanol; D011092:Polyethylene Glycols