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".
OBJECTIVE
To compare 1% and 3% POL foam in treating the great saphenous vein (GSV) by ultrasound guided sclerotherapy.


METHODS
Multicentre, prospective, randomised, double-blind trial with 2 year-follow-up.


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.


CONCLUSIONS
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.
Hamel-Desnos
C
C
Société Française de Phlébologie, 46 rue Saint-Lambert, 75015 Paris, France. claudine@desnos.eu
Ouvry
P
P
Benigni
J-P
JP
Boitelle
G
G
Schadeck
M
M
Desnos
P
P
Allaert
F-A
FA
D000328:Adult; D004304:Dosage Forms; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077423:Polidocanol; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011446:Prospective Studies; D011859:Radiography; D012008:Recurrence; D012501:Saphenous Vein / Q000000981:diagnostic imaging; D012597:Sclerosing Solutions / Q000008:administration & dosage*; D015911:Sclerotherapy / Q000295:instrumentation*; D018084:Ultrasonography, Interventional; D014648:Varicose Veins / Q000000981:diagnostic imaging / Q000628:therapy*
D004304:Dosage Forms; D012597:Sclerosing Solutions; D000077423:Polidocanol; D011092:Polyethylene Glycols