FOVELASS: A Randomised Trial of Endovenous Laser Ablation Versus Polidocanol Foam for Small Saphenous Vein Incompetence

Published:December 02, 2022DOI:


      To compare the outcomes of ultrasound guided foam sclerotherapy (UGFS) and endovenous laser ablation (EVLA) to treat isolated small saphenous vein (SSV) incompetence in a multicentre randomised controlled study (RCT; identifier: NCT05468450).


      Patients aged ≥ 18 years undergoing isolated SSV treatment (reflux > 0.5 seconds) were randomised to UGFS or EVLA. Patients treated with UGFS were allowed one additional truncal treatment at six weeks. Tributary treatments (phlebectomy or sclerotherapy) were permitted after six months. Participants were assessed at eight days, six months, and one, two, and three years. The primary endpoint was the absence of SSV reflux (> 0.5 seconds). Secondary outcomes included clinical scores and quality of life (QoL) scores. All analyses were done by intention to treat.


      Of 1 522 screened patients, 161were randomised to UGFS (n = 82) and EVLA (n = 79). Only 3% of patients who received UGFS had the second (allowed) treatment and 86% of patients completed the three year study. Forty-one and 19 tributary treatments (by sclerotherapy) were performed in 27 UGFS patients (33%) and 15 EVLA patients (19%), respectively. The complete absence of reflux at three years was significantly better after EVLA (86%) than after UGFS (56%) (odds ratio [OR] 5.36, 95% confidence interval [CI] 2.31 – 12.44; risk ratio 1.59, 95% CI 1.26 – 2.01). Two deep vein thromboses (DVTs; one femoropopliteal and one gastrocnemius) and one endovenous heat induced thrombosis occurred in the EVLA group. Seven DVTs were seen in the UGFS group, including two partial popliteal DVTs and five gastrocnemius veins thromboses (four asymptomatic and incidental on day 8 screening). At three years, there was no difference between groups for the following: rate of visible varices (p = .87), revised Venous Clinical Severity Score (p = .28), and QoL (p = .59). Patient satisfaction scores were high in both groups (median score: EVLA 97/100 and UGFS 93/100; p = .080). Symptoms were significantly improved in both groups. (p < .001)


      Technical success was better for EVLA than for UGFS three years after SSV treatment. This agrees with studies that have reported on these treatments in the great saphenous vein. However, improvements in clinical outcome were similar for both groups.


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      1. National Institute for Health and Care Excellence. Varicose veins: diagnosis and management. Clinical guideline. Available at: [Accessed 24 July 2022].

        • De Maeseneer M.G.
        • Kakkos S.K.
        • Aherne T.
        • Baekgaard N.
        • Black S.
        • Blomgren L.
        • et al.
        Editor's Choice – European Society for Vascular Surgery (ESVS) 2022 Clinical Practice Guidelines on the Management of Chronic Venous Disease of the Lower Limbs.
        Eur J Vasc Endovasc Surg. 2022; 63: 184-267
        • Rabe E.
        • Breu F.X.
        • Cavezzi A.
        • Coleridge Smith P.
        • Frullini A.
        • Gillet J.L.
        • et al.
        for the Guideline Group. European guidelines for sclerotherapy in chronic venous disorders.
        Phlebology. 2014; 29: 338-354
        • Hamel-Desnos C.
        L’échosclérothérapie à la mousse en pratique courante: indications et technique.
        Phlebology. 2013; 66: 23-27
        • Agence Nationale de Sécurité du Médicament
        Résumé des Caractéristiques du Produit Aetoxisclerol Tamponné 2 pour Cent.
        2013 (Available at:)
        • Traitement des varices des membres inférieurs
        Rapport de l’Agence Nationale d’Accréditation et d’Évaluation en Santé. Service Évaluation en santé publique – Évaluation technologique.
        • Rasmussen L.
        • Lawaetz M.
        • Serup J.
        • Bjoern L.
        • Vennits B.
        • Blemings A.
        • et al.
        Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy, and surgical stripping for great saphenous varicose veins with 3-year follow-up.
        J Vasc Surg Venous Lymphat Disord. 2013; 1: 349-356
        • Bouhassira D.
        • Attala N.
        • Fermanianc J.
        • Alchaard H.
        • Gautrona M.
        • Masqueliere E.
        • et al.
        Development and validation of the Neuropathic Pain Symptom Inventory.
        Pain. 2004; 108: 248-257
        • Vasquez M.A.
        • Rabe E.
        • McLafferty R.B.
        • Shortell C.K.
        • Marston W.A.
        • Gillespie D.
        • et al.
        American Venous Forum Ad Hoc Outcomes Working Group. Revision of the venous clinical severity score: venous outcomes consensus statement: special communication of the American Venous Forum Ad Hoc Outcomes Working Group.
        J Vasc Surg. 2010; 52: 1387-1396
        • Perrin M.
        • Eklöf B.
        • Van Rij A.
        • Labropoulos N.
        • Vasquez M.
        • Nicolaides A.
        Venous symptoms: the SyM Vein Consensus statement developed under the auspices of the European Venous Forum.
        Int Angiol. 2016; 35: 374-398
        • Hamel-Desnos C.
        • Josnin M.
        • Allaert F.-A.
        Etude contrôlée randomisée de l’efficacité du laser endoveineux (1470 nm) versus échosclérothérapie à la mousse dans le traitement de l’insuffisance de la petite veine saphène.
        Phlebology. 2019; 72: 8-18
        • Engelhorn C.A.
        • Engelhorn A.L.
        • Cassou M.F.
        • Salles-Cunha S.X.
        Patterns of saphenous reflux in women with primary varicose veins.
        J Vasc Surg. 2005; 41: 645-651
        • García-Gimeno M.
        • Rodríguez-Camarero S.
        • Tagarro-Villalba S.
        • Ramalle-Gomara E.
        • González-González E.
        • Arranz M.A.
        • et al.
        Duplex mapping of 2036 primary varicose veins.
        J Vasc Surg. 2009; 49: 681-689
        • Brittenden J.
        • Cooper D.
        • Dimitrova M.
        • Scotland G.
        • Cotton S.C.
        • Elders A.
        Five-year outcomes of a randomized trial of treatments for varicose veins.
        N Engl J Med. 2019; 381: 912-922
        • Coleridge P.
        Chronic venous disease treated by ultrasound guided foam sclerotherapy.
        Eur J Vasc Endovasc Surg. 2006; 32: 577-583
        • Darvall K.A.L.
        • Bate G.R.
        • Silverman S.H.
        • Adam D.J.
        • Bradbury A.W.
        Medium-term results of ultrasound-guided foam sclerotherapy for small saphenous varicose veins.
        Br J Surg. 2009; 96: 1268-1273
        • Boersma D.
        • Kornmann V.N.
        • Van Eekeren R.R.
        • Tromp E.
        • Ünlü Ç.
        • Reijnen M.M.
        • et al.
        Treatment modalities for small saphenous vein insufficiency: systematic review and meta-analysis.
        J Endovasc Ther. 2016; 23: 199-211
        • Pittaluga P.
        • Chastanet S.
        • Locret T.
        • Barbe R.
        The effect of isolated phlebectomy on reflux and diameter of the great saphenous vein: a prospective study.
        Eur J Vasc Endovasc Surg. 2010; 40: 122-128
        • Myers K.
        • Jolley D.
        • Clough A.
        • Kirwan J.
        Outcome of ultrasound-guided sclerotherapy for varicose veins: medium-term results assessed by ultrasound surveillance.
        Eur J Vasc Endovasc Surg. 2007; 33: 116-121
        • Shadid N.
        • Nelemans P.
        • Lawson J.
        • Sommer A.
        Predictors of recurrence of great saphenous vein reflux following treatment with ultrasound-guided foam sclerotherapy.
        Phlebology. 2015; 30: 194-199
        • Venermo M.
        • Saarinen J.
        • Eskelinen E.
        • Vähäaho S.
        • Saarinen E.
        • Railo M.
        • et al.
        Randomized clinical trial comparing surgery, endovenous laser ablation and ultrasound-guided foam sclerotherapy for the treatment of great saphenous varicose veins.
        Br J Surg. 2016; 103: 1438-1444