Five-year results of a randomized clinical trial of conventional surgery, endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins

BackgroundA variety of techniques exist for the treatment of patients with great saphenous vein (GSV) varicosities. Few data exist on the long-term outcomes of these interventions. MethodsPatients undergoing conventional surgery, endovenous laser ablation (EVLA) and ultrasound-guided foam sclerotherapy (UGFS) for GSV varicose veins were followed up for 5years. Primary outcome was obliteration or absence of the treated GSV segment; secondary outcomes were absence of GSV reflux, and change in Chronic Venous Insufficiency quality-of-life Questionnaire (CIVIQ) and EuroQol-5D (EQ-5D) scores. ResultsA total of 224 legs were included (69 conventional surgery, 78 EVLA, 77 UGFS), 193 (862 per cent) of which were evaluated at final follow-up. At 5years, Kaplan-Meier estimates of obliteration or absence of the GSV were 85 (95 per cent c.i. 75 to 92), 77 (66 to 86) and 23 (14 to 33) per cent in the conventional surgery, EVLA and UGFS groups respectively. Absence of above-knee GSV reflux was found in 85 (73 to 92), 82 (72 to 90) and 41 (30 to 53) per cent respectively. CIVIQ scores deteriorated over time in patients in the UGFS group (098 increase per year, 95 per cent c.i. 016 to 179), and were significantly worse than those in the EVLA group (-044 decrease per year, 95 per cent c.i. -122 to 035) (P=0013). CIVIQ scores for the conventional surgery group did not differ from those in the EVLA and UGFS groups (044 increase per year, 95 per cent c.i. -041 to 129). EQ-5D scores improved equally in all groups. ConclusionEVLA and conventional surgery were more effective than UGFS in obliterating the GSV 5years after intervention. UGFS was associated with substantial rates of GSV reflux and inferior CIVIQ scores compared with EVLA and conventional surgery. Registration number: NCT00529672 (http://www.clinicaltrials.gov).