Five-year follow-up of a randomized clinical trial comparing open surgery, foam sclerotherapy and endovenous laser ablation for great saphenous varicose veins

Abstract

Background: New treatment methods have challenged open surgery as a treatment for great saphenous vein (GSV) insufficiency, the most common being ultrasound-guided foam sclerotherapy (UGFS) and endovenous laser ablation (EVLA). This study evaluated the long-term results of surgery, EVLA and UGFS in the treatment of GSV reflux.

Methods: Patients with symptomatic GSV reflux were randomized to undergo either open surgery, EVLA or UGFS. The main outcome measure was the occlusion rate of the GSV at 5 years after operation.

Results: The study included 196 patients treated during 2008-2010; of these, 166 (84·7 per cent) participated in the 5-year follow-up. At 5 years, the GSV occlusion rate was 96 (95 per cent c.i. 91 to 100) per cent in the open surgery group, 89 (82 to 98) per cent after EVLA and 51 (38 to 64) per cent after UGFS (P < 0·001). For patients who had received no additional treatment during follow-up, the occlusion rates were 96 per cent (46 of 48), 89 per cent (51 of 57) and 41 per cent (16 of 39) respectively. UGFS without further GSV treatment was successful in only 16 of 59 patients (27 per cent) at 5 years.

Conclusion: UGFS has significantly inferior occlusion rates compared with open surgery or EVLA, and results in additional treatments.

Trial registration: ClinicalTrials.gov NCT01298908.