Randomized Clinical Trial Comparing Endovenous Laser Ablation of the Great Saphenous Vein with and without Ligation of the Sapheno-femoral Junction: 2-year Results

Objective: To evaluate whether ligation of the sapheno-femoral junction (SFJ) improves the 2-year results of endovenous laser ablation (EVA). Methods: Forty-three symptomatic patients with bilateral varicose veins were studied in which one limb was randomly assigned to receive EVA without SFJ ligation, and the other limb received EVA with SFJ ligation. Recurrence of varicose veins and abolition of great saphenous vein (GSV) reflux on duplex ultrasound imaging, and venous clinical severity score (VCSS) were investigated at 6, 12, and 24 months after treatment. Results: Two-year life table analysis showed freedom from groin varicose vein recurrence in 83% of 43 limbs (95% CI; 67-95%) in the EVA without ligation group and in 87% of 43 limbs (95%; CI 73-97) of limbs in the EVA with ligation group (P = 0.47). Thirty-eight (88%) treated GSV segments were ablated completely in the EVA without ligation group and 42 (98%) in the EVA with ligation group (N.S.). Groin recurrence was due to an incompetent SFJ/GSV (9%) and to incompetent tributaries (7%) in the EVA without ligation group and due to neovascularisation (12%) in the EVA with ligation group. The VCSS improved significantly and was comparable in both groups. Conclusion: The addition of SFJ ligation to EVA makes no difference to the short-term outcome of varicose veins treatment. Establishing whether SFJ ligation results in a poorer tong-term outcome because of neovascularisation needs to be studied in Larger populations with longer follow-up. Registration number: ISRCTN60300873 (http://www.controlled-trials.com). (C) 2008 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.