Five-year results of a randomised clinical trial of endovenous laser ablation of the great saphenous vein with and without ligation of the saphenofemoral junction

Abstract

Objective: To evaluate whether ligation of the saphenofemoral junction (SFL) improves the results of endovenous laser ablation (EVLA) of the great saphenous vein (GSV) in a 5-year randomised clinical trial (RCT).

Methods: Forty-three symptomatic patients (86 limbs) with bilateral incompetent GSVs were randomised so that one limb underwent EVLA without SFL and the other limb underwent EVLA with SFL. Eleven patients were lost to follow-up and two patients died, leaving 30 patients (60 limbs) for analysis. Duplex-confirmed groin varicose vein recurrence and venous clinical severity score (VCSS) were investigated at 6, 12, 24 and 60 months after treatment.

Results: Five-year life table analysis showed freedom from groin varicose vein recurrence in 79% of limbs (95% confidence interval (CI); 67-92%) in the EVLA without SFL group and in 65% of limbs (95%; CI; 51-82) in the EVLA with SFL group (P = 0.36). Groin varicose vein recurrence was due to neo-vascularisation (0%), re-canalisation (9%) and incompetent tributaries in 14% in the EVLA without SFL group, and to neo-vascularisation (33%), re-canalisation (0%) and incompetent tributaries (0%) in the EVLA with SFL group. The VCSS improved significantly and was comparable in both groups.

Conclusion: The rate of varicose vein recurrence was similar in both study groups. There was less neo-vascularisation in the EVLA without SFL group, but more incompetent tributaries and early re-canalisation at 5-year follow-up than in the EVLA with SFL group.

Registration number: ISRCTN60300873 (http://www.clinical-trials.com).