A randomized clinical trial of endovenous laser ablation versus conventional surgery for small saphenous varicose veins

Abstract

Background: This randomized clinical trial compared endovenous laser ablation (EVLA) and surgical ligation with attempted stripping in the treatment of small saphenous vein (SSV) insufficiency. The early results demonstrated that EVLA was more likely to eradicate axial reflux and was also associated with a faster recovery, lower periprocedural pain, and fewer sensory complications. The aim of this 2-year follow-up was to establish whether these benefits remained stable over time and whether these improved technical outcomes were associated with less clinical recurrence.

Methods: Patients with primary saphenopopliteal junction and SSV reflux were randomized to EVLA or saphenopopliteal junction ligation and attempted stripping/excision. Outcomes assessed at 2 years included the presence of residual or recurrent reflux, clinical recurrence, sensory complications, the need for secondary intervention, and patient-reported quality of life on the Aberdeen Varicose Veins Questionnaire, SF-36, and EuroQol.

Results: Of 106 patients who were equally randomized and successfully treated according to the protocol, 88 (83%) were successfully assessed at 2 years. The groups were comparable at baseline. At 2 years, EVLA remained superior to surgery in eradicating axial reflux in 36 patients (81.2%) compared with 29 (65.9%) in the surgery group (P = .002). There was no significant difference in clinical recurrence (EVLA: seven of 44 [16%] vs surgery: 10 of 44 [23%]; P = .736), sensory disturbance (EVLA: one [2.4%] vs surgery vs three [6.8%]; P = 1.000) or any quality of life domain.

Conclusions: The results of treatment of SSV insufficiency with EVLA appear durable up until 2 years. The study does not appear to suggest that the improved abolition of reflux after EVLA compared with surgery is associated with superior outcomes than those seen after surgery by this time point, because equal effect was shown in both groups. The sensory disturbance associated with surgery appears to settle over this time frame. EVLA is therefore superior in the short-term and not inferior by 2 years.