Randomized clinical trial comparing endovenous laser ablation and stripping of the great saphenous vein with clinical and duplex outcome after 5 years

Abstract

Objective: This is the first randomized controlled trial with a 5-year follow-up comparing endovenous laser ablation (EVLA) with high ligation and pin-stripping in patients with great saphenous vein (GSV) incompetence.

Methods: One hundred twenty-one consecutive patients (137 legs) with GSV incompetence were randomized to EVLA (980 nm bare fiber) or high ligation and stripping using tumescent local anesthesia with light sedation. Mini-phlebectomies were performed in all patients. The patients were examined with duplex scanning before treatment and after 12 days, and then after 1, 3, and 6 months, and yearly thereafter for up to 5 years. The primary end point was open refluxing GSV. Secondary end points were recurrent varicose veins, frequency of reoperations, Venous Clinical Severity Score, and quality of life scores (Aberdeen Varicose Vein Symptoms Severity Score and Short Form-36).

Results: In the EVLA and stripping group, nine (Kaplan-Meier [KM] estimate, 17.9%) and four (KM estimate, 10.1%) of GSVs had open refluxing segments of 5 cm or more (ns). Clinical recurrence was recorded in 24 (KM estimate, 46.6%) and 25 (KM estimate, 54.6%), whereas reoperations were performed in 17 (KM estimate, 38.6%) and 15 (KM estimate, 37.7%) legs (ns). Venous Clinical Severity Score and Aberdeen Varicose Vein Symptoms Severity Score improved whereas Medical Outcomes Study Short Form-36 quality of life score improved in several domains in both groups with no difference between the groups.

Conclusions: Five-year follow-up of our randomized controlled trial comparing EVLA with open surgery in patients with GSV incompetence did not show any significant difference between the two groups in primary or secondary end points, perhaps because of the small sample size. EVLA seems to be a valid alternative to open surgery.