Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up.

Background: Endovenous laser therapy (EVLT) for ablation of the great saphenous vein (GSV) is thought to minimize postoperative morbidity compared with high ligation and stripping (HL/S). Only a few randomized trials have reported early results. This prospective randomized trial compared EVLT (980 nm) and HL/S results at 1 and 2 years after the intervention.

Method: Patients with symptomatic varicose veins due to GSV insufficiency were randomized to HL/S (100 limbs) or EVLT (104 limbs). Four EVLT procedures failed primarily and were excluded. Phlebectomy and ligature of incompetent perforators were performed whenever indicated in both groups. Patients were re-examined clinically and by duplex ultrasound imaging preoperatively and at 12 days and at 1 and 2 years after treatment. Closure rate, complication rate, time to return to normal activity, the Aberdeen Varicose Vein Symptom Severity Score (AVVSS), the Varicose Venous Clinical Severity Score (VVCSS), and the Medical Outcome Study Short Form-36 scores were also recorded.

Results: There were no differences in patient demographics, CEAP class, Widmer class, or severity scores between the groups. Simultaneous interventions did not differ between the groups. Similar times for the return to normal activity and scores for postoperative pain were reported. No major complications after treatment were recorded. HL/S limbs had significantly more postoperative hematomas than EVLT limbs, and EVLT patients reported more bruising. Follow-up at 1 year was 100% for HL/S and 99% for EVLT. Two GSVs in the EVLT group reopened and three partially reopened. No open GSVs occurred in HL/S limbs. Ninety-eight percent of the limbs in both groups were free of symptoms. VCSS, AVVSS, and Short Form-36 scores did not reveal any group differences. At 2 years, no differences compared with 1-year results were observed, except that two more GSVs in the EVLT group were partially reopened.

Conclusions: Abolition of GSV reflux and improvement in quality of life was similar after HL/S and EVLT. After EVLT, however, two GSVs were found completely reopened and five were partially reopened, which was significantly higher than after HL/S. A prolonged follow-up is ongoing.