Fourteen Year Outcomes of a Randomised Controlled Trial Comparing Endovenous Laser Ablation, High Ligation and Stripping, and Ultrasound Guided Foam Sclerotherapy for Great Saphenous Varicose Veins

OBJECTIVE: To compare high ligation and stripping (HLS), endovenous laser ablation (EVLA), and ultrasound guided foam sclerotherapy (UGFS) for symptomatic great saphenous vein (GSV) reflux in the long term, given the limited comparative data beyond ten years. METHODS: Patients with symptomatic GSV reflux were randomised (1:1:1) to undergo HLS, EVLA, or UGFS. One hundred and ninety-six patients treated at Helsinki University Hospital were invited to 14 year follow up. Primary outcomes were above knee GSV reflux and GSV re-intervention rates. Secondary outcomes included quality of life. RESULTS: Of 233 randomised patients, 214 were included. UGFS increased the risk of GSV reflux recurrence compared with both HLS (risk ratio [RR] 11.7, 95% confidence interval [CI] 1.6 - 85.6) and EVLA (RR 5.0, 95% CI 1.5 - 16.6; 30.8% [12 of 39] after UGFS vs. 2.6% [one of 38] and 6.1% [three of 49] after HLS and EVLA, respectively; overall p < .001). UGFS was associated with a higher risk of GSV re-interventions compared with HLS (RR 4.3, 95% CI 1.8 - 10.2) and EVLA (RR 6.9, 95% CI 2.6 - 18.4; 56.4% for UGFS vs. 13.2% for HLS and 8.2% for EVLA; overall p < .001). Neovascularisation rates did not differ between the treatments (29.0%, 22.5%, and 23.1% for HLS, EVLA, and UGFS, respectively; overall p = .76). Aberdeen Varicose Vein Questionnaire scores were comparable across the groups (median [interquartile range] 8.9 [3.7, 13.3] in HLS, 6.1 [0.8, 12.2] in EVLA, and 8.8 [4.1, 13.4] in UGFS, with median differences of +2.8 [HLS vs. EVLA], +0.1 [HLS vs. UGFS], and -2.7 [EVLA vs. UGFS]; overall p = .21). CONCLUSION: UGFS demonstrated inferior outcomes in terms of GSV recurrent reflux and re-intervention rates compared with both HLS and EVLA, whereas HLS and EVLA showed comparable performance across these outcomes. Long term quality of life was comparable across all groups.