Editor's Choice - Five Year Follow Up of a Randomised Clinical Trial of Endovenous Laser Ablation versus Mechanochemical Ablation for Superficial Venous Incompetence (LAMA trial).

Abstract

In this randomised clinical trial, patients treated with mechanochemical ablation (MOCA) with ambulatory phlebectomy (AP) had a lower anatomical occlusion (AO) rate at one year and no benefit in peri-procedural pain compared with endovenous laser ablation (EVLA) with AP. Early quality of life (QoL) improvements were similar. This study aimed to study comparative outcomes at five years. One hundred and fifty patients with unilateral, symptomatic varicose veins in association with an isolated incompetent great saphenous vein, small saphenous vein, or anterior accessory saphenous vein were equally randomised to either MOCA or EVLA with AP (NCT02627846). Outcomes at five years included AO, need for re-intervention, venous clinical severity score (VCSS), and disease specific QoL measured by the Aberdeen Varicose Vein Questionnaire (AVVQ). At five years, 52 of 75 (69%) and 57 of 75 (76%) patients attended follow up in the EVLA and MOCA groups, respectively. Anatomical occlusion following EVLA was statistically significantly higher than after MOCA (91% vs. 47%; p < .001). The absolute risk reduction in failure of AO using EVLA rather than MOCA was 45% (95% confidence interval 29 - 60%). The rate of re-intervention was also statistically significantly lower following EVLA (8% vs. 21%; p = .031). There was no statistically significant difference between groups in median (interquartile range) VCSS (EVLA 1 [0, 3] vs. MOCA 2 [0, 4]; p = .33) and AVVQ (EVLA 3.06 [0.6, 6.4] vs. MOCA 3.63 [0.0, 8.6]; p = .86). Five year AO following MOCA remained significantly lower than EVLA, leading to a higher rate of re-intervention. Following these additional procedures, there was no statistically significant difference in QoL outcomes between groups.