RESUMO
BACKGROUND: The aim was to compare endovenous laser ablation (EVLA) and endovenous steam ablation (EVSA) for great saphenous varicose veins in a non-inferiority study. METHODS: Patients with primary great saphenous vein reflux were randomized to EVLA (940 nm) or EVSA (SVS™). Primary outcomes were treatment success (vein obliteration or abolition of reflux) [corrected] at 52 weeks, and Venous Clinical Severity Score (VCSS) at 12 weeks. Secondary outcomes were pain, satisfaction with treatment, duration of analgesia use and days lost from daily activities, changes in Aberdeen Varicose Vein Questionnaire (AVVQ) and EQ-5D™ scores after 12 weeks, and complications at 2 and 12 weeks. RESULTS: A total of 227 legs were treated (EVSA, 117; EVLA, 110); 36 legs treated with EVSA received a low dose and the remaining 81 a higher dose. At 1 year, the treatment success rate after high-dose EVSA was not inferior to that of EVLA: 92 (95 per cent confidence interval (c.i.) 86 to 98) versus 96 (92 to 100) per cent respectively. Changes in VCSS after 12 weeks were similar: -2·69 (95 per cent c.i. -2·34 to -3·04) and -2·51 (-2·10 to -2·93). AVVQ, EQ-5D™ and EQ VAS scores improved equally 12 weeks after both treatments. Patients treated with EVSA reported less postprocedural pain, fewer days of analgesia use, were more satisfied with therapy, and had a shorter convalescence. Complication rates were comparable. CONCLUSION: The 1-year treatment success of high-dose EVSA was not inferior to that of EVLA. Several secondary outcomes were in favour of EVSA. Registration number NCT02046967 (http://www.clinicaltrials.gov).