The aim was to compare endovenous laser ablation (EVLA) and endovenous steam ablation (EVSA) for great saphenous varicose veins in a non-inferiority study.
- Patients with primary great saphenous vein reflux were randomized to EVLA (940 nm) or EVSA (SVS™).
- Primary outcomes were treatment success (vein obliteration) 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.
- 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.
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 ( www.clinicaltrials.gov ).