Clinical and technical outcomes from a randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins

Abstract

Abstract Background This report describes the clinical effectiveness and recurrence rates from a randomized trial of endovenous laser ablation (EVLA) and surgery for varicose veins. Methods Some 280 patients were randomized equally using sealed opaque envelopes to two parallel groups: surgery and EVLA. Inclusion criteria included symptomatic disease secondary to primary, unilateral, isolated saphenofemoral junction incompetence, leading to reflux into the great saphenous vein (GSV). Outcomes were: technical success, recurrent varicose veins on clinical examination, patterns of reflux on duplex ultrasound examination, and the effect of recurrence on quality of life, assessed by the Aberdeen Varicose Vein Questionnaire (AVVQ). Assessments were at 1, 6, 12 and 52 weeks after the procedure. Results Initial technical success was greater following EVLA: 99·3 versus 92·4 per cent (P = 0·005). Surgical failures related mainly to an inability to strip the above-knee GSV. The clinical recurrence rate at 1 year was lower after EVLA: 4·0 versus 20·4 per cent (P < 0·001). The number of patients needed to treat with EVLA rather than surgery to avoid one recurrence at 1 year was 6·3 (95 per cent confidence interval 4·0 to 12·5). Twelve of 23 surgical recurrences were related to an incompetent below-knee GSV and ten to neovascularization. Of five recurrences after EVLA, two were related to neoreflux in the groin tributaries and one to recanalization. Clinical recurrence was associated with worse AVVQ scores (P < 0·001). Conclusion EVLA treatment had lower rates of clinical recurrence than conventional surgery in the short term. Registration number: NCT00759434 (http://www.clinicaltrials.gov).