title: Clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the Comparison of LAser, Surgery and foam Sclerotherapy (CLASS) randomised controlled trial.
abstract: BACKGROUND
  Foam sclerotherapy (foam) and endovenous laser ablation (EVLA) have emerged as alternative treatments to surgery for patients with varicose veins, but uncertainty exists regarding their effectiveness in the medium to longer term.
  
  
  OBJECTIVE
  To assess the clinical effectiveness and cost-effectiveness of foam, EVLA and surgery for the treatment of varicose veins.
  
  
  METHODS
  A parallel-group randomised controlled trial (RCT) without blinding, and economic modelling evaluation.
  
  
  METHODS
  Eleven UK specialist vascular centres.
  
  
  METHODS
  Seven hundred and ninety-eight patients with primary varicose veins (foam, n = 292; surgery, n = 294; EVLA, n = 212).
  
  
  METHODS
  Patients were randomised between all three treatment options (eight centres) or between foam and surgery (three centres).
  
  
  METHODS
  Disease-specific [Aberdeen Varicose Vein Questionnaire (AVVQ)] and generic [European Quality of Life-5 Dimensions (EQ-5D), Short Form questionnaire-36 items (SF-36) physical and mental component scores] quality of life (QoL) at 6 months. Cost-effectiveness as cost per quality-adjusted life-year (QALY) gained.
  
  
  METHODS
  Quality of life at 6 weeks; residual varicose veins; Venous Clinical Severity Score (VCSS); complication rates; return to normal activity; truncal vein ablation rates; and costs.
  
  
  RESULTS
  The results appear generalisable in that participants' baseline characteristics (apart from a lower-than-expected proportion of females) and post-treatment improvement in outcomes were comparable with those in other RCTs. The health gain achieved in the AVVQ with foam was significantly lower than with surgery at 6 months [effect size -1.74, 95% confidence interval (CI) -2.97 to -0.50; p = 0.006], but was similar to that achieved with EVLA. The health gain in SF-36 mental component score for foam was worse than that for EVLA (effect size 1.54, 95% CI 0.01 to 3.06; p = 0.048) but similar to that for surgery. There were no differences in EQ-5D or SF-36 component scores in the surgery versus foam or surgery versus EVLA comparisons at 6 months. The trial-based cost-effectiveness analysis showed that, at 6 months, foam had the highest probability of being considered cost-effective at a ceiling willingness-to-pay ratio of £20,000 per QALY. EVLA was found to cost £26,107 per QALY gained versus foam, and was less costly and generated slightly more QALYs than surgery. Markov modelling using trial costs and the limited recurrence data available suggested that, at 5 years, EVLA had the highest probability (≈ 79%) of being cost-effective at conventional thresholds, followed by foam (≈ 17%) and surgery (≈ 5%). With regard to secondary outcomes, health gains at 6 weeks (p < 0.005) were greater for EVLA than for foam (EQ-5D, p = 0.004). There were fewer procedural complications in the EVLA group (1%) than after foam (7%) and surgery (8%) (p < 0.001). Participants returned to a wide range of behaviours more quickly following foam or EVLA than following surgery (p < 0.05). There were no differences in VCSS between the three treatments. Truncal ablation rates were higher for surgery (p < 0.001) and EVLA (p < 0.001) than for foam, and were similar for surgery and EVLA.
  
  
  CONCLUSIONS
  Considerations of both the 6-month clinical outcomes and the estimated 5-year cost-effectiveness suggest that EVLA should be considered as the treatment of choice for suitable patients.
  
  
  CONCLUSIONS
  Five-year trial results are currently being evaluated to compare the cost-effectiveness of foam, surgery and EVLA, and to determine the recurrence rates following each treatment. This trial has highlighted the need for long-term outcome data from RCTs on QoL, recurrence rates and costs for foam sclerotherapy and other endovenous techniques compared against each other and against surgery.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN51995477.
  
  
  BACKGROUND
  This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 27. See the NIHR Journals Library website for further project information.
authors: Division of Applied Medicine, University of Aberdeen, Aberdeen, UK.
authors: Julie
authors: J
authors: Brittenden
authors: Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
authors: Seonaidh C
authors: SC
authors: Cotton
authors: Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
authors: Andrew
authors: A
authors: Elders
authors: Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.
authors: Emma
authors: E
authors: Tassie
authors: Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
authors: Graham
authors: G
authors: Scotland
authors: Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
authors: Craig R
authors: CR
authors: Ramsay
authors: Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
authors: John
authors: J
authors: Norrie
authors: School of Medicine, University of St Andrews, St Andrews, UK.
authors: Jennifer
authors: J
authors: Burr
authors: School of Health Sciences, City University London, London, UK.
authors: Jill
authors: J
authors: Francis
authors: Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
authors: Samantha
authors: S
authors: Wileman
authors: Department of Vascular Surgery, Royal Devon and Exeter Hospital (Wonford), Exeter, UK.
authors: Bruce
authors: B
authors: Campbell
authors: Division of Applied Medicine, University of Aberdeen, Aberdeen, UK.
authors: Paul
authors: P
authors: Bachoo
authors: Department of Vascular Surgery, Hull Royal Infirmary, Hull, UK.
authors: Ian
authors: I
authors: Chetter
authors: Vascular Surgery, St James University Hospital, Leeds, UK.
authors: Michael
authors: M
authors: Gough
authors: Vascular Surgery, Gloucestershire Royal Hospital, Gloucester, UK.
authors: Jonothan
authors: J
authors: Earnshaw
authors: Vascular Surgery, Freeman Hospital, Newcastle upon Tyne, UK.
authors: Tim
authors: T
authors: Lees
authors: Vascular Surgery, St James University Hospital, Leeds, UK.
authors: Julian
authors: J
authors: Scott
authors: Vascular Surgical Unit, Royal Bournemouth Hospital, Bournemouth, UK.
authors: Sara A
authors: SA
authors: Baker
authors: Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
authors: Graeme
authors: G
authors: MacLennan
authors: Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
authors: Maria
authors: M
authors: Prior
authors: Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
authors: Denise
authors: D
authors: Bolsover
authors: Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
authors: Marion K
authors: MK
authors: Campbell
mesh_terms: D000203:Activities of Daily Living; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003362:Cost-Benefit Analysis; D005260:Female; D005102:Health Expenditures / Q000706:statistics & numerical data; D006801:Humans; D053685:Laser Therapy / Q000009:adverse effects / Q000191:economics / Q000379:methods / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D010043:Outcome and Process Assessment, Health Care / Q000191:economics / Q000706:statistics & numerical data*; D019057:Quality-Adjusted Life Years; D012008:Recurrence; D015911:Sclerotherapy / Q000009:adverse effects / Q000191:economics / Q000379:methods / Q000706:statistics & numerical data; D012720:Severity of Illness Index; D013222:State Medicine / Q000191:economics; D013673:Technology Assessment, Biomedical; D006113:United Kingdom; D014648:Varicose Veins / Q000191:economics / Q000601:surgery / Q000628:therapy*; D055815:Young Adult