Clinical and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the CLASS trial

Brittenden, Julie; Cotton, Seonaidh C; Elders, Andrew; Tassie, Emma; Scotland, Graham; Ramsay, Craig R; Norrie, John; Burr, Jennifer; Francis, Jill; Wileman, Samantha; Campbell, Bruce; Bachoo, Paul; Chetter, Ian; Gough, Michael; Earnshaw, Jonothan; Lees, Tim; Scott, Julian; Baker, Sara A; MacLennan, Graeme; Prior, Maria; Bolsover, Denise; Campbell, Marion K

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.

Objectives
To assess the clinical effectiveness and cost-effectiveness of foam, EVLA and surgery for the treatment of varicose veins.

Design
A parallel-group randomised controlled trial (RCT) without blinding, and economic modelling evaluation.

Setting
Eleven UK specialist vascular centres.

Participants
Seven hundred and ninety-eight patients with primary varicose veins (foam, nâ =â 292; surgery, nâ =â 294; EVLA, nâ =â 212).

Interventions
Patients were randomised between all three treatment options (eight centres) or between foam and surgery (three centres).

Primary outcome measures
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.

Secondary outcome measures
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; pâ =â 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; pâ =â 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 (â â 79%) of being cost-effective at conventional thresholds, followed by foam (â â 17%) and surgery (â â 5%). With regard to secondary outcomes, health gains at 6 weeks (pâ

Citation

Brittenden, J., Cotton, S. C., Elders, A., Tassie, E., Scotland, G., Ramsay, C. R., Norrie, J., Burr, J., Francis, J., Wileman, S., Campbell, B., Bachoo, P., Chetter, I., Gough, M., Earnshaw, J., Lees, T., Scott, J., Baker, S. A., MacLennan, G., Prior, M., …Campbell, M. K. (2015). Clinical and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the CLASS trial. Health Technology Assessment, 19(27), 1-342. https://doi.org/10.3310/hta19270

• Acceptance Date: Apr 1, 2015
• Publication Date: Apr 1, 2015
• Publicly Available Date: Dec 8, 2017
• Print ISSN: 1366-5278
• Publisher: NIHR Journals Library
• Peer Reviewed: Peer Reviewed
• Volume: 19
• Issue: 27
• Pages: 1-342
• DOI: https://doi.org/10.3310/hta19270
• Keywords: Health Policy
• Public URL: https://hull-repository.worktribe.com/output/432711
• Additional Information: Contractual start date: 06-2008; Editorial review begun: 09-2013; Accepted for publication: 06-2014