Five-Year outcomes of a randomized trial of treatments for varicose veins

Brittenden, J. et al. (2019) Five-Year outcomes of a randomized trial of treatments for varicose veins. New England Journal of Medicine, 381(10), pp. 912-922. (doi: 10.1056/nejmoa1805186) (PMID:31483962)

Abstract

Background: Endovenous laser ablation and ultrasound-guided foam sclerotherapy are recommended alternatives to surgery for the treatment of primary varicose veins, but their long-term comparative effectiveness remains uncertain. Methods: In a randomized, controlled trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom, we compared the outcomes of laser ablation, foam sclerotherapy, and surgery. Primary outcomes at 5 years were disease-specific quality of life and generic quality of life, as well as cost-effectiveness based on models of expected costs and quality-adjusted life-years (QALYs) gained that used data on participants’ treatment costs and scores on the EuroQol EQ-5D questionnaire. Results: Quality-of-life questionnaires were completed by 595 (75%) of the 798 trial participants. After adjustment for baseline scores and other covariates, scores on the Aberdeen Varicose Vein Questionnaire (on which scores range from 0 to 100, with lower scores indicating a better quality of life) were lower among patients who underwent laser ablation or surgery than among those who underwent foam sclerotherapy (effect size [adjusted differences between groups] for laser ablation vs. foam sclerotherapy, −2.86; 95% confidence interval [CI], −4.49 to −1.22; P<0.001; and for surgery vs. foam sclerotherapy, −2.60; 95% CI, −3.99 to −1.22; P<0.001). Generic quality-of-life measures did not differ among treatment groups. At a threshold willingness-to-pay ratio of £20,000 ($28,433 in U.S. dollars) per QALY, 77.2% of the cost-effectiveness model iterations favored laser ablation. In a two-way comparison between foam sclerotherapy and surgery, 54.5% of the model iterations favored surgery. Conclusions: In a randomized trial of treatments for varicose veins, disease-specific quality of life 5 years after treatment was better after laser ablation or surgery than after foam sclerotherapy. The majority of the probabilistic cost-effectiveness model iterations favored laser ablation at a willingness-to-pay ratio of £20,000 ($28,433) per QALY. (Funded by the National Institute for Health Research; CLASS Current Controlled Trials number, ISRCTN51995477. opens in new tab.)

• Item Type: Articles
• Additional Information: Supported by the NIHR Health Technology Assessment Program (Project number 06/45/02). The Health Services Research Unit is core-funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorate.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Brittenden, Professor Julie and Norrie, Prof John
• Authors: Brittenden, J., Cooper, D., Dimitrova, M., Scotland, G., Cotton, S., Elders, A., MacLennan, G., Ramsay, C. R., Norrie, J., Burr, J. M., Campbell, B., Bachoo, P., Chetter, I., Gough, M., Earnshaw, J., Lees, T., Scott, J., Baker, S. A., Tassie, E., Francis, J., and Campbell, M. K.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health; College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre
• Journal Name: New England Journal of Medicine
• Publisher: Massachusetts Medical Society
• ISSN: 0028-4793
• ISSN (Online): 1533-4406
• Published Online: 05 September 2019
• Copyright Holders: Copyright © 2019 Massachusetts Medical Society
• First Published: First published in 381(10):912-922
• Publisher Policy: Reproduced in accordance with the publisher copyright policy