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)

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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:Norrie, Prof John and Brittenden, Professor Julie
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 > Institute of Cardiovascular and Medical Sciences
College of Medical Veterinary and Life Sciences > Institute of Health and 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

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