Five-year outcomes of a randomized trial of treatments for varicose veins
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.
Citation
Brittenden , J , Cooper , D , Dimitrova , M , Scotland , G , Cotton , S C , 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 & Campbell , M K 2019 , ' Five-year outcomes of a randomized trial of treatments for varicose veins ' , New England Journal of Medicine , vol. 381 , pp. 912-922 . https://doi.org/10.1056/NEJMoa1805186
Publication
New England Journal of Medicine
Status
Peer reviewed
ISSN
0028-4793Type
Journal article
Rights
Copyright © 2019 Massachusetts Medical Society. This work has been made available online in accordance with publisher policies or with permission. Permission for further reuse of this content should be sought from the publisher or the rights holder. This is the final published version of the work, which was originally published at https://doi.org/10.1056/NEJMoa1805186
Description
Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN51995477.Collections
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