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

Julie Brittenden; David Cooper; Maria Dimitrova; Graham Scotland; Seonaidh C. Cotton; Andrew Elders; Graeme MacLennan; Craig R. Ramsay; John Norrie; Jennifer M. Burr; Bruce Campbell; Paul Bachoo; Ian Chetter; Michael Gough; Jonothan Earnshaw; Tim Lees; Julian Scott; Sara A. Baker; Emma Tassie; Jill Francis; Marion K. Campbell

doi:10.1056/NEJMoa1805186

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

Julie Brittenden^*, David Cooper, Maria Dimitrova, Graham Scotland, Seonaidh C. Cotton, Andrew Elders, Graeme MacLennan, Craig R. Ramsay, John Norrie, Jennifer M. Burr, Bruce Campbell, Paul Bachoo, Ian Chetter, Michael Gough, Jonothan Earnshaw, Tim Lees, Julian Scott, Sara A. Baker, Emma Tassie, Jill FrancisMarion K. Campbell

^*Corresponding author for this work

NMAHP

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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.)

Original language	English
Pages (from-to)	912-922
Number of pages	11
Journal	New England Journal of Medicine
Volume	381
Issue number	10
DOIs	https://doi.org/10.1056/NEJMoa1805186
Publication status	Published - 5 Sep 2019

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10.1056/NEJMoa1805186

Brittenden, J. et al (2019) Five-Year Outcomes of a Randomized Trial of Treatments for Varicose Veins
Copyright © 2019 Massachusetts Medical Society. All rights reserved. This is the final published version of the article available from the publisher's website at: https://doi.org/10.1056/NEJMoa1805186
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Cite this

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., ... Campbell, M. K. (2019). Five-year outcomes of a randomized trial of treatments for varicose veins. New England Journal of Medicine, 381(10), 912-922. https://doi.org/10.1056/NEJMoa1805186

@article{ee5782cd2ce84b1b9c2c733a24dfc21d,

title = "Five-year outcomes of a randomized trial of treatments for varicose veins",

abstract = "BackgroundEndovenous 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. MethodsIn 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{\textquoteright} treatment costs and scores on the EuroQol EQ-5D questionnaire. ResultsQuality-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. ConclusionsIn 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.)",

author = "Julie Brittenden and David Cooper and Maria Dimitrova and Graham Scotland and Cotton, {Seonaidh C.} and Andrew Elders and Graeme MacLennan and Ramsay, {Craig R.} and John Norrie and Burr, {Jennifer M.} and Bruce Campbell and Paul Bachoo and Ian Chetter and Michael Gough and Jonothan Earnshaw and Tim Lees and Julian Scott and Baker, {Sara A.} and Emma Tassie and Jill Francis and Campbell, {Marion K.}",

note = "Acceptance in SAN AAM: not permitted by journal VoR provided by author; 6m embargo required. ET 13/9/19 ",

year = "2019",

month = sep,

day = "5",

doi = "10.1056/NEJMoa1805186",

language = "English",

volume = "381",

pages = "912--922",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

number = "10",

}

Brittenden, J, Cooper, D, Dimitrova, M, Scotland, G, Cotton, SC, Elders, A, MacLennan, G, Ramsay, CR, Norrie, J, Burr, JM, Campbell, B, Bachoo, P, Chetter, I, Gough, M, Earnshaw, J, Lees, T, Scott, J, Baker, SA, Tassie, E, Francis, J & Campbell, MK 2019, 'Five-year outcomes of a randomized trial of treatments for varicose veins', New England Journal of Medicine, vol. 381, no. 10, pp. 912-922. https://doi.org/10.1056/NEJMoa1805186

TY - JOUR

T1 - Five-year outcomes of a randomized trial of treatments for varicose veins

AU - Brittenden, Julie

AU - Cooper, David

AU - Dimitrova, Maria

AU - Scotland, Graham

AU - Cotton, Seonaidh C.

AU - Elders, Andrew

AU - MacLennan, Graeme

AU - Ramsay, Craig R.

AU - Norrie, John

AU - Burr, Jennifer M.

AU - Campbell, Bruce

AU - Bachoo, Paul

AU - Chetter, Ian

AU - Gough, Michael

AU - Earnshaw, Jonothan

AU - Lees, Tim

AU - Scott, Julian

AU - Baker, Sara A.

AU - Tassie, Emma

AU - Francis, Jill

AU - Campbell, Marion K.

N1 - Acceptance in SAN AAM: not permitted by journal VoR provided by author; 6m embargo required. ET 13/9/19

PY - 2019/9/5

Y1 - 2019/9/5

N2 - BackgroundEndovenous 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. MethodsIn 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. ResultsQuality-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. ConclusionsIn 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.)

AB - BackgroundEndovenous 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. MethodsIn 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. ResultsQuality-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. ConclusionsIn 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.)

U2 - 10.1056/NEJMoa1805186

DO - 10.1056/NEJMoa1805186

M3 - Article

VL - 381

SP - 912

EP - 922

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 10

ER -

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

Abstract

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