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^* (Corresponding Author), 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

Research output: Contribution to journal › Article › peer-review

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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.)

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

Bibliographical note

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.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

No potential conflict of interest relevant to this article was reported.

The views and opinions expressed are those of the authors and not necessarily those of the National Institute for Health Research (NIHR) or the Department of Health and Social Care.

A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.

We thank Janice Cruden for secretarial support and data management; Gladys McPherson, Mark Forrest, and the programming team at the Centre for Healthcare Randomized Trials; members of the Project Management Group for ongoing advice and support of the trial; the independent members of the trial steering committee and data and safety monitoring committee; and the staff at recruitment sites who facilitated recruitment, treatment, and follow-up of trial participants.

Keywords

CLINICAL-TRIAL
CONVENTIONAL SURGERY
COST-EFFECTIVENESS
ENDOVENOUS LASER-ABLATION
FOLLOW-UP
GREAT SAPHENOUS-VEIN
GUIDED FOAM SCLEROTHERAPY
HEALTH
HIGH LIGATION
QUALITY-OF-LIFE

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10.1056/NEJMoa1805186Licence: Unspecified

Five-Year Outcomes of a Randomized Trial of Treatments for Varicose Veins
From The New England Journal of Medicine. Brittenden, Julie et al. "Five-Year Outcomes of a Randomized Trial of Treatments for Varicose Veins". 2019, 381(10). 912-922. Copyright © 2019 Massachusetts Medical Society. Reprinted with permission.
Final published version, 295 KBLicence: Unspecified

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. The New England Journal of Medicine, 381(10), 912-922. https://doi.org/10.1056/NEJMoa1805186

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', The New England Journal of Medicine, vol. 381, no. 10, pp. 912-922. https://doi.org/10.1056/NEJMoa1805186

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title = "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{\textquoteright} 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.)",

keywords = "CLINICAL-TRIAL, CONVENTIONAL SURGERY, COST-EFFECTIVENESS, ENDOVENOUS LASER-ABLATION, FOLLOW-UP, GREAT SAPHENOUS-VEIN, GUIDED FOAM SCLEROTHERAPY, HEALTH, HIGH LIGATION, QUALITY-OF-LIFE",

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 = "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. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. No potential conflict of interest relevant to this article was reported. The views and opinions expressed are those of the authors and not necessarily those of the National Institute for Health Research (NIHR) or the Department of Health and Social Care. A data sharing statement provided by the authors is available with the full text of this article at NEJM.org. We thank Janice Cruden for secretarial support and data management; Gladys McPherson, Mark Forrest, and the programming team at the Centre for Healthcare Randomized Trials; members of the Project Management Group for ongoing advice and support of the trial; the independent members of the trial steering committee and data and safety monitoring committee; and the staff at recruitment sites who facilitated recruitment, treatment, and follow-up of trial participants.",

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doi = "10.1056/NEJMoa1805186",

language = "English",

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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 - 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. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. No potential conflict of interest relevant to this article was reported. The views and opinions expressed are those of the authors and not necessarily those of the National Institute for Health Research (NIHR) or the Department of Health and Social Care. A data sharing statement provided by the authors is available with the full text of this article at NEJM.org. We thank Janice Cruden for secretarial support and data management; Gladys McPherson, Mark Forrest, and the programming team at the Centre for Healthcare Randomized Trials; members of the Project Management Group for ongoing advice and support of the trial; the independent members of the trial steering committee and data and safety monitoring committee; and the staff at recruitment sites who facilitated recruitment, treatment, and follow-up of trial participants.

PY - 2019/9/5

Y1 - 2019/9/5

N2 - 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.)

AB - 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.)

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KW - CONVENTIONAL SURGERY

KW - COST-EFFECTIVENESS

KW - ENDOVENOUS LASER-ABLATION

KW - FOLLOW-UP

KW - GREAT SAPHENOUS-VEIN

KW - GUIDED FOAM SCLEROTHERAPY

KW - HEALTH

KW - HIGH LIGATION

KW - QUALITY-OF-LIFE

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Five-Year Outcomes of a Randomized Trial of Treatments for Varicose Veins

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Graham Scotland

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Five-Year Outcomes of a Randomized Trial of Treatments for Varicose Veins

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Graham Scotland

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