A randomized trial comparing treatments for varicose veins

Julie Brittenden, Seonaidh C Cotton, Andrew Elders, Craig R Ramsay, John Norrie, Jennifer Burr, Bruce Campbell, Paul Bachoo, Ian Chetter, Michael Gough, Jonothan Earnshaw, Tim Lees, Julian Scott, Sara A Baker, Jill Francis, Emma Tassie, Graham Scotland, Samantha Wileman, Marion Kay Campbell

Research output: Contribution to journalArticle

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Abstract

BACKGROUND: Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins, but their comparative effectiveness and safety remain uncertain.

METHODS: In a randomized trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom, we compared the outcomes of foam, laser, and surgical treatments. Primary outcomes at 6 months were disease-specific quality of life and generic quality of life, as measured on several scales. Secondary outcomes included complications and measures of clinical success.

RESULTS: After adjustment for baseline scores and other covariates, the mean disease-specific quality of life was slightly worse after treatment with foam than after surgery (P=0.006) but was similar in the laser and surgery groups. There were no significant differences between the surgery group and the foam or the laser group in measures of generic quality of life. The frequency of procedural complications was similar in the foam group (6%) and the surgery group (7%) but was lower in the laser group (1%) than in the surgery group (P<0.001); the frequency of serious adverse events (approximately 3%) was similar among the groups. Measures of clinical success were similar among the groups, but successful ablation of the main trunks of the saphenous vein was less common in the foam group than in the surgery group (P<0.001).

CONCLUSIONS: Quality-of-life measures were generally similar among the study groups, with the exception of a slightly worse disease-specific quality of life in the foam group than in the surgery group. All treatments had similar clinical efficacy, but complications were less frequent after laser treatment and ablation rates were lower after foam treatment. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN51995477.).

Original languageEnglish
Pages (from-to)1218-1227
Number of pages10
JournalThe New England Journal of Medicine
Volume371
Issue number13
DOIs
Publication statusPublished - 25 Sep 2014

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Varicose Veins
Quality of Life
Laser Therapy
Lasers
Therapeutics
Biomedical Technology Assessment
Sclerotherapy
Saphenous Vein
National Institutes of Health (U.S.)
Safety
Research

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A randomized trial comparing treatments for varicose veins. / Brittenden, Julie; Cotton, Seonaidh C; Elders, Andrew; Ramsay, Craig R; Norrie, John; Burr, Jennifer; Campbell, Bruce; Bachoo, Paul; Chetter, Ian; Gough, Michael; Earnshaw, Jonothan; Lees, Tim; Scott, Julian; Baker, Sara A; Francis, Jill; Tassie, Emma; Scotland, Graham; Wileman, Samantha; Campbell, Marion Kay.

In: The New England Journal of Medicine, Vol. 371, No. 13, 25.09.2014, p. 1218-1227.

Research output: Contribution to journalArticle

Brittenden, J, Cotton, SC, Elders, A, Ramsay, CR, Norrie, J, Burr, J, Campbell, B, Bachoo, P, Chetter, I, Gough, M, Earnshaw, J, Lees, T, Scott, J, Baker, SA, Francis, J, Tassie, E, Scotland, G, Wileman, S & Campbell, MK 2014, 'A randomized trial comparing treatments for varicose veins', The New England Journal of Medicine, vol. 371, no. 13, pp. 1218-1227. https://doi.org/10.1056/NEJMoa1400781
Brittenden, Julie ; Cotton, Seonaidh C ; Elders, Andrew ; Ramsay, Craig R ; Norrie, John ; Burr, Jennifer ; Campbell, Bruce ; Bachoo, Paul ; Chetter, Ian ; Gough, Michael ; Earnshaw, Jonothan ; Lees, Tim ; Scott, Julian ; Baker, Sara A ; Francis, Jill ; Tassie, Emma ; Scotland, Graham ; Wileman, Samantha ; Campbell, Marion Kay. / A randomized trial comparing treatments for varicose veins. In: The New England Journal of Medicine. 2014 ; Vol. 371, No. 13. pp. 1218-1227.
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abstract = "BACKGROUND: Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins, but their comparative effectiveness and safety remain uncertain.METHODS: In a randomized trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom, we compared the outcomes of foam, laser, and surgical treatments. Primary outcomes at 6 months were disease-specific quality of life and generic quality of life, as measured on several scales. Secondary outcomes included complications and measures of clinical success.RESULTS: After adjustment for baseline scores and other covariates, the mean disease-specific quality of life was slightly worse after treatment with foam than after surgery (P=0.006) but was similar in the laser and surgery groups. There were no significant differences between the surgery group and the foam or the laser group in measures of generic quality of life. The frequency of procedural complications was similar in the foam group (6{\%}) and the surgery group (7{\%}) but was lower in the laser group (1{\%}) than in the surgery group (P<0.001); the frequency of serious adverse events (approximately 3{\%}) was similar among the groups. Measures of clinical success were similar among the groups, but successful ablation of the main trunks of the saphenous vein was less common in the foam group than in the surgery group (P<0.001).CONCLUSIONS: Quality-of-life measures were generally similar among the study groups, with the exception of a slightly worse disease-specific quality of life in the foam group than in the surgery group. All treatments had similar clinical efficacy, but complications were less frequent after laser treatment and ablation rates were lower after foam treatment. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN51995477.).",
author = "Julie Brittenden and Cotton, {Seonaidh C} and Andrew Elders and Ramsay, {Craig R} and John Norrie and Jennifer Burr 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 Jill Francis and Emma Tassie and Graham Scotland and Samantha Wileman and Campbell, {Marion Kay}",
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T1 - A randomized trial comparing treatments for varicose veins

AU - Brittenden, Julie

AU - Cotton, Seonaidh C

AU - Elders, Andrew

AU - Ramsay, Craig R

AU - Norrie, John

AU - Burr, Jennifer

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 - Francis, Jill

AU - Tassie, Emma

AU - Scotland, Graham

AU - Wileman, Samantha

AU - Campbell, Marion Kay

PY - 2014/9/25

Y1 - 2014/9/25

N2 - BACKGROUND: Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins, but their comparative effectiveness and safety remain uncertain.METHODS: In a randomized trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom, we compared the outcomes of foam, laser, and surgical treatments. Primary outcomes at 6 months were disease-specific quality of life and generic quality of life, as measured on several scales. Secondary outcomes included complications and measures of clinical success.RESULTS: After adjustment for baseline scores and other covariates, the mean disease-specific quality of life was slightly worse after treatment with foam than after surgery (P=0.006) but was similar in the laser and surgery groups. There were no significant differences between the surgery group and the foam or the laser group in measures of generic quality of life. The frequency of procedural complications was similar in the foam group (6%) and the surgery group (7%) but was lower in the laser group (1%) than in the surgery group (P<0.001); the frequency of serious adverse events (approximately 3%) was similar among the groups. Measures of clinical success were similar among the groups, but successful ablation of the main trunks of the saphenous vein was less common in the foam group than in the surgery group (P<0.001).CONCLUSIONS: Quality-of-life measures were generally similar among the study groups, with the exception of a slightly worse disease-specific quality of life in the foam group than in the surgery group. All treatments had similar clinical efficacy, but complications were less frequent after laser treatment and ablation rates were lower after foam treatment. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN51995477.).

AB - BACKGROUND: Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins, but their comparative effectiveness and safety remain uncertain.METHODS: In a randomized trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom, we compared the outcomes of foam, laser, and surgical treatments. Primary outcomes at 6 months were disease-specific quality of life and generic quality of life, as measured on several scales. Secondary outcomes included complications and measures of clinical success.RESULTS: After adjustment for baseline scores and other covariates, the mean disease-specific quality of life was slightly worse after treatment with foam than after surgery (P=0.006) but was similar in the laser and surgery groups. There were no significant differences between the surgery group and the foam or the laser group in measures of generic quality of life. The frequency of procedural complications was similar in the foam group (6%) and the surgery group (7%) but was lower in the laser group (1%) than in the surgery group (P<0.001); the frequency of serious adverse events (approximately 3%) was similar among the groups. Measures of clinical success were similar among the groups, but successful ablation of the main trunks of the saphenous vein was less common in the foam group than in the surgery group (P<0.001).CONCLUSIONS: Quality-of-life measures were generally similar among the study groups, with the exception of a slightly worse disease-specific quality of life in the foam group than in the surgery group. All treatments had similar clinical efficacy, but complications were less frequent after laser treatment and ablation rates were lower after foam treatment. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN51995477.).

U2 - 10.1056/NEJMoa1400781

DO - 10.1056/NEJMoa1400781

M3 - Article

VL - 371

SP - 1218

EP - 1227

JO - The New England Journal of Medicine

JF - The New England Journal of Medicine

SN - 0028-4793

IS - 13

ER -