Julie Brittenden1, David Cooper1, Maria Dimitrova1, Graham Scotland1, Seonaidh C Cotton1, Andrew Elders1, Graeme MacLennan1, Craig R Ramsay1, John Norrie1, Jennifer M Burr1, Bruce Campbell1, Paul Bachoo1, Ian Chetter1, Michael Gough1, Jonothan Earnshaw1, Tim Lees1, Julian Scott1, Sara A Baker1, Emma Tassie1, Jill Francis1, Marion K Campbell1. 1. From the Institute of Cardiovascular Research, University of Glasgow (J.B.), and the Institute of Applied Health Research, Nursing, Midwifery, and Allied Health Professions Research Unit, Glasgow Caledonian University (A.E.), Glasgow, the Health Services Research Unit (D.C., S.C.C., G.M., C.R.R., M.K.C.) and the Health Economics Research Unit (M.D., G.S., E.T.), University of Aberdeen, and the Department of Vascular Surgery, NHS Grampian, Aberdeen Royal Infirmary (P.B.), Aberdeen, the Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh (J.N.), the School of Medicine, Medical and Biological Sciences, University of St. Andrews, St. Andrews (J.M.B.), the Department of Vascular Surgery, Royal Devon and Exeter Hospital, Exeter (B.C.), the Department of Vascular Surgery, Hull Royal Infirmary, Hull (I.C.), the School of Surgery, University of Leeds (M.G.), and Vascular Surgery, St. James University Hospital (J.S.), Leeds, Vascular Surgery, Gloucestershire Royal Hospital, Gloucester (J.E.), Vascular Surgery, Freeman Hospital, Newcastle upon Tyne (T.L.), the Vascular Surgical Unit, Royal Bournemouth Hospital, Bournemouth (S.A.B.), and the School of Health Sciences, City University of London, London (J.F.) - all in the United Kingdom.
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.).
RCT Entities:
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.).
Authors: Juha T Laakso; Juha Silvola; Timo Hirvonen; Samuli Suutarla; Ilkka Kivekäs; Riitta Saarinen; Lotta Haavisto; Jaakko Laitakari; Antti A Aarnisalo; Aarno Dietz; Jussi Jero; Maija Hytönen; Saku T Sinkkonen Journal: J Otol Date: 2021-01-20