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.)
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.
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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.
- CONVENTIONAL SURGERY
- ENDOVENOUS LASER-ABLATION
- GREAT SAPHENOUS-VEIN
- GUIDED FOAM SCLEROTHERAPY
- HIGH LIGATION