随机对照试验治疗静脉曲张的 5 年结果。

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

机构信息

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.

出版信息

N Engl J Med. 2019 Sep 5;381(10):912-922. doi: 10.1056/NEJMoa1805186.

DOI:10.1056/NEJMoa1805186

PMID:31483962

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.).

摘要

背景

对于原发性静脉曲张的治疗，静脉内激光消融和超声引导下泡沫硬化疗法是手术的替代方法，但其长期比较效果尚不确定。

方法

在英国 11 个中心的一项涉及 798 名原发性静脉曲张患者的随机对照试验中，我们比较了激光消融、泡沫硬化疗法和手术的结果。主要终点是 5 年时的疾病特异性生活质量和一般生活质量，以及基于预期成本和质量调整生命年（QALY）模型的成本效益，该模型使用了参与者的治疗成本和 EuroQol EQ-5D 问卷评分的数据。

结果

798 名试验参与者中有 595 名（75%）完成了生活质量问卷。在调整基线评分和其他协变量后，接受激光消融或手术的患者的Aberdeen 静脉曲张问卷评分（评分范围为 0 至 100，评分越低表示生活质量越好）低于接受泡沫硬化疗法的患者（激光消融与泡沫硬化疗法之间的效应大小[组间调整差异]，-2.86；95%置信区间[CI]，-4.49 至-1.22；P<0.001；手术与泡沫硬化疗法之间，-2.60；95%CI，-3.99 至-1.22；P<0.001）。一般生活质量测量在治疗组之间没有差异。在每 QALY 20000 英镑（28433 美元）的意愿支付比值阈值下，77.2%的成本效益模型迭代支持激光消融。在泡沫硬化疗法与手术的双向比较中，54.5%的模型迭代支持手术。

结论

在一项静脉曲张治疗的随机试验中，治疗后 5 年的疾病特异性生活质量在激光消融或手术后优于泡沫硬化疗法。在每 QALY 20000 英镑（28433 美元）的意愿支付比值下，大多数概率成本效益模型迭代支持激光消融。（由英国国家卫生研究院资助；CLASS 当前对照试验编号，ISRCTN51995477。）