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' 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-oflife measures did not differ among treatment groups. At a threshold willingness-topay 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.

Heart Disease and Stroke Statistics—2022 Update: A Report From the American Heart Association

“…In a 2019 RCT of patients with severe varicose veins, quality of life 5 years after treatment assessed with the Varicose Vein Questionnaire was better after laser ablation (effect size, −2.86 [95% CI, −4.49 to −1.22]) or surgery (effect size, −2.60 [95% CI, −3.99 to −1.22]) than after foam sclerotherapy. 92 The success of these procedures is critically compromised according to the progressive increase in weight, especially in those with a BMI ≥ 35 kg/m 2 . 93…”

Treatment of superficial venous insufficiency in a large patient cohort with retrograde administration of ultrasound-guided polidocanol endovenous microfoam versus endovenous laser ablation

“…However, PCF was limited in its clinical efficacy and overall safety profile. 19,20 PEM was developed to eliminate the physical properties of PCF that led to neurological and cardiac adverse events including inconsistent bubble size and nitrogen bubbles that lead to gas embolism. 8,11,[20][21][22][23][24] In our practice, the main treatment has been EVLA.…”

“…19,20 PEM was developed to eliminate the physical properties of PCF that led to neurological and cardiac adverse events including inconsistent bubble size and nitrogen bubbles that lead to gas embolism. 8,11,[20][21][22][23][24] In our practice, the main treatment has been EVLA. However, in most patients, there is a requirement to introduce a second treatment modality to reach smaller veins, tortuous veins, or areas of the leg that present with venous ulceration.…”

Patient perceptions and preferences of minimally invasive treatment modalities in varicose veins: a cross-sectional survey

“…These MIT have consistently been reported to reduce trauma, improve aesthetic outcomes, and expedite recovery compared to traditional surgical modalities. Although multiple studies have demonstrated the long-term efficacy of MIT (12,13), additional research is necessary to confirm their sustained effectiveness (10,14).…”