The CLASS trial: laser ablation and surgery improve quality-of-life for varicose vein patients compared to sclerotherapy

1. In patients with primary varicose veins followed for 5 years after treatment, those randomized to receive laser ablation or surgery reported greater improvements in disease-specific quality-of-life compared to patients who received ultrasound-guided foam sclerotherapy.

2. Cost-effectiveness models favored laser ablation over both foam sclerotherapy and surgery.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Minimally invasive alternatives to surgery for varicose veins, including laser ablation and ultrasound-guided foam sclerotherapy, have been studied out to 3 years, but data regarding quality-of-life and recurrence rates among the three procedures are limited at the 5-year interval. The Comparison of Laser, Surgery, and Foam Sclerotherapy (CLASS) trial assessed quality-of-life and cost effectiveness of laser ablation, foam sclerotherapy, and surgery with follow-up out to 5 years. The primary outcome of patient-reported disease-specific quality-of-life ratings at 5 years, as assessed by the Aberdeen Varicose Vein Questionnaire (AVVQ), indicated higher quality-of-life for the laser ablation and surgery groups than the foam sclerotherapy group. Using a cost effectiveness per quality-adjusted life-year (QALY) model, laser ablation had a higher cost-effectiveness than foam sclerotherapy or surgery, with foam sclerotherapy and surgery showing similar cost-effectiveness outcomes.

This randomized trial provides evidence that laser ablation and surgery are superior to foam sclerotherapy toward improving quality-of-life in patients with varicose veins, and that laser ablation is usually more cost-effective than foam sclerotherapy or surgery. Limitations include lack of a sham procedure, no single or double blinding, and the notable quantity of missing data at the 5-year timepoint.

Click to read the study in NEJM

Relevant Reading: Commonly Used Endovenous Laser Ablation (EVLA) Parameters Do Not Influence Efficacy: Results of a Systematic Review and Meta-Analysis

In-Depth [randomized controlled trial]: This randomized, controlled trial enrolled 798 patients from 11 centers in the United Kingdom from 2008 to 2012. Inclusion criteria included adult age, primary symptomatic varicose veins in one or both legs with diameter >3mm, and reflux of the greater saphenous or small saphenous veins >1 second as measured by duplex ultrasound. Exclusion criteria included current deep vein thrombosis and acute superficial-vein thrombosis. Patients were randomized into three treatment groups: laser ablation (with subsequent foam sclerotherapy if needed; n=212), foam sclerotherapy (n=292), and surgery (n=294). Patients were followed for 5 years using primary outcomes of disease-specific quality-of-life as measured by the Aberdeen Varicose Vein Questionnaire (AVVQ), generic quality-of-life as measured by the Euro-Qol EQ-5D (EQ-5D) questionnaire, a medical outcomes survey (SF-36), and model-based cost effectiveness calculations. The primary disease-specific quality-of-life AVVQ scores in the laser ablation and surgery groups were significantly lower compared to the foam sclerotherapy group (effect size for laser ablation vs foam sclerotherapy, -2.86; 95% confidence interval [CI], -4.49 to -1.22; P<0.001) (effect size for surgery vs foam sclerotherapy, -2.60; 95% CI, -3.99 to -1.22; P<0.001). EQ-5D and SF-36 measurements did not differ significantly among groups. In a three-way analysis using the Markov model to predict cost effectiveness with a threshold willingness-to-pay ratio of £20,000 ($28,433) per QALY, 77.2% of model iterations favored laser ablation. In a two-way comparison between foam sclerotherapy and surgery, 54.5% of iterations favored surgery. Absence of residual varicose veins at 5 years occurred for 58%, 54%, and 47% of laser ablation, surgery, and foam sclerotherapy patients, respectfully (odds ratio for foam therapy vs laser ablation, 0.56; 95% CI, 0.41 to 0.85). Referencing a previous study that found surgery did not improve disease-specific quality-of-life more than foam sclerotherapy, authors name this study’s higher absence of residual disease among laser ablation and surgery groups compared to the foam sclerotherapy group as a positive contributor toward improved quality-of-life.

Image: PD

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