Comparison of treatment options for varicose veins [CLASS trial]

1. Numerous options are available to treat varicose veins, including foam sclerotherapy, laser therapy, and surgical vein stripping.

2. At 6 months, patients undergoing foam therapy were found to have significantly worse disease-specific quality of life compared to patients undergoing surgical treatment.

3. There were no significant differences in disease-specific quality of life when comparing laser therapy with surgery or foam at 6 months.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Varicose veins refer to veins that become tortuous or enlarged secondary to valvular incompetence. As a result, blood pools in the vein, thereby leading to venous distension and impaired return. Often, impaired quality of life leads people to seek treatment. Varicose veins can be painful, especially when standing. Moreover, people with varicosities may also develop venous eczema, ulcerations and general skin thickening. Several options are available to treat varicosities. Foam sclerotherapy involves injecting chemicals into the affected veins, leading to scarring and blockage. Laser therapy uses radiation to scar the veins, while surgical management often refers to stripping the damaged veins.

In this study, researchers compared these different treatment options in terms of their effect on patient quality of life. At 6 months, patients treated with foam therapy were found to have higher Aberdeen Varicose Veins Questionnaire (AVVQ) scores compared with those managed by surgery, thereby suggesting poorer quality of life. There were no differences in AVVQ scores when comparing laser therapy with surgery or foam. There were no significant differences between groups in the rates of serious adverse events.

This study does have some limitations that should be noted. Patient and outcome assessors were not blinded and this issue is augmented by the fact that the study outcomes were largely self-reported by study participants. Longer-term studies would assist clinical decision-making, as the study follow-up was limited to 6 months.

Click to read the study, published today in NEJM

Relevant Reading: Endovenous Laser: A New Minimally Invasive Method of Treatment for Varicose Veins—Preliminary Observations Using an 810 nm Diode Laser

In-Depth [randomized controlled trial]: This randomized trial was conducted at 11 centres across the United Kingdom. A total of 798 patients diagnosed with primary varicose veins underwent randomization to three different treatment groups: 1) foam sclerotherapy, 2) laser therapy (with subsequent foam sclerotherapy, if needed), and 3) surgery. Patients were assessed by a vascular surgeon and screened with duplex ultrasound for entry into the study. Patients were eligible if they were ≥18 years of age, had symptomatic varicose veins, and reflux of the small or great saphenous vein of more than 1 second on duplex ultrasound. Patients were excluded if they had current deep-vein thrombosis, acute superficial vein thrombosis, saphenous vein diameter of <3 mm or >15 mm, had tortuous veins thought unsuitable for laser treatment, or had contraindications to foam or anesthetics. Outcomes were assessed at baseline, and 6 weeks and 6 months after treatment. The primary outcomes were measured at the 6-month mark using the Aberdeen Varicose Veins Questionnaire (AVVQ), EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D) and Medical Outcomes Study 36-Item Short-Forma Health Survery (SF-36). Secondary outcomes included clinical success at 6 weeks and 6 months (i.e., proportion with residual varicose veins), venous clinical severity score, and related complications.

At 6 months, the foam group had a significantly higher AVVQ score than the surgery group, demonstrating worse disease-specific quality of life (effect size -1.74; 95%CI -2.97 to -0.50). There were no significant differences in AVVQ score change when comparing laser with surgery or foam. At 6 weeks, secondary quality-of-life outcomes were significantly worse in the foam group as compared with surgery in terms of AVVQ score (effect size -2.3; 95%CI -3.7 to -0.9). SF-36 scores at 6 weeks were significantly lower in the surgery group when compared with laser, thereby suggesting significantly worse quality of life. At 6 months, there was no significant difference between the groups in the venous clinical severity score, suggesting no difference in residual disease at this timepoint. Moreover, there were no significant differences between groups in the rates of serious adverse events.

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