Initial results from this trial (CLASS) found that the three main treatments for varicose veins all improved symptoms and quality of life six months after treatment. On a balance of scores, laser treatment was more effective than foam treatment or surgery.
Laser involved fewest complications six weeks after the procedure and may be the most cost effective option in the long term. Foam was the most cost effective option at six months and enabled the most rapid recovery but was less effective than laser or surgery.
The NIHR funded CLASS trial results are in line with current NICE guidance to offer minimally invasive treatments in preference to surgery. A change in practice towards these treatments could be cost saving to the NHS.
Why was this study needed?
Varicose veins are swollen, enlarged veins with damaged valves and disrupted blood flow. They usually occur in the legs. As a result, the veins form unsightly bulges near the skin surface. The impact of varicose veins ranges from cosmetic effects, to troublesome symptoms such as itching, aching legs, cramps and lower leg fluid retention, to more severe complications such as bleeding and leg ulcers. Around a third of the UK population have visible varicose veins, and in 2009/10 nearly 36,000 procedures were carried out by the NHS to treat varicose veins. Surgery to remove damaged sections of varicose veins is the longest-established treatment, but is costly and involves one to three weeks recovery. This study compared the effectiveness and quality of life improvements of two less invasive operations, foam and laser therapy, with surgery.
What did this study do?
The CLASS trial was carried out at 11 UK hospitals and included 798 patients with troubling symptoms of varicose veins. They were randomly allocated to one of three treatments: foam (foam sclerotherapy), laser (endovascular laser ablation) or surgery. Surgery was a one-stage process, whereas laser and initial foam therapy could be followed by foam six weeks later if varicose veins remained. The main outcome was patient reported quality of life six months after the procedure.
The CLASS study data were combined with existing data on long-term treatment effects to estimate clinical and cost-effectiveness at five years after the initial treatment. A limitation of the study was that it did not measure long term recurrence of varicose veins. Also, it did not study radiofrequency ablation, a minimally invasive treatment like laser treatment.
What did it find?
- All three treatments were effective at treating varicose veins and improved quality of life at six months after treatment (for example, in each group, quality of life improved by an average of around 9 points on a 0-100 disease-specific scale, the Aberdeen Varicose Vein Questionnaire).
- Laser and surgery were more successful at treating varicose veins than foam at six months after treatment.
- Based on costs to health services and patients by 6 months, estimates of long-term cost effectiveness showed that laser was the option most likely to be cost effective at usual NHS thresholds. In a five year model, laser was most likely to be value for money (79% probability), followed by foam (17% probability), then surgery (5% probability).
- Foam had the most complications at six months, of which the most common were lumpiness, skin staining and tenderness. This treatment gave the smallest quality of life improvement and was least likely to close the vein.
What does current guidance say on this issue?
Where there is damage to leg vein valves and impaired blood flow, or troublesome symptoms such as aching legs, 2013 NICE guidance recommends treatment using minimally invasive procedures. The first choice is endothermal ablation (which includes laser), the second is foam. If neither is suitable, surgery is the final option. NICE will make a decision about whether to update this guidance in September 2015.
What are the implications?
Initial results from the CLASS trial broadly support current NICE guidance in terms of the best order to offer varicose vein treatments. Five year results from the trial will include recurrence rate of varicose veins for the three options. This could change estimates of long-term cost effectiveness. Also approaches to carrying out radiofrequency ablation are changing. These changes may have an impact on future guidance.
The CLASS trial provides evidence that choosing less invasive procedures such as laser and foam therapy over surgery can offer cost savings in the longer term. However, foam led to slightly smaller quality of life improvements and more complications compared with laser or surgery.
A NICE costing report and template was produced in 2013 to model the impact for local health communities that follow its recommendations. An estimated 27,084 interventional procedures were carried out in the UK to treat varicose veins in 2011. If the referral patterns changed as expected, the proportion of surgical procedures would reduce from 52% to 5%, with increases in endothermal ablation including laser from 35% to 70% and in foam treatments from 13% to 25%. This could create a net saving of £7,800 per year per 100,000 population.
Brittenden J, Cotton SC, Elders A, et al. Clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the Comparison of LAser, Surgery and foam Sclerotherapy (CLASS) randomised controlled trial. Health Technol Assess. 2015;19(27):1-342.
This project was funded by the National Institute of Health Research under the Health Technology Assessment programme (project number: 06/45/02).
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Produced by the University of Southampton and Bazian on behalf of NIHR through the NIHR Dissemination Centre