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Initial results from this trial (CLASS) found that the three main treatments for varicose veins improved symptoms and quality of life six months after treatment. On a balance of scores, laser therapy was more effective than foam therapy or surgery.
Laser involved fewer complications six weeks after the procedure and may be the more cost-effective option in the long run. Foam was the most cost-effective option at six months and allowed the fastest recovery, but was less effective than laser or surgery.
The results of the NIHR-funded CLASS trials are in line with current NICE guidance on offering minimally invasive treatments in preference to surgery. A shift in practice towards these treatments could save costs for the NHS.
Why was this study needed?
Varicose veins are swollen, enlarged veins with damaged valves and disrupted blood flow. They usually appear on the legs. As a result, the veins form unsightly bulges near the surface of the skin. The impact of varicose veins ranges from cosmetic effects, bothersome symptoms such as itching, leg pain, cramping and fluid retention in the lower leg, to more serious complications such as bleeding and leg ulcers. Around a third of the UK population has visible varicose veins and in 2009/10 almost 36,000 procedures were carried out by the NHS to treat varicose veins. Surgery to remove damaged parts of varicose veins is the longest-lasting treatment, but it is expensive and involves a recovery period of one to three weeks. This study compared the effectiveness and improvement in quality of life of two less invasive procedures, foam and laser therapy, with surgery.
What did this study do?
The CLASS trial was carried out in 11 UK hospitals and included 798 patients with worrying symptoms of varicose veins. They were randomly assigned to one of three treatments: foam (foam sclerotherapy), laser (endovascular laser ablation), or surgery. Surgery was a one-stage procedure, while the laser treatment and initial foam treatment could be followed by foam six weeks later if varicose veins remained. The primary outcome was patient-reported quality of life six months after the procedure.
Data from the CLASS study were combined with existing data on long-term treatment effects to estimate clinical and cost-effectiveness at five years after initial treatment. A limitation of the study was that it did not measure long-term recurrence of varicose veins. It also did not study radiofrequency ablation, a minimally invasive treatment like laser therapy.
What did he find?
- All three treatments were effective in treating varicose veins and improved quality of life six months after treatment (for example, in each group, quality of life improved by an average of about 9 points on a disease-specific scale of 0-100, the Aberdeen Varicose Vein Questionnaire).
- Laser and surgery were more successful in treating varicose veins than foam at six months after treatment.
- Based on costs to health services and patients at 6 months, long-term cost-effectiveness estimates showed that laser was the most likely option to be cost-effective within usual NHS limits. In a five-year model, laser was most likely to be value for money (79% probability), followed by foam (17% probability) and then surgery (5% probability).
- The foam had the most complications at six months, the most common of which were tumor, skin staining, and tenderness. This treatment provided the least improvement in quality of life and was less likely to close the vein.
What does the current guidance say about this?
Where there is damage to the valves in the leg veins and impaired blood flow or bothersome symptoms such as leg pain, the 2013 NICE guidance recommends treatment with minimally invasive procedures. The first option is endothermic removal (which involves a laser), the second is foam. If neither is suitable, surgery is the final option. NICE will decide whether to update this guidance in September 2015.
What are the consequences;
Initial results from the CLASS trial broadly support current NICE guidance on the best order to offer treatments for varicose veins. Five-year results from the trial will include the recurrence rate of varicose veins for the three options. This could change estimates of long-term cost-effectiveness. Approaches to performing radiofrequency ablation are also 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 provide cost savings in the long term. However, foam led to slightly smaller improvements in quality of life and more complications compared to laser or surgery.
A NICE costing report and template was produced in 2013 to model the impact on local health communities following its recommendations. An estimated 27,084 interventions were performed in the UK to treat varicose veins in 2011. If referral patterns changed as expected, the rate of surgery would decrease from 52% to 5%, with increases in endothermic ablation including laser from 35% to 70% and in foam treatments from 13% to 25%. This could generate a net saving of £7,800 per year per 100,000 population.
Reference
Brittenden J, Cotton SC, Elders A, et al. Clinical effectiveness and cost-effectiveness of foam sclerotherapy, intravenous laser ablation, and surgery for varicose veins: results from the LAser, surgery, and foam sclerotherapy (CLASS) randomized controlled trial comparison. Health Technology Assessment. 2015? 19 (27): 1-342.
This project was funded by the National Institute of Health Research under the Health Technology Assessment program (project number: 06/45/02).
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