NIHR Signal Laser treatment is the preferred treatment for troublesome varicose veins

Published on 11 April 2015

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.

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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.

Citation

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 for Health Research HTA Programme (project number 06/45/02).

Bibliography

Brittenden J, Cotton SC, Elders A, et al. A randomized trial comparing treatments for varicose veins. NEJM. 2014;371:1218-27.

Knott, L. Varicose veins. PatientPlus. Leeds: EMIS Group; 2013

NICE. Endovenous laser treatment of the long saphenous vein. IPG52. London: National Institute for Health and Care Excellence; 2004.

NICE. Ultrasound-guided foam sclerotherapy for varicose veins. IPG440. London: National Institute for Health and Care Excellence; 2013.

NICE. Varicose veins in the legs. NICE Pathway. London: National Institute for Health and Care Excellence; 2015.

NICE. Varicose veins in the legs: the diagnosis and management of varicose veins. CG168. London: National Institute for Health and Care Excellence; 2013.

NICE CKS. Varicose veins. London: National Institute for Health and Care Excellence; 2014.

Tassie E, Scotland G, Brittenden J, et al., on behalf of the CLASS Study team. Cost-effectiveness of ultrasound guided foam sclerotherapy (UGFS), endovenous laser ablation (EVLA), and surgery as treatments for primary varicose veins: results based on the CLASS trial. Br J Surg. 2014;101(12):1532-40.

Veins. General Information – Varicose Veins. London: Circulation Foundation; [2015]

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.

Citation

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 for Health Research HTA Programme (project number 06/45/02).

Bibliography

Brittenden J, Cotton SC, Elders A, et al. A randomized trial comparing treatments for varicose veins. NEJM. 2014;371:1218-27.

Knott, L. Varicose veins. PatientPlus. Leeds: EMIS Group; 2013

NICE. Endovenous laser treatment of the long saphenous vein. IPG52. London: National Institute for Health and Care Excellence; 2004.

NICE. Ultrasound-guided foam sclerotherapy for varicose veins. IPG440. London: National Institute for Health and Care Excellence; 2013.

NICE. Varicose veins in the legs. NICE Pathway. London: National Institute for Health and Care Excellence; 2015.

NICE. Varicose veins in the legs: the diagnosis and management of varicose veins. CG168. London: National Institute for Health and Care Excellence; 2013.

NICE CKS. Varicose veins. London: National Institute for Health and Care Excellence; 2014.

Tassie E, Scotland G, Brittenden J, et al., on behalf of the CLASS Study team. Cost-effectiveness of ultrasound guided foam sclerotherapy (UGFS), endovenous laser ablation (EVLA), and surgery as treatments for primary varicose veins: results based on the CLASS trial. Br J Surg. 2014;101(12):1532-40.

Veins. General Information – Varicose Veins. London: Circulation Foundation; [2015]

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

Published on 11 April 2015

Brittenden, J.,Cotton, S. C.,Elders, A.,Tassie, E.,Scotland, G.,Ramsay, C. R.,Norrie, J.,Burr, J.,Francis, J.,Wileman, S.,Campbell, B.,Bachoo, P.,Chetter, I.,Gough, M.,Earnshaw, J.,Lees, T.,Scott, J.,Baker, S. A.,MacLennan, G.,Prior, M.,Bolsover, D.,Campbell, M. K.

Health Technol Assess Volume 19 , 2015

BACKGROUND: Foam sclerotherapy (foam) and endovenous laser ablation (EVLA) have emerged as alternative treatments to surgery for patients with varicose veins, but uncertainty exists regarding their effectiveness in the medium to longer term. OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of foam, EVLA and surgery for the treatment of varicose veins. DESIGN: A parallel-group randomised controlled trial (RCT) without blinding, and economic modelling evaluation. SETTING: Eleven UK specialist vascular centres. PARTICIPANTS: Seven hundred and ninety-eight patients with primary varicose veins (foam, n = 292; surgery, n = 294; EVLA, n = 212). INTERVENTIONS: Patients were randomised between all three treatment options (eight centres) or between foam and surgery (three centres). PRIMARY OUTCOME MEASURES: Disease-specific [Aberdeen Varicose Vein Questionnaire (AVVQ)] and generic [European Quality of Life-5 Dimensions (EQ-5D), Short Form questionnaire-36 items (SF-36) physical and mental component scores] quality of life (QoL) at 6 months. Cost-effectiveness as cost per quality-adjusted life-year (QALY) gained. SECONDARY OUTCOME MEASURES: Quality of life at 6 weeks; residual varicose veins; Venous Clinical Severity Score (VCSS); complication rates; return to normal activity; truncal vein ablation rates; and costs. RESULTS: The results appear generalisable in that participants' baseline characteristics (apart from a lower-than-expected proportion of females) and post-treatment improvement in outcomes were comparable with those in other RCTs. The health gain achieved in the AVVQ with foam was significantly lower than with surgery at 6 months [effect size -1.74, 95% confidence interval (CI) -2.97 to -0.50; p = 0.006], but was similar to that achieved with EVLA. The health gain in SF-36 mental component score for foam was worse than that for EVLA (effect size 1.54, 95% CI 0.01 to 3.06; p = 0.048) but similar to that for surgery. There were no differences in EQ-5D or SF-36 component scores in the surgery versus foam or surgery versus EVLA comparisons at 6 months. The trial-based cost-effectiveness analysis showed that, at 6 months, foam had the highest probability of being considered cost-effective at a ceiling willingness-to-pay ratio of pound20,000 per QALY. EVLA was found to cost pound26,107 per QALY gained versus foam, and was less costly and generated slightly more QALYs than surgery. Markov modelling using trial costs and the limited recurrence data available suggested that, at 5 years, EVLA had the highest probability ( approximately 79%) of being cost-effective at conventional thresholds, followed by foam ( approximately 17%) and surgery ( approximately 5%). With regard to secondary outcomes, health gains at 6 weeks (p < 0.005) were greater for EVLA than for foam (EQ-5D, p = 0.004). There were fewer procedural complications in the EVLA group (1%) than after foam (7%) and surgery (8%) (p < 0.001). Participants returned to a wide range of behaviours more quickly following foam or EVLA than following surgery (p < 0.05). There were no differences in VCSS between the three treatments. Truncal ablation rates were higher for surgery (p < 0.001) and EVLA (p < 0.001) than for foam, and were similar for surgery and EVLA. CONCLUSIONS: Considerations of both the 6-month clinical outcomes and the estimated 5-year cost-effectiveness suggest that EVLA should be considered as the treatment of choice for suitable patients. FUTURE WORK: Five-year trial results are currently being evaluated to compare the cost-effectiveness of foam, surgery and EVLA, and to determine the recurrence rates following each treatment. This trial has highlighted the need for long-term outcome data from RCTs on QoL, recurrence rates and costs for foam sclerotherapy and other endovenous techniques compared against each other and against surgery. TRIAL REGISTRATION: Current Controlled Trials ISRCTN51995477. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 27. See the NIHR Journals Library website for further project information.

Endothermal ablation involves directing radiowaves or high-intensity laser (endovascular laser ablation) to the inside wall of the varicose vein. This causes the damaged vein to seal itself and the blood diverts to healthy veins.

Foam sclerotherapy involves injecting sodium tetradecyl sulphate foam inside the varicose vein, guided by ultrasound. The foam encourages the formation of blood clots, which seal the vein, again diverting blood to healthy veins.

Surgery involves removing parts or all ('stripping') of the varicose vein.

Commentary

This is an excellently conducted study comparing three treatment modalities. Overall it gives a real life representation of results. It supports the concept of the NICE guidelines with respect to endothermal (laser) treatment being the recommended treatment for truncal (varicose) veins. The long term follow up of this study at 5 years will be eagerly awaited.

Professor Alun H Davies, Professor of Vascular Surgery & Honorary Consultant Surgeon, Imperial College London.