Randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins

Carradice, Daniel; Mekako, A. I.; Mazari, Fayyaz; Samuel, Nehemiah; Hatfield, J.; Chetter, Ian

doi:10.1002/bjs.7394

Cited by 161 publications

(143 citation statements)

References 48 publications

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“…2,5,6,[8][9][10]12,32 The nature and frequency of complications were also similar to those previously reported in the literature. [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16] The three groups had similar improvements in the venous clinical severity score at 6 months. However, successful ablation of the great saphenous veins at 6 weeks occurred significantly less often after foam treatment (complete ablation, 55%; partial ablation with a patent segment and no reflux, 23%) than after either surgery (complete ablation, 84%; partial ablation, 6%) or laser treatment (complete ablation, 83%; partial ablation, 8%).…”

Section: Discussionsupporting

confidence: 86%

“…Previous randomized trials and meta-analyses have shown these treatments to be effective in terms of short-term technical success and clinician-reported outcomes. [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19] Clinical practice guidelines recommend the use of patient-reported quality of life to assess the outcomes of treatment of varicose veins. 20 Quality of life was a primary outcome measure in two small randomized trials that compared surgery and endovenous laser ablation, 5,9 but to our knowledge, it has not been assessed as a primary outcome in randomized trials involving foam sclerotherapy.…”

mentioning

confidence: 99%

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A Randomized Trial Comparing Treatments for Varicose Veins

Brittenden¹,

Cotton²,

Elders³

et al. 2014

N Engl J Med

179

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Section: Discussionsupporting

confidence: 86%

mentioning

confidence: 99%

A Randomized Trial Comparing Treatments for Varicose Veins

Brittenden¹,

Cotton²,

Elders³

et al. 2014

N Engl J Med

179

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“…Concerning the patients' overall satisfaction with the treatment, the available studies do not present any statistically significant results [25,30,34,35]. Although in our study a slightly higher percentage of patients who received open surgery claimed that they would choose the same technique again or would recommend it to their relatives or friends, the difference between the surgery and the EVLA groups was not statistically significant.…”

Section: Discussioncontrasting

confidence: 71%

A comparison of endovenous laser ablation and conventional surgery in patients with varicose veins of the lower limbs

2016

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“…15 By mid-2013, a further eight RCTs had been published which compared EVLA against surgery of the GSV, 29,31,[34][35][36][38][39][40][49][50][51] and one which compared EVLA against surgery to the SSV 37 ( Table 2). Two of these studies 31,49 also included foam sclerotherapy; these are the only currently published studies which have compared foam sclerotherapy against EVLA.…”

Section: Literature Update: Randomised Controlled Trials Comparing Enmentioning

confidence: 99%

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

Brittenden

Cotton

Elders

et al. 2015

Health Technology Assessment

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BackgroundFoam 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.ObjectivesTo assess the clinical effectiveness and cost-effectiveness of foam, EVLA and surgery for the treatment of varicose veins.DesignA parallel-group randomised controlled trial (RCT) without blinding, and economic modelling evaluation.SettingEleven UK specialist vascular centres.ParticipantsSeven hundred and ninety-eight patients with primary varicose veins (foam,n = 292; surgery,n = 294; EVLA,n = 212).InterventionsPatients were randomised between all three treatment options (eight centres) or between foam and surgery (three centres).Primary outcome measuresDisease-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 measuresQuality 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.ResultsThe 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 £20,000 per QALY. EVLA was found to cost £26,107 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 (≈ 79%) of being cost-effective at conventional thresholds, followed by foam (≈ 17%) and surgery (≈ 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.ConclusionsConsiderations 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 workFive-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 registrationCurrent Controlled Trials ISRCTN51995477.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 27. See the NIHR Journals Library website for further project information.

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Randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins

Abstract: NCT00759434 (http://www.clinicaltrials.gov).

Cited by 161 publications

References 48 publications

A Randomized Trial Comparing Treatments for Varicose Veins

A Randomized Trial Comparing Treatments for Varicose Veins

A comparison of endovenous laser ablation and conventional surgery in patients with varicose veins of the lower limbs

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

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