Randomised Clinical Trial Comparing Endovenous Laser Ablation with Stripping of the Great Saphenous Vein: Clinical Outcome and Recurrence After 2Years

Rasmussen, Lars Hvilsted; Bjoern, Lars; Lawaetz, Martin; Lawaetz, B.; Blemings, Allan; Eklöf, B

doi:10.1016/j.ejvs.2009.11.040

Cited by 138 publications

(84 citation statements)

References 17 publications

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“…Higher 2-year clinical recurrence rates were reported by Rasmussen et al 49 (surgery 37%, EVLA 26%). In the 5-year results from this study, there was no difference in recurrence rates (surgery 55%, EVLA 47%, p = 0.72).…”

Section: Clinical Recurrence Ratessupporting

confidence: 48%

“…Two of these studies 31,49 also included foam sclerotherapy; these are the only currently published studies which have compared foam sclerotherapy against EVLA. The outcomes of these studies in terms of QoL, technical success, return to normal activities, VCSS, recurrence rates and costs are discussed below.…”

Section: Literature Update: Randomised Controlled Trials Comparing Enmentioning

confidence: 99%

“…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%

“…15,29,34,37,49,51 In the study by Rass et al, 38 an alternative assessment tool (the Homburg Varicose Vein Severity Score) was used; again there was no difference between treatment groups.…”

Section: Venous Clinical Severity Scorementioning

confidence: 99%

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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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Section: Clinical Recurrence Ratessupporting

confidence: 48%

Section: Literature Update: Randomised Controlled Trials Comparing Enmentioning

confidence: 99%

Section: Literature Update: Randomised Controlled Trials Comparing Enmentioning

confidence: 99%

Section: Venous Clinical Severity Scorementioning

confidence: 99%

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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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“…Therefore, one factor that can contribute to recurrence is reflux in the accessory saphenous vein (ASV), which should be treated with ablation in these cases, and according to some authors should be treated even if competent. 12 In order to achieve successful results, all SFJ or proximal GSV tributaries in which reflux is demonstrated must be ligated during surgical treatment of conventional varicose veins. This should also be considered important when endovenous treatment is conducted; since if reflux remains at the SFJ after thermal ablation, it could be transferred into the GSV or another of its principle affluents, such as the ASV.…”

Section: Discussionmentioning

confidence: 99%

Influência da termoablação com baixa e alta densidade de energia na junção safeno-femoral, utilizando laser endovenoso 1470 nm

et al. 2017

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Background: It is important to acquire technical knowledge about the power and linear endovenous energy density (LEED) settings needed to achieve the ultimate goal of endovenous laser ablation (EVLA). Objectives: To evaluate the influence of different LEEDs in terms of patency and presence of reflux and to determine clinical outcomes. Methods: Sixty great saphenous veins (GSVs) were included. Patients were randomized into 2 groups, low-power EVLA (7 W and LEED of 20-40 J/cm) and high-power EVLA (15 W and LEED of 80-100 J/cm). Patients were followedup with duplex ultrasound and calculation of venous clinical severity score (VCSS) at 3-5 days, 30 days, 180 days, and 1 year after the procedure. Results: 18 patients (29 limbs) treated with 7 W of laser power and 13 patients (23 limbs) treated with 15 W of laser power completed the study. There was no significant difference regarding age, operating time, use of analgesics, laterality, sex, or presence of comorbidities. Mean LEED was 33.54 J/cm in the 7-W group and 88.66 J/cm in the 15-W group. Both groups exhibited improvements in VCSS and significant reductions in SFJ diameters, and there were no significant difference in increase of length of the GSV stump or rates of reflux after treatment. Conclusions: The higher energy density setting was more effective for stabilizing the length of the GSV stump and was associated with a lower incidence of reflux at 6 months. Further studies with a longer follow-up period are required to substantiate this hypothesis.

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Comparable Effectiveness of Endovenous Laser Ablation and High Ligation With Stripping of the Great Saphenous Vein

Rass

Frings²,

Glowacki³

et al. 2012

Arch Dermatol

126

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Objective: To compare the clinical efficacy and safety of endovenous laser treatment (EVLT) with high ligation and stripping (HLS) as standard treatment for great saphenous vein (GSV) insufficiency. Design: Two-center randomized controlled trial with 2-year follow-up. Setting: Interventions were performed on ambulatory and hospitalized patients at 2 vein centers, a university dermatology department (EVLT-treated group), and a specialized vein clinic (HLS-treated group). Patients: Random sample of 400 patients with GSV insufficiency. Interventions: Patients were assigned (1:1) to EVLT or HLS of the GSV from September 2004 through March 2007; 185 and 161 patients (limbs), respectively, were treated per protocol. Main Outcome Measures: Clinically recurrent varicose veins after surgery (REVAS classification, primary study objective), duplex-detected saphenofemoral recurrence, clinical venous severity scoring (Homburg Varicose Vein Severity Score), hemodynamics (venous refilling time), quality of life (Chronic Venous Insufficiency Questionnaire 2), adverse effects, and visual analog scalebased evaluations of patients' satisfaction. Results: Clinically recurrent varicose veins after surgery were similarly observed in both groups: 16.2% (EVLTtreated group) vs 23.1% (HLS-treated group); P=.15. Duplex-detected saphenofemoral refluxes occurred significantly more frequently after EVLT (17.8% vs 1.3%; PϽ.001). Both treatments equally improved medical condition (Homburg Varicose Vein Severity Score) and diseaserelated quality of life. Endovenous laser treatment caused more adverse effects (phlebitic reaction, tightness, dyspigmentation) but revealed advantages concerning hemodynamics, recovery, and cosmetic outcome. Conclusions: Both EVLT and HLS are comparably safe and effective procedures to treat GSV incompetence. The significantly higher rate and the course of duplexdetected saphenofemoral recurrences after EVLT remain a matter of further investigations.

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Randomised Clinical Trial Comparing Endovenous Laser Ablation with Stripping of the Great Saphenous Vein: Clinical Outcome and Recurrence After 2Years

Abstract: No significant differences in clinical or ultrasound recurrences were found between EVLA and surgery groups. Our study also shows that similar improvements in clinical severity scores and quality of life were gained in both treatments.

Cited by 138 publications

References 17 publications

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

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

Influência da termoablação com baixa e alta densidade de energia na junção safeno-femoral, utilizando laser endovenoso 1470 nm

Comparable Effectiveness of Endovenous Laser Ablation and High Ligation With Stripping of the Great Saphenous Vein

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