A Systematic Review and Meta-analysis of Randomised Controlled Trials Comparing Endovenous Ablation and Surgical Intervention in Patients with Varicose Vein

Siribumrungwong, Boonying; Noorit, Pinit; Wilasrusmee, Chumpon; Attia, John; Thakkinstian, Ammarin

doi:10.1016/j.ejvs.2012.05.017

Cited by 176 publications

(56 citation statements)

References 52 publications

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“…28,52,56,93 The most recent of these was carried out for NICE Clinical Guideline 168 on varicose veins in the legs. 28 Within the review prepared for the NICE evaluation, the authors presented the findings of a random-effects network meta-analysis of treatment-specific probabilities of clinical recurrence over time.…”

Section: Clinical Recurrencementioning

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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Section: Clinical Recurrencementioning

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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“…С одной стороны, частота рецидива может показаться высокой, но в литературе содержатся многочисленные указания на то, что вероятность рецидива при традиционном подходе не меньше по лученных нами данных. При сроке наблюдения 3-5 лет рецидив происходит в 15-20% случаев вне зависимости от использованного хирургического метода [10][11][12][13][14][15][16]. L. Rassmussen и соавт.…”

Section: Discussionunclassified

Isolated Phlebectomy Leads to Disappearance of Great Saphenous Vein Reflux

Золотухин¹,

Селиверстов²,

Захарова³

et al. 2016

Flebol.

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Оригинальные статьиУдаление или облитерация несостоятельного ствола большой подкожной вены (БПВ) у пациен тов с варикозной болезнью нижних конечностей представляет собой обязательный компонент любо го инвазивного лечения. Это практически постулат, основанный на традиционном объяснении этапов развития болезни: начало и дальнейшее прогресси рование варикозного расширения вен связано с формированием рефлюкса в БПВ, что вызывает трансформацию ее притоков и появление видимого варикозного расширения вен. В литературе послед них лет такое объяснение происходящих патологи Цель исследования -оценить влияние изолированной минифлебэктомии на рефлюкс в стволе большой подкожной вены (БПВ) и на его диаметр, а также определить частоту рецидива варикозной болезни после этого вмешательства. Материал и методы. В проспективное обсервационное исследование включены 66 больных (51 женщина и 15 мужчин) в возрасте от 17 лет до 71 года. у всех пациентов диагностирована варикозная болезнь с несостоятельностью ствола БПВ не ниже верхней трети голени. оперировано 76 нижних конечностей: класса С2 -в 62 (82%) случаях, класса С2-C3 -в 11 (14%) случаях, класса С2-С4 -в 3 (4%) случаях. Всем пациентам выполняли изолированную минифлебэктомию под местной анестезией, не удаляя несостоятельную БПВ. Контрольное дуплексное ангиосканирование проводили на следующий день (2-е сутки), а затем через 1 нед, 1, 3, 6, 12 мес. Во время ультразвукового исследования оценивали рефлюкс по БПВ и ее диаметр. Частоту рецидива варикозной болезни оценивали через 12 мес после вмешательства. результаты. Частота выявления рефлюкса по стволу БПВ проанализирована в подгруппе, включившей 58 нижних конечностей, со сроком наблюдения не менее 12 мес. Через год 39 (67%) БПВ были состоятельны. диаметр всех БПВ уменьшился независимо от того, исчез рефлюкс или нет. Рецидив заболевания в виде появления новых видимых варикозно-расширенных вен раз-вился на 7 (12%) из 58 нижних конечностей, осмотренных через 12 мес. Заключение. Изолированная минифлебэктомия с сохранением несостоятельного ствола БПВ приводит к исчезновению рефлюкса по нему в 67% случаев. диаметр ствола значительно уменьшается после удаления расширенных притоков. Вероятность исчезновения рефлюкса по БПВ особенно высока при протяженности несостоятельного сегмента ствола не ниже середины бедра. Aim -the aim of our study was to establish an effect of isolated phlebectomy in patients with primary varicose veins on reflux and diameter of incompetent great saphenous vein (GsV) and to assess clinical results of the procedure in terms of recurrence rate of varicose veins. Material and methods. 66 patients (51 women and 15 men) were included and prospectively followed. Age varied from 17 to 71 years. All the patients had primary varicose veins and GsV reflux not lower than the upper third of the calf. limbs were classified as C2 in 62 (82%) cases, as C2-C3 in 11 (14%) cases, and as С2-C4 in 3 (4%) cases. All the patients underwent isolated phlebectomy under local anaesthesia with preservation of incompetent GsV. All the limbs wer...

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“…Unfortunately, numerous papers are published, but papers with adequate methodology are few, as proven in many systematic reviews. 2,4,5 As previously mentioned, the majority of these reviews have favoured endovenous procedures; however, none of them gives information regarding how many patients are not appropriate for endovenous treatment.This lack of information introduces bias, as pooling effects are limited to long saphenous vein (LSV) outcome.…”

mentioning

confidence: 93%

“…Lack of evidence is particularly common in venous publications for almost all comparisons among different procedures (radiofrequency ablation [RFA], endovenous laser ablation, surgery, and ultrasound venous ablation). 5 van Der Velden et al's paper looks at a relevant problem: prognostic factors for recanalisation of the LSV after endothermal ablation. 1 However, should we consider LSV recanalisation as the only parameter for success or failure?…”

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confidence: 98%

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Commentary on ‘Predictors for Recanalization of the Great Saphenous Vein in RCTs 1 Year After Endovenous Thermal Ablation’: The Dark Side of Systematic Reviews

Cairols

2016

European Journal of Vascular and Endovascular Surgery

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Natura inest in mentibus nostris insatiabilis quaedam cupiditas very vivendi" (Cicero, Tusculanes,1, 19) "Nature has put in our minds an insatiable desire to know the truth"The paper by van der Velden et al., authors with extensive experience of chronic superficial venous insufficiency (CVI) therapy, published in this issue, is excellent. 1 Beyond congratulating the editors of EJVES for its publication, the world of venous publications gives us the opportunity to comment on systematic review papers.It is obvious that endovenous procedures have been introduced for treating varicose veins in order to reduce post-operative complications. Their main advantages are quicker recovery, fewer complications, and improvement in quality of life compared with conventional surgery. 2 As has been the rule, many physicians around the world have enthusiastically adopted those new methods. Nevertheless, as is clear in the paper by van der Velden et al., we do not know much about the prognostic factors for success. 1,3 Moreover, is there an appropriate patient for these technologies? Despite this obvious limited knowledge, almost all doctors, sometimes not specialists, have dared to manage these patients.The previous comments support the fact that this widespread use of endovascular procedures produces a huge variety of papers, probably to back their practice. Unfortunately, numerous papers are published, but papers with adequate methodology are few, as proven in many systematic reviews. 2,4,5 As previously mentioned, the majority of these reviews have favoured endovenous procedures; however, none of them gives information regarding how many patients are not appropriate for endovenous treatment.This lack of information introduces bias, as pooling effects are limited to long saphenous vein (LSV) outcome.The paper by van Der Velden et al. also proves what has already been stated: there are too many venous publications under the heading of endothermal ablation with methodological flaws. 1 Moreover, not all published papers have enough information with which to assess results properly and, surprisingly, these low quality papers are accepted in many reputable medical journals. Lack of evidence is particularly common in venous publications for almost all comparisons among different procedures (radiofrequency ablation [RFA], endovenous laser ablation, surgery, and ultrasound venous ablation). 5 van Der Velden et al.'s paper looks at a relevant problem: prognostic factors for recanalisation of the LSV after endothermal ablation. 1 However, should we consider LSV recanalisation as the only parameter for success or failure? Many readers will agree that it is a relevant parameter with which to explain the recurrence of varicose veins, but recurrence of varicose veins is a complex phenomenon in which many other factors contribute, among them below knee LSV reflux, reflux in the tributaries, neovascularisation, saphenopopliteal reflux, and perforator insufficiency. Neovascularisation might differ between the procedures, which may influence l...

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A Systematic Review and Meta-analysis of Randomised Controlled Trials Comparing Endovenous Ablation and Surgical Intervention in Patients with Varicose Vein

Abstract: The primary failure and recurrence in EVLA and RFA were non-significantly different compared with surgery. However, they had lower haematoma, less wound infection, less pain and quicker return to normal activities.

Cited by 176 publications

References 52 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

Isolated Phlebectomy Leads to Disappearance of Great Saphenous Vein Reflux

Commentary on ‘Predictors for Recanalization of the Great Saphenous Vein in RCTs 1 Year After Endovenous Thermal Ablation’: The Dark Side of Systematic Reviews

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