A Randomized Trial of Early Endovenous Ablation in Venous Ulceration

Gohel, Manjit; Heatley, Francine; Liu, Xinxue; Bradbury, Andrew W.; Bulbulia, Richard; Cullum, Nicky; Epstein, David; Nyamekye, Isaac; Poskitt, K. R.; Renton, Sophie; Warwick, Jane; Davies, Alun H.

doi:10.1056/nejmoa1801214

Cited by 287 publications

(204 citation statements)

References 24 publications

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“…Baseline characteristics for the study groups, described in full elsewhere, were evenly matched across the arms of the EVRA trial ( Table ).…”

Section: Resultsmentioning

confidence: 99%

“…This study did not consider whether cost‐effectiveness might vary across subgroups. The EVRA trial assessed the clinical benefit across several predefined subgroups and detected some interesting trends for potentially greater benefits for early intervention, such as in patients with longer ulcer duration. However, the clinical study was not powered to detect differences across subgroups, and furthermore patients with ulcer duration of more than 6 months were excluded.…”

Section: Discussionmentioning

confidence: 99%

“…In the clinical study, protocol deviations were seen in 117 patients (59 and 58 in the early and deferred groups respectively), the majority of which were late or missed follow‐up appointments (40 of 59 patients in the early intervention group and 34 of 58 in the deferred intervention group). A sensitivity analysis was carried out excluding these patients.…”

Section: Methodsmentioning

confidence: 99%

“…Current guidelines recommend treatment of superficial venous reflux using endovenous ablation techniques (ultrasound‐guided foam sclerotherapy (UGFS), endovenous laser or radiofrequency ablation), but many practitioners delay intervention until the ulcer has healed. More recently, the EVRA (Early Venous Reflux Ablation) trial found that early endovenous ablation significantly reduced time to ulcer healing. This study presents an analysis of the cost‐effectiveness of early versus delayed endovenous treatment, based on the EVRA trial data to 1 year.…”

Section: Introductionmentioning

confidence: 99%

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Cost-effectiveness analysis of a randomized clinical trial of early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration

Epstein

Gohel

Heatley

et al. 2019

British Journal of Surgery

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Background: Treatment of superficial venous reflux in addition to compression therapy accelerates venous leg ulcer healing and reduces ulcer recurrence. The aim of this study was to evaluate the costs and cost-effectiveness of early versus delayed endovenous treatment of patients with venous leg ulcers.Methods: This was a within-trial cost-utility analysis with a 1-year time horizon using data from the EVRA (Early Venous Reflux Ablation) trial. The study compared early versus deferred endovenous ablation for superficial venous truncal reflux in patients with a venous leg ulcer. The outcome measure was the cost per quality-adjusted life-year (QALY) over 1 year. Sensitivity analyses were conducted with alternative methods of handling missing data, alternative preference weights for health-related quality of life, and per protocol.Results: After early intervention, the mean(s.e.m.) cost was higher (difference in cost per patient £163(318) (€184(358))) and early intervention was associated with more QALYs at 1 year (mean(s.e.m.) difference 0⋅041(0⋅017)). The incremental cost-effectiveness ratio (ICER) was £3976 (€4482) per QALY. There was an 89 per cent probability that early venous intervention is cost-effective at a threshold of £20 000 (€22 546)/QALY. Sensitivity analyses produced similar results, confirming that early treatment of superficial reflux is highly likely to be cost-effective.Conclusion: Early treatment of superficial reflux is highly likely to be cost-effective in patients with venous leg ulcers over 1 year. Registration number: ISRCTN02335796 (http://www.isrctn.com). * The full list of EVRA trial investigators can be found under the heading Collaborators

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“…Baseline characteristics for the study groups, described in full elsewhere, were evenly matched across the arms of the EVRA trial ( Table ).…”

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Cost-effectiveness analysis of a randomized clinical trial of early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration

Epstein

Gohel

Heatley

et al. 2019

British Journal of Surgery

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“…The benefits of early endovenous ablation in improving healing of venous leg ulcers has been demonstrated. 45 Future research may also enable the identification of those at high risk of recurrence following surgery, a significant problem in current management of VVs patients.…”

Section: Discussionmentioning

confidence: 99%

Genome-wide association analysis and replication in 810,625 individuals identifies novel therapeutic targets for varicose veins

Ahmed

Wiberg

et al. 2020

Preprint

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Background: Varicose veins (VVs) affect one-third of Western society, with a significant subset of patients developing venous ulceration, and ongoing management of venous leg ulcers costing around $14.9 billion annually in the USA. There is no current medical management for VVs, with approaches limited to compression stockings, ablation techniques, or open surgery for more advanced disease. A significant proportion of patients report a positive family history, and heritability is ~17%, suggesting a strong genetic component. We aimed to identify novel therapeutic targets by improving our understanding of the aetiopathology and genetic architecture of VVs. Methods:We performed the largest two-stage genome-wide association study of VVs in 401,656 subjects from UK Biobank, and replication in 408,969 subjects from 23andMe (total 135,514 varicose veins cases and 675,111 controls). We constructed a genetic risk score for VVs to investigate its use as a prognostic tool. Genes and pathways were prioritised using a suite of bioinformatic tools, and therapeutic targets identified using the Open Targets Platform. Results:We discovered 49 signals at 46 susceptibility loci associated with VVs, including 29 previously unreported genetic associations (28 susceptibility loci). We demonstrated that patients with VVs requiring surgery have a higher genetic risk score than those managed non-surgically. We map 237 genes to these loci, many of which are biologically relevant and tractable to therapeutic targeting or repurposing (notably 4 VEGFA, COL27A1, EFEMP1, PPP3R1 and NFATC2). Tissue enrichment analyses implicated vascular tissue, and several genes were enriched in biological pathways relating to extracellular matrix biology, inflammation, angiogenesis, lymphangiogenesis, vascular smooth muscle cell migration, and apoptosis. Conclusions:Genes and pathways identified represent biologically plausible contributors to the pathobiology of VVs, identifying promising candidates for further investigation of venous biology and potential therapeutic targets. We have provided the proof-of-principle that genetic risk score correlates with disease severity, which represents a first step in personalised medicine approaches to varicose veins.Varicose veins (VVs) are a very common manifestation of chronic venous disease, affecting over 30% of the population in Western countries. 1 In the USA, chronic venous disease affects over 11 million males and 22 million females aged 40-80 years 2 , meaning it is twice as prevalent as coronary heart disease. 3 Chronic venous insufficiency leads to serious complications in 10% of cases, including lipodermatosclerosis, venous ulceration, and rarely amputation. Despite best care, 25-50% of venous leg ulcers remain unhealed after 6 months of treatment. 4 Ongoing management of venous leg ulcers costs around $14.9 billion annually and 4.5 million work days per year are lost to venous-related illness in the USA. 5,6 Despite this, at present there are no medical treatments for VVs. For symptomatic patients, endove...

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Exercise for Leg Ulcers

Kirsner

2018

JAMA Dermatol

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A Randomized Trial of Early Endovenous Ablation in Venous Ulceration

Cited by 287 publications

References 24 publications

Cost-effectiveness analysis of a randomized clinical trial of early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration

Cost-effectiveness analysis of a randomized clinical trial of early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration

Genome-wide association analysis and replication in 810,625 individuals identifies novel therapeutic targets for varicose veins

Exercise for Leg Ulcers

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