Imperial College London

Dr Francine Heatley

Faculty of MedicineDepartment of Surgery & Cancer

Clinical Trials Manager
 
 
 
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Contact

 

+44 (0)20 3311 7371f.heatley Website

 
 
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Location

 

3E4East WingCharing Cross Campus

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Summary

 

Publications

Citation

BibTex format

@article{Gohel:2020,
author = {Gohel, M and Mora, J and Szigeti, M and Epstein, D and Heatley, F and Bradbury, A and Bulbulia, R and Cullum, N and Nyameke, I and Poskitt, K and Renton, S and Warwick, J and Davies, A},
journal = {JAMA: Journal of the American Medical Association},
title = {Long-term clinical and cost-effectiveness of early endovenous ablation in venous ulceration (The EVRA randomized clinical trial)},
year = {2020}
}

RIS format (EndNote, RefMan)

TY  - JOUR
AB - ImportanceOne-year outcomes from the Early Venous Reflux Ablation (EVRA) randomized trial showed accelerated venous leg ulcer healing and greater ulcer free time for participants treated with early endovenous ablation of lower extremity superficial reflux. Outcomes up to 5 years are presented here.ObjectiveTo evaluate the clinical and cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with venous leg ulceration.DesignRandomized clinical trial.SettingVascular surgery departments in twenty United Kingdom hospitalsParticipantsBetween October 2013 and September 2016, 450 participants (450 legs) with venous leg ulceration of <6 months and superficial venous reflux were enrolled. InterventionsPatients were randomly assigned to receive compression therapy with early endovenous ablation within 2 weeks of randomization (early intervention, n=224) or compression with deferred endovenous treatment of superficial venous reflux (deferred intervention, n=226). Endovenous modality and strategy were left to the preference of the treating clinical team. Main outcomes and measuresThe primary outcome for the extended phase was time to first ulcer recurrence. Secondary outcomes included ulcer recurrence rate and cost effectiveness.ResultsOf 426 participants whose leg ulcer had healed, 121 (28.4%) experienced at least one recurrence during follow-up. There was no clear difference in time to first ulcer recurrence between the two groups (hazard ratio 0.82; 95% confidence interval [CI] 0.57 to 1.17; P=0.278). Ulcers recurred at a lower rate of 0.107 per person year (PY) in the early-intervention group compared to 0.162 per PY in the deferred-intervention group (incidence rate ratio 0.658; 95% CI: 0.480 to 0.898, p=0.003). Time to ulcer healing was shorter in the early-intervention group for primary ulcers (hazard ratio 1.36; 95% CI 1.12 to 1.64, p=0.002). At three years, early intervention is 91.6% likely to be cost-effective at a willingness to pa
AU - Gohel,M
AU - Mora,J
AU - Szigeti,M
AU - Epstein,D
AU - Heatley,F
AU - Bradbury,A
AU - Bulbulia,R
AU - Cullum,N
AU - Nyameke,I
AU - Poskitt,K
AU - Renton,S
AU - Warwick,J
AU - Davies,A
PY - 2020///
SN - 0098-7484
TI - Long-term clinical and cost-effectiveness of early endovenous ablation in venous ulceration (The EVRA randomized clinical trial)
T2 - JAMA: Journal of the American Medical Association
ER -