Gohel MS, Mora MSc J, Szigeti M, Epstein DM, Heatley F, Bradbury A, Bulbulia R, Cullum N, Nyamekye I, Poskitt KR, Renton S, Warwick J, Davies AH, Early Venous Reflux Ablation Trial Group, et al.
JAMA surgery. Date of publication 2020 Dec 1;volume 155(12):1113-1121.
1. JAMA Surg. 2020 Dec 1;155(12):1113-1121. doi: 10.1001/jamasurg.2020.3845.
Long-term Clinical and Cost-effectiveness of Early Endovenous Ablation in Venous
Ulceration: A Randomized Clinical Trial.
Gohel MS(1)(2), Mora MSc J(2), Szigeti M(3), Epstein DM(4), Heatley F(2),
Bradbury A(5), Bulbulia R(6)(7)(8), Cullum N(9), Nyamekye I(10), Poskitt KR(6),
Renton S(11), Warwick J(3)(12), Davies AH(2); Early Venous Reflux Ablation Trial
Group.
Author information:
(1)Cambridge University Hospitals National Health Service Foundation Trust,
Cambridge, United Kingdom.
(2)Department of Surgery and Cancer, Imperial College London, London, United
Kingdom.
(3)Imperial Clinical Trials Unit, School of Public Health, Imperial College
London, London, United Kingdom.
(4)Department of Applied Economics, University of Granada, Granada, Spain.
(5)Institute of Cardiovascular Sciences, University of Birmingham, Birmingham,
United Kingdom.
(6)Gloucestershire Hospitals National Health Service Foundation Trust,
Cheltenham, United Kingdom.
(7)Medical Research Council Population Health Research Unit, Nuffield Department
of Population Health, University of Oxford, Oxford, United Kingdom.
(8)Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield
Department of Population Health, University of Oxford, Oxford, United Kingdom.
(9)University of Manchester & Manchester University National Health Service
Foundation Trust, Manchester, United Kingdom.
(10)Worcestershire Acute Hospitals National Health Service Trust,
Worcestershire, United Kingdom.
(11)North West London Hospitals National Health Service Trust, London, United
Kingdom.
(12)Warwick Clinical Trials Unit, University of Warwick, Warwick, United
Kingdom.
Comment in
JAMA Surg. 2020 Dec 1;155(12):1121-1122.
IMPORTANCE: One-year outcomes from the Early Venous Reflux Ablation (EVRA)
randomized trial showed accelerated venous leg ulcer healing and greater
ulcer-free time for participants who are treated with early endovenous ablation
of lower extremity superficial reflux.
OBJECTIVE: To evaluate the clinical and cost-effectiveness of early endovenous
ablation of superficial venous reflux in patients with venous leg ulceration.
DESIGN, SETTING, AND PARTICIPANTS: Between October 24, 2013, and September 27,
2016, the EVRA randomized clinical trial enrolled 450 participants (450 legs)
with venous leg ulceration of less than 6 months' duration and superficial
venous reflux. Initially, 6555 patients were assessed for eligibility, and 6105
were excluded for reasons including ulcer duration greater than 6 months, healed
ulcer by the time of randomization, deep venous occlusive disease, and
insufficient superficial venous reflux to warrant ablation therapy, among
others. A total of 426 of 450 participants (94.7%) from the vascular surgery
departments of 20 hospitals in the United Kingdom were included in the analysis
for ulcer recurrence. Surgeons, participants, and follow-up assessors were not
blinded to the treatment group. Data were analyzed from August 11 to November 4,
2019.
INTERVENTIONS: Patients 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 MEASURES: The primary outcome for the extended phase was time
to first ulcer recurrence. Secondary outcomes included ulcer recurrence rate and
cost-effectiveness.
RESULTS: The early-intervention group consisted of 224 participants (mean [SD]
age, 67.0 [15.5] years; 127 men [56.7%]; 206 White participants [92%]). The
deferred-intervention group consisted of 226 participants (mean [SD] age, 68.9
[14.0] years; 120 men [53.1%]; 208 White participants [92%]). Of the 426
participants whose leg ulcer had healed, 121 (28.4%) experienced at least 1
recurrence during follow-up. There was no clear difference in time to first
ulcer recurrence between the 2 groups (hazard ratio, 0.82; 95% CI, 0.57-1.17;
P = .28). Ulcers recurred at a lower rate of 0.11 per person-year in the
early-intervention group compared with 0.16 per person-year in the
deferred-intervention group (incidence rate ratio, 0.658; 95% CI, 0.480-0.898;
P = .003). Time to ulcer healing was shorter in the early-intervention group for
primary ulcers (hazard ratio, 1.36; 95% CI, 1.12-1.64; P = .002). At 3 years,
early intervention was 91.6% likely to be cost-effective at a willingness to pay
of £20 000 ($26 283) per quality-adjusted life year and 90.8% likely at a
threshold of £35 000 ($45 995) per quality-adjusted life year.
CONCLUSIONS AND RELEVANCE: Early endovenous ablation of superficial venous
reflux was highly likely to be cost-effective over a 3-year horizon compared
with deferred intervention. Early intervention accelerated the healing of venous
leg ulcers and reduced the overall incidence of ulcer recurrence.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: ISRCTN02335796.
DOI: 10.1001/jamasurg.2020.3845
PMCID: PMC7512122
PMID: 32965493 [Indexed for MEDLINE]
Conflict of interest statement: Conflict of Interest Disclosures: Dr Gohel
reported receiving grants from the National Institute for Health Research during
the conduct of the study and personal fees from Medtronic and Cook Medical
outside the submitted work. Dr Epstein reported receiving grants from the
National Institute for Health Research during the conduct of the study. Dr
Heatley reported receiving grants from the National Institute for Health
Research during the conduct of the study. Dr Bradbury reported receiving grants
from the National Institute for Health Research Health Technology Assessment
during the conduct of the study. Dr. Bulbulia reported receiving grants from the
United Kingdom Medical Research Council during the conduct of the study and
outside the submitted work. Dr Cullum reported receiving grants from the
National Institute for Health Research during the conduct of the study. Dr
Nyamekye reported receiving grants from the National Institute for Health
Research during the conduct of the study. Dr Davies reported receiving grants
from the National Institute for Health Research during the conduct of the study.
No other disclosures were reported.
