Cai PL, Hitchman LH, Mohamed AH, Smith GE, Chetter I, Carradice D, et al.
The Cochrane database of systematic reviews. Date of publication 2023 Jul 27;volume 7(7):CD009494.
1. Cochrane Database Syst Rev. 2023 Jul 27;7(7):CD009494. doi:
10.1002/14651858.CD009494.pub3.
Endovenous ablation for venous leg ulcers.
Cai PL(1), Hitchman LH(1), Mohamed AH(1), Smith GE(1), Chetter I(1), Carradice
D(1).
Author information:
(1)Academic Vascular Surgical Unit, Hull York Medical School, Hull University
Teaching Hospitals NHS Trust, Hull, UK.
Update of
Cochrane Database Syst Rev. 2013 Oct 04;(10):CD009494.
BACKGROUND: Venous leg ulcers (VLUs) are a serious manifestation of chronic
venous disease affecting up to 3% of the adult population. This typically
recalcitrant and recurring condition significantly impairs quality of life, and
its treatment places a heavy financial burden upon healthcare systems. The
longstanding mainstay treatment for VLUs is compression therapy. Surgical
removal of incompetent veins reduces the risk of ulcer recurrence. However, open
surgery is an unpopular option amongst people with VLU, and many people are
unsuitable for it. The efficacy of the newer, minimally-invasive endovenous
techniques has been established in uncomplicated superficial venous disease, and
these techniques can also be used in the management of VLU. When used with
compression, endovenous ablation aims to further reduce pressure in the veins of
the leg, which may impact ulcer healing.
OBJECTIVES: To determine the effects of superficial endovenous ablation on the
healing and recurrence of venous leg ulcers and the quality of life of people
with venous ulcer disease.
SEARCH METHODS: In April 2022 we searched the Cochrane Wounds Specialised
Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid
MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and
EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and
unpublished studies, and scrutinised reference lists of relevant included
studies as well as reviews, meta-analyses and health technology reports to
identify additional studies. There were no restrictions on the language of
publication, but there was a restriction on publication year from 1998 to April
2022 as superficial endovenous ablation is a comparatively new technology.
SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing endovenous
ablative techniques with compression versus compression therapy alone for the
treatment of VLU were eligible for inclusion. Studies needed to have assessed at
least one of the following primary review outcomes related to objective measures
of ulcer healing such as: proportion of ulcers healed at a given time point;
time to complete healing; change in ulcer size; proportion of ulcers recurring
over a given time period or at a specific point; or ulcer-free days. Secondary
outcomes of interest were patient-reported quality of life, economic data and
adverse events.
DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed studies for
eligibility, extracted data, carried out risk of bias assessment using the
Cochrane RoB 1 tool, and assessed GRADE certainty of evidence.
MAIN RESULTS: The previous version of this review found no RCTs meeting the
inclusion criteria. In this update, we identified two eligible RCTs and included
them in a meta-analysis. There was a total of 506 participants with an active
VLU, with mean durations of 3.1 months ± 1.1 months in the EVRA trial and 60.5
months ± 96.4 months in the VUERT trial. Both trials randomised participants to
endovenous treatment and compression or compression alone, however the
compression alone group in the EVRA trial received deferred endovenous treatment
(after ulcer healing or from six months). There is high-certainty evidence that
combined endovenous ablation and compression compared with compression therapy
alone, or compression with deferred endovenous treatment, improves time to
complete ulcer healing (pooled hazard ratio (HR) 1.41, 95% CI 1.36 to 1.47; I2 =
0%; 2 studies, 466 participants). There is moderate-certainty evidence that the
proportion of ulcers healed at 90 days is probably higher with combined
endovenous ablation and compression compared with compression therapy alone or
compression with deferred endovenous treatment (risk ratio (RR) 1.14, 95% CI
1.00 to 1.30; I2 = 0%; 2 studies, 466 participants). There is low-certainty
evidence showing an unclear effect on ulcer recurrence at one year in people
with healed ulcers with combined endovenous treatment and compression when
compared with compression alone or compression with deferred endovenous
treatment (RR 0.29, 95% CI 0.03 to 2.48; I2 = 78%; 2 studies, 460 participants).
There is also low-certainty evidence that the median number of ulcer-free days
at one year may not differ (306 (interquartile range (IQR) 240 to 328) days
versus 278 (IQR 175 to 324) days) following combined endovenous treatment and
compression when compared with compression and deferred endovenous treatment; (1
study, 450 participants). There is low-certainty evidence of an unclear effect
in rates of thromboembolism between groups (RR 2.02, 95% CI 0.51 to 7.97; I2 =
78%, 2 studies, 506 participants). The addition of endovenous ablation to
compression is probably cost-effective at one year (99% probability at GBP
20,000/QALY; 1 study; moderate-certainty evidence).
AUTHORS' CONCLUSIONS: Endovenous ablation of superficial venous incompetence in
combination with compression improves leg ulcer healing when compared with
compression alone. This conclusion is based on high-certainty evidence. There is
moderate-certainty evidence to suggest that it is probably cost-effective at one
year and low certainty evidence of unclear effects on recurrence and
complications. Further research is needed to explore the additional benefit of
endovenous ablation in ulcers of greater than six months duration and the
optimal modality of endovenous ablation.
Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons,
Ltd.
DOI: 10.1002/14651858.CD009494.pub3
PMCID: PMC10373122
PMID: 37497816 [Indexed for MEDLINE]
Conflict of interest statement: Paris L Cai: I work as a health professional.
Louise H Hitchman: I work as a health professional. Abduraheem H Mohamed: I work
as a health professional. George E Smith: I have received consultancy fees and
payments/honoraria for lectures from BSN Medical Inc. (now part of Essity
Medical Solutions). Ian Chetter: I work as a health professional. I have worked
as a consultant and developed training materials for the technology companies
Angiodynamics and Medtronic, and I have also been a collaborator/co‐author on
one of the included trials. I was not involved in extracting data or assessing
risk of bias for this trial. Daniel Carradice: I work as a health professional.
I have worked as a consultant and developed training materials for the
technology companies Angiodynamics and Medtronic, and I have also been a
collaborator/co‐author on one of the included trials. I was not involved in
extracting data or assessing risk of bias for this trial.
