Gohel MS, Heatley F, Liu X, Bradbury A, Bulbulia R, Cullum N, Epstein DM, Nyamekye I, Poskitt KR, Renton S, Warwick J, Davies AH, EVRA Trial Investigators., et al.
The New England journal of medicine. Date of publication 2018 May 31;volume 378(22):2105-2114.
1. N Engl J Med. 2018 May 31;378(22):2105-2114. doi: 10.1056/NEJMoa1801214. Epub
2018 Apr 24.
A Randomized Trial of Early Endovenous Ablation in Venous Ulceration.
Gohel MS(1), Heatley F(1), Liu X(1), Bradbury A(1), Bulbulia R(1), Cullum N(1),
Epstein DM(1), Nyamekye I(1), Poskitt KR(1), Renton S(1), Warwick J(1), Davies
AH(1); EVRA Trial Investigators.
Collaborators: Read D, Hargreaves S, Dhillon K, Anwar M, Liddle A, Brown H,
Mercer K, Gill F, Liu A, Jepson W, Wormwell A, Rafferty H, Davies AH, Kaur R,
Solomon E, Sritharan K, Velineni R, Lim CS, Busuttil A, Bootun R, Bicknell C,
Jenkins M, Lane T, Serjeant E, Waldron J, Wolfrey G, Slim F, Davies C, Emerson L,
Grasty M, Whyman M, Wakeley C, Cooper A, Clapp J, Hogg N, Howard J, Dyer J, Lyes
S, Teemul D, Harvey K, Pride M, Kindon A, Price H, Flemming L, Birch G, Holmes H,
Weston J, Joseph T, Eiffel R, Ojimba T, Wilson T, Hodgson A, Robinson L,
Todhunter J, Heagarty D, Mckeane A, McCarthy R, Barwell J, Northcott C, Elstone
A, West C, Chong P, Gerrard D, Croucher A, Levy S, Martin C, Craig T, Carradice
D, Firth A, Clarke E, Oswald A, Sinclair J, Chetter I, El-Sheikha J, Nandhra S,
Leung C, Scott J, Dewhirst N, Woods J, Russell D, Darwood R, Troxler M, Thackeray
J, Bell D, Watson D, Williamson L, Coulston J, Eyers P, Darvall K, Hunter I,
Stewart A, Moss A, Rewbury J, Adams C, Vickery L, Foote L, Durman H, Venn F, Hill
P, James K, Luxton F, Greenwell D, Roberts K, Mitchell S, Tate M, Mills H,
Garnham A, McIntosh D, Green M, Collins K, Rankin J, Poulton P, Isgar V, Trivedi
M, Kafeza M, Parsapour S, Moore H, Najem M, Connarty S, Albon H, Lloyd C, Trant
J, Vohra R, McCormack J, Marshall J, Hardy V, Rogoveanu R, Goff W, Gidda R,
Merotra S, Shiralkar S, Jayatunga A, Pathak R, Rehman A, Randhawa K, Lewis J,
Fullwood S, Jennings S, Cole S, Wall M, Ranaboldo C, Hulin S, Clarke C, Fennelly
R, Cooper R, Boyes R, Draper C, Harris L, Mead D, Kelly L, Bate G, Davies H,
Popplewell M, Claridge M, Gannon M, Khaira H, Scriven M, Wilmink T, Adam D, Nasr
H, Dodd D, Nawaz S, Humphreys J, Barnes M, Sorrell J, Swift D, Phillips P,
Trender H, Fenwick N, Rittoo D, Baker S, Mitchell R, Andrews S, Williams S,
Stephenson J, Holloway S, Hayes W, Day J, Clayton C, Harding D, Thompson A,
Gibson A, Murphy Z, Smith T, Brittenden J, Winterborn RJ, Nelson A, Haynes R,
Ley-Greaves B, Stansby G, Smith F, Flather M, Nunney I.
Author information:
(1)From Cambridge University Hospitals NHS Foundation Trust, Cambridge (M.S.G.),
the Department of Surgery and Cancer (M.S.G., F.H., A.H.D.) and Imperial Clinical
Trials Unit (X.L., J.W.), Imperial College London, London, University of
Birmingham, Birmingham (A.B.), Gloucestershire Hospitals NHS Foundation Trust,
Gloucester (R.B., K.R.P.), the Medical Research Council Population Health
Research Unit and the Clinical Trial Service Unit and Epidemiological Studies
Unit, Nuffield Department of Population Health, University of Oxford, Oxford
(R.B.), University of Manchester, Manchester (N.C.), Worcestershire Acute
Hospitals NHS Trust, Worcester (I.N.), North West London Hospitals NHS Trust,
Harrow (S.R.), and University of Warwick, Coventry (J.W.) - all in the United
Kingdom; and the University of Granada, Granada, Spain (D.M.E.).
BACKGROUND: Venous disease is the most common cause of leg ulceration. Although
compression therapy improves venous ulcer healing, it does not treat the
underlying causes of venous hypertension. Treatment of superficial venous reflux
has been shown to reduce the rate of ulcer recurrence, but the effect of early
endovenous ablation of superficial venous reflux on ulcer healing remains
unclear.
METHODS: In a trial conducted at 20 centers in the United Kingdom, we randomly
assigned 450 patients with venous leg ulcers to receive compression therapy and
undergo early endovenous ablation of superficial venous reflux within 2 weeks
after randomization (early-intervention group) or to receive compression therapy
alone, with consideration of endovenous ablation deferred until after the ulcer
was healed or until 6 months after randomization if the ulcer was unhealed
(deferred-intervention group). The primary outcome was the time to ulcer healing.
Secondary outcomes were the rate of ulcer healing at 24 weeks, the rate of ulcer
recurrence, the length of time free from ulcers (ulcer-free time) during the
first year after randomization, and patient-reported health-related quality of
life.
RESULTS: Patient and clinical characteristics at baseline were similar in the two
treatment groups. The time to ulcer healing was shorter in the early-intervention
group than in the deferred-intervention group; more patients had healed ulcers
with early intervention (hazard ratio for ulcer healing, 1.38; 95% confidence
interval [CI], 1.13 to 1.68; P=0.001). The median time to ulcer healing was 56
days (95% CI, 49 to 66) in the early-intervention group and 82 days (95% CI, 69
to 92) in the deferred-intervention group. The rate of ulcer healing at 24 weeks
was 85.6% in the early-intervention group and 76.3% in the deferred-intervention
group. The median ulcer-free time during the first year after trial enrollment
was 306 days (interquartile range, 240 to 328) in the early-intervention group
and 278 days (interquartile range, 175 to 324) in the deferred-intervention group
(P=0.002). The most common procedural complications of endovenous ablation were
pain and deep-vein thrombosis.
CONCLUSIONS: Early endovenous ablation of superficial venous reflux resulted in
faster healing of venous leg ulcers and more time free from ulcers than deferred
endovenous ablation. (Funded by the National Institute for Health Research Health
Technology Assessment Program; EVRA Current Controlled Trials number,
ISRCTN02335796 .).
DOI: 10.1056/NEJMoa1801214
PMID: 29688123 [Indexed for MEDLINE]
