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A randomized trial of early endovenous ablation in venous ulceration
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Gohel, Manjit S., Heatley, Francine, Liu, Xinxue, Bradbury, Andrew, Bulbulia, Richard, Cullum, Nicky, Epstein, David M., Nyamekye, Isaac, Poskitt, Keith R., Renton, Sophie , Warwick, Jane and Davies, Alun H. (2018) A randomized trial of early endovenous ablation in venous ulceration. New England Journal Of Medicine . doi:10.1056/NEJMoa1801214 (In Press)
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Official URL: http://dx.doi.org/10.1056/NEJMoa1801214
Abstract
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.
| Item Type: | Journal Article | ||||||
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| Subjects: | R Medicine > RC Internal medicine | ||||||
| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit Faculty of Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Veins -- Diseases -- Treatment, Leg -- Ulcers -- Treatment, Clinical trials | ||||||
| Journal or Publication Title: | New England Journal Of Medicine | ||||||
| Publisher: | Massachusetts Medical Society | ||||||
| ISSN: | 0028-4793 | ||||||
| Official Date: | 24 April 2018 | ||||||
| Dates: |
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| Date of first compliant deposit: | 26 April 2018 | ||||||
| DOI: | 10.1056/NEJMoa1801214 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | In Press | ||||||
| Access rights to Published version: | Restricted or Subscription Access | ||||||
| RIOXX Funder/Project Grant: |
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