Patients who underwent early endovenous ablation of superficial venous reflux experienced faster healing of venous leg ulcers and more time free from ulcers than those who had deferred endovenous ablation. The results of the landmark study were reported at Charing Cross 2018 and simultaneously published in the New England Journal of Medicine.
“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,” the authors stated. The investigators conducted the Early Venous Reflux Ablation (EVRA) trial to better determine the role of early endovenous treatment of superficial venous reflux as an adjunct to compression therapy in patients with venous leg ulcers.
The EVRA trial took place at 20 centers in the United Kingdom and involved 450 patients with venous leg ulcers who were randomly assigned to the early- or deferred-intervention group. The early-intervention group received compression therapy and early endovenous ablation of superficial venous reflux within 2 weeks after randomization. The deferred-intervention group considered endovenous ablation after the ulcers had healed or after 6 months had elapsed following randomization if the ulcer was unhealed.
Both primary and secondary outcomes were assessed. Primary outcome was defined as time to ulcer healing, while secondary outcomes were the rate of ulcer healing at 24 weeks, the rate of ulcer recurrence, the length of time free from ulcers during the first year after randomization, and health-related quality of life as reported by patients.
Results showed that the two treatment groups had similar patient and clinical characteristics at baseline. In the early-intervention group, patients had shorter time until ulcer healing (median 52 days) compared with the deferred group (median 82 days). Additionally, more ulcers healed with early intervention. At 24 weeks, the rate of ulcer healing was 85.6% in the early-intervention group, whereas it was 76.3% in the deferred-intervention group.
In the year following trial enrollment, patients in the early-intervention group had a median ulcer-free time of 306 days versus 278 days in the deferred-intervention group. Procedural complications of endovenous ablation most often included pain and deep-vein thrombosis.
“In conclusion, this multicenter, randomized trial showed that early endovenous ablation of superficial venous reflux as an adjunct to compression therapy was associated with a shorter time to healing of venous leg ulcers than compression therapy alone,” the researchers wrote.
Gohel MS, Heatley F, Liu X, et al. A randomized trial of endovenous ablation in venous ulceration. N Engl J Med. 24 April 2018. doi: 10.1056/NEJMoa1801214.