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Venous leg ulcers

ERVA: Endovenous ablation betters compression therapy

After 24 weeks the ulcer healing rates were 85.6 per cent in the group who received rapid treatment, compared to 76.3 per cent in the group who received delayed treatment

Early endovenous ablation of superficial venous reflux as an adjunct to compression therapy is associated with a shorter time to healing of venous leg ulcers than compression therapy alone, according to the firsts results from the Early Venous Reflux Ablation (EVRA) ulcer randomised controlled trial.

The outcomes published in the paper, ‘A Randomized Trial of Early Endovenous Ablation in Venous Ulceration’, in the New England Journal of Medicine, showed that treating leg ulcers within two weeks by endovenous ablation improves healing by 12 per cent, compared to compression therapy alone. The research was led by Imperial College London and funded by the National Institute for Health Research.

It is estimated that the NHS manages 731,000 leg ulcers each year, the majority of which are venous. These leg ulcers are more common in obese people, and in the elderly - around one in 50 people over the age of 80 are thought to have a venous leg ulcer. Because ulcers can take a long time to heal - and lead to serious complications such as amputation - some estimates suggest their treatment and management cost the NHS £1.94 billion a year.

Professor Alun Davies (Credit: Imperial College)

"Leg ulcers can significantly impact on a patient's quality of life and in severe cases can lead to someone losing part of their limb. They also represent a huge cost to the NHS,” said Professor Alun Davies, lead author of the research from the Department of Surgery and Cancer at Imperial. “However, at the moment, most patients are offered only compression stockings without being referred on for treatment that tackles root of the problem - the faulty vein."

Until now there has been no robust trial to assess whether treatments to close the vein are effective – EVRA is the first such randomised controlled trial to do so.

"With this trial we have shown that by intervening early you improve the healing of the leg ulcer, and help a patient recover quicker. We recommend that patients are referred to a vascular clinic upon diagnosis with a venous ulcer, to see if they would be suitable for early treatment," he added.

The EVRA trial was conducted at 20 centres in the United Kingdom and 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 six months after randomisation if the ulcer was unhealed (deferred-intervention group).

The primary outcome was the time to ulcer healing and the 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 randomisation and patient-reported health-related quality of life. The researchers noted that patient and clinical characteristics at baseline were similar in the two treatment groups.

Outcomes

The results demonstrated that time to ulcer healing was shorter in the early-intervention group than in the deferred-intervention group and more patients had healed ulcers with early intervention (p=0.001). The median time to ulcer healing was 56 days (49 to 66) in the early-intervention group and 82 days (69 to 92) in the deferred-intervention group.

In addition, 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 enrolment was 306 days (240 to 328 days) in the early-intervention group and 278 days (175 to 324 days) in the deferred-intervention group (p=0.002). The most common procedural complications of endovenous ablation were pain and deep-vein thrombosis.

The authors acknowledge that all patients in the trial received optimal treatment and say increasing research is needed into the problem of leg ulcers, especially treatment pathways.

"As our population ages, and obesity rises, leg ulcers look set to become an increasing issue for patients and the NHS,” said Francine Heatley, trial manager of the study from the Department of Surgery and Cancer at Imperial. “We need to find the most effective, and cost-efficient, method of treating this condition."

The team added that further analysis showed that early treatment to destroy the vein was cost-effective. This work will be published shortly.

To access this paper, please click here