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Results of the EVRA trial will be a game-changer for the management of every venous ulcer

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The prevalence of venous leg ulceration (VLU) in the adult population is up to 3% with higher prevalence seen with increasing age and female gender. Active ulceration has a profound… Click to show full abstract

The prevalence of venous leg ulceration (VLU) in the adult population is up to 3% with higher prevalence seen with increasing age and female gender. Active ulceration has a profound detrimental effect upon the quality of life and is associated with significant pain and mobility restriction limiting a patient’s physical and social roles. Mean lifetime with a venous ulcer is between 5–10 years. 1–3% of the western healthcare budget is spent on managing this condition because of its chronic and relapsing nature. The gold standard of care until now for VLU has been compression bandaging with initial ulcer healing rates in excess of 70% at six months, but subsequently 25% of these ulcers recur by one year. The Effect of Surgery and Compression on Healing And Recurrence (ESCHAR) trial from the late 1990s showed that ulcer recurrence was significantly reduced for patients who had superficial venous surgery in combination with compression therapy compared to those who had compression alone (31% vs. 56% leg ulcer recurrence at four years) but did not show improved ulcer healing rate. A number of factors may have reduced the benefit of surgery on overall time to achieve ulcer healing in this landmark trial. One perception was the lack of statistical power in which participants with healed rather than open active ulcers predominated. The analysis was performed on an intention to treat principle and 19% of those randomized to the surgery arm did not receive an intervention, because a lot of patients with venous ulcer disease were elderly with significant co-morbidities and were deemed not fit for a general anaesthetic. In those who underwent surgery, the majority did not have their superficial venous reflux eliminated, and perforator disease was not primarily treated because of the limitations of open surgery. Furthermore, surgery was delayed on average for 7 weeks out of the 24-week ulcer healing phase of the study. This led to a widely held view until now that superficial venous surgery can be deferred until the leg ulcer had healed and on the grounds of increased risk of wound infection, although the ESCHAR trial only showed a 2% wound infection rate in those treated with surgery. The recent publication of the primary results of the Early Venous Reflux Ablation (EVRA) multicentre trial has changed the VLU landscape and will renew the interest for early ablation of superficial venous reflux for CEAP 6 disease. The world of VLU enthusiasts has finally gained significant Level 1 evidence that has the potential to change the clinical practice worldwide. EVRA was a non-commercial study conducted at 20 National Health Service (NHS) hospitals across the UK and randomised 450 patients with active venous ulceration of less than six months duration to two groups; the first to receive therapeutic compression therapy and early endovenous ablation of their superficial venous reflux within two weeks of randomisation and the other group to receive compression alone. This group received deferred endovenous intervention once the ulcer was healed. Those who had early endovenous intervention as an adjunct to compression therapy demonstrated faster healing time, rate of ulcer healing at six months, median ulcer-free time and decreased recurrence of their VLU. The investigators are to be congratulated on a monumental effort over the past five years, culminating in a landmark trial in vascular surgery, which will likely be a game changer and have a global impact as to how venous ulcers should now be treated – patients should have an expedited vascular assessment and offered early intervention to ablate their superficial venous reflux. Patient and care provider education is now essential. This is borne out by the fact

Keywords: compression; surgery; trial; venous ulcer; ulcer healing; superficial venous

Journal Title: Phlebology
Year Published: 2018

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