Background
Venous disease is the most common cause of leg ulceration. 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. It is
generally accepted that there is considerable global variation in the management of leg ulcers.
Objectives
To determine: the clinical and cost-effectiveness of early endovenous treatment of superficialvenous reflux in addition to standard care compared to standard care alone in patients with venous ulceration; the current standards of global management of venous leg management and the impact on these following the results of the randomised controlled trial.
Methods
i. The Early Venous Reflux Ablation Trial (EVRA) multi-centre randomised clinical trial of
450 participants compared early versus deferred intervention at 12 months and at 3.5 years.
ii. Health professionals treating patients with leg ulcers globally were surveyed before and
after the publication of the RCT results to gain insight on the management of venous leg
ulceration, and subsequent impact on practice.
Results
i. EVRA:
i. time to ulcer healing was shorter in the early group at 12 months; no clear
difference in time to first ulcer recurrence at 3.5 years; early intervention at 3 years is 91%
likely to be cost-effective at £20,000/QALY.
ii. Surveys: ⁃ Pre/post-EVRA UK primary care: 90/643 responses received; Pre/post-EVRA
global clinicians: 799/644 responses were received.
Conclusions
The EVRA RCT showed that early intervention reduces the time to healing of venous leg
ulcers, does not affect the time to recurrent ulceration but is highly likely to be cost-effective
and therefore is beneficial for both patients and healthcare providers. The surveys
demonstrated that the management of venous ulceration is disparate globally. It is likely that
the EVRA RCT results influenced the timing of intervention worldwide.