Prompt endovenous ablation shortens leg ulcer healing time
Early treatment of superficial venous reflux (varicose veins) with endovenous ablation and compression therapy shortened healing time of venous leg ulcers compared with compression therapy either alone or in addition to delayed ablation, according to the EVRA* trial.
“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,” said study lead author Professor Alun Davies from the Department of Surgery and Cancer at Imperial College London, London, UK.
In this multicentre (20 centres in the UK) trial, 450 patients with open venous leg ulcers (present for 6 weeks to 6 months) were randomized to either an early intervention (compression therapy and endovenous ablation of superficial venous reflux within 2 weeks of randomization; n=224, mean age 67.0 years, 43.3 percent female) or deferred intervention (compression therapy only with endovenous ablation considered after healing of ulcer or 6 months post-randomization for unhealed ulcer; n=226, mean age 68.9 years, 46.9 percent female).
A total of 389 patients underwent endovenous ablation within 1 year of randomization. The most common interventions were foam sclerotherapy alone (49.6 and 44.2 percent in the early and deferred intervention groups, respectively) and endothermal ablation alone (31.7 and 23.9 percent, respectively).
A greater proportion of patients who received early intervention had healed ulcers (hazard ratio [HR], 1.38, 95 percent confidence interval [CI], 1.13–1.68; p=0.001), with a shorter time to ulcer healing observed in the early vs deferred intervention group (median, 56 vs 82 days). [N Engl J Med 2018;378:2105-2114]
Patients who received early intervention also had a superior rate of ulcer healing at 24 weeks compared with those who received deferred intervention (85.6 percent vs 76.3 percent), while the length of time without ulcers in the first year following randomization was longer among those who received early vs deferred intervention (median, 306 vs 278 days; p=0.002).
Within 1 year of randomization, 93.8 and 85.8 percent of patients in the early and deferred intervention groups, respectively, had healed ulcers, with a lower rate of recurrence within 1 year among patients assigned the early vs the deferred intervention (11.4 percent vs 16.5 percent).
The most frequently occurring procedural complications of ablation were pain and deep vein thrombosis.
“Pathways of care for leg ulcers, in general, do not include a provision for early assessment and treatment of superficial venous reflux,” said the researchers. “[W]orldwide, many patients with venous leg ulcers are not assessed or treated for superficial venous reflux, possibly because of the perception that treatment for varicose veins does not improve ulcer healing,” they said.
“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. 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,” said Davies.
As the clinicians were given the option to choose the procedure they considered the most suitable for their patients, the best method of ablation is yet undetermined, particularly pertaining to the impact on ulcer recurrence, said the researchers. Furthermore, patients who received early intervention were required to undergo follow-up duplex ultrasonography 6 weeks postintervention, which could have resulted in repeated procedures culminating in a higher success rate compared with those who received deferred treatment, they said.