Early endovenous ablation improves outcomes in patients with venous leg ulcers

Reference

Gohel MS, Heatley F, Liu X, et al, for the EVRA Trial Investigators. A randomized trial of early endovenous ablation in venous ulceration. N Engl J Med 2018;378(22):2105-2114.

Synopsis

Patients with venous leg ulcers also have varicose veins caused by superficial venous reflux. Endovenous procedures, such as thermal or nonthermal sclerotherapy, to ablate these varicose veins have been shown in a previous trial to reduce the likelihood of venous ulcer recurrence. These researchers recruited adults with an open venous leg ulcer of 6 weeks to 6 months duration, no peripheral arterial disease, and clinically significant superficial venous reflux. In patients with bilateral disease, only the worst leg was included; pregnant patients and those unable to tolerate compression therapy were excluded. Of the more than 6000 patients assessed for eligibility, 450 were randomized to early endovenous ablation (within 2 weeks) or delayed endovenous ablation (after the ulcer had healed, or at 6 months if the ulcer had not healed by that time). All patients received standard compression therapy. Withdrawals were similar between groups, with 10% or fewer unavailable at the 12-month follow-up. The primary outcome was assessed using the intention-to-treat principle. At baseline, groups were similar: 55% were women; 53% had a previous ulcer in the treatment leg; and the groups had a mean age of 68 years, a mean body mass index of 30 kg/m2, and a mean ulcer size of 2.4 cm to 2.9 cm. Ulcer size was evaluated by an observer masked to the treatment assignment, but all other outcomes do not appear to have been assessed in a masked fashion. The early ablation group had better outcomes than the delayed ablation group, with a shorter time to ulcer healing (median 56 days vs 82 days; hazard ratio for healing 1.38; 95% CI 1.13 - 1.68). At 24 weeks, healing was also significantly more likely in the early ablation group (86% vs 76%; number needed to treat = 10). There was no clear difference in quality of life scores. Adverse events related to endovenous ablation included 9 patients with deep vein thrombosis and 6 patients with postprocedural pain in the early ablation group compared with 3 patients and 6 patients, respectively, in the delayed treatment group. Most of the deep vein thromboses were calf vein thromboses discovered incidentally, and only 1 patient had pain classified as severe.