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Reference: EVRA trial (N Engl J Med 2018 Apr 24 early online) (level 1 [likely reliable] evidence)
- Endovenous ablation for superficial venous reflux (SVR) in addition to compression therapy has been shown to prevent ulcer recurrence in patients with recent or current venous leg ulcers.
- To evaluate endovenous ablation for ulcer healing, 450 adults with current ulcers and SVR were randomized to compression therapy with early vs. deferred endovenous ablation.
- Ulcers healed at median 56 days with early ablation vs. 82 days with deferred ablation (adjusted hazard ratio 1.42, 95% CI 1.16-1.73).
Superficial venous reflux (SVR) is often observed in patients with venous ulcers and may contribute to ulcer formation (J Vasc Surg 2014). Endovenous ablation for SVR may prevent venous ulcer recurrence when added to routine compression therapy for venous ulcers (Lancet 2004), but there is limited evidence evaluating ulcer healing after ablation (J Vasc Surg 2014). In the recent EVRA trial, 450 adults with open venous leg ulcers for 1.5 to 6 months and clinically significant SVR were randomized to routine compression therapy plus early vs. deferred endovenous ablation. Early endovenous ablation occurred within 2 weeks of randomization. For patients allocated to deferred ablation, ablation was offered (but not required) after the ulcer had healed or after 6 months for unhealed ulcers. The endovenous ablation regimen was determined by the treating clinical team. Patients ineligible for compression therapy were excluded. Outcome assessors evaluating ulcer healing over this year-long trial were blinded to group allocation, but patients and treating clinicians were not. Endovenous ablation was ultimately performed in 97% of patients allocated to early ablation and 76% allocated to deferred ablation, with the most common procedures being foam sclerotherapy (in 47% of all patients) and endothermal ablation (28%).
Venous ulcers healed at a faster rate among patients allocated to early endovenous ablation: the median time to heal was 56 days with early ablation vs. 82 days with deferred ablation (adjusted hazard ratio 1.42, 95% CI 1.16-1.73), and ulcer healing within 1 year occurred in 93.8% vs. 85.8% (p < 0.05, NNT 13). There were no significant differences in disease-specific and generic quality of life questionnaire scores. The most common ablation-related adverse events were deep vein thrombosis (in 3% of all patients who had ablation), pain (3%), infection (2%), and allergic reaction not requiring systemic treatment (2%).
The EVRA trial demonstrated that endovenous ablation added to compression therapy increases venous leg ulcer healing in patients with ulcers and SVR. A possible source of bias is that there may have been differences in patient and caregiver behavior between the two groups: patients and caregivers weren’t blinded to treatment allocation and a follow-up ultrasound assessment was performed after early ablation but was not required after deferred ablation. Also, there is some concern regarding generalizability—before the target sample size of 450 patients was reached, over 5,600 screened patients were excluded, most commonly for ulcer duration > 6 months. While the limitations add a small amount of uncertainty to the results of this trial, endovenous ablation for SVR is a relatively safe procedure that should be considered in addition to compression therapy to hasten venous leg ulcer healing.
For more information, see the topic Venous ulcer in DynaMed Plus. DynaMed users click here.