Early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration: the EVRA RCT and economic evaluation

Background Venous ulceration is a common and costly healthcare issue worldwide, with poor healing rates greatly impacting patient quality of life. Compression bandaging has been shown to improve healing rates and reduce recurrence but does not address the underlying cause, which is often superficial venous reflux. Surgical correction of the reflux reduces ulcer recurrence, but the effect of early endovenous ablation of superficial venous reflux on ulcer healing is unclear. Objective(s) To determine the clinical and cost effectiveness of compression therapy with early endovenous ablation of superficial venous reflux compared with compression therapy with deferred endovenous ablation in patients with venous ulceration. Design A pragmatic, two-arm, multicentre, parallel-group, open randomised controlled trial (RCT) with a health economic evaluation. Setting Secondary care vascular centres within England. Participants Patients aged >= 18 years with a venous leg ulcer of between six weeks and six months duration, an ankle-brachial pressure index (ABPI) ≥0.8 who could tolerate compression and were deemed suitable for endovenous ablation of superficial venous reflux. Interventions Participants were randomised 1:1 to either early (compression therapy and superficial endovenous ablation within two weeks of randomisation) or deferred ablation (compression therapy followed by endovenous ablation once the ulcer had healed).