1. Patients with leg ulcers caused by superficial venous reflux treated with compression therapy experienced earlier time to healing if they were treated with early-ablation therapy and opposed to deferred-ablation.
2. For patients whose ulcers had healed within the first year after randomization, ulcer recurrence trended towards being lower in the early-ablation group compared to patients treated with deferred-ablation.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Leg ulceration commonly caused by superficial venous reflux, or varicose veins, is often treated with compression therapy to promote ulcer healing. Endovenous interventions such as sclerotherapy and/or ablation have been utilized with the goal of promoting ulcer healing when combined with compression therapy, though strong randomized trials have not yet supported this practice. The Early Venous Reflux Ablation (EVRA) trial sought to evaluate if early endovenous treatment of superficial venous reflux aids compression therapy in promoting leg ulcer healing. All patients received compression therapy and were then randomized to receive early endovenous ablation or deferred ablation. The primary outcome of time to ulcer healing was significantly shorter in the early ablation group.
Strengths of this study include its multicenter randomized design and follow-up for rates of ulcer recurrence. Limitations include differing methods of ablation used by clinicians and exclusion of patients with longstanding ulcers present for greater than 6 months.
In-Depth [randomized controlled trial]: This multicenter, randomized controlled trial enrolled patients between 2013 and 2016 who were referred to participating vascular surgery departments via established referral pathways. Eligible adult patients had leg ulcers present between 6 weeks and 6 months, an ankle-brachial index of 0.8 or greater, and clinically significant superficial venous reflux. Patients were randomized to early-ablation (n = 224) and deferred-ablation (n = 226) groups. All patients received compression therapy, while those in the early-ablation group had ablation performed within 2 weeks of randomization, while those in the deferred-ablation group had ablation performed after the ulcer healed or 6 months after randomization if the ulcer had not healed. The technique used for ablation was per the clinician decision. The primary outcome of time to ulcer healing was shorter in the early-ablation group (mean time 56 days vs. 82 days; hazard ratio [HR], 1.42; 95% confidence interval [CI], 1.16 to 1.73; p = 0.001). At 24 weeks, ulcer healing was greater in the early-ablation group (85.6% [95% CI, 80.6 to 89.8%] vs. 76.3% [70.5 to 81.7%]). Of patients whose ulcers healed before 1-year post-randomization, ulcers recurred in 11.4% of early-ablation and 16.5% of deferred-ablation patients.
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