A randomized trial of early endovenous ablation in venous ulceration

New England Journal of Medicine Apr 30, 2018

Gohel MS, et al. - Researchers determined the impact of early endovenous ablation of superficial venous reflux on venous ulcer healing. Early endovenous ablation of superficial venous reflux vs deferred endovenous ablation provided faster healing and more time free from ulcers.

Methods

  • Researchers performed a trial at 20 centers in the United Kingdom.
  • Study participants were 450 patients with venous leg ulcers.
  • Patients were divided into early-intervention group or deferred-intervention group.
  • The early-intervention group received compression therapy and underwent early endovenous ablation of superficial venous reflux within 2 weeks after randomization while deferred-intervention group received compression therapy alone, with consideration of endovenous ablation deferred until after the ulcer was healed or until 6 months after randomization if the ulcer was unhealed.
  • The primary outcome was the time to ulcer healing.
  • Secondary outcomes were the rate of ulcer healing at 24 weeks, the rate of ulcer recurrence, the length of time free from ulcers (ulcer-free time) during the first year after randomization, and patient-reported health-related quality of life.

Results

  • The two treatment groups showed similar patient and clinical characteristics at baseline.
  • In the early-intervention group vs in the deferred-intervention group, shorter time to ulcer healing was observed; more patients had healed ulcers with early intervention (hazard ratio for ulcer healing, 1.38; 95% confidence interval [CI], 1.13 to 1.68; P=0.001).
  • In the early-intervention group and the deferred-intervention group, the median time to ulcer healing was 56 days (95% CI, 49 to 66) and 82 days (95% CI, 69 to 92), respectively.
  • In the early-intervention group and in the deferred-intervention group, the reported rate of ulcer healing at 24 weeks was 85.6% and 76.3%, respectively.
  • After trial enrollment, the observed median ulcer-free time during the first year was 306 days (interquartile range, 240 to 328) in the early-intervention group and 278 days (interquartile range, 175 to 324) in the deferred-intervention group (P=0.002).
  • Pain and deep-vein thrombosis were identified as the most common procedural complications of endovenous ablation.

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