Compared with delayed ablation, early endovenous ablation conferred faster healing from leg ulcers due to venous disease and more time free from ulcers, according to findings presented at the Charing Cross International Symposium and published in The New England Journal of Medicine.
For the EVRA trial, researchers randomly assigned 450 patients with venous ulcers in the leg to compression therapy and to undergo early endovenous ablation of superficial venous reflux within 2 weeks of randomization (n = 224; mean age, 67 years; 43% women) or to compression therapy alone with endovenous ablation deferred until the ulcer was healed or after 6 months (n = 226; mean age, 69 years; 47% women).
The primary outcome was time to ulcer healing. Secondary outcomes included rate of ulcer healing at 24 weeks, rate of ulcer recurrence, length of time free from ulcers at 1 year and patient-reported health-related quality of life.
Compared with the deferred group, the early group had shorter median time to ulcer healing (early group, 56 days; 95% CI, 49-66; deferred group, 82 days; 95% CI, 69-92) and had more patients with healed ulcers (HR = 1.38; 95% CI, 1.13-1.68), Manjit S. Gohel, MD, from Cambridge University Hospitals NHS Foundation Trust and the department of surgery and cancer at Imperial College London, and colleagues reported.
The rate of ulcer healing at 24 weeks in the early group was 85.6% vs. 76.3% for the deferred group, according to the researchers.
Median ulcer-free time at 1 year was 306 days (interquartile range, 240-328) in the early group and 278 days (interquartile range, 175-324; P = .002), the researchers found.
Among those who underwent endovenous ablation, the most common adverse events were pain and deep vein thrombosis.
“In the current trial, we found that faster ulcer healing can be attained if an endovenous intervention is performed promptly,” the researchers wrote in NEJM. “This benefit was observed despite the provision of high-quality compression therapy, which might explain the good healing rates observed in both treatment groups.” – by Erik Swain
Gohel MS, et al. Late-breaking trials. Presented at: Charing Cross International Symposium; April 24-27, 2018; London.
Gohel MS, et al. N Engl J Med. 2018;doi:10.1056/NEJMoa1801214.
Disclosure: Gohel reports he received grants from the National Institute for Health Research.