A randomized trial of early endovenous ablation in venous ulceration: a critical appraisal

Abstract

Summary Aim Gohel et al. aimed to compare early endovenous ablation vs. deferred endovenous ablation of superficial venous reflux with regard to time to healing of venous leg ulcers, rate of healing at 24 weeks, recurrence rate, ulcer‐free time and health‐related quality of life. Setting and design This multicentre, parallel‐group (ratio 1 : 1), randomized controlled trial was conducted in a vascular surgery department setting at 20 participating centres across the U.K. Study exposure A total of 450 patients with venous leg ulcers were randomly assigned to receive compression therapy and undergo early endovenous ablation of superficial venous reflux within 2 weeks after randomization (early‐intervention group) or to receive 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 (deferred‐intervention group). Outcomes 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. Trial interventions Endovenous laser or radiofrequency ablation, ultrasound‐guided foam sclerotherapy, or nonthermal, nontumescent methods of treatment (such as cyanoacrylate glue or mechanochemical ablation) were performed either alone or in combination. The treating clinical team determined the method and strategy of endovenous treatment. Results The time to ulcer healing was shorter in the early‐intervention group than in the deferred‐intervention group. Furthermore, more patients had healed ulcers with early intervention [hazard ratio for ulcer healing 1·38, 95% confidence interval (CI) 1·13–1·68; P = 0·001]. The median time to ulcer healing was 56 days (95% CI 49–66) in the early‐intervention group and 82 days (95% CI 69–92) in the deferred‐intervention group. The rate of ulcer healing at 24 weeks was 85·6% in the early‐intervention group and 76·3% in the deferred‐intervention group. The median ulcer‐free time during the first year after trial enrolment was 306 days (interquartile range 240–328) in the early‐intervention group and 278 days (interquartile range 175–324) in the deferred‐intervention group (P = 0·002). The most common complications were pain and deep vein thrombosis (DVT) (early‐intervention group: pain, six of 28; DVT, nine of 28; deferred‐intervention group: pain, six of 24; DVT, three of 24). Conclusions Gohel et al. conclude that early endovenous ablation of superficial venous reflux results in faster healing of venous leg ulcers than deferred endovenous ablation. Patients assigned to the early‐intervention group also had longer ulcer‐free time during the first year after randomization.

The role of glue ablation in patients with venous ulcer

“…Non-tumescent-non thermal glue ablation is a new and hopeful technique for treatment of superficial saphenous vein insufficiency. 2 Venous ulceration is the most severe pathology of venous insufficiency, especially in the adult woman and obese populations, 3 and Kanchanabat et al published the benefit of superficial venous intervention in patients with venous leg ulcers. 4 In this study, 24 patients (4%) were in C6 group by CEAP classification, but there are no data about ulcer numbers and size.…”

“…In literature, the compression stockings are the mainstay of treatment for venous ulcers. 3 Why did not the author consider to use compression stockings during the follow-up period for C6 patients?We congratulate Sarac, for his valuable, long-term safe treatment methods of incompetent GSV. We would like to hear the authors' opinions on these matters.…”

“…In literature, the compression stockings are the mainstay of treatment for venous ulcers. 3 Why did not the author consider to use compression stockings during the follow-up period for C6 patients?…”

“…Also in material and methods section, the author stated that “No compression stockings were used after the procedure.” In literature, the compression stockings are the mainstay of treatment for venous ulcers. 3 Why did not the author consider to use compression stockings during the follow-up period for C6 patients?…”