大伏在静脈瘤に対するグルーアブレーション療法の有効性：無作為化並行比較多施設非劣性試験

Treatment for varicose veins has transitioned from invasive surgical interventions to minimally invasive, targeted, and personalized procedures. Limited data exist on the longterm outcomes of glue ablation (GA) as a new minimally invasive treatment. This study was conducted to evaluate the long-term safety and efficacy of GA for varicose veins.

Data were collected in a multicenter, prospective registry. Patients were randomly allocated to the experimental group (GA) or the control group (radiofrequency ablation [RFA]). The follow-up assessments were conducted at 7 days, 30 days, 3 months, 6 months, and 12 months after surgery. The non-inferiority of GA to RFA was assessed based on the primary outcome of the rate of complete great saphenous vein (GSV) closure at 3 months. Additional outcomes included the rate of complete GSV closure at 12 months, procedural duration, pain score, ecchymosis, and preoperative and postoperative Venous Clinical Severity Score and Aberdeen Varicose Vein Questionnaire Score.

Overall, 177 patients were treated (experimental group, n = 89; control group, n = 88). The mean age was 56.25 ± 12.23 years, and 61.58% were female. The mean target vessel diameter was 7.94 ± 2.09 mm, with a maximum diameter of 12 mm. The GA group did not experience any device-related adverse complications. Tumescent fluid was utilized in the RFA group but not in the GA group. GA was statistically non-inferior to RFA (lower boundary of the 95% confidence interval [CI] for the absolute difference in the mean rate of 3-month complete GSV closure did not reach the non-inferiority margin of -10%) (absolute difference -0.03%; one-sided 95% CI -3.19%; P < 0.001). The GSV closure rate at 12 months was higher in the GA group than in the RFA group (absolute difference 7.04%; one-sided 95% CI 1.09%). The GA group exhibited a significantly longer surgical duration than the RFA group (P = 0.031). The comparisons of other secondary endpoints between the groups did not yield any significant findings.

The 3-month rate of complete GSV closure with GA was non-inferior to that with RFA in the treatment of varicosity, but the surgical duration was longer. The efficacy of GA therapy still requires validation through large-scale clinical trials with long-term follow-up periods.