Randomised Clinical Trials Comparing Cyanoacrylate Closure with Surgical Stripping and Endovenous Thermal Ablation for Chronic Venous Disease.

Abstract

Chronic venous disease affects > 40% of adults. The effectiveness of cyanoacrylate closure for the treatment of saphenous vein reflux compared with current global standard modalities remains unclear. The aim of this study was to assess patient centred and traditional venous outcomes comparing cyanoacrylate closure with surgical stripping and endothermal ablation, two global standards of care. VenaSeal Spectrum randomised controlled trials (RCTs) are prospective, global, multicentre, 1:1 randomised studies evaluating the VenaSeal cyanoacrylate closure system for patients with chronic venous disease. Participants were enrolled in 23 centres across four continents. In the first RCT, 106 participants were randomly assigned to receive cyanoacrylate closure or surgical stripping. In the second RCT, 275 participants were randomly assigned to receive cyanoacrylate closure or endothermal ablation. The primary outcomes were patient satisfaction through 30 days using the peri- and post-procedural Venous Treatment Satisfaction Questionnaire (VenousTSQ), and proportion of saphenous reflux treated in each target vein. Adverse events were adjudicated by an independent committee and reported through 6 months. Traditional venous outcomes are evaluated as secondary outcomes. In both studies, baseline characteristics were similar between groups. Peri-procedural patient satisfaction at 30 days was greater in participants randomised to cyanoacrylate closure compared with surgical stripping (venous treatment satisfaction score 29.3 ± 4.94 vs. 25.0 ± 6.24, p = .001), but post-procedure patient satisfaction at 30 days and proportion of superficial truncal reflux treated were similar. There was no statistical difference detected in the three primary endpoints comparing cyanoacrylate closure and endothermal ablation. Overall adverse event rates were low, with the most common adverse events following cyanoacrylate being mild to moderate hypersensitivity, which was self limiting. Cyanoacrylate closure for treatment of saphenous reflux resulted in superior peri-procedural patient treatment satisfaction compared with surgical stripping. Patient satisfaction and proportion of superficial reflux treated after cyanoacrylate closure were comparable to endothermal ablation. https://www. gov, unique identifier NCT03820947.