A multicenter randomized controlled trial evaluating a new radiofrequency ablation system in the treatment of primary great saphenous vein incompetence: Six-month results of the ACOART RF CLOSURE study

Background Radiofrequency ablation (RFA) has been recommended as the first-line treatment with primary great saphenous vein (GSV) incompetence. A multicenter randomized controlled trial was performed to evaluate the performance, efficacy, and safety of the new radiofrequency ablation system (AcoArt Cedar TM ) with ClosureFast TM RFA system (Medtronic). Methods Consecutive eligible patients with primary GSV incompetence were randomized 1:1 to treatment with AcoArt Cedar TM or ClosureFast TM at multiple sites. The primary endpoint was the total occlusion rate of GSV 6 months after the procedure. Secondary outcomes included device success, immediate technical success, performance evaluation of the devices, and the mean change of the Revised Venous Clinical Severity Score (VCSS) and Aberdeen Varicose Vein Questionnaire (AVVQ) scores from baseline to 6 months post-treatment. Safety endpoint was device-related adverse events (AEs). All adverse events were recorded in the study. Results A total of 188 eligible patients were randomly assigned to treatment with AcoArt Cedar TM or ClosureFast TM . All patients achieved 100% device and immediate technical success. The performance of the RFA catheter and generator was evaluated as excellent for both groups. The total GSV occlusion rates at 6 months were 97.78% (88/90) versus 98.86% (87/88) for AcoArt Cedar TM and ClosureFast TM , respectively ( p = 1.000). Changes in AVVQ and VCSS scores from baseline to 6 months after treatment were similar in the two groups: AVVQ ( p = 0.802) and VCSS ( p = 0.984). Procedure-related adverse events occurred in 9.6% (9/94) versus 7.5% (7/93) of patients, for AcoArt Cedar TM and ClosureFast TM , respectively ( p = 0.9928). No device-related AEs or SAEs were found. Conclusion The AcoArt Cedar TM is a device associated with non-inferior effectiveness and safety compared to ClosureFast TM , with similar complete occlusion rates in the GSV with a low incidence of AEs. Trial registry name ClinicalTrials.gov ; URL: https://clinicaltrials.gov/study/NCT04658901?term=NCT04658901&rank=1 ; registration number: NCT04658901.