Comparison of cyanoacrylate closure and radiofrequency ablation for the treatment of incompetent great saphenous veins: 36-Month outcomes of the VeClose randomized controlled trial

Abstract

Objective To evaluate the 36-month efficacy and safety of cyanoacrylate closure for the treatment of incompetent great saphenous veins in comparison with radiofrequency ablation. Methods In this multicenter, prospective, randomized controlled trial, 222 symptomatic subjects with incompetent great saphenous veins were assigned to either cyanoacrylate closure or radiofrequency ablation. The primary endpoint, complete closure of the target great saphenous vein, was determined using duplex ultrasound examination starting from three-month visit. Results At month 36, the great saphenous vein closure rates were 94.4% for the cyanoacrylate closure group and 91.9% for the radiofrequency ablation group. Stable improvement in symptoms and quality of life was observed in both groups. Adverse event rates between the 24- and 36-month visits were similar between the groups as were serious adverse events which were infrequent and judged unrelated to either the device or the procedure in both groups. Conclusions This trial continues to demonstrate the safety and efficacy of cyanoacrylate closure for the treatment of great saphenous vein incompetence with great saphenous vein closure rate at 36 months similar to that of radiofrequency ablation, indicating non-inferiority of cyanoacrylate closure to radiofrequency ablation. The improvement in quality of life outcomes were also sustained and similar between the two treatment groups.

NTNT Methods – Efficacy and Safety Issue

“…Several studies have shown that CAC is effective with cumulative occlusion rates comparable to those for EVTA in the early and midterm observations. [3][4][5][6][7][8][9][10] In the first-in-men prospective study by Almeida et al, a 36-month occlusion rate was 94.7 % in 29 out of 38 patients with great saphenous vein (GSV) incompetence and a vein diameter of 3-12 mm. [3] A subsequent multicenter European trial (eSCOPE) presented by Proebstle et al enrolling 70 subjects with GSV incompetence and a vein diameter of 6.6-14 mm showed a 12-month occlusion rate of 92.9 %.…”

“…[12] Comparison with thermal ablation A few RCTs compared CAC with EVTA. [4,6,8] In RCT by Çalık et al including 400 patients with GSV incompetence, CAC was compared with endovenous laser ablation (EVLA) and at 12-month follow-up the occlusion rate was 96.6 % and 94.1 %, respectively. [4] The VeClose multicenter RCT, involving 10 centers in USA and 222 patients with GSV reflux in veins up to 12 mm in diameter has shown that CAC was noninferior to radiofrequency ablation (RFA), because the 36-month occlusion rate for CAC was 94.4 % and for RFA, 91.9 %.…”

“…[4] The VeClose multicenter RCT, involving 10 centers in USA and 222 patients with GSV reflux in veins up to 12 mm in diameter has shown that CAC was noninferior to radiofrequency ablation (RFA), because the 36-month occlusion rate for CAC was 94.4 % and for RFA, 91.9 %. [8] Another RCT compared CAC with EVLA and RFA in 525 patients and found 24-month occlusion rates of 94.7 %, 90.9 % and 91.5 % after CAC, RFA and EVLA, respectively. [6] A systematic review and meta-analysis by Hassanin et al has also shown that there was no significant difference in outcomes, when CAC was compared with EVLA and RFA (RR, 1.02; 95 % CI, 0.94-1.11).…”

“…[6] A systematic review and meta-analysis by Hassanin et al has also shown that there was no significant difference in outcomes, when CAC was compared with EVLA and RFA (RR, 1.02; 95 % CI, 0.94-1.11). [13] Clinical and quality of life assessment All studies on CAC, reporting the Venous Clinical Severity Score (VCSS) found a significant or clinically relevant reduction in these scores after treatment, compared with the baseline value [3,9,10], with no statistical difference between EVTA techniques and CAC in comparative studies, [4,8,13] with an exception of RCT by Eroglu et al, where VCSS scores were significantly lower in the CAC group than in EVTA groups at 6-month and 2-year follow-up (p < 0.001). [6] The HLQoL, measured by Aberdeen Varicose Vein Questionnaire (AVVQ), EQ-D5 quality of life survey and Chronic Venous Insufficiency Quality of Life Questionnaire (CVIQ), improved significantly after CAC in all studies.…”

“…No statistical difference between EVTA techniques and CAC was found in any comparative studies. [4,6,[8][9][10]13] Both clinical and HLQoL assessment reminded improved at all follow-up intervals in all studies reporting these patient-reported outcomes.…”