학술논문

Comparison of cyanoacrylate closure and radiofrequency ablation for the treatment of incompetent great saphenous veins: 36-Month outcomes of the VeClose randomized controlled trial.
Document Type
Article
Source
Phlebology. Jul2019, Vol. 34 Issue 6, p380-390. 11p.
Subject
*VENOUS insufficiency
*ADHESIVES
*CATHETER ablation
*COMPARATIVE studies
*MEDICAL cooperation
*QUALITY of life
*RESEARCH
*SAPHENOUS vein
*RADIO frequency therapy
*RANDOMIZED controlled trials
*TREATMENT effectiveness
*ADVERSE health care events
*DESCRIPTIVE statistics
*VASCULAR closure devices
*THERAPEUTICS
Language
ISSN
0268-3555
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. [ABSTRACT FROM AUTHOR]