Morrison N, Kolluri R, Vasquez M, Madsen M, Jones A, Gibson K, et al.
Phlebology. Date of publication 2019 Jul 1;volume 34(6):380-390.
1. Phlebology. 2019 Jul;34(6):380-390. doi: 10.1177/0268355518810259. Epub 2018
Nov 7.
Comparison of cyanoacrylate closure and radiofrequency ablation for the
treatment of incompetent great saphenous veins: 36-Month outcomes of the VeClose
randomized controlled trial.
Morrison N(1), Kolluri R(2), Vasquez M(3), Madsen M(4), Jones A(5), Gibson K(6).
Author information:
(1)1 Center for Vein Restoration, Morrison Vein Institute, Scottsdale, AZ, USA.
(2)2 OhioHealth, Riverside Methodist Hospital, Columbus, USA.
(3)3 Venous Institute of Buffalo, Buffalo, USA.
(4)4 Medtronic Santa Rosa, Santa Rosa, USA.
(5)5 Inovia Vein Specialty Center, Bend, USA.
(6)6 Lake Washington Vascular, Bellevue, USA.
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.
DOI: 10.1177/0268355518810259
PMCID: PMC6587361
PMID: 30403154 [Indexed for MEDLINE]
