VeClose trial 12-month outcomes of cyanoacrylate closure versus radiofrequency ablation for incompetent great saphenous veins

Abstract

Objective: Endovenous cyanoacrylate closure (CAC) is a new U.S. Food and Drug Administration-approved therapy for treatment of clinically symptomatic venous reflux in saphenous veins. The device is indicated for the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV). Early results from a randomized trial of CAC have been reported previously. Herein we report 1-year outcomes.

Methods: There were 222 subjects with symptomatic GSV incompetence randomly assigned to receive either CAC (n = 108) or radiofrequency ablation (RFA; n = 114). After the month 3 visit, subjects could receive adjunctive therapies aimed at treating visible varicosities and incompetent tributaries. Vein closure was assessed at day 3 and months 1, 3, 6, and 12 using duplex ultrasound. Additional study visit assessments included the Venous Clinical Severity Score; Clinical, Etiology, Anatomy, and Pathophysiology classification; EuroQol-5 Dimension; and Aberdeen Varicose Vein Questionnaire. Both time to closure and time to first reopening of the target vein were evaluated using survival curve analysis. Adverse events were evaluated at each visit.

Results: Of 222 enrolled and randomized subjects, a 12-month follow-up was obtained for 192 (95 CAC and 97 RFA; total follow-up rate, 192/222 [86.5%]). By month 1, 100% of CAC subjects and 87% of RFA subjects demonstrated complete occlusion of the target vein. By month 12, the complete occlusion rate was nearly identical in both groups (97.2% in the CAC group and 97.0% in the RFA group). Twelve-month freedom from recanalization was similar in the CAC and RFA groups, although there was a trend toward greater freedom from recanalization in the CAC group (P = .08). Symptoms and quality of life improved equally in both groups. Most adverse events were mild to moderate and not related to the device or procedure.

Conclusions: In patients with incompetent GSVs, treatment with both CAC and RFA results in high occlusion rates. Time to complete occlusion was faster with CAC, and freedom from reopening was higher after CAC. Quality of life scores improved equally with both therapies.

Trial registration: ClinicalTrials.gov NCT01807585.