A Randomised Clinical Trial Comparing N-Butyl Cyanoacrylate, Radiofrequency Ablation and Endovenous Laser Ablation for the Treatment of Superficial Venous Incompetence: Two Year Follow up Results

Abstract

Objective: To compare early and two year results for N-butyl cyanoacrylate (NBCA), radiofrequency ablation (RFA), and endovenous laser ablation (EVLA) in the treatment of varicose veins.

Methods: This was a randomised clinical trial. Five hundred and twenty five patients were blindly randomised into NBCA, RFA, and EVLT groups (175 patients to each group; block randomisation using sealed envelopes). Four hundred and fifty six patients were monitored for 2 years (ultrasound at 2 days, and 6, 12, and 24 months). The primary endpoint was the saphenous vein occlusion rates, and the secondary endpoints were peri- and post-procedural pain, complications, and time to return to work. No simultaneous phlebectomies were performed.

Results: The numbers of patients lost to follow up were NBCA seven, RFA 26, and EVLA 36. Occlusion rates were similar at 6, 12, and 24 months (6 months [NBCA 98.1%, RFA 94.1%, and EVLA 95.1%, p = .14], 1 year [NBCA 94.7%, RFA 92.5%, and EVLA 94.2%, p = .72], 2 years [NBCA 92.6%, RFA 90.9%, and EVLA 91.5%, p = .89]). Peri-procedural pain was significantly lower after NBCA (p < .001), but complication rates (DVT, bleeding, and phlebitis) were similar. Time to return to work was shortest after NBCA (NBCA 1.04 days, RFA 1.56 days and EVLA 1.31 days (p < .001) with 95% (NBCA), 50% (RFA) and 75% (EVLA) of patients returning to work on Day 1. Pre-procedural venous clinical severity scores (VCSSs) were the same in all groups. A decrease was observed in VCSS values in all groups at 6 months, and this persisted at 1 and 2 years. However, VCSS scores at 6 months and 2 years were significantly lower in the NBCA group (p < .001). Foam sclerotherapy was subsequently applied to varicose tributaries in 18 patients from all groups.

Conclusion: No differences were observed in occlusion rates between the three modalities, but NBCA appeared superior with respect to peri-procedural pain, return to work and decreased VCSS.

Keywords: Endovenous laser ablation; N-butyl cyanoacrylate; Radiofrequency ablation; Varicose vein.