• Eur J Vasc Endovasc Surg · Oct 2018

    Randomized Controlled Trial

    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.

    • Erdinc Eroglu and Alptekin Yasim.
    • Department of Cardiovascular Surgery, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey. Electronic address: erdinc046@hotmail.com.
    • Eur J Vasc Endovasc Surg. 2018 Oct 1; 56 (4): 553-560.

    ObjectiveTo 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.MethodsThis 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.ResultsThe 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.ConclusionNo 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.Copyright © 2018 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.

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