Randomized clinical trial of VNUS® ClosureFAST radiofrequency ablation versus laser for varicose veins

Authors

  • A. C. Shepherd,

    1. Imperial Vascular Unit, Department of Surgery, Division of Surgery and Cancer, Imperial College, Charing Cross Hospital, London, UK
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  • M. S. Gohel,

    1. Imperial Vascular Unit, Department of Surgery, Division of Surgery and Cancer, Imperial College, Charing Cross Hospital, London, UK
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  • L. C. Brown,

    1. Imperial Vascular Unit, Department of Surgery, Division of Surgery and Cancer, Imperial College, Charing Cross Hospital, London, UK
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  • M. J. Metcalfe,

    1. Imperial Vascular Unit, Department of Surgery, Division of Surgery and Cancer, Imperial College, Charing Cross Hospital, London, UK
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  • M. Hamish,

    1. Imperial Vascular Unit, Department of Surgery, Division of Surgery and Cancer, Imperial College, Charing Cross Hospital, London, UK
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  • Professor A. H. Davies

    Corresponding author
    1. Imperial Vascular Unit, Department of Surgery, Division of Surgery and Cancer, Imperial College, Charing Cross Hospital, London, UK
    • 4 East Department of Vascular Surgery, Charing Cross Hospital, Fulham Palace Road, London W6 8RF, UK
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  • Based on an abstract presented to the Annual Meeting of the Vascular Society of Great Britain and Ireland, Liverpool, UK, November 2009, that was awarded the Venous Forum Prize and published as Br J Surg 2010; 97(Suppl 1): 13

Abstract

Background:

Endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) are both associated with excellent technical, clinical and patient-reported outcomes for the treatment of varicose veins. The aim of this study was to compare the techniques in a randomized clinical trial.

Methods:

Consecutive patients with primary great saphenous vein reflux were randomized to EVLA (980 nm) or RFA (VNUS® ClosureFAST) at a single centre. The primary outcome measure was postprocedural pain after 3 days. Secondary outcome measures were quality of life at 6 weeks, determined by the Aberdeen Varicose Vein Questionnaire (AVVQ) and Short Form 12 (SF-12®), and clinical improvement assessed by the Venous Clinical Severity Score (VCSS). Analyses were performed on the basis of intention to treat using multivariable linear regression.

Results:

Some 131 patients were randomized to EVLA (64 patients) or RFA (67). Mean(s.d.) pain scores over 3 days were 26·4(22·1) mm for RFA and 36·8(22·5) mm for EVLA (P = 0·010). Over 10 days, mean(s.d.) pain scores were 22·0(19·8) mm versus 34·3(21·1) mm for RFA and EVLA respectively (P = 0·001). The mean(s.d.) number of analgesic tablets used was lower for RFA than for EVLA over 3 days (8·8(9·5) versus 14·2(10·7); P = 0·003) and 10 days (20·4(22·6) versus 35·9(29·4) respectively; P = 0·001). Changes in AVVQ, SF-12® and VCSS scores at 6 weeks were similar in the two groups: AVVQ (P = 0·887), VCSS (P = 0·993), SF-12® physical component score (P = 0·276) and mental component score (P = 0·449).

Conclusion:

RFA using VNUS® ClosureFAST was associated with less postprocedural pain than EVLA. However, clinical and quality-of-life improvements were similar after 6 weeks for the two treatments. Registration number: ISRCTN66818013 (http://www.controlled-trials.com). Copyright © 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

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