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

Abstract

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).