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Randomized Controlled Trial
. 2019 Jul;106(8):998-1004.
doi: 10.1002/bjs.11187. Epub 2019 May 16.

Randomized clinical trial of endovenous laser ablation versus direct and indirect radiofrequency ablation for the treatment of great saphenous varicose veins

S A S Hamann  1 , L Timmer-de Mik  2 , W M Fritschy  3 , G R R Kuiters  2 , T E C Nijsten  1 , R R van den Bos  1
Affiliations
Randomized Controlled Trial

Randomized clinical trial of endovenous laser ablation versus direct and indirect radiofrequency ablation for the treatment of great saphenous varicose veins

S A S Hamann et al. Br J Surg. 2019 Jul.

Abstract

Background: The current treatment strategy for many patients with varicose veins is endovenous thermal ablation. The most common forms of this are endovenous laser ablation (EVLA) and radiofrequency ablation (RFA). However, at present there is no clear consensus on which of these treatments is superior. The objective of this study was to compare EVLA with two forms of RFA: direct RFA (dRFA; radiofrequency-induced thermotherapy) and indirect RFA (iRFA; VNUS ClosureFast™).

Methods: Patients with symptomatic great saphenous vein (GSV) incompetence were randomized to receive EVLA, dRFA or iRFA. Patients were followed up at 2 weeks, 6 and 12 months. The primary outcome was GSV occlusion rate. Secondary outcomes included Venous Clinical Severity Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ) score and adverse events.

Results: Some 450 patients received the allocated treatment (EVLA, 148; dRFA, 152; iRFA, 150). The intention-to-treat analysis showed occlusion rates of 75·0 (95 per cent c.i. 68·0 to 82·0), 59·9 (52·1 to 67·7) and 81·3 (75·1 to 87·6) per cent respectively after 1 year (P = 0·007 for EVLA versus dRFA, P < 0·001 for dRFA versus iRFA, P = 0·208 for EVLA versus iRFA). VCSS improved significantly for all treatments with no significant differences between them. AVVQ scores also improved significantly for all treatments, but iRFA had significantly better scores than dRFA at 12 months. Significantly more adverse events were reported after treatment with EVLA (103) than after dRFA (61) and iRFA (65), especially more pain.

Conclusion: Primary GSV occlusion rates were better after iRFA and EVLA than dRFA. All three interventions were effective in improving the clinical severity of varicose veins at 1 year.

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Figures

Figure 1
Figure 1
CONSORT flow chart showing patient inclusion *One patient was excluded as the incompetent vein was actually a tributary and not the great saphenous vein. EVLA, endovenous laser ablation; dRFA, direct radiofrequency ablation; iRFA, indirect radiofrequency ablation; PP, per protocol; ITT, intention to treat; LOCF, last observation carried forward.
Figure 2
Figure 2
Adverse events in each treatment group EVLA, endovenous laser ablation; dRFA, direct radiofrequency ablation; iRFA, indirect radiofrequency ablation; SVT, superficial vein thrombosis; DVT, deep vein thrombosis; PE, pulmonary embolism.
See this image and copyright information in PMC

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