Comparison of Endovenous Radiofrequency Ablation, Laser Ablation, Foam Sclerotherapy and Surgical Stripping for Great Saphenous Varicose Veins. Extended 5-Year Follow-up of a RCT

Abstract

Background: This study compares the outcome 5 years after treatment of varicose veins with endovenous radiofrequency ablation (RFA), endovenous laser ablation (EVLA), ultrasound guided foam sclerotherapy (UGFS) or high ligation and stripping (HL/S) by assessing efficacy, clinical recurrence and the rate of reoperations. Methods: A total of 500 patients (580 legs) with Great Saphenous Vein (GSV) reflux and varicose veins were randomized to one of the 4 treatments. Follow-up included clinical and duplex ultrasound examinations. Results: During 5 years the highest rate of GSV recanalization was seen in the UGFS group. Thus 8 in the RFA group (Kaplan Meier (KM) estimate 5.8 %), 8 in the EVLA group (KM estimate 6.8 %), 37 (KM estimate 31.5 %) in the UGFS group and 8 in the HL/S group (KM estimate 6.3 %) of GSVs recanalized or had a failed stripping procedure (P < .001). Nineteen (KM estimate 18.7 %), 42 (KM estimate 38.6 %), 28 (KM estimate 31.7 %) and 38 (KM estimate 34.6 %) legs developed recurrent varicose veins, respectively (P < 0.001). Within 5 years after treatment, 19 (KM estimate 17 %), 19 (KM estimate 18.7 %), 43 (KM estimate 37.7 %) and 25 (KM estimate 23.4 %) legs were retreated in the RFA, EVLA, UGFS and HL/S groups (P < .001). Conclusion: Our study showed, that more recanalizations of the GSV occurred after UGFS and no difference in the technical efficacy was found between the other modalities during a 5-year follow-up period. The higher frequency of clinical recurrence after EVLA requires confirmation in other studies.