Comparison of endovenous ablation techniques, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Extended 5-year follow-up of a RCT.

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 technical efficacy, clinical recurrence and the rate of reoperations. METHODS: Five hundred 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 there was a difference in the rate of GSV recanalization, recurrence and reoperations across the groups, KM P<0.001, P<0.01, P<0.001 respectively. 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. Nineteen (RFA) (KM estimate 18.7%), 42 (EVLA) (KM estimate 38.6%), 28 (UGFS) (KM estimate 31.7%) and 38 (HL/S) (KM estimate 34.6%) legs developed recurrent varicose veins. Within 5 years after treatment, 19 (RFA) (KM estimate 17%), 19 (EVLA) (KM estimate 18.7%), 43 (UGFS) (KM estimate 37.7%) and 25 (HL/S) (KM estimate 23.4%) legs were retreated. CONCLUSIONS: More recanalization's of the GSV occurred after UGFS and no difference in the technical efficacy was found between the other modalities during 5-year follow-up. The higher frequency of clinical recurrence after EVLA and HL/S cannot be explained and requires confirmation in other studies.

Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy, and surgical stripping for great saphenous varicose veins with 3-year follow-up.

INTRODUCTION: This study compares the outcome 3 years after treatment of varicose veins by endovenous laser ablation (EVLA), radiofrequency ablation, ultrasound-guided foam sclerotherapy (UGFS), or surgery by assessing recurrence, Venous Clinical Severity Score (VCSS), and quality of life (QOL). METHODS: A total of 500 patients (580 legs) were randomized to one of the three endovenous treatments or high ligation and stripping of the great saphenous vein (GSV). Follow-up included clinical and duplex ultrasound examinations and VCSS and QOL questionnaires. Kaplan-Meier (KM) life-table analysis was used. P values below .05 were considered statistically significant. RESULTS: At 3 years, eight (KM estimate, 7%), eight (KM estimate, 6.8%), 31 (KM estimate, 26.4%), and eight (KM estimate, 6.5%) of GSVs recanalized or had a failed stripping procedure (more than 10 cm open refluxing part of the treated GSV; CLF, EVLA, UGFS, and stripping, respectively; P < .01). Seventeen (KM estimate, 14.9%), 24 (KM estimate, 20%), 20 (KM estimate, 19.1%), and 22 (KM estimate, 20.2%) legs developed recurrent varicose veins (P = NS). The patterns of reflux and location of recurrent varicose veins were not different between the groups. Within 3 years after treatment, 12 (KM estimate, 11.1%), 14 (KM estimate, 12.5%), 37 (KM estimate, 31.6%), and 18 (KM estimate, 15.5%) legs were retreated in the CLF, EVLA, UGFS, and stripping groups, respectively (P < .01). VCSS, SF-36, and Aberdeen QOL scores improved significantly in all the groups with no difference between the groups. CONCLUSIONS: All treatment modalities were efficacious and resulted in a similar improvement in VCSS and QOL. However, more recanalization and reoperations were seen after UGFS.