Abstract
OBJECTIVE: Mechanochemical ablation is a feasible endovenous nonthermal, nontumescent treatment method for saphenous vein insufficiency. Nevertheless, the ideal approach to managing varicose veins following intervention of the saphenous trunk remains ambiguous. Treatment of varicose veins can be administered either simultaneously or in a staged manner. The aim of this 3-year follow-up study was to present the midterm outcomes of a randomized controlled trial, comparing concomitant and staged treatment of tributaries. METHODS: Venous outpatient clinic patients with unilateral Clinical, Etiological, Anatomical, Pathophysiological (CEAP) C2-4 venous disease were enrolled in a randomized controlled trial during 2016 to 2017 at Helsinki University Hospital. After eligibility assessment of 1149 patients, 85 met the inclusion criteria: age of 20 to 70 years, ultrasound-verified refluxing above-knee great saphenous vein with a diameter of 5 to 10 mm, written consent from patients, and not having deep venous reflux, peripheral artery disease, pregnancy, lymphoedema, body mass index >40 kg/m(2), allergy to the sclerosant, a history of deep vein thrombosis, or any form of coagulopathy. Participants were randomized, in a 1:1 ratio, to receive either staged tributary treatment with foam sclerotherapy at 3 months, if required (Group 1), or concomitant phlebectomies (Group 2), adjunct to mechanochemical ablation of the great saphenous trunk. All patients were invited to attend a 3-year follow-up, during which the initially treated leg was assessed with duplex ultrasound. The primary outcome was reintervention rate during follow-up. Secondary outcomes comprised presence of above-knee great saphenous vein reflux, patient satisfaction, status of the great saphenous vein, number of varicose veins, and symptoms at follow-up. RESULTS: During follow-up, 11.4% (n = 5/44) (95% confidence interval [CI], 0.02-0.21) in Group 1 and 4.9% (n = 2/41) (95% CI, -0.02 to 0.11) in Group 2 was in need of additional treatment (Group 1 vs Group 2, odds ratio [OR], 2.5; 95% CI, 0.46-13.67; P = .435). The treatment groups did not elicit statistically significant variances in above-knee great saphenous vein reflux (P = .603), disease-specific and health-related quality of life (P = .238 and P = .255, respectively), status of the great saphenous vein (P = .112), or symptoms. However, noninferiority analysis suggests the staged approach to be inferior to the concomitant approach. Furthermore, Group 1 exhibited more varicosities at 3 years compared with Group 2, but this did not cause differences in the extent of symptoms or overall patient satisfaction. CONCLUSIONS: Staged treatment of tributaries in C2-4 venous disease provides acceptable midterm outcomes compared with simultaneous treatment. However, its potential inferiority should be taken into consideration when prioritizing durable treatment outcomes in the long term.