Three-year follow-up of a randomized controlled trial comparing concomitant and staged treatment of varicose veins following mechanochemical ablation of the great saphenous vein.

Abstract

Objective: Mechanochemical ablation is a feasible endovenous nonthermal, nontumescent treatment method for saphenous vein insufficiency.^1,2,3 Nevertheless, the ideal approach to managing varicose veins following intervention of the saphenous trunk remains ambiguous.¹ Treatment of varicose veins can be administered either simultaneously or in a staged manner.¹ 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/m², 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.