Early Outcomes of a Randomised Controlled Trial Comparing Concomitant with Staged Tributary Treatment as an Adjunct to Endovenous Laser Ablation of the Saphenous Trunk: The FinnTrunk Study.

Abstract

Simultaneous treatment of tributaries alongside saphenous trunk ablation is considered the standard practice for managing symptomatic varicose disease. Nevertheless, uncertainty persists regarding the optimal timing of tributary treatment. This study aimed to compare early outcomes of concomitant vs. staged tributary treatment performed as an adjunct to saphenous trunk endovenous laser ablation (EVLA). This was a multicentre, non-blinded, parallel arm, randomised controlled trial (NCT04774939). Patients with symptomatic varicose disease and great, small, or anterior saphenous vein reflux requiring treatment were randomised to isolated laser ablation (ILA) or laser ablation with foam sclerotherapy (LA+FS). Patients randomised to ILA received isolated EVLA of the saphenous trunk, and those randomised to LA+FS received saphenous trunk EVLA with concomitant ultrasound guided foam sclerotherapy (UGFS) of tributaries. The primary outcome was the need for additional tributary intervention at three months, as determined by the patient. A power analysis, set to detect a 29.8% difference in additional intervention rates, allowing a 14% dropout rate (α = 0.05, β = 0.20), indicated a required sample size of 66 patients. At three months, 20.7% of patients post ILA compared with 0.0% post LA+FS pursued additional UGFS of tributaries (p < .001). The median (interquartile range [IQR]) procedure time was shorter for ILA compared with LA+FS (median 46 minutes [IQR 41, 55] vs. 55 minutes [49, 63]; p < .001), with a higher three month Venous Clinical Severity Score following ILA (median 2.0 [IQR 1.0, 3.0] vs. 1.0 [IQR 0.0, 2.0]; p <.001). Complication rates and three month quality of life were similar between the groups. Despite some early clinical advantages seen with concomitant tributary treatment, isolated EVLA met the main therapeutic objectives in most patients, thereby representing an acceptable but slightly less effective alternative to concomitant tributary treatment in the short term. Extended follow up is needed to assess the durability of these results.