To compare the safety, need for additional foam sclerotherapy, and 1-year venous clinical severity score (VCSS) improvement in limbs of chronic venous disease patients with great saphenous vein (GSV) reflux treated with endovenous laser ablation (EVLA; 1470 nm diode laser) and concurrent foam sclerotherapy (1% polidocanol) through the access sheath [transluminal injection of foam sclerotherapy (TLFS)] to those treated with EVLA and concurrent direct-puncture ultrasound-guided foam sclerotherapy (UGFS).

This study screened 467 patients (577 legs) with symptomatic primary GSV reflux for randomization to either TLFS with EVLA (103 legs; TLFS group) or UGFS with EVLA (94 legs; UGFS group). Exclusion criteria were (1) recurrent varicose veins after a previous intervention, (2) hypersensitivity reaction to sclerotherapy, (3) acute deep vein thrombosis, (4) serious lower-limb ischemic disease, (5) coagulation disorder, and (6) simultaneous EVLA of both GSV and small saphenous veins. The correlations of VCSS changes with clinical features, such as age, sex, clinical-etiological-anatomical-pathophysiological (CEAP) classification, total amount of sclerosant at the original procedure, multiple punctures (>2 times) for sclerotherapy at the original procedure, use of TLFS, and linear endovenous energy density, were estimated by logistic regression.

No significant differences in the distribution of CEAP classification were observed between the groups. After 12 months of follow-up, all truncal veins were occluded. VCSS was significantly improved in the TLFS group compared to the UGFS group (UGFS -7.4±1.8, TLFS -8.7±1.5; p<.0001). Multivariate analysis revealed that TLFS was the only significant factor for improved VCSS (hazard ratio, 0.63; 95% confidence interval, 0.32–0.96; p<.0001). Additional second-stage sclerotherapy was significantly avoided in the TLFS group [n=10 (10%)] compared to the UGFS group [n=51 (54%); p<.0001].

TLFS combined with EVLA is a safe and feasible procedure that improves VCSS and reduces additional second-stage interventions compared to UGFS combined with EVLA.