Varisolve^® polidocanol microfoam compared with surgery or sclerotherapy in the management of varicose veins in the presence of trunk vein incompetence: European randomized controlled trial

Abstract

Objective: To compare the safety and efficacy of Varisolve® 1% polidocanol microfoam sclerosant with alternative treatments for patients with varicose veins and trunk vein incompetence. Methods: An open-label, multicentre, prospective trial of 710 patients randomized to receive either Varisolve® or alternative treatment (surgery or sclerotherapy). The endpoint was ultrasound-determined occlusion of trunk vein(s) and elimination of reflux, analysed against a non-inferiority hypothesis. Results: Overall, non-inferiority was demonstrated with 83.4% efficacy for Varisolve® compared with 88.1% for alternative treatment at three months, and the corresponding magnitudes were 78.9 and 80.4% at 12 months. Surgery was superior to Varisolve®, but the success rate of 68.2% for Varisolve® (surgery 87.2%) was poor compared with 93.8% success for Varisolve® achieved in those randomized to Varisolve® or sclerotherapy. Varisolve® was superior to sclerotherapy at 12 months ( P = 0.001). Deep vein thrombosis occurred in 11/437 (2.5%) after Varisolve®, in 1/125 (0.8%) after sclerotherapy and in none after surgery. No pulmonary emboli were detected. Conclusion: Overall, Varisolve® was non-inferior to alternative treatment. Surgery was more efficacious, but Varisolve® caused less pain and patients returned to normal more quickly. The Varisolve® technique is a useful additional treatment for varicose veins and trunk vein incompetence.

A Randomized Trial Comparing Treatments for Varicose Veins

“…2,5,6,[8][9][10]12,32 The nature and frequency of complications were also similar to those previously reported in the literature. [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16] The three groups had similar improvements in the venous clinical severity score at 6 months. However, successful ablation of the great saphenous veins at 6 weeks occurred significantly less often after foam treatment (complete ablation, 55%; partial ablation with a patent segment and no reflux, 23%) than after either surgery (complete ablation, 84%; partial ablation, 6%) or laser treatment (complete ablation, 83%; partial ablation, 8%).…”

“…Observed ablation rates, in particular for foam sclerotherapy, were lower than the rates in some previous studies, which used less strict definitions of success, 1,6,10,14 but were similar to the rates reported in two randomized trials that used definitions of technical success that were similar to ours. 12,15 In contrast to the assessment of ablation in previous trials, we determined whether ablation was complete or partial on the basis of duplex ultrasound scans obtained by independent, accredited vascular technologists rather than by the surgeons who had performed the treatment. The disparity between clinical measures of success and technical success observed in this study has also been observed in other trials of treatment for varicose veins.…”

“…Previous randomized trials and meta-analyses have shown these treatments to be effective in terms of short-term technical success and clinician-reported outcomes. [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19] Clinical practice guidelines recommend the use of patient-reported quality of life to assess the outcomes of treatment of varicose veins. 20 Quality of life was a primary outcome measure in two small randomized trials that compared surgery and endovenous laser ablation, 5,9 but to our knowledge, it has not been assessed as a primary outcome in randomized trials involving foam sclerotherapy.…”

Comparative Study of Endovenous Laser Ablation over Conventional Surgery of Varicose Veins of Lower Limbs

“…In a study comparing HL/S and EVLA methods, EVLA was reported to result with less edema and blisters but no other significant differences found between (13). In comparison of foam sclerotherapy to HL/S, HL/S procedure was reported to be superior (14).…”

Color Duplex Ultrasound-Guided Foam Sclerotherapy: An Approach in the Management of Patients with Superficial Varicosities of Lower Extremity

“…In Wright et al study [9] of 259 patients, 27% belong to C2, 46.33% to C3, 5.01% to C4, 8.88% to C5 and 12.74% to C6 and 100% with primary in etiology and pathophysiology. Superficial and deep reflux accounts for 92.66% and superficial was only 7.34%.…”