Varisolve (R) polidocanol microfoam compared with surgery or sclerotherapy in the management of varicose veins in the presence of trunk vein incompetence: European randomized controlled trial
(2006) Phlebology — Vol. 21, n° 4, p. 180-190 (2006)
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- Abstract
- Objective: To compare the safety and efficacy of Varisolve (R) 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 (R) 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 (R) 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 (R), but the success rate of 68.2% for Varisolve (R) (surgery 87.2%) was poor compared with 93.8% success for Varisolve (R) achieved in those randomized to Varisolve (R) or sclerotherapy. Varisolve (R) was superior to sclerotherapy at 12 months (P = 0.001). Deep vein thrombosis occurred in 11/437 (2.5%) after Varisolve (R), in 1/125 (0.8%) after sclerotherapy and in none after surgery. No pulmonary emboli were detected. Conclusion: Overall, Varisolve (R) was non-inferior to alternative treatment. Surgery was more efficacious, but Varisolve (R) caused less pain and patients returned to normal more quickly. The Varisolve (R) technique is a useful additional treatment for varicose veins and trunk vein incompetence.
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Wright, D., Gobin, J. P., Bradbury, A. W., Coleridge-Smith, P., Spoelstra, H., Berridge, D., Wittens, C. H. A., Sommer, A., Nelzen, O., & Chanter, D. (2006). Varisolve (R) polidocanol microfoam compared with surgery or sclerotherapy in the management of varicose veins in the presence of trunk vein incompetence: European randomized controlled trial. Phlebology, 21(4), 180-190. https://doi.org/10.1258/026835506779115807 (Original work published 2006)