Microthrombectomy reduces postsclerotherapy pigmentation: Multicenter randomized trial

Objective: Postsclerotherapy pigmentation occurs in nearly 30% of patients. Hemosiderin, from degradation of the venous thrombus, is the possible cause. The hypothesis that early removal of the thrombus may eliminate or decrease the incidence of pigmentation has not been proved or documented. The objective of this study was to investigate the effects of early microthrombectomy on incidence of postsclerotherapy pigmentation. Material and methods. This multicenter, randomized, controlled study involved 101 patients with varicose veins (100 women, I man; mean age, 46 years [range, 25-68 years]). Patients were divided into two groups, with veins 1 mm or less in diameter (group 1, n = 50) or veins 3 mm or less in diameter (group 2, n = 51). Group 1 was treated with Sotradecol (STD) 0.25%, and group 2 with STD 0.50%. In each patient, an area of varicosities was selected and divided into halves. One half was randomized to microthrombectomy and the other half served as control. Microthrombectomy was performed 1 to 3 weeks after treatment in the randomized half. Standard photographs were obtained before and 16 weeks after treatment, and were evaluated by three independent reviewers who were blinded to treatment assignments. Each reviewer received an identical set of pretreatment and posttreatment 10 x 15-cm color photographs of the study area, and completed a scoring sheet. Average of the scores was used to evaluate primary (pigmentation) and secondary (overall clinical improvement) end points. The paired t test and chi-square test were used for statistical analysis. Results: In group 1, microthrombectomized areas had statistically significant less pigmentation (P = .0047) and better overall clinical improvement scores (P = .0002) compared with the control side. In group 2 there was no significant difference between the two areas, but patients reported significant relief of pain and inflammation associated with postsclerotherapy thrombophlebitis. Conclusion: In veins 1 mm or smaller, microthrombectomy reduced pigmentation and improved overall clinical results. In veins 3 mm or smaller, statistical significance was not achieved, but thrombectomy resulted in faster resolution of the postsclerotherapy pain and inflammation. On the basis of these results, microthrombectomy after sclerotherapy is recommended.