The French Polidocanol Study on Long‐Term Side Effects: A Survey Covering 3,357 Patient Years

BACKGROUND, AIMS Short‐ and mid‐term side effects of sclerotherapy, in particular with polidocanol (lauromacrogol 400), have been previously described in our registry of 12,173 sessions. The objective of this follow‐up registry was to evaluate the long‐term incidence of adverse events with polidocanol. METHODS The physicians involved in the initial French registry were contacted and asked to partake in the follow‐up survey. Initially included patients were controlled at the latest possible date to determine whether a complication had occurred after the end of the initial survey. RESULTS Data on 1,605 patients included in the French registry were reviewed with a maximum follow‐up of 60 months, covering 3,357 patient years. Five (0.4%) adverse events were observed in patients treated with liquid polidocanol and 46 (1.1%) in patients treated with polidocanol foam. The most frequent side effects were visual disturbances (n=14), and the most severe were muscular vein thrombosis (n=8). The onset of side effects was mostly observed directly after sclerotherapy or in the 6 months after (84% in the first year). One deep vein thrombosis recurrence occurred in a patient with heterozygote Factor V Leiden after stopping anticoagulant treatment (foam sclerotherapy). CONCLUSIONS Foam sclerotherapy is a recognized reference method in the treatment of varicose veins of all types. This study demonstrates that polidocanol is a safe sclerosing agent in the short and long term. This study was fully sponsored by Kreussler & Co (Germany). Dorothe. Schliephake, Joachim Otto, and Serge Mako are employees of Kreussler.