EFFECTS OF DEFIBROTIDE IN PATIENTS WITH CHRONIC DEEP INSUFFICIENCY. THE PROVEDIS STUDY

Salvatore Novo, Gian Franco Gensini, D'Addato, Coccheri, Andreozzi

    Research output: Contribution to journalArticle

    15 Citations (Scopus)

    Abstract

    Aim. In the present study the effect of defibrotide, an antithrombotic and profibrinolytic agent, was investigated in patients with chronic venous insufficiency (CVI) due to deep vein obstruction and/or reflux (chronic deep vein insufficiency, CDVI).Methods. The study was a multicenter, randomized, double blind placebo controlled trial in which only patients with CDVI confirmed by ultrasound were enrolled. All patients were treated with adequate elastic compression and randomized to receive either oral defibrotide (800 mg/die) or matching placebo for 1 year. Patients with active or previous leg ulcer were excluded.Results. A total of 288 patients were randomized and 159 completed the study. At baseline ultrasound investigation, obstructive changes were found in 2/3 of all patients thus ascertaining a post-thrombotic syndrome (PTS). The primary endpoint, ankle circumpherence, was significantly reduced under defibrotide from day 120 throughout 360. Scores for pain and edema were improved. The number of episodes of superficial thrombophlebitis and deep vein thrombosis was significantly lower under defibrotide (n=2) than under placebo (n=10). The majority of these events occurred in the subset of patients with documented PTS.Conclusion. Treatment with defibrotide in addition to elastic compression in patients with objectively assessed CDVI, mostly due to PTS, resulted in clinical benefits and prevented thrombotic complications harmful to the limb conditions
    Original languageEnglish
    Pages (from-to)100-107
    Number of pages8
    JournalINTERNATIONAL ANGIOLOGY
    Volume23
    Publication statusPublished - 2004

      Fingerprint

    All Science Journal Classification (ASJC) codes

    • Cardiology and Cardiovascular Medicine

    Cite this