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

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 to…