6533b831fe1ef96bd12980d8

RESEARCH PRODUCT

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

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description

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