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

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

    Research output: Contribution to journalArticle

    14 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

    All Science Journal Classification (ASJC) codes

    • Cardiology and Cardiovascular Medicine

    Cite this

    EFFECTS OF DEFIBROTIDE IN PATIENTS WITH CHRONIC DEEP INSUFFICIENCY. THE PROVEDIS STUDY. / Novo, Salvatore; Coccheri; Andreozzi; Gensini, Gian Franco; D'Addato.

    In: International Angiology, Vol. 23, 2004, p. 100-107.

    Research output: Contribution to journalArticle

    Novo, S, Coccheri, Andreozzi, Gensini, GF & D'Addato 2004, 'EFFECTS OF DEFIBROTIDE IN PATIENTS WITH CHRONIC DEEP INSUFFICIENCY. THE PROVEDIS STUDY', International Angiology, vol. 23, pp. 100-107.
    Novo, Salvatore ; Coccheri ; Andreozzi ; Gensini, Gian Franco ; D'Addato. / EFFECTS OF DEFIBROTIDE IN PATIENTS WITH CHRONIC DEEP INSUFFICIENCY. THE PROVEDIS STUDY. In: International Angiology. 2004 ; Vol. 23. pp. 100-107.
    @article{1f0c76dbe3bf485887a7c5fe9b27a689,
    title = "EFFECTS OF DEFIBROTIDE IN PATIENTS WITH CHRONIC DEEP INSUFFICIENCY. THE PROVEDIS STUDY",
    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",
    author = "Salvatore Novo and Coccheri and Andreozzi and Gensini, {Gian Franco} and D'Addato",
    year = "2004",
    language = "English",
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    pages = "100--107",
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    AU - Novo, Salvatore

    AU - Coccheri, null

    AU - Andreozzi, null

    AU - Gensini, Gian Franco

    AU - D'Addato, null

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    N2 - 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

    AB - 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

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