Sulodexide for the Prevention of Recurrent Venous Thromboembolism The Sulodexide in Secondary Prevention of Recurrent Deep Vein Thrombosis (SURVET) Study: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Patients with a first episode of unprovoked venous thromboembolism have a high risk of recurrence after discontinuation of anticoagulant therapy. Extending anticoagulation reduces the risk of recurrence but is associated with increased bleeding. Sulodexide, a glycosaminoglycan, exerts antithrombotic...

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Published inCirculation (New York, N.Y.) Vol. 132; no. 20; pp. 1891 - 1897
Main Authors Andreozzi, Giuseppe M., Bignamini, Angelo A., Davì, Giovanni, Palareti, Gualtiero, Matuška, Jiří, Holý, Martin, Pawlaczyk-Gabriel, Katarzyna, Džupina, Andrej, Sokurenko, German Y., Didenko, Yury P., Andrei, Laurentia D., Lessiani, Gianfranco, Visonà, Adriana
Format Journal Article
LanguageEnglish
Published United States Lippincott Williams & Wilkins 17.11.2015
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Abstract Patients with a first episode of unprovoked venous thromboembolism have a high risk of recurrence after discontinuation of anticoagulant therapy. Extending anticoagulation reduces the risk of recurrence but is associated with increased bleeding. Sulodexide, a glycosaminoglycan, exerts antithrombotic and profibrinolytic actions with a low bleeding risk when administered orally, but its benefit for preventing recurrent venous thromboembolism is not well known. In this multicenter, double-blind study, 615 patients with first-ever unprovoked venous thromboembolism who had completed 3 to 12 months of oral anticoagulant treatment were randomly assigned to sulodexide 500 lipasemic units twice daily or placebo for 2 years, in addition to elastic stockings. The primary efficacy outcome was recurrence of venous thromboembolism. Major or clinically relevant bleeding was the primary safety outcome. Venous thromboembolism recurred in 15 of the 307 patients who received sulodexide and in 30 of the 308 patients who received placebo (hazard ratio, 0.49; 95% confidence interval [CI], 0.27-0.92; P=0.02). The analysis in which lost to follow-up was assigned to failure yielded a risk ratio among treated versus control subjects of 0.54 (95% confidence interval, 0.35-0.85; P=0.009). No major bleeding episodes occurred; 2 patients in each treatment group had a clinically relevant bleeding episode. Adverse events were similar in the 2 groups. Sulodexide given after discontinuation of anticoagulant treatment reduced the risk of recurrence in patients with unprovoked venous thromboembolism, with no apparent increase of bleeding risk. URL: https://www.clinicaltrialsregister.eu/. Identifier: EudraCT number 2009-016923-77.
AbstractList Patients with a first episode of unprovoked venous thromboembolism have a high risk of recurrence after discontinuation of anticoagulant therapy. Extending anticoagulation reduces the risk of recurrence but is associated with increased bleeding. Sulodexide, a glycosaminoglycan, exerts antithrombotic and profibrinolytic actions with a low bleeding risk when administered orally, but its benefit for preventing recurrent venous thromboembolism is not well known.BACKGROUNDPatients with a first episode of unprovoked venous thromboembolism have a high risk of recurrence after discontinuation of anticoagulant therapy. Extending anticoagulation reduces the risk of recurrence but is associated with increased bleeding. Sulodexide, a glycosaminoglycan, exerts antithrombotic and profibrinolytic actions with a low bleeding risk when administered orally, but its benefit for preventing recurrent venous thromboembolism is not well known.In this multicenter, double-blind study, 615 patients with first-ever unprovoked venous thromboembolism who had completed 3 to 12 months of oral anticoagulant treatment were randomly assigned to sulodexide 500 lipasemic units twice daily or placebo for 2 years, in addition to elastic stockings. The primary efficacy outcome was recurrence of venous thromboembolism. Major or clinically relevant bleeding was the primary safety outcome. Venous thromboembolism recurred in 15 of the 307 patients who received sulodexide and in 30 of the 308 patients who received placebo (hazard ratio, 0.49; 95% confidence interval [CI], 0.27-0.92; P=0.02). The analysis in which lost to follow-up was assigned to failure yielded a risk ratio among treated versus control subjects of 0.54 (95% confidence interval, 0.35-0.85; P=0.009). No major bleeding episodes occurred; 2 patients in each treatment group had a clinically relevant bleeding episode. Adverse events were similar in the 2 groups.METHODS AND RESULTSIn this multicenter, double-blind study, 615 patients with first-ever unprovoked venous thromboembolism who had completed 3 to 12 months of oral anticoagulant treatment were randomly assigned to sulodexide 500 lipasemic units twice daily or placebo for 2 years, in addition to elastic stockings. The primary efficacy outcome was recurrence of venous thromboembolism. Major or clinically relevant bleeding was the primary safety outcome. Venous thromboembolism recurred in 15 of the 307 patients who received sulodexide and in 30 of the 308 patients who received placebo (hazard ratio, 0.49; 95% confidence interval [CI], 0.27-0.92; P=0.02). The analysis in which lost to follow-up was assigned to failure yielded a risk ratio among treated versus control subjects of 0.54 (95% confidence interval, 0.35-0.85; P=0.009). No major bleeding episodes occurred; 2 patients in each treatment group had a clinically relevant bleeding episode. Adverse events were similar in the 2 groups.Sulodexide given after discontinuation of anticoagulant treatment reduced the risk of recurrence in patients with unprovoked venous thromboembolism, with no apparent increase of bleeding risk.CONCLUSIONSulodexide given after discontinuation of anticoagulant treatment reduced the risk of recurrence in patients with unprovoked venous thromboembolism, with no apparent increase of bleeding risk.URL: https://www.clinicaltrialsregister.eu/. Identifier: EudraCT number 2009-016923-77.CLINICAL TRIAL REGISTRATIONURL: https://www.clinicaltrialsregister.eu/. Identifier: EudraCT number 2009-016923-77.
Supplemental Digital Content is available in the text. Patients with a first episode of unprovoked venous thromboembolism have a high risk of recurrence after discontinuation of anticoagulant therapy. Extending anticoagulation reduces the risk of recurrence but is associated with increased bleeding. Sulodexide, a glycosaminoglycan, exerts antithrombotic and profibrinolytic actions with a low bleeding risk when administered orally, but its benefit for preventing recurrent venous thromboembolism is not well known.
Patients with a first episode of unprovoked venous thromboembolism have a high risk of recurrence after discontinuation of anticoagulant therapy. Extending anticoagulation reduces the risk of recurrence but is associated with increased bleeding. Sulodexide, a glycosaminoglycan, exerts antithrombotic and profibrinolytic actions with a low bleeding risk when administered orally, but its benefit for preventing recurrent venous thromboembolism is not well known. In this multicenter, double-blind study, 615 patients with first-ever unprovoked venous thromboembolism who had completed 3 to 12 months of oral anticoagulant treatment were randomly assigned to sulodexide 500 lipasemic units twice daily or placebo for 2 years, in addition to elastic stockings. The primary efficacy outcome was recurrence of venous thromboembolism. Major or clinically relevant bleeding was the primary safety outcome. Venous thromboembolism recurred in 15 of the 307 patients who received sulodexide and in 30 of the 308 patients who received placebo (hazard ratio, 0.49; 95% confidence interval [CI], 0.27-0.92; P=0.02). The analysis in which lost to follow-up was assigned to failure yielded a risk ratio among treated versus control subjects of 0.54 (95% confidence interval, 0.35-0.85; P=0.009). No major bleeding episodes occurred; 2 patients in each treatment group had a clinically relevant bleeding episode. Adverse events were similar in the 2 groups. Sulodexide given after discontinuation of anticoagulant treatment reduced the risk of recurrence in patients with unprovoked venous thromboembolism, with no apparent increase of bleeding risk. URL: https://www.clinicaltrialsregister.eu/. Identifier: EudraCT number 2009-016923-77.
Author Andreozzi, Giuseppe M.
Holý, Martin
Palareti, Gualtiero
Pawlaczyk-Gabriel, Katarzyna
Sokurenko, German Y.
Davì, Giovanni
Matuška, Jiří
Visonà, Adriana
Didenko, Yury P.
Džupina, Andrej
Lessiani, Gianfranco
Bignamini, Angelo A.
Andrei, Laurentia D.
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/26408273$$D View this record in MEDLINE/PubMed
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ContentType Journal Article
Contributor Madycki, Grzegorz
Tatiana, Vorontsova
Sergey, Basos
Nikolaevna, Matevosyan Elena
Zotta, Laura
Lesiak, Tomasz
Ivanovich, Kirienko Alexander
Wasiewicz, Mirosla
Valeria, Korzhova
Ruslan, Linchak
Temirlan, Gamzatov
Valerii, Melnik
Džupina, Andrej
Andrei, Laurentia Doina
Svetlana, Androsova
Failla, Giacomo
Vladimir, Popovich
Vladimirovich, Svetlikov Alexei
Mikhailovich, Sarana Andrey
Pereira, Albino
Arpaia, Guido Giuseppe
Martini, Romeo
Hirmerova, Jana
Yurievich, Malygin Alexander
Parisi, Roberto
Hruboň, Antonín
Mikosiński, Jacek
Holý, Martin
Addolorata, S Giovanni
Pecháček, Václav
Śmigielski, Jacek
Roztočil, Karel
Davì, Giovanni
Visonà, Adriana
Mikhail, Gladchenko
Blaj, Stefan
Tonello, Chiara
Alina, Agafina
Camporese, Giuseppe
Feliksovna, Balluzek Marina
Sajkowski, Marek
Gabriel, Marcin
Krasiński, Zbigniew
Nikolaevich, Sonkin Igor
Pavlovich, Didenko Yury
Aleksandrovna, Chernyatina Marina
Ospedaliero, Presidio
Niedziela, Piotr
Militaru, Constantin
Pawlaczyk-Gabriel, Katarzyna
Stoenescu, Radu Dumitru
Ferrara, Filippo
Vladimirovich, Rodoman Gr
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Issue 20
Keywords glycosaminoglycans
recurrence
venous thromboembolism
randomized controlled trial
Language English
License 2015 The Authors.
Circulation is published on behalf of the American Heart Association, Inc., by Wolters Kluwer. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited.
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Snippet Patients with a first episode of unprovoked venous thromboembolism have a high risk of recurrence after discontinuation of anticoagulant therapy. Extending...
Supplemental Digital Content is available in the text. Patients with a first episode of unprovoked venous thromboembolism have a high risk of recurrence after...
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StartPage 1891
SubjectTerms Adult
Aged
Anticoagulants - administration & dosage
Double-Blind Method
Drug Administration Schedule
Female
Follow-Up Studies
Glycosaminoglycans - administration & dosage
Humans
Male
Middle Aged
Original
Recurrence
Secondary Prevention - methods
Venous Thromboembolism - diagnosis
Venous Thromboembolism - prevention & control
Subtitle The Sulodexide in Secondary Prevention of Recurrent Deep Vein Thrombosis (SURVET) Study: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Title Sulodexide for the Prevention of Recurrent Venous Thromboembolism
URI https://www.ncbi.nlm.nih.gov/pubmed/26408273
https://www.proquest.com/docview/1734281918
https://pubmed.ncbi.nlm.nih.gov/PMC4643750
Volume 132
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