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 in | Circulation (New York, N.Y.) Vol. 132; no. 20; pp. 1891 - 1897 |
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Main Authors | , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
Lippincott Williams & Wilkins
17.11.2015
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Subjects | |
Online Access | Get full text |
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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. |
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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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Keywords | glycosaminoglycans recurrence venous thromboembolism randomized controlled trial |
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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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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 |
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