Format

Send to

Choose Destination
Circulation. 2015 Nov 17;132(20):1891-7. doi: 10.1161/CIRCULATIONAHA.115.016930. Epub 2015 Sep 25.

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.

Author information

1
From Angiology Unit, University Hospital, Padua, Italy (G.M.A.); School of Specialization in Hospital Pharmacy, Department of Pharmaceutical Sciences, University of Milan, Italy (A.A.B.); Department of Medicine and Aging, "G. D'Annunzio" University, Chieti, Italy (G.D., G.L.); Cardiovascular Diseases, University of Bologna, Italy (G.P.); Angiologická Ambulance, Hodonín, Czech Republic (J.M.); Nemocnice České Budějovice-Interní Oddělení, České Budějovice, Czech Republic (M.H.); Department of Hypertensiology, Angiology and Internal Diseases, Medical University, Poznań, Poland (K.P.-G.); ALIAN s.r.o., Bardejov, Slovakia (A.D.); Federal State Institute, Nikiforov Russian Center of Emergency and Radiation Medicine, St. Petersburg, Russia (G.Y.S.); St. Petersburg State Medical Institution, City Multidisciplinary Hospital No. 2, Russia (Y.P.D.); Spitalul Clinic Judetean de Urgenta, Braşov, Romania (L.D.A.); and Angiology Unit, Hospital of Castelfranco Veneto, Italy (A.V.). gm.andreozzi@gmail.com.
2
From Angiology Unit, University Hospital, Padua, Italy (G.M.A.); School of Specialization in Hospital Pharmacy, Department of Pharmaceutical Sciences, University of Milan, Italy (A.A.B.); Department of Medicine and Aging, "G. D'Annunzio" University, Chieti, Italy (G.D., G.L.); Cardiovascular Diseases, University of Bologna, Italy (G.P.); Angiologická Ambulance, Hodonín, Czech Republic (J.M.); Nemocnice České Budějovice-Interní Oddělení, České Budějovice, Czech Republic (M.H.); Department of Hypertensiology, Angiology and Internal Diseases, Medical University, Poznań, Poland (K.P.-G.); ALIAN s.r.o., Bardejov, Slovakia (A.D.); Federal State Institute, Nikiforov Russian Center of Emergency and Radiation Medicine, St. Petersburg, Russia (G.Y.S.); St. Petersburg State Medical Institution, City Multidisciplinary Hospital No. 2, Russia (Y.P.D.); Spitalul Clinic Judetean de Urgenta, Braşov, Romania (L.D.A.); and Angiology Unit, Hospital of Castelfranco Veneto, Italy (A.V.).

Abstract

BACKGROUND:

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.

METHODS AND RESULTS:

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.

CONCLUSION:

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.

CLINICAL TRIAL REGISTRATION:

URL: https://www.clinicaltrialsregister.eu/. Identifier: EudraCT number 2009-016923-77.

KEYWORDS:

glycosaminoglycans; randomized controlled trial; recurrence; venous thromboembolism

PMID:
26408273
PMCID:
PMC4643750
DOI:
10.1161/CIRCULATIONAHA.115.016930
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Atypon Icon for PubMed Central
Loading ...
Support Center