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

Circulation

Volumn 132, Issue 20, 2015, Pages 1891-1897

  Andreozzi, Giuseppe M ^a   Bignamini, Angelo A ^b   Davì, Giovanni ^c   Palareti, Gualtiero ^d   Matuška, Jiří ^e   Holý, Martin ^f   Pawlaczyk Gabriel, Katarzyna ^g   Džupina, Andrej ^h   Sokurenko, German Y ⁱ   Didenko, Yury P ^j   Andrei, Laurentia D ^k   Lessiani, Gianfranco ^c   Visonà, Adriana ^l  

^a UNIVERSITY HOSPITAL OF PADOVA   (Italy)

^b UNIVERSITY OF MILAN   (Italy)

^c UNIVERSITY OF CHIETI   (Italy)

^d UNIVERSITY OF BOLOGNA   (Italy)

^e Angiologická Ambulance   (Czech Republic)

^f Onkologické odd lení Nemocnice eské Bud jovice   (Czech Republic)

^g POZNAN UNIVERSITY OF MEDICAL SCIENCES   (Poland)

^h ALIAN sro   (Slovakia)

ⁱ All Russian Centre of Emergency and Radiation Medicine   (Russian Federation)

^j ST PETERSBURG STATE UNIVERSITY   (Russian Federation)

^k Spitalul Clinic Judetean de Urgenta Cluj   (Romania)

^l Department of Cardiology   (Italy)

more..

Author keywords

glycosaminoglycans; randomized controlled trial; recurrence; venous thromboembolism

Indexed keywords

PLACEBO; SULODEXIDE; ANTICOAGULANT AGENT; GLYCOSAMINOGLYCAN;

ADULT; ANTICOAGULANT THERAPY; ARTICLE; BLEEDING; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DOUBLE BLIND PROCEDURE; DRUG SAFETY; DRUG TREATMENT FAILURE; EPISTAXIS; FEMALE; FOLLOW UP; HUMAN; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; METRORRHAGIA; MIDDLE AGED; MULTICENTER STUDY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECTUM HEMORRHAGE; RECURRENT DEEP VEIN THROMBOSIS; RECURRENT DISEASE; RECURRENT LUNG EMBOLISM; RECURRENT VENOUS THROMBOEMBOLISM; RISK ASSESSMENT; SECONDARY PREVENTION; TREATMENT DURATION; VENOUS THROMBOEMBOLISM; AGED; CLINICAL TRIAL; DRUG ADMINISTRATION; PROCEDURES;

ADULT; AGED; ANTICOAGULANTS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; GLYCOSAMINOGLYCANS; HUMANS; MALE; MIDDLE AGED; RECURRENCE; SECONDARY PREVENTION; VENOUS THROMBOEMBOLISM;

EID: 84947460258     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.115.016930     Document Type: Article

References (33)

1. Schafer AI, Venous thrombosis as a chronic disease. N Engl J Med 1999 340 955 956. doi: 10.1056/NEJM199903253401209
2. Prandoni P, Lensing AW, Cogo A, Cuppini S, Villalta S, Carta M, Cattelan AM, Polistena P, Bernardi E, Prins MH, The long-term clinical course of acute deep venous thrombosis. Ann Intern Med 1996 125 1 7
3. Schulman S, Rhedin AS, Lindmarker P, Carlsson A, Lärfars G, Nicol P, Loogna E, Svensson E, Ljungberg B, Walter H, A comparison of six weeks with six months of oral anticoagulant therapy after a first episode of venous thromboembolism: Duration of Anticoagulation Trial Study Group. N Engl J Med 1995 332 1661 1665. doi: 10.1056/NEJM199506223322501
4. Agnelli G, Prandoni P, Santamaria MG, Bagatella P, Iorio A, Bazzan M, Moia M, Guazzaloca G, Bertoldi A, Tomasi C, Scannapieco G, Ageno W, Warfarin Optimal Duration Italian Trial Investigators Three months versus one year of oral anticoagulant therapy for idiopathic deep venous thrombosis: Warfarin Optimal Duration Italian Trial Investigators. N Engl J Med 2001 345 165 169. doi: 10.1056/NEJM200107193450302
5. Kearon C, Gent M, Hirsh J, Weitz J, Kovacs MJ, Anderson DR, Turpie AG, Green D, Ginsberg JS, Wells P, MacKinnon B, Julian JA, A comparison of three months of anticoagulation with extended anticoagulation for a first episode of idiopathic venous thromboembolism. N Engl J Med 1999 340 901 907. doi: 10.1056/NEJM199903253401201
6. Agnelli G, Prandoni P, Becattini C, Silingardi M, Taliani MR, Miccio M, Imberti D, Poggio R, Ageno W, Pogliani E, Porro F, Zonzin P, Warfarin Optimal Duration Italian Trial Investigators Extended oral anticoagulant therapy after a first episode of pulmonary embolism. Ann Intern Med 2003 139 19 25
7. Agnelli G, Becattini C, Treatment of DVT: how long is enough and how do you predict recurrence. J Thromb Thrombolysis 2008 25 37 44. doi: 10.1007/s11239-007-0103-z
8. Kearon C, Akl EA, Comerota AJ, Prandoni P, Bounameaux H, Goldhaber SZ, Nelson ME, Wells PS, Gould MK, Dentali F, Crowther M, Kahn SR, American College of Chest Physicians Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines [published correction appears in Chest. 2012;142:1698-1704]. Chest 2012 141 suppl e419S e494S
9. Schulman S, Kearon C, Kakkar AK, Mismetti P, Schellong S, Eriksson H, Baanstra D, Schnee J, Goldhaber SZ, RE-COVER Study Group Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med 2009 361 2342 2352. doi: 10.1056/NEJMoa0906598
10. EINSTEIN Investigators Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, Lensing AW, Misselwitz F, Prins MH, Raskob GE, Segers A, Verhamme P, Wells P, Agnelli G, Bounameaux H, Cohen A, Davidson BL, Piovella F, Schellong S, EINSTEIN Investigators Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010 363 2499 2510. doi: 10.1056/NEJMoa1007903
11. Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Masiukiewicz U, Pak R, Thompson J, Raskob GE, Weitz JI, AMPLIFY Investigators Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med 2013 369 799 808. doi: 10.1056/NEJMoa1302507
12. Hokusai-VTE Investigators Büller HR, Décousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P, Hokusai-VTE Investigators Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med 2013 369 1406 1415. doi: 10.1056/NEJMoa1306638
13. Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Porcari A, Raskob GE, Weitz JI, AMPLIFY-EXT Investigators Apixaban for extended treatment of venous thromboembolism. N Engl J Med 2013 368 699 708. doi: 10.1056/NEJMoa1207541
14. Schulman S, Kearon C, Kakkar AK, Schellong S, Eriksson H, Baanstra D, Kvamme AM, Friedman J, Mismetti P, Goldhaber SZ, RE-MEDY Trial Investigators; RE-SONATE Trial Investigators Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med 2013 368 709 718. doi: 10.1056/NEJMoa1113697
15. Coccheri S, Mannello F, Development and use of sulodexide in vascular diseases: implications for treatment. Drug Des Devel Ther 2014 8 49 65. doi: 10.2147/DDDT.S6762
16. Condorelli M, Chiariello M, Dagianti A, Penco M, Dalla Volta S, Pengo V, Schivazappa L, Mattioli G, Mattioli AV, Brusoni B, Trotta E, Bignamini A, IPO-V2: a prospective, multicenter, randomized, comparative clinical investigation of the effects of sulodexide in preventing cardiovascular accidents in the first year after acute myocardial infarction. J Am Coll Cardiol 1994 23 27 34
17. Coccheri S, Scondotto G, Agnelli G, Aloisi D, Palazzini E, Zamboni V, Venous arm of the SUAVIS (Sulodexide Arterial Venous Italian Study) Group Randomised, double blind, multicentre, placebo controlled study of sulodexide in the treatment of venous leg ulcers. Thromb Haemost 2002 87 947 952
18. Errichi BM, Cesarone MR, Belcaro G, Marinucci R, Ricci A, Ippolito A, Brandolini R, Vinciguerra G, Dugall M, Felicita A, Pellegrini L, Gizzi G, Ruffini M, Acerbi G, Bavera P, Renzo AD, Corsi M, Scoccianti M, Hosoi M, Lania M, Prevention of recurrent deep venous thrombosis with sulodexide: the SanVal registry. Angiology 2004 55 243 249
19. Hoppensteadt DA, Fareed J, Pharmacological profile of sulodexide. Int Angiol 2014 33 229 235
20. Buchanan MR, Liao P, Smith LJ, Ofosu FA, Prevention of thrombus formation and growth by antithrombin III and heparin cofactor II-dependent thrombin inhibitors: importance of heparin cofactor II. Thromb Res 1994 74 463 475
21. Iacoviello L, D'Adamo MC, Pawlak K, Polishchuck R, Wollny T, Buczko W, Donati MB, Antithrombotic activity of dermatan sulphates, heparins and their combination in an animal model of arterial thrombosis. Thromb Haemost 1996 76 1102 1107
22. Borawski J, Dubowski M, Rydzewska-Rosolowska A, Mysliwiec M, Intravenous and oral sulodexide versus coagulation activation markers in humans. Clin Appl Thromb Hemost 2009 15 596 598. doi: 10.1177/1076029609333674
23. Andreozzi GM, Sulodexide in the treatment of chronic venous disease. Am J Cardiovasc Drugs 2012 12 73 81. doi: 10.2165/11599360-000000000-00000
24. Masola V, Zaza G, Onisto M, Lupo A, Gambaro G, Glycosaminoglycans, proteoglycans and sulodexide and the endothelium: biological roles and pharmacological effects. Int Angiol 2014 33 243 254
25. Cirujeda JL, Granado PC, A study on the safety, efficacy, and efficiency of sulodexide compared with acenocoumarol in secondary prophylaxis in patients with deep venous thrombosis. Angiology 2006 57 53 64
26. Prandoni P, Lensing AW, Bernardi E, Villalta S, Bagatella P, Girolami A, DERECUS Investigators Group The diagnostic value of compression ultrasonography in patients with suspected recurrent deep vein thrombosis. Thromb Haemost 2002 88 402 406. doi: 10.1267/THRO88030402
27. van Gogh Investigators Buller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE, van Gogh Investigators Idraparinux versus standard therapy for venous thromboembolic disease. N Engl J Med 2007 357 1094 1104. doi: 10.1056/NEJMoa064247
28. Stevenson M, Nunes T, Sanchez J, Thornton T, Reiczigel J, Robison-Cox J, Sebastiani P, Solymos P, epiR: An R package for the analysis of epidemiological data. R package version 0.9-48 2013. http://CRAN.R-project.org/package=epiR. Accessed January 2, 2015
29. R Core Team R: A language and environment for statistical computing 2013 Vienna, Austria R Foundation for Statistical Computing. URL http://www.R-project.org/. Accessed January 2, 2015
30. Becattini C, Agnelli G, Schenone A, Eichinger S, Bucherini E, Silingardi M, Bianchi M, Moia M, Ageno W, Vandelli MR, Grandone E, Prandoni P, WARFASA Investigators Aspirin for preventing the recurrence of venous thromboembolism. N Engl J Med 2012 366 1959 1967. doi: 10.1056/NEJMoa1114238
31. Brighton TA, Eikelboom JW, Mann K, Mister R, Gallus A, Ockelford P, Gibbs H, Hague W, Xavier D, Diaz R, Kirby A, Simes J, ASPIRE Investigators Low-dose aspirin for preventing recurrent venous thromboembolism. N Engl J Med 2012 367 1979 1987. doi: 10.1056/NEJMoa1210384
32. Jiménez D, Díaz G, Marín E, Vidal R, Sueiro A, Yusen RD, The risk of recurrent venous thromboembolism in patients with unprovoked symptomatic deep vein thrombosis and asymptomatic pulmonary embolism. Thromb Haemost 2006 95 562 566. doi: 10.1267/THRO06030562
33. Martinez C, Cohen AT, Bamber L, Rietbrock S, Epidemiology of first and recurrent venous thromboembolism: a population-based cohort study in patients without active cancer. Thromb Haemost 2014 112 255 263. doi: 10.1160/TH13-09-0793