U.S. flag

An official website of the United States government

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

Rivaroxaban (Xarelto): Treatment of Venous Thromboembolic Events (Deep Vein Thrombosis [DVT], Pulmonary Embolism [PE]) and Prevention of Recurrent DVT and PE [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2015 Aug.

Cover of Rivaroxaban (Xarelto)

Rivaroxaban (Xarelto): Treatment of Venous Thromboembolic Events (Deep Vein Thrombosis [DVT], Pulmonary Embolism [PE]) and Prevention of Recurrent DVT and PE [Internet].

Show details

REFERENCES

1.
Torbicki A, Perrier A, Konstantinides S, Agnelli G, Galie N, Pruszczyk P, et al. Guidelines on the diagnosis and management of acute pulmonary embolism: the Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). Eur Heart J. 2008 Sep;29(18):2276–2315. [PubMed: 18757870]
2.
Xarelto® rivaroxaban tablet 10mg, 15mg and 20mg anticoagulant [product monograph]. Toronto: Bayer, Inc; Feb 13, 2012.
3.
Kearon C, Akl EA, Comerota AJ, Prandoni P, Bounameaux H, Goldhaber SZ, et al. Antithrombotic therapy for VTE disease: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012 Feb;141(2 Suppl):e419S–e494S. [PMC free article: PMC3278049] [PubMed: 22315268]
4.
Clinical study report: oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep vein thrombosis - The EINSTEIN DVT study. Study number: 11702 [CONFIDENTIAL internal manufacturer's report]. Leverkusen, Germany: Bayer HealthCare AG; Oct 25, 2010.
5.
EINSTEIN Investigators. Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, et al. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med [Internet] 2010 Dec 23;363(26):2499–2510. [cited 2013 Jun 25]; Available from: http://www​.nejm.org/doi/pdf/10​.1056/NEJMoa1007903. [PubMed: 21128814]
6.
EINSTEIN-PE Investigators. Buller HR, Prins MH, Lensin AW, Decousus H, Jacobson BF, et al. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med [Internet] 2012 Apr 5;366(14):1287–1297. [cited 2013 Jun 25]; Available from: http://www​.nejm.org/doi/pdf/10​.1056/NEJMoa1113572. [PubMed: 22449293]
7.
Clinical study report: Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic pulmonary embolism - The EINSTEIN PE study [CONFIDENTIAL internal manufacturer's report]. Toronto: Bayer; Mar 28, 2011.
8.
Prins MH, Lensing AW. Derivation of the non-inferiority margin for the evaluation of direct oral anticoagulants in the treatment of venous thromboembolism. Thromb J [Internet] 2013;11(1):13. [cited 2013 Jul 19]; Available from: http://www​.ncbi.nlm.nih​.gov/pmc/articles/PMC3710481. [PMC free article: PMC3710481] [PubMed: 23829521]
9.
Moser KM, Fedullo PF, LitteJohn JK, Crawford R. Frequent asymptomatic pulmonary embolism in patients with deep venous thrombosis. JAMA. 1994 Jan 19;271(3):223–225. [PubMed: 8277550]
10.
Dalen JE. Pulmonary embolism: what have we learned since Virchow? Natural history, pathophysiology, and diagnosis. Chest. 2002 Oct;122(4):1440–1456. [PubMed: 12377877]
11.
Kearon C. Natural history of venous thromboembolism. Circulation. 2003 Jun 17;107(23 Suppl 1):I22–I30. [PubMed: 12814982]
12.
Goldhaber SZ, Visani L, De Rosa M. Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER). Lancet. 1999 Apr 24;353(9162):1386–1389. [PubMed: 10227218]
13.
CDR submission binder: Xarelto (rivaroxaban tablet) 15 mg, 20 mg. Company: Bayer. [CONFIDENTIAL manufacturer's submission]. Toronto: Bayer; May, 2013.
14.
Alikhan R, Peters F, Wilmott R, Cohen AT. Fatal pulmonary embolism in hospitalised patients: a necropsy review. J Clin Pathol [Internet] 2004 Dec;57(12):1254–1257. [cited 2013 Jun 11]; Available from: http://www​.ncbi.nlm.nih​.gov/pmc/articles/PMC1770519. [PMC free article: PMC1770519] [PubMed: 15563663]
15.
Heit JA, O'Fallon WM, Petterson TM, Lohse CM, Silverstein MD, Mohr DN, et al. Relative impact of risk factors for deep vein thrombosis and pulmonary embolism: a population-based study. Arch Intern Med. 2002 Jun 10;162(11):1245–1248. [PubMed: 12038942]
16.
Anderson FA Jr, Spencer FA. Risk factors for venous thromboembolism. Circulation. 2003 Jun 17;107(23 Suppl 1):I9–I16. [PubMed: 12814980]
17.
Scottish Intercollegiate Guidelines Network. Prevention and management of venous thromboembolism: a national clinical guideline [Internet]. Edinburgh: SIGN; Dec, 2010. [cited 2013 Jun 11]. (SIGN publication no. 122). Available from: http://sign​.ac.uk/pdf/sign122.pdf.
18.
Le Gal G, Righini M, Roy PM, Sanchez O, Aujesky D, Bounameaux H, et al. Prediction of pulmonary embolism in the emergency department: the revised Geneva score. Ann Intern Med. 2006 Feb 7;144(3):165–171. [PubMed: 16461960]
19.
Wells PS, Anderson DR, Rodger M, Ginsberg JS, Kearon C, Gent M, et al. Derivation of a simple clinical model to categorize patients probability of pulmonary embolism: increasing the models utility with the SimpliRED D-dimer. Thromb Haemost. 2000 Mar;83(3):416–420. [PubMed: 10744147]
20.
Valentine KA. UpToDate [Internet]. Version 23.0. Waltham (MA): UpToDate; Nov 12, 2012. [cited 2013 Jun 11]. Anticoagulation in acute pulmonary embolism. Available from: www​.uptodate.com Subscription required.
21.
Morpurgo M, Marzagalli M. Death in pulmonary embolism. In: Morpurgo M, editor. Pulmonary embolism. New York: Marcel Dekker; 1994. pp. 107–114.
22.
Jardin F, Dubourg O, Bourdarias JP. Echocardiographic pattern of acute cor pulmonale. Chest. 1997 Jan;111(1):209–217. [PubMed: 8996019]
23.
Tapson VF. UpToDate [Internet]. Version 18. Waltham (MA): UpToDate; Dec 7, 2012. [cited 2013 Jun 11]. Treatment of acute pulmonary embolism. Available from: www​.uptodate.com Subscription required.
24.
Lip GYH, Hull R. UpToDate [Internet]. Version 14.3. Waltham (MA): UpToDate; Oct 12, 2011. [cited 2012 Mar 8]. Treatment of lower extremity deep vein thrombosis. c2005 -. Available from: www​.uptodate.com Subscription required.
25.
Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, et al. Prevention of venous thromboembolism: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition). Chest [Internet] 2008 Jun;133(6 Suppl):381S–453S. [cited 2013 Jun 12]; Available from: http://journal​.publications​.chestnet.org/article​.aspx?articleid=1085923. [PubMed: 18574271]
26.
Leung LLK. UpToDate [Internet]. Version 20.12. Waltham (MA): UpToDate; Sep 5, 2012. [cited 2013 Jan 14]. Anticoagulants other than heparin and warfarin. c2005 -. Available from: www​.uptodate.com Subscription required.
27.
Merli G, Spyropoulos AC, Caprini JA. Use of emerging oral anticoagulants in clinical practice: translating results from clinical trials to orthopedic and general surgical patient populations. Ann Surg. 2009 Aug;250(2):219–228. [PubMed: 19638915]
28.
Buller HR, Lensing AW, Prins MH, Agnelli G, Cohen A, Gallus AS, et al. A dose-ranging study evaluating once-daily oral administration of the factor Xa inhibitor rivaroxaban in the treatment of patients with acute symptomatic deep vein thrombosis: the Einstein-DVT Dose-Ranging Study. Blood [Internet] 2008 Sep 15;112(6):2242–2247. [cited 2013 Jun 13]; Available from: http://bloodjournal​.hematologylibrary​.org​/content/112/6/2242.long. [PubMed: 18621928]
29.
van Es J, Douma RA, Kamphuisen PW, Gerdes VEA, Verhamme P, Wells PS, et al. Clot resolution after 3 weeks of anticoagulant treatment for pulmonary embolism: comparison of computed tomography and perfusion scintigraphy. J Thromb Haemost. 2013;11(4):679–685. [PubMed: 23347140]
30.
Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ. CONSORT Group. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA. 2006 Mar 8;295(10):1152–1160. [PubMed: 16522836]
31.
Le Henanff A, Giraudeau B, Baron G, Ravaud P. Quality of reporting of noninferiority and equivalence randomized trials. JAMA. 2006 Mar 8;295(10):1147–1151. [PubMed: 16522835]
32.
Hull R, Delmore T, Genton E, Hirsh J, Gent M, Sackett D, et al. Warfarin sodium versus low-dose heparin in the long-term treatment of venous thrombosis. N Engl J Med. 1979 Oct 18;301(16):855–858. [PubMed: 384248]
33.
Betaseron (interferon beta-1b) - lyophilized powder for subcutaneous injection 0.3 mg/vial [product monograph]. Toronto: Bayer Inc; Nov 28, 2012.
34.
Tysabri (natalizumab) concentrate for solution for intravenous infusion 300mg/15mL [product monograph]. Mississauga (ON): Biogen Idec Canada Inc; Jan 3, 2013.
35.
Schulman S, Rhedin AS, Lindmarker P, Carlsson A, Larfars G, Nicol P, et al. 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 [Internet] 1995 Jun 22;332(25):1661–1665. [cited 2013 Jul 10]; Available from: http://www​.nejm.org/doi/pdf/10​.1056/NEJM199506223322501. [PubMed: 7760866]
36.
Schulman S, Granqvist S, Holmstrom M, Carlsson A, Lindmarker P, Nicol P, et al. The duration of oral anticoagulant therapy after a second episode of venous thromboembolism. N Engl J Med [Internet] 1997 Feb 6;336(6):393–398. [cited 2013 Jul 10]; Available from: http://www​.nejm.org/doi/pdf/10​.1056/NEJM199702063360601. [PubMed: 9010144]
37.
Raschke RA, Reilly BM, Guidry JR, Fontana JR, Srinivas S. The weight-based heparin dosing nomogram compared with a "standard care" nomogram. A randomized controlled trial. Ann Intern Med. 1993 Nov 1;119(9):874–881. [PubMed: 8214998]
38.
Beyer-Westendorf J, Buller H. External and internal validity of open label or double-blind trials in oral anticoagulation: better, worse or just different? J Thromb Haemost. 2011 Nov;9(11):2153–2158. [PubMed: 21920015]
39.
Hübel K, Fresen MM, Apperley JF, Basak GW, Douglas KW, Gabriel IH, et al. European data on stem cell mobilization with plerixafor in non-Hodgkin's lymphoma, Hodgkin's lymphoma and multiple myeloma patients. A subgroup analysis of the European Consortium of stem cell mobilization. Bone Marrow Transplant. 2012;47(8):1046–1050. [PubMed: 22080971]
40.
Prandoni P, Noventa F, Ghirarduzzi A, Pengo V, Bernardi E, Pesavento R, et al. The risk of recurrent venous thromboembolism after discontinuing anticoagulation in patients with acute proximal deep vein thrombosis or pulmonary embolism. A prospective cohort study in 1,626 patients. Haematologica. 2007 Feb;92(2):199–205. [PubMed: 17296569]
41.
White RH. The epidemiology of venous thromboembolism. Circulation. 2003 Jun 17;107(23 Suppl 1):I4–I8. [PubMed: 12814979]
42.
Holley AB, King CS, Jackson JL, Moores LK. Different finite durations of anticoagulation and outcomes following idiopathic venous thromboembolism: a meta-analysis. Thrombosis. 2010;2010(540386):1–9. [PMC free article: PMC3211079] [PubMed: 22084660]
43.
Prandoni P, Prins MH, Lensing AW, Ghirarduzzi A, Ageno W, Imberti D, et al. Residual thrombosis on ultrasonography to guide the duration of anticoagulation in patients with deep venous thrombosis: a randomized trial. Ann Intern Med. 2009 May 5;150(9):577–585. [PubMed: 19414836]
44.
Health Canada reviewer's report: Xarelto (rivaroxaban) [CONFIDENTIAL internal report]. Ottawa: Therapeutics Products Directorate, Health Canada; 2012.
45.
Xarelto: assessment report [Internet]. London: European Medicines Agency (EMA) Committee for Medicinal Products for Human Use; Sep 22, 2011. [cited 2013 Jul 8]. Available from: http://www​.ema.europa​.eu/docs/en_GB/document_library​/EPAR_-_Assessment​_Report_-_Variation​/human/000944/WC500120736.pdf.
46.
Barritt DW, Jordan SC. Anticoagulant drugs in the treatment of pulmonary embolism. A controlled trial. Lancet. 1960 Jun 18;275(7138):1309–1312. [PubMed: 13797091]
47.
Agnelli G, Prandoni P, Becattini C, Silingardi M, Taliani MR, Miccio M, et al. Extended oral anticoagulant therapy after a first episode of pulmonary embolism. Ann Intern Med. 2003 Jul 1;139(1):19–25. [PubMed: 12834314]
48.
Holmgren K, Andersson G, Fagrell B, Johnsson H, Ljungberg B, Nilsson E, et al. One-month versus six-month therapy with oral anticoagulants after symptomatic deep vein thrombosis. Acta Med Scand. 1985;218(3):279–284. [PubMed: 3907286]
49.
Hull RD, Raskob GE, Hirsh J, Jay RM, Leclerc JR, Geerts WH, et al. Continuous intravenous heparin compared with intermittent subcutaneous heparin in the initial treatment of proximal-vein thrombosis. N Engl J Med. 1986 Oct 30;315(18):1109–1114. [PubMed: 3531862]
50.
Brandjes DP, Heijboer H, Buller HR, de Rijk M, Jagt H, ten Cate JW. Acenocoumarol and heparin compared with acenocoumarol alone in the initial treatment of proximal-vein thrombosis. N Engl J Med [Internet] 1992 Nov 19;327(21):1485–1489. [cited 2013 Jun 17]; Available from: http://www​.nejm.org/doi/pdf/10​.1056/NEJM199211193272103. [PubMed: 1406880]
51.
Levine MN, Hirsh J, Gent M, Turpie AG, Weitz J, Ginsberg J, et al. Optimal duration of oral anticoagulant therapy: a randomized trial comparing four weeks with three months of warfarin in patients with proximal deep vein thrombosis. Thromb Haemost. 1995 Aug;74(2):606–611. [PubMed: 8584992]
52.
Agnelli G, Prandoni P, Santamaria MG, Bagatella P, Iorio A, Bazzan M, et al. Three months versus one year of oral anticoagulant therapy for idiopathic deep venous thrombosis. N Engl J Med [Internet] 2001 Jul 19;345(3):165–169. [cited 2013 Jul 10]; Available from: http://www​.nejm.org/doi/pdf/10​.1056/NEJM200107193450302. [PubMed: 11463010]
53.
Kearon C, Gent M, Hirsh J, Weitz J, Kovacs MJ, Anderson DR, et al. A comparison of three months of anticoagulation with extended anticoagulation for a first episode of idiopathic venous thromboembolism. N Engl J Med [Internet] 1999 Mar 25;340(12):901–907. [cited 2013 Jul 10]; Available from: http://www​.nejm.org/doi/pdf/10​.1056/NEJM199903253401201. [PubMed: 10089183]
54.
Pinede L, Ninet J, Duhaut P, Chabaud S, Demolombe-Rague S, Durieu I, et al. Comparison of 3 and 6 months of oral anticoagulant therapy after a first episode of proximal deep vein thrombosis or pulmonary embolism and comparison of 6 and 12 weeks of therapy after isolated calf deep vein thrombosis. Circulation [Internet] 2001 May 22;103(20):2453–2460. [cited 2013 Jul 10]; Available from: http://circ​.ahajournals​.org/content/103/20/2453​.full.pdf+html. [PubMed: 11369685]
55.
Hung HMJ, Wang S-J, Tsong Y, Lawrence J, O'Neil RT. Some fundamental issues with non-inferiority testing in active controlled trials. Statist Med. 2003;22:213–225. [PubMed: 12520558]
56.
International conference on harmonisation; guidance on statistical principles for clinical trials; availability-FDA Notice. Fed Regist. 1998 Sep 16;63(179):49583–49598. [PubMed: 10185190]
57.
Lagerstedt CI, Olsson CG, Fagher BO, Oqvist BW, Albrechtsson U. Need for long-term anticoagulant treatment in symptomatic calf-vein thrombosis. Lancet. 1985 Sep 7;326(8454):515–518. [PubMed: 2863541]
58.
Riley RD, Higgins JP, Deeks JJ. Interpretation of random effects meta-analyses. BMJ. 2011;342:d549. [PubMed: 21310794]
59.
Borenstein M, Hedges L, Rothstein H. Meta-analysis: fixed effect vs. random effects. Tampa (FL): BioStat International; 2007.
60.
Schumi J, Wittes JT. Through the looking glass: understanding non-inferiority. Trials [Internet] 2011;12:106. [cited 2014 Feb 5]; Available from: http://www​.ncbi.nlm.nih​.gov/pmc/articles/PMC3113981. [PMC free article: PMC3113981] [PubMed: 21539749]
61.
Borenstein M, Hedges LV, Higgins JPT, Rothstein HR. Introduction to meta-analysis. Chichester, U.K.: John Wiley & Sons; 2009.
62.
Ukoumunne OC, Forbes AB, Carlin JB, Gulliford MC. Comparison of the risk difference, risk ratio and odds ratio scales for quantifying the unadjusted intervention effect in cluster randomized trials. Stat Med. 2008 Nov 10;27(25):5143–5155. [PubMed: 18613226]
63.
Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions [Internet]. Version 5.1.0. Oxford, United Kingdom: The Cochrane Collaboration; Mar, 2011. [cited 2014 Apr 28]. Available from: http://www​.cochrane-handbook.org.
64.
James Hung HM, Wang SJ, Tsong Y, Lawrence J, O'Neil RT. Some fundamental issues with non-inferiority testing in active controlled trials. Stat Med. 2003 Jan 30;22(2):213–225. [PubMed: 12520558]
65.
Wang S-J, Hung HM, Tsong Y. Utility and pitfalls of some statistical methods in active controlled clinical trials. Control Clin Trials. 2002 Feb;23(1):15–28. [PubMed: 11852161]
Copyright © CADTH 2015.

You are permitted to make copies of this document for non-commercial purposes, provided it is not modified when reproduced and appropriate credit is given to CADTH. You may not otherwise copy, modify, translate, post on a website, store electronically, republish, or redistribute any material from this document in any form or by any means without the prior written permission of CADTH.

Please contact CADTH’s Vice-President of Corporate Services at ac.htdac@secivresetaroproc with any inquiries about this notice or other legal matters relating to CADTH’s services.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

Bookshelf ID: NBK344338

Views

  • PubReader
  • Print View
  • Cite this Page

Other titles in this collection

Related information

  • PMC
    PubMed Central citations
  • PubMed
    Links to PubMed

Recent Activity

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

See more...