Treatment options for venous thromboembolism: Lessons learnt from clinical trials

Thrombosis Journal

Volumn 12, Issue 1, 2014, Pages

  McRae, Simon ^a  

^a QUEEN ELIZABETH HOSPITAL   (Australia)

Author keywords

Apixaban; Dabigatran; Disease management; Edoxaban; Rivaroxaban; Venous thromboembolism

Indexed keywords

ACETYLSALICYLIC ACID; ANTICOAGULANT AGENT; ANTIVITAMIN K; APIXABAN; DABIGATRAN; EDOXABAN; ENOXAPARIN; FONDAPARINUX; FRESH FROZEN PLASMA; HEPARIN; LOW MOLECULAR WEIGHT HEPARIN; NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO; PROCOAGULANT; RIVAROXABAN; WARFARIN;

ANTICOAGULANT THERAPY; BLEEDING; BODY WEIGHT; BRAIN HEMORRHAGE; DEEP VEIN THROMBOSIS; GERIATRIC PATIENT; HEMATOLOGIST; HUMAN; LUNG EMBOLISM; PATIENT COMPLIANCE; PREGNANT WOMAN; RECURRENT DISEASE; REVIEW; SECONDARY PREVENTION; SEVERE RENAL IMPAIRMENT; VENOUS THROMBOEMBOLISM;

EID: 84924198098     PISSN: None     EISSN: 14779560     Source Type: Journal    
DOI: 10.1186/s12959-014-0027-8     Document Type: Review

References (85)

1. Goldhaber SZ: Pulmonary embolism thrombolysis: a clarion call for international collaboration. J Am Coll Cardiol 1992, 19:246-247.
2. Beckman MG, Hooper WC, Critchley SE, Ortel TL: Venous thromboembolism: a public health concern. Am J Prev Med 2010, 38:S495-S501.
3. Deitelzweig SB, Johnson BH, Lin J, Schulman KL: Prevalence of clinical venous thromboembolism in the USA: Current trends and future projections. Am J Hematol 2011, 86:217-220.
4. Cohen AT, Agnelli G, Anderson FA, Arcelus JI, Bergqvist D, Brecht JG, Greer IA, Heit JA, Hutchinson JL, Kakkar AK, Mottier D, Oger E, Samama MM, Spannagl M, VTE Impact Assessment Group in Europe (VITAE): Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb Haemost 2007, 98:756-764.
5. White RH: The epidemiology of venous thromboembolism. Circulation 2003, 107:14-18.
6. Kearon C: Natural history of venous thromboembolism. Circulation 2003, 107:I22-I30.
7. Kahn SR: The post-thrombotic syndrome: progress and pitfalls. Br J Haematol 2006, 134:357-365.
8. Prandoni P: Healthcare burden associated with the post-thrombotic syndrome and potential impact of the new oral anticoagulants. Eur J Haematol 2012, 88:185-194.
9. Silverstein MD, Heit JA, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ III: Trends in the incidence of deep vein thrombosis and pulmonary embolism: a 25-year population-based study. Arch Intern Med 1998, 158:585-593.
10. Oger E: Incidence of venous thromboembolism: a community-based study in Western France. EPI-GETBP Study Group. Groupe d'Etude de la Thrombose de Bretagne Occidentale. Thromb Haemost 2000, 83:657-660.
11. Jang MJ, Bang SM, Oh D: Incidence of venous thromboembolism in Korea: from the Health Insurance Review and Assessment Service database. J Thromb Haemost 2011, 9:85-91.
12. Naess IA, Christiansen SC, Romundstad P, Cannegieter SC, Rosendaal FR, Hammerstrom J: Incidence and mortality of venous thrombosis: a population-based study. J Thromb Haemost 2007, 5:692-699.
13. Arnold DM, Kahn SR, Shrier I: Missed opportunities for prevention of venous thromboembolism: an evaluation of the use of thromboprophylaxis guidelines. Chest 2001, 120:1964-1971.
14. Schiro TA, Sakowski J, Romanelli RJ, Jukes T, Newman J, Hudnut A, Leonard T: Improving adherence to best-practice guidelines for venous thromboembolism risk assessment and prevention. Am J Health Syst Pharm 2011, 68:2184-2189.
15. Spencer FA, Lessard D, Emery C, Reed G, Goldberg RJ: Venous thromboembolism in the outpatient setting. Arch Intern Med 2007, 167:1471-1475.
16. Heit JA: The epidemiology of venous thromboembolism in the community. Arterioscler Thromb Vasc Biol 2008, 28:370-372.
17. Lyman GH: Venous thromboembolism in the patient with cancer: focus on burden of disease and benefits of thromboprophylaxis. Cancer 2011, 117:1334-1349.
18. Anderson FA Jr, Spencer FA: Risk factors for venous thromboembolism. Circulation 2003, 107:I9-I16.
19. Heit JA, Silverstein MD, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ III: Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med 2000, 160:809-815.
20. Kearon C: A conceptual framework for two phases of anticoagulant treatment of venous thromboembolism. J Thromb Haemost 2012, 10:507-511.
21. Barritt DW, Jordan SC: Anticoagulant drugs in the treatment of pulmonary embolism. A controlled trial. Lancet 1960, 1:1309-1312.
22. Doyle DJ, Turpie AGG, Hirsh J, Best C, Kinch D, Levine MN, Gent M: Adjusted subcutaneous heparin or continuous intravenous heparin in patients with acute deep vein thrombosis. A randomized trial. Ann Intern Med 1987, 107:441-445.
23. Palareti G, Legnani C, Cosmi B, Guazzaloca G, Cini M, Mattarozzi S: Poor anticoagulation quality in the first 3 months after unprovoked venous thromboembolism is a risk factor for long-term recurrence. J Thromb Haemost 2005, 3:955-961.
24. Hull R, Delmore T, Genton E, Hirsh J, Gent M, Sackett D, McLoughlin D, Armstrong P: Warfarin sodium versus low-dose heparin in the long-term treatment of venous thrombosis. N Engl J Med 1979, 301:855-858.
25. Kearon C, Akl EA, Comerota AJ, Prandoni P, Bounameaux H, Goldhaber SZ, Nelson ME, Wells PS, Gould MK, Dentali F, Crowther M, Kahn SR: 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, 141:e419S-e494S.
26. Torbicki A, Perrier A, Konstantinides S, Agnelli G, Galiè N, Pruszczyk P, Bengel F, Brady AJ, Ferreira D, Janssens U, Klepetko W, Mayer E, Remy-Jardin M, Bassand JP: 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, 29:2276-2315.
27. Erkens PM, Prins MH: Fixed dose subcutaneous low molecular weight heparins versus adjusted dose unfractionated heparin for venous thromboembolism. Cochrane Database Syst Rev 2010, 9:CD001100.
28. Nutescu E, Chuatrisorn I, Hellenbart E: Drug and dietary interactions of warfarin and novel oral anticoagulants: an update. J Thromb Thrombolysis 2011, 31:326-343.
29. Jorgensen AL, FitzGerald RJ, Oyee J, Pirmohamed M, Williamson PR: Influence of CYP2C9 and VKORC1 on patient response to warfarin: a systematic review and meta-analysis. PLoS One 2012, 7:e44064.
30. Wysowski DK, Nourjah P, Swartz L: Bleeding complications with warfarin use: a prevalent adverse effect resulting in regulatory action. Arch Intern Med 2007, 167:1414-1419.
31. Health Quality Ontario: Point-of-care international normalized ratio (INR) monitoring devices for patients on long-term oral anticoagulation therapy: an evidence-based analysis. Ont Health Technol Assess Ser 2009, 9:1-114.
32. The EINSTEIN Investigators: Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010, 363:2499-2510.
33. The EINSTEIN-PE Investigators: Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012, 366:1287-1297.
34. 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.
35. Schulman S, Kearon C, Kakkar AK, Mismetti P, Schellong S, Eriksson H, Baanstra D, Schnee J, Goldhaber SZ, for the RE-COVER Study Group: Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med 2009, 361:2342-2352.
36. Schulman S, Kakkar AK, Goldhaber SZ, Schellong S, Eriksson H, Mismetti P, Vedel Christiansen A, Friedman J, Le Maulf F, Peter N, Kearon C, RE-COVER II Trial Investigators: Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation 2014, 129:764-772.
37. 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.
38. Schulman S, Kearon C, Kakkar AK, Schellong S, Eriksson H, Baanstra D, Kvamme AM, Friedman J, Mismetti P, Goldhaber SZ: Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med 2013, 368:709-718.
39. The Hokusai-VTE Investigators: Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med 2013, 369:1406.
40. Bayer Pharma AG: Xarelto® (rivaroxaban) Summary of Product Characteristics.; 2014 [ http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000944/WC500057108.pdf ]
41. Prins MH, Lensing AWA, Bauersachs R, van Bellen B, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Decousus H, Raskob GE, Berkowitz SD, Wells PS: Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J 2013, 11:21.
42. Bristol-Myers Squibb, Pfizer EEIG: Eliquis® (apixaban) Summary of Product Characteristics. 2013 [ http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002148/WC500107728.pdf ]
43. Ogata K, Mendell-Harary J, Tachibana M, Matsumoto H, Oguma T, Kojima M, Kunitada S: Clinical safety, tolerability, pharmacokinetics, and pharmacodynamics of the novel Factor Xa inhibitor edoxaban in healthy volunteers. J Clin Pharmacol 2010, 50:743-753.
44. Boehringer Ingelheim International GmbH: Pradaxa® (dabigatran etexilate) Summary of Product Characteristics. 2014 [ http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000829/WC500041059.pdf ]
45. Eriksson BI, Quinlan DJ, Weitz JI: Comparative pharmacodynamics and pharmacokinetics of oral direct thrombin and Factor Xa inhibitors in development. Clin Pharmacokinet 2009, 48:1-22.
46. Cohen AT, Imfeld S, Rider T: Phase III trials of new oral anticoagulants in the acute treatment and secondary prevention of VTE: comparison and critique of study methodology and results. Adv Ther 2014, 31:473-493.
47. Raskob G, Büller H, Prins M, Segers A, Shi M, Schwocho L, van Kranen R, Mercuri M, The Hokusai-VTE Investigators: Edoxaban for the long-term treatment of venous thromboembolism: rationale and design of the Hokusai-venous thromboembolism study - methodological implications for clinical trials. J Thromb Haemost 2013, 11:1287-1294.
48. Lensing AW: Rivaroxaban for the treatment of symptomatic venous thromboembolism: is there a need for initial heparin treatment? A subgroup analysis of the EINSTEIN DVT and PE studies [abstract]. J Am Coll Cardiol 2014, 63:1177-1273.
49. Heit JA, Mohr DN, Silverstein MD, Petterson TM, O'Fallon WM, Melton LJ III: Predictors of recurrence after deep vein thrombosis and pulmonary embolism: a population-based cohort study. Arch Intern Med 2000, 160:761-768.
50. Prandoni P, Lensing AWA, 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.
51. Pengo V, Lensing AWA, Prins MH, Marchiori A, Davidson BL, Tiozzo F, Albanese P, Biasiolo A, Pegoraro C, Iliceto S, Prandoni P, Thromboembolic Pulmonary Hypertension Study Group: Incidence of chronic thromboembolic pulmonary hypertension after pulmonary embolism. N Engl J Med 2004, 350:2257-2264.
52. Baglin T, Bauer K, Douketis J, Buller H, Srivastava A, Johnson G: Duration of anticoagulant therapy after a first episode of an unprovoked pulmonary embolus or deep vein thrombosis: guidance from the SSC of the ISTH. J Thromb Haemost 2012, 10:698-702.
53. Eichinger S, Hron G, Bialonczyk C, Hirschl M, Minar E, Wagner O, Heinze G, Kyrle PA: Overweight, obesity, and the risk of recurrent venous thromboembolism. Arch Intern Med 2008, 168:1678-1683.
54. Kahn SR, Springmann V, Schulman S, Martineau J, Stewart JA, Komari N, McLeod A, Strulovitch C, Blostein M, Faucher JP, Gamble G, Gordon W, Kagoma PK, Miron MJ, Laverdiere D, Game M, Mills A: Management and adherence to VTE treatment guidelines in a national prospective cohort study in the Canadian outpatient setting. The Recovery Study. Thromb Haemost 2012, 108:493-498.
55. Mak KH: Coronary and mortality risk of novel oral antithrombotic agents: a meta-analysis of large randomised trials. BMJ Open 2012, 2:e001592.
56. Schulman S, Eriksson H, Goldhaber SZ, Kakkar A, Kearon C, Schellong SM, Kreuzer J, Peter N, Friedman J: Influence of age on the efficacy and safety of dabigatran versus warfarin for the treatment of acute venous thromboembolism: a pooled analysis of RE-COVER and RE-COVER II [abstract]. Blood (ASH Annual Meeting Abstracts) 2013, 122:2375.
57. Poulsen BK, Grove EL, Husted SE: New oral anticoagulants: a review of the literature with particular emphasis on patients with impaired renal function. Drugs 2012, 72:1739-1753.
58. Turpie AGG, Kreutz R, Llau J, Norrving B, Haas S: Management consensus guidance for the use of rivaroxaban - an oral, direct Factor Xa inhibitor. Thromb Haemost 2012, 108:876-886.
59. Janssen Pharmaceuticals Inc: Xarelto® (rivaroxaban) Prescribing Information. ; 2014 [ http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022406s009lbl.pdf ]
60. Boehringer Ingelheim Pharmaceuticals Inc: Pradaxa® (dabigatran etexilate) Prescribing Information. 2014 [ http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing%20Information/PIs/Pradaxa/Pradaxa.pdf ]
61. Bristol-Myers Squibb Company, Pfizer Inc: Eliquis® (Apixaban) Prescribing Information. 2014 [ http://packageinserts.bms.com/pi/pi_eliquis.pdf ]
62. Prins MH, Lensing AWA, Brighton TA, Lyons RM, Rehm J, Trajanovic M, Davidson BL, Beyer-Westendorf J, Pap ÁF, Berkowitz SD, Cohen AT, Kovacs MJ, Wells PS, Prandoni P: Oral rivaroxaban versus enoxaparin with vitamin K antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer (EINSTEIN-DVT and EINSTEIN-PE): a pooled subgroup analysis of two randomised controlled trials. Lancet Haematol 2014, 1:e37-e46.
63. Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Pak R, Raskob GE, Weitz JI, Yamabe T: Apixaban for the treatment of venous thromboembolism in cancer patients: data from the AMPLIFY trial [abstract]. Eur Heart J 2014, 35:994. Abstract P5527.
64. Cirillo M, Anastasio P, De Santo NG: Relationship of gender, age, and body mass index to errors in predicted kidney function. Nephrol Dial Transplant 2005, 20:1791-1798.
65. Beauloye C, CHU Mont-Godinne writing and review committee: Rivaroxaban: a practical guide V1.0. ; [ http://www.uclmontgodinne.be/files/RivaroxabanPracticalGuide06072012.pdf ]
66. Davidson BL, Verheijen S, Lensing AWA, Gebel M, Brighton TA, Lyons RM, Rehm J, Prins MH: Bleeding risk of patients with acute venous thromboembolism taking nonsteroidal anti-inflammatory drugs or aspirin. JAMA Intern Med 2014, 174:947-953.
67. Chitsike RS, Rodger MA, Kovacs MJ, Betancourt MT, Wells PS, Anderson DR, Chagnon I, Le Gal G, Solymoss S, Crowther MA, Perrier A, White RH, Vickars LM, Ramsay T, Kahn SR: Risk of post-thrombotic syndrome after subtherapeutic warfarin anticoagulation for a first unprovoked deep vein thrombosis: results from the REVERSE study. J Thromb Haemost 2012, 10:2039-2044.
68. Hull RD, Liang J, Townshend G: Long-term low-molecular-weight heparin and the post-thrombotic syndrome: a systematic review. Am J Med 2011, 124:756-765.
69. Fenger-Eriksen C, Münster AM, Grove EL: New oral anticoagulants: clinical indications, monitoring and treatment of acute bleeding complications. Acta Anaesthesiol Scand 2014, 58:651-659.
70. Heidbuchel H, Verhamme P, Alings M, Antz M, Hacke W, Oldgren J, Sinnaeve P, Camm AJ, Kirchhof P: European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation. Europace 2013, 15:625-651.
71. Freyburger G, Macouillard G, Labrouche S, Sztark F: Coagulation parameters in patients receiving dabigatran etexilate or rivaroxaban: two observational studies in patients undergoing total hip or total knee replacement. Thromb Res 2011, 127:457-465.
72. Lindahl TL, Baghaei F, Blixter IF, Gustafsson KM, Stigendal L, Sten-Linder M, Strandberg K, Hillarp A: Effects of the oral, direct thrombin inhibitor dabigatran on five common coagulation assays. Thromb Haemost 2011, 105:371-378.
73. van Ryn J, Stangier J, Haertter S, Liesenfeld KH, Wienen W, Feuring M, Clemens A: Dabigatran etexilate - a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemost 2010, 103:1116-1127.
74. Lindhoff-Last E, Ansell J, Spiro T, Samama MM: Laboratory testing of rivaroxaban in routine clinical practice: When, how, and which assays. Ann Med 2013, 45:423-429.
75. Becker RC, Yang H, Barrett Y, Mohan P, Wang J, Wallentin L, Alexander JH: Chromogenic laboratory assays to measure the Factor Xa-inhibiting properties of apixaban - an oral, direct and selective Factor Xa inhibitor. J Thromb Thrombolysis 2011, 32:183-187.
76. Budnitz DS, Lovegrove MC, Shehab N, Richards CL: Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med 2011, 365:2002-2012.
77. Halbritter K, Beyer-Westendorf J, Nowotny J, Pannach S, Kuhlisch E, Schellong SM: Hospitalization for vitamin-K-antagonist-related bleeding: treatment patterns and outcome. J Thromb Haemost 2013, 11:651-659.
78. Dowlatshahi D, Butcher KS, Asdaghi N, Nahirniak S, Bernbaum ML, Giulivi A, Wasserman JK, Poon MC, Coutts SB, Canadian PCC, Registry (CanPro) Investigators: Poor prognosis in warfarin-associated intracranial hemorrhage despite anticoagulation reversal. Stroke 2012, 43:1812-1817.
79. Kaatz S, Kouides PA, Garcia DA, Spyropolous AC, Crowther M, Douketis JD, Chan AK, James A, Moll S, Ortel TL, Van Cott EM, Ansell J: Guidance on the emergent reversal of oral thrombin and Factor Xa inhibitors. Am J Hematol 2012, 87(Suppl 1):S141-S145.
80. Crowther M, Mathur A, Kitt M, Genmin L, Conley PB, Hollenbach S, Castillo J, Hutchaleelaha A, Karbarz MJ, Lin JP, Barron L, Russell S, Levy G, Connolly S, Curnutte JT: A phase 2 randomized, double-blind, placebo-controlled trial demonstrating reversal of rivaroxaban-induced anticoagulation in healthy subjects by andexanet alfa (PRT064445), an antidote for FXa inhibitors [abstract]. Blood (ASH Annual Meeting Abstracts) 2013, 122:3636.
81. Portola Pharmaceuticals: Portola Pharmaceuticals begins enrollment in phase 3 study of FDA-designated breakthrough therapy andexanet alfa and Factor Xa inhibitor Xarelto®. 2014 [ http://investors.portola.com/phoenix.zhtml?c=198136&p=irol-newsroomArticle&ID=1929823&highlight =]
82. Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H: Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation 2011, 123:2736-2747.
83. Fang MC, Go AS, Chang Y, Borowsky LH, Pomernacki NK, Udaltsova N, Singer DE: Thirty-day mortality after ischemic stroke and intracranial hemorrhage in patients with atrial fibrillation on and off anticoagulants. Stroke 2012, 43:1795-1799.
84. Beyer-Westendorf J, Forster K, Pannach S, Ebertz F, Gelbricht V, Thieme C, Michalski F, Kohler C, Werth S, Sahin K, Tittl L, Hansel U, Weiss N: Rates, management, and outcome of rivaroxaban bleeding in daily care: results from the Dresden NOAC registry. Blood 2014, 124:955-962.
85. Sherid M, Sifuentes H, Sulaiman S, Samo S, Husein H, Tupper R, Thiruvaiyaru D, Spurr C, Sridhar S: Risk of gastrointestinal bleeding with dabigatran: a head-to-head comparative study with rivaroxaban. Digestion 2014, 90:137-146.