Management of bleeding in patients receiving conventional or new anticoagulants: A practical and case-based approach

Drugs

Volumn 72, Issue 15, 2012, Pages 1965-1975

  Donadini, Marco P ^a   Ageno, Walter ^a   Douketis, James D ^b  

^a UNIVERSITY OF INSUBRIA   (Italy)

^b MCMASTER UNIVERSITY   (Canada)

Author keywords

Acenocoumarol; Anticoagulants; Apixaban; Avidin; Betrixaban; Dabigatran etexilate; Edoxaban; Fondaparinux sodium; Haemorrhage; Idrabiotaparinux sodium; Idraparinux sodium; Oral; Parenteral; Phenprocoumon; Phytomenadione; Protamine sulfate; Prothrombin complex concentrate; Recombinant proteins; Rivaroxaban; Vitamin K; Vitamin K antagonists; Warfarin; Ximelagatran

Indexed keywords

ACENOCOUMAROL; ACTIVATED PROTHROMBIN COMPLEX; ANTICOAGULANT AGENT; ANTIVITAMIN K; APIXABAN; BETRIXABAN; DABIGATRAN; EDOXABAN; ENOXAPARIN; FONDAPARINUX; HEPARIN; IDRABIOTAPARINUX; LOW MOLECULAR WEIGHT HEPARIN; PHENPROCOUMON; PROTHROMBIN COMPLEX; RIVAROXABAN; WARFARIN;

AGED; ANTICOAGULANT THERAPY; BLEEDING; BRAIN HEMORRHAGE; CASE REPORT; CEREBROVASCULAR ACCIDENT; CONGESTIVE HEART FAILURE; CONTINUOUS INFUSION; DEEP VEIN THROMBOSIS; DRUG ABSORPTION; DRUG COST; DRUG HALF LIFE; DRUG MECHANISM; FEMALE; GASTROINTESTINAL HEMORRHAGE; HUMAN; LUNG EMBOLISM; MALE; REVIEW; VEIN THROMBOSIS; VENOUS THROMBOEMBOLISM;

ANIMALS; ANTICOAGULANTS; HEMORRHAGE; HUMANS; THROMBOEMBOLISM;

EID: 84867289249     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.2165/11641160-000000000-00000     Document Type: Review

References (61)

1. Warkentin AE, Donadini MP, Spencer FA, et al. Bleeding risk in randomized controlled trials comparing warfarin and aspirin: a systematic review and meta-analysis. J Thromb Haemost 2012; 10: 512-20
2. Schulman S, Kearon C. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005; 3: 692-4 (Pubitemid 41647882)
3. Schulman S, Angeras U, Bergqvist D, et al. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients. J Thromb Haemost 2010; 8: 202-4
4. Ost D, Tepper J, Mihara H, et al. Duration of anticoagulation following venous thromboembolism: a meta-analysis. JAMA 2005; 294: 76-715
5. Palareti G, Leali N, Coccheri S, et al. Bleeding complication of anticoagulant treatment: an inception-cohort, prospective collaborative study (ISCOAT). Lancet 1996; 348: 423-8 (Pubitemid 26267872)
6. Sørensen R, Hansen ML, Abildstrom SZ, et al. Risk of bleeding in patients with acute myocardial infarction treated with different combinations of aspirin, clopidogrel, and vitamin Kantagonists in Denmark: a retrospective analysis of nationwide registry data. Lancet 2009; 374: 1947-8
7. Kearon C, Akl EA, Comerota AJ, et al. Antithrombotic therapy for VTE disease: antithrombotic therapy and prevention of thrombosis, 9th edition: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2012; 141 (2 Suppl.): e419S-94S
8. Schulman S, Beyth RJ, Kearon C, et al. Hemorrhagic complications of anticoagulant and thrombolytic treatment: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition). Chest 2008; 133 (6 Suppl.): 257S-98S (Pubitemid 351892969)
9. Carrier M, Le Gal G, Wells PS, et al. Systematic review: case-fatality rates of recurrent venous thromboembolism andmajor bleeding events among patients treated for venous thromboembolism. Ann Intern Med 2010; 152: 578-89
10. Linkins LA, Choi PT, Douketis JD. Clinical impact of bleeding in patients taking oral anticoagulant therapy for venous thromboembolism: a meta-analysis. Ann Intern Med 2003; 139: 893-900
11. Appelboam R, Thomas EO. Warfarin and intracranial haemorrhage. Blood Rev 2009; 23: 1-9
12. Ageno W, Gallus AS, Wittkowsky A, et al. Oral anticoagulant therapy: antithrombotic therapy and prevention of thrombosis, 9th edition: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2012; 141 (2 Suppl.): e44S-88S
13. Holbrook A, Schulman S, Witt DM, et al. Evidencebased management of anticoagulant therapy: antithrombotic therapy and prevention of thrombosis, 9th edition: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2012; 141 (2 Suppl.): e152S-84S
14. Fiore LD, Scola MA, Cantillon CE, et al. Anaphylactoid reactions to vitamin K. J Thromb Thrombolysis 2001; 11: 175-83 (Pubitemid 32694362)
15. Riegert-Johnson DL, Volcheck GW. The incidence of anaphylaxis following intravenous phytonadione (vitamin K1): a 5-year retrospective review. Ann Allergy Asthma Immunol 2002; 89: 400-6 (Pubitemid 36188012)
16. White RH, McKittrick T, Hutchinson R, et al. Temporary discontinuation of warfarin therapy: changes in international normalized ratio. Ann Intern Med 1995; 122: 40-2
17. Contreras M, Ala FA, Greaves M, et al. Guidelines for the use of fresh frozen plasma. British Committee for Standards in Haematology, Working Party of the Blood Transfusion Task Force. Transfus Med 1992; 2: 57-63
18. O'Shaughnessy DF, Atterbury C, Bolton Maggs P, et al. Guidelines for the use of fresh-frozen plasma, cryoprecipitate and cryosupernatant. Br J Haematol 2004; 126: 11-28 (Pubitemid 38859478)
19. Khan H, Belsher J, Yilmaz M, et al. Fresh-frozen plasma and platelet transfusions are associated with development of acute lung injury in critically ill medical patients. Chest 2007; 131: 1308-14 (Pubitemid 46762333)
20. Lubetsky A, Hoffman R, Zimlichman R, et al. Efficacy and safety of a Prothrombin Complex Concentrate (Octaplex) for rapid reversal of oral anticoagulation. Thromb Res 2004; 113: 371-8 (Pubitemid 38844367)
21. Dentali F, Marchesi C, Giorgi PiefranceschiM, et al. Safety of prothrombin complex concentrates for rapid anticoagulation reversal of vitamin K antagonists. Thromb Haemost 2011; 106: 429-38
22. Dentali F, Ageno W, Crowther M. Treatment of coumarinassociated coagulopathy: a systematic review and proposed treatment algorithms. J Thromb Haemost 2006; 4: 1853-63 (Pubitemid 44226758)
23. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361: 1139-51
24. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365: 883-91
25. EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010; 363: 2499-510
26. EINSTEIN-PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012; 366: 1287-97
27. Douketis JD, Arneklev K, Goldhaber SZ, et al. Comparison of bleeding in patients with nonvalvular atrial fibrillation treated with ximelagatran or warfarin: assessment of incidence, case-fatality rate, time course and sites of bleeding, and risk factors for bleeding. Arch Intern Med 2006; 166: 853-9
28. Ufer M. Comparative efficacy and safety of the novel oral anticoagulants dabigatran, rivaroxaban and apixaban in preclinical and clinical development. Thromb Haemost 2010; 103: 572-85
29. Weinz C, Schwarz T, Kubitza D, et al. Metabolism and excretion of rivaroxaban, an oral, direct factor Xa inhibitor, in rats, dogs, and humans. Drug Metab Dispos 2009; 37: 1056-64
30. van Ryn J, Stangier J, Haertter S, et al. Dabigatran etexilate: a novel, reversible, oral direct thrombin inhibitor. Interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemost 2010; 103: 1116-27
31. Kubitza D, Becka M, Mueck W, et al. Effects of renal impairment on the pharmacokinetics, pharmacodynamics and safety of rivaroxaban, an oral, direct factor Xa inhibitor. Br J Clin Pharmacol 2010; 70: 703-12
32. van Ryn J, Sieger P, Kink-Eiband M, et al. Adsorption of dabigatran etexilate in water or dabigatran in pooled human plasma by activated charcoal in vitro [abstract]. 51st ASH Annual Meeting and Exposition; 2009 Dec 7-8; New Orleans (LA)
33. Zhou W, Schwarting S, Illanes S, et al. Hemostatic therapy in experimental intracerebral hemorrhage associated with the direct thrombin inhibitor dabigatran. Stroke 2011; 42: 3594-9
34. Eerenberg ES, Kamphuisen PW, Sijpkens MK, et al. Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects. Circulation 2011; 124: 1573-9
35. Marlu R, Hodaj E, Paris A, et al. Effect of non-specific reversal agents on anticoagulant activity of dabigatran and rivaroxaban: a randomised crossover ex vivo study in healthy volunteers. Thromb Haemost 2012 Jul 25; 108 (2): 217-24
36. van Ryn J, Kink-Eiband M, Clemens A. The successful reversal of dabigatran-induced bleeding by coagulation factor concentrates in a rat tail bleeding model do not correlate with ex vivo markers of anticogulation [abstract]. 53rd ASH Annual Meeting and Exposition; 2011 Dec 10-13; San Diego (CA)
37. Tinel H, Huetter J, Perzborn E. Recombinant factor VIIA partially reverses the anticoagulant effect of high-dose rivaroxaban a novel, oral, direct factor Xa inhibitor in rats [abstract no. P-W-652]. J Thromb Haemost 2007; 5
38. Gruber A, Marzec UM, Holcomb JB. Potential of activated prothrombin complex concentrate and activated factor VII to reverse the anticoagulant effects of rivaroxaban in primates [abstract]. 50th ASH Annual Meeting and Exposition; 2008 Dec 6-9; San Francisco (CA)
39. Stangier J, Rathgen K, Stahle H, et al. Influence of renal impairment on the pharmacokinetics and pharmacodynamics of oral dabigatran etexilate: an open-label, parallel-group, single-centre study. Clin Pharmacokinet 2010; 49: 259-68
40. Kaatz S, Kouides PA, Garcia DA, et al. Guidance on the emergent reversal of oral thrombin and factor Xa inhibitors. Am J Hematol 2012; 87 Suppl. 1: S141-5
41. Bü ller HR, Davidson BL, Decousus H, et al. Fondaparinux or enoxaparin for the initial treatment of symptomatic deep venous thrombosis: a randomized trial. Ann Intern Med 2004; 140: 867-73
42. Bü ller HR, Davidson BL, Decousus H, et al. Subcutaneous fondaparinux versus intravenous unfractionated heparin in the initial treatment of pulmonary embolism.NEngl J Med 2003; 349: 1695-702 (Pubitemid 37315006)
43. Decousus H, Prandoni P, Mismetti P, et al. Fondaparinux for the treatment of superficial-vein thrombosis in the legs. N Engl J Med 2010; 363: 1222-32
44. Garcia DA, Baglin TP, Weitz JI, et al. Parenteral anticoagulants: antithrombotic therapy and prevention of thrombosis, 9th edition: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2012; 141 (2 Suppl.): e24S-43S
45. Bara L, Billaud E, Gramond G, et al. Comparative pharmacokinetics of a low molecular weight heparin (PK 10 169) and unfractionated heparin after intravenous and subcutaneous administration. Thromb Res 1985; 39: 631-6 (Pubitemid 15228564)
46. Levi M, Eerenberg E, Kamphuisen PW. Bleeding risk and reversal strategies for old and new anticoagulants and antiplatelet agents. J Thromb Haemost 2011; 9 (9): 1705-12
47. Caplan SN, Berkman EM. Protamine sulfate and fish allergy [letter]. N Engl J Med 1976; 295 (3): 172
48. Levi M, Eerenberg E, Lowenberg E, et al. Bleeding in patients using new anticoagulants or antiplatelet agents: risk factors and management. Neth J Med 2010; 68: 68-76
49. Ng HJ, Koh LP, Lee LH. Successful control of postsurgical bleeding by recombinant factor VIIa in a renal failure patient given low molecular weight heparin and aspirin. Ann Hematol 2003; 82: 257-8 (Pubitemid 36701022)
50. Elmer J, Wittels KA. Emergency reversal of pentasaccharide anticoagulants: a systematic review of the literature. Transfus Med 2012; 22: 108-15
51. Desmurs-Clavel H, Huchon C, Chatard B, et al. Reversal of the inhibitory effect of fondaparinux on thrombin generation by rFVIIa, aPCC and PCC. Thromb Res 2009; 123: 796-8
52. Bijsterveld NR, Vink R, van Aken BE, et al. Recombinant factor VIIa reverses the anticoagulant effect of the longacting pentasaccharide idraparinux in healthy volunteers. Br J Haematol 2004; 124: 653-8 (Pubitemid 38297099)
53. Bijsterveld NR, Moons AH, Boekholdt SM, et al. Ability of recombinant factor VIIa to reverse the anticoagulant effect of the pentasaccharide fondaparinux in healthy volunteers. Circulation 2002; 106: 2550-4 (Pubitemid 35340690)
54. Bianchini EP, Fazavana J, Picard V, et al. Development of a recombinant antithrombin variant as a potent antidote to fondaparinux and other heparin derivatives. Blood 2011; 117: 2054-60
55. Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011; 365: 981-92
56. Connolly SJ, Eikelboom J, Joyner C, et al.Apixaban in patients with atrial fibrillation. N Engl J Med 2011; 364: 806-17
57. Equinox Investigators. Efficacy and safety of once weekly subcutaneous idrabiotaparinux in the treatment of patients with symptomatic deep venous thrombosis. J Thromb Haemost 2011; 9: 92-9
58. Paty J, Trellu M, Destors JM, et al. Reversibility of the anti-Xa activity of idrabiotaparinux (biotinylated idraparinux) by intravenous avidin infusion. J Thromb Haemost 2010; 8: 722-9
59. Bü ller HR, Gallus AS, Pillion G, et al. Enoxaparin followed by once-weekly idrabiotaparinux versus enoxaparin plus warfarin for patients with acute symptomatic pulmonary embolism: a randomised, double-blind, double-dummy, non-inferiority trial. Lancet 2012; 379: 123-9
60. Bianchini EP, Fazavana J, Picard V, et al. Development of a recombinant antithrombin variant as a potent antidote to fondaparinux and other heparin derivatives. Blood 2011 Feb 10; 117 (6): 2054-60
61. Lu G, Deguzman FR, Karbarz MJ, et al. Reversal of rivaroxaban mediated anticoagulation in animal models by a recombinant antidote protein (r-Antidote, PRT064445). Eur Heart J 2011; 32 (Abstract Suppl.):640-1