Safety, efficacy, and dosing requirements of bivalirudin in patients with heparin-induced thrombocytopenia

Pharmacotherapy

Volumn 28, Issue 9, 2008, Pages 1115-1124

  Kiser, Tyree H ^a   Burch, Jessica C ^a   Klem, Patrick M ^b   Hassell, Kathryn L ^a  

^a UNIVERSITY OF COLORADO   (United States)

^b UNIVERSITY OF COLORADO HOSPITAL   (United States)

Author keywords

Anticoagulation; Bivalirudin; Bleeding; Clcr; Creatinine clearance; Direct thrombin inhibitor; Dose; Heparin induced thrombocytopenia; HIT; Platelet; Renal function; Renal replacement therapy; RRT; Thrombus

Indexed keywords

HEPARIN; HIRULOG;

ADULT; AGED; ANTICOAGULATION; ARTICLE; BLEEDING; CLINICAL ARTICLE; CONTROLLED STUDY; CREATININE CLEARANCE; DISEASE COURSE; DISEASE SEVERITY; DOSE RESPONSE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG HALF LIFE; DRUG MECHANISM; DRUG SAFETY; FEMALE; HEPARIN INDUCED THROMBOCYTOPENIA; HUMAN; INTERNATIONAL NORMALIZED RATIO; KIDNEY DISEASE; KIDNEY FUNCTION; MALE; PARTIAL THROMBOPLASTIN TIME; THROMBOSIS; TREATMENT DURATION; TREATMENT INDICATION; TREATMENT OUTCOME;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTICOAGULANTS; COHORT STUDIES; CREATININE; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HEPARIN; HIRUDINS; HUMANS; KIDNEY FUNCTION TESTS; MALE; MIDDLE AGED; PARTIAL THROMBOPLASTIN TIME; PEPTIDE FRAGMENTS; RECOMBINANT PROTEINS; RETROSPECTIVE STUDIES; THROMBOCYTOPENIA; TREATMENT OUTCOME; YOUNG ADULT;

EID: 51849162822     PISSN: 02770008     EISSN: None     Source Type: Journal    
DOI: 10.1592/phco.28.9.1115     Document Type: Article

References (43)

1. Greinacher A, Potzsch B, Amiral J, Dummel V, Eichner A, Mueller-Eckhardt C. Heparin-associated thrombocytopenia: isolation of the antibody and characterization of a multimolecular PF4-heparin complex as the major antigen. Thromb Haemost 1994;71:247-51.
2. Visentin GP, Ford SE, Scott JP, Aster RH. Antibodies from patients with heparin-induced thrombocytopenia/thrombosis are specific for platelet factor 4 complexed with heparin or bound to endothelial cells. J Clin Invest 1994;93:81-8.
3. Warkentin TE, Levine MN, Hirsh J, et al. Heparin-induced thrombocytopenia in patients treated with low-molecular-weight heparin or unfractionated heparin. N Engl J Med 1995;332:1330-5.
4. Lindhoff-Last E, Nakov R, Misselwitz F, Breddin HK, Bauersachs R. Incidence and clinical relevance of heparin-induced antibodies in patients with deep vein thrombosis treated with unfractionated or low-molecular-weight heparin. Br J Haematol 2002;118:1137-42.
5. Warkentin TE, Sheppard JA, Horsewood P, Simpson PJ, Moore JC, Kelton JG. Impact of the patient population on the risk for heparin-induced thrombocytopenia. Blood 2000;96:1703-8.
6. Schmitt BP Adelman B. Heparin-associated thrombocytopenia: a critical review and pooled analysis. Am J Med Sci 1993;305:208-15.
7. Girolami B, Prandoni P, Stefani PM, et al. The incidence of heparin-induced thrombocytopenia in hospitalized medical patients treated with subcutaneous unfractionated heparin: a prospective cohort study. Blood 2003;101:2955-9.
8. Prandoni P, Siragusa S, Girolami B, Fabris F. The incidence of heparin-induced thrombocytopenia in medical patients treated with low-molecular-weight heparin: a prospective cohort study. Blood 2005;106:3049-54.
9. Selleng K, Warkentin TE, Greinacher A. Heparin-induced thromboevtopenia in intensive care patients. Crit Care Med 2007;35:1165-76.
10. Warkentin TE, Kelton JG. Temporal aspects of heparin-induced thrombocytopenia. N Engl J Med 2001;344:1286-92.
11. Nand S, Wong W, Yuen B, Yetter A, Schmulbach E, Gross Fisher S. Heparin-induced thrombocytopenia with thrombosis: incidence, analysis of risk factors, and clinical outcomes in 108 consecutive patients treated at a single institution. Am J Hematol 1997;56:12-16.
12. Warkentin TE, Kelton JG. A 14-year study of heparin-induced thrombocytopenia. Am J Med 1996;101:502-7.
13. Wallis DE, Workman DL, Lewis BE, Steen L, Pifarre R, Moran JF. Failure of early heparin cessation as treatment for heparin-induced thrombocytopenia. Am J Med 1999;106:629-35.
14. Lewis BE, Wallis DE, Berkowitz SD, et al. Argatroban anticoagulant therapy in patients with heparin-induced thrombocytopenia. Circulation 2001;103:1838-43.
15. Lewis BE, Wallis DE, Leya F, Hursting MJ, Kelton JG. Argatroban anticoagulation in patients with heparin-induced thrombocytopenia. Arch Intern Med 2003;163:1849-56.
16. Greinacher A, Janssens U, Berg G, et al, for the Heparin-Associated Thrombocytopenia Study (HAT) Investigators. Lepirudin (recombinant hirudin) for parenteral anticoagulation in patients with heparin-induced thrombocytopenia. Circulation 1999;100:587-93.
17. Greinacher A, Volpel H, Janssens U, et al. Recombinant hirudin (lepirudin) provides safe and effective anticoagulation in patients with heparin-induced thrombocytopenia: a prospective study. Circulation 1999;99:73-80.
18. Lubenow N, Eichler P, Lietz T, Greinacher A. Lepirudin in patients with heparin-induced thrombocytopenia: results of the third prospective study (HAT-3) and a combined analysis of HAT-1, HAT-2, and HAT-3. J Thromb Haemost 2005;3:2428-36.
19. Nand S. Hirudin therapy for heparin-associated thrombocytopenia and deep venous thrombosis. Am J Hematol 1993;43: 310-1.
20. Francis J, Drexler A, Gwyn G, Moroose R. Successful use of bivalirudin in the treatment of patients suspected, or at risk of, heparin-induced thrombocytopenia [abstract]. Blood 2004;103: 4077.
21. Kiser TH, Fish DN. Evaluation of bivalirudin treatment for heparin-induced thrombocytopenia in critically ill patients with hepatic and/or renal dysfunction. Pharmacotherapy 2006;26:452-60.
22. Dang CH, Durkalski VL, Nappi JM. Evaluation of treatment with direct thrombin inhibitors in patients with heparin-induced thrombocytopenia. Pharmacotherapy 2006;26:461-8.
23. Seybert AL, Coons JC, Zerumsky K. Treatment of heparin-induced thrombocytopenia: is there a role for bivalirudin? Pharmacotherapy 2006;26:229-41.
24. Warkentin TE, Greinacher A. Heparin-induced thrombocytopenia: recognition, treatment, and prevention - the seventh ACCP conference on antithrombotic and thrombolytic therapy. Chest 2004;126(3 suppl):S311-37.
25. Robson R. The use of bivalirudin in patients with renal impairment. J Invasive Cardiol 2000;12(suppl F):F33-6.
26. Robson R, White H, Aylward P, Frampton C. Bivalirudin pharmacokinetics and pharmacodynamics: effect of renal function, dose, and gender. Clin Pharmacol Ther 2002;71:433-9.
27. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976;16:31-41.
28. Fox I, Dawson A, Loynds P, et al. Anticoagulant activity of Hirulog, a direct thrombin inhibitor, in humans. Thromb Haemost 1993;69:157-63.
29. Kiser TH, Jung R, MacLaren R, Fish DN. Evaluation of diagnostic tests and argatroban or lepirudin therapy in patients with suspected heparin-induced thrombocytopenia. Pharmacotherapy 2005;25:1736-45.
30. Lubenow N, Eichler P, Greinacher A. Results of a large drug monitoring program confirms the safety and efficacy of Refludan (lepirudin) in patients with immune-mediated heparin-induced thrombocytopenia [abstract]. Blood 2002;100(suppl 1):502a.
31. Dager WE, White RH. Argatroban for heparin-induced thrombocytopenia in hepato-renal failure and CVVHD. Ann Pharmacother 2003;37:1232-6.
32. Hein OV, von Heymann C, Diehl T, et al. Intermittent hirudin versus continuous heparin for anticoagulation in continuous renal replacement therapy. Ren Fail 2004;26:297-303.
33. Lincoff AM, Bittl JA, Harrington RA, et al. Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial. JAMA 2003;289:853-63.
34. Lincoff AM, Bittl JA, Kleiman NS, et al. Comparison of bivalirudin versus heparin during percutaneous coronary intervention (the randomized evaluation of PC1 linking angiomax to reduced clinical events [REPLACE]-1 trial). Am J Cardiol 2004;93:1092-6.
35. Lubenow N, Eichler P, Lietz T, Farner B, Greinacher A. Lepirudin for prophylaxis of thrombosis in patients with acute isolated heparin-induced thrombocytopenia: an analysis of 3 prospective studies. Blood 2004;104:3072-7.
36. Warkentin TE. New approaches to the diagnosis of heparin-induced thrombocytopenia. Chest 2005;127(2 suppl):S35-45.
37. Pouplard C, May MA, Iochmann S, et al. Antibodies to platelet factor 4-heparin after cardiopulmonary bypass in patients anticoagulated with unfractionated heparin or a low-molecular-weight heparin: clinical implications for heparin-induced thrombocytopenia. Circulation 1999;99:2530-6.
38. Pouplard C, Amiral J, Borg JY, Laporte-Simitsidis S, Delahousse B, Gruel Y. Decision analysis for use of platelet aggregation test, carbon 14-serotonin release assay, and heparin-platelet factor 4 enzyme-linked immunosorbent assay for diagnosis of heparin-induced thrombocytopenia. Am J Clin Pathol 1999;111:700-6.
39. Warkentin TE, Hayward CP, Smith CA, Kelly PM, Kelton JG. Determinants of donor platelet variability when testing for heparin-induced thrombocytopenia. J Lab Clin Med 1992;120:371-9.
40. Chong BH, Burgess J, Ismail F. The clinical usefulness of the platelet aggregation test for the diagnosis of heparin-induced thrombocytopenia. Thromb Haemost 1993;69:344-50.
41. Price EA, Hayward CP Moffat KA, Moore JC, Warkentin TE, Zehnder JL. Laboratory testing for heparin-induced thrombocytopenia is inconsistent in North America: a survey of North American specialized coagulation laboratories. Thromb Haemost 2007;98:1357-61.
42. Warkentin TE. Platelet count monitoring and laboratory testing for heparin-induced thrombocytopenia. Arch Pathol Lab Med 2002;126:1415-23.
43. Wells M, Lipman J. Measurements of glomerular filtration in the intensive care unit are only a rough guide to renal function. S Afr J Surg 1997;35:20-3.