Rationale and design of the PREVENT-HIT study: A randomized, open-label pilot study to compare desirudin and argatroban in patients with suspected heparin-induced thrombocytopenia with or without thrombosis

Clinical Therapeutics

Volumn 32, Issue 4, 2010, Pages 626-636

  Frame, James N ^a   Rice, Lawrence ^b   Bartholomew, John R ^c   Whelton, Andrew ^d,e,f,g  

^a West Virginia University School of Medicine Charleston   (United States)

^b HOUSTON METHODIST HOSPITAL   (United States)

^c LERNER RESEARCH INSTITUTE   (United States)

^d Universal Clinical Research Center Inc   (United States)

^e JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f ScienceFirst LLC ^*  (United States)

^g ScienceFirst LLC   (United States)

Author keywords

Antithrombin; Argatroban; Desirudin; Hirudin; Randomized controlled; Thrombocytopenia; Trial

Indexed keywords

ARGATROBAN; DESULFATOHIRUDIN; HEPARIN; LOW MOLECULAR WEIGHT HEPARIN; THROMBIN INHIBITOR;

ADULT; AMPUTATION; ARTICLE; BLEEDING; CLINICAL TRIAL; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DETERIORATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG METABOLISM; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HEPARIN INDUCED THROMBOCYTOPENIA; HUMAN; MAJOR CLINICAL STUDY; MALE; MORTALITY; OPEN STUDY; OUTCOME ASSESSMENT; PILOT STUDY; RANDOMIZED CONTROLLED TRIAL; THROMBOCYTE COUNT; THROMBOSIS;

ANTICOAGULANTS; FEMALE; HEPARIN; HIRUDINS; HUMANS; MALE; MULTICENTER STUDIES AS TOPIC; PILOT PROJECTS; PIPECOLIC ACIDS; PROSPECTIVE STUDIES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECOMBINANT PROTEINS; THROMBOCYTOPENIA; THROMBOSIS;

EID: 77952485636     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2010.04.012     Document Type: Article

References (56)

1. Warkentin TE, Greinacher A, Koster A, Lincoff AM Treatment and prevention of heparin-induced thrombocytopenia: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008, 133(Suppl 6):340S-380S. for the American College of Chest Physicians.
2. Arepally GM, Ortel TL Clinical practice. Heparin-induced thrombocytopenia. N Engl J Med 2006, 355:809-817.
3. Baroletti S, Piovella C, Fanikos J, et al. Heparin-induced thrombocytopenia (HIT): Clinical and economic outcomes. Thromb Haemost 2008, 100:1130-1135.
4. Warkentin TE, Kelton JG Temporal aspects of heparin-induced thrombocytopenia. N Engl J Med 2001, 344:1286-1292.
5. Rice L, Attisha WK, Drexler A, Francis JL Delayed-onset heparin-induced thrombocytopenia. Ann Intern Med 2002, 136:210-215.
6. Warkentin TE, Kelton JG Delayed-onset heparin-induced thrombocytopenia and thrombosis. Ann Intern Med 2001, 135:502-506.
7. Di Nisio M, Middeldorp S, Büller HR Direct thrombin inhibitors [published correction appears in N Engl J Med. 2005;353:2827]. N Engl J Med 2005, 353:1028-1040.
8. Rice L Heparin-induced thrombocytopenia: Myths and misconceptions (that will cause trouble for you and your patient). Arch Intern Med 2004, 164:1961-1964.
9. Greinacher A, Eichler P, Lubenow N, et al. Heparin-induced thrombocytopenia with thromboembolic complications: Meta-analysis of 2 prospective trials to assess the value of parenteral treatment with lepirudin and its therapeutic aPTT range. Blood 2000, 96:846-851.
10. Wallis DE, Workman DL, Lewis BE, et al. Failure of early heparin cessation as treatment for heparin-induced thrombocytopenia. Am J Med 1999, 106:629-635.
11. Warkentin TE, Kelton JG A 14-year study of heparin-induced thrombocytopenia. Am J Med 1996, 101:502-507.
12. Argatroban [package insert] 2008, GlaxoSmithKline, Research Triangle Park, NC.
13. Angiomax [package insert] 2005, The Medicines Company, Parsippany, NJ.
14. Refludan [package insert] 2006, Bayer HealthCare, Wayne, NJ.
15. Arixtra [package insert] 2008, GlaxoSmithKline, Research Triangle Park, NC.
16. Rota E, Bazzan M, Fantino G Fondaparinux-related thrombocytopenia in a previous low-molecular-weight heparin (LMWH)-induced heparin-induced thrombocytopenia (HIT). Thromb Haemost 2008, 99:779-781.
17. Warkentin TE, Maurer BT, Aster RH Heparin-induced thrombocytopenia associated with fondaparinux. N Engl J Med 2007, 356:2653-2655.
18. Iprivask [package insert] 2010, Canyon Pharmaceuticals, Inc, Hunt Valley, Md.
19. Crespo EM, Oliveira GB, Honeycutt EF, et al. Evaluation and management of thrombocytopenia and suspected heparin-induced thrombocytopenia in hospitalized patients: The Complications After Thrombocytopenia Caused by Heparin (CATCH) registry. Am Heart J 2009, 157:651-657. for the CATCH Registry Investigators.
20. Oliveira GB, Crespo EM, Becker RC, et al. Incidence and prognostic significance of thrombocytopenia in patients treated with prolonged heparin therapy. Arch Intern Med 2008, 168:94-102. for the Complications After Thrombocytopenia Caused by Heparin (CATCH) Registry Investigators.
21. Eriksson BI, Ekman S, Lindbratt S, et al. Prevention of thromboembolism with use of recombinant hirudin. Results of a double-blind, multicenter trial comparing the efficacy of desirudin (Revasc) with that of unfractionated heparin in patients having a total hip replacement. J Bone Joint Surg Am 1997, 79:326-333.
22. Eriksson BI, Wille-Jørgensen P, Kälebo P, et al. A comparison of recombinant hirudin with a low-molecular-weight heparin to prevent thromboembolic complications after total hip replacement. N Engl J Med 1997, 337:1329-1335.
23. Eriksson BI, Ekman S, Kälebo P, et al. Prevention of deep-vein thrombosis after total hip replacement: Direct thrombin inhibition with recombinant hirudin, CGP 39393. Lancet 1996, 347:635-639.
24. Serruys PW, Herrman JP, Simon R, et al. A comparison of hirudin with heparin in the prevention of restenosis after coronary angioplasty. N Engl J Med 1995, 333:757-763. for the Helvetica Investigators.
25. Topol EJ, Fuster V, Harrington RA, et al. Recombinant hirudin for unstable angina pectoris. A multicenter, randomized angiographic trial. Circulation 1994, 89:1557-1566.
26. Randomized trial of intravenous heparin versus recombinant hirudin for acute coronary syndromes. Circulation 1994, 90:1631-1637. The Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) IIa Investigators.
27. A comparison of recombinant hirudin with heparin for the treatment of acute coronary syndromes. N Engl J Med 1996, 335:775-782. The Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) IIb Investigators.
28. Antman EM Hirudin in acute myocardial infarction. Thrombolysis and Thrombin Inhibition in Myocardial Infarction (TIMI) 9B trial. Circulation 1996, 94:911-921.
29. Antman EM Hirudin in acute myocardial infarction. Safety report from the Thrombolysis and Thrombin Inhibition in Myocardial Infarction (TIMI) 9A Trial. Circulation 1994, 90:1624-1630.
30. Cannon CP, McCabe CH, Henry TD, et al. A pilot trial of recombinant desulfatohirudin compared with heparin in conjunction with tissue-type plasminogen activator and aspirin for acute myocardial infarction: Results of the Thrombolysis in Myocardial Infarction (TIMI) 5 trial. J Am Coll Cardiol 1994, 23:993-1003.
31. Lee LV Initial experience with hirudin and streptokinase in acute myocardial infarction: Results of the Thrombolysis in Myocardial Infarction (TIMI) 6 trial. Am J Cardiol 1995, 75:7-13.
32. van den Bos AA, Deckers JW, Heyndrickx GR, et al. Safety and efficacy of recombinant hirudin (CGP 39 393) versus heparin in patients with stable angina undergoing coronary angioplasty. Circulation 1993, 88:2058-2066.
33. Lewis BE, Wallis DE, Berkowitz SD, et al. Argatroban anticoagulant therapy in patients with heparin-induced thrombocytopenia. Circulation 2001, 103:1838-1843. for the ARG-911 Study Investigators.
34. Lewis BE, Wallis DE, Leya F, et al. Argatroban anticoagulation in patients with heparin-induced thrombocytopenia. Arch Intern Med 2003, 163:1849-1856. for the Argatroban-915 Investigators.
35. Hirsh J, Bauer KA, Donati MB, et al. Parenteral anticoagulants: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition) [published correction appears in Chest. 2008;134:473]. Chest 2008, 133(Suppl 6):141S-159S. for the American College of Chest Physicians.
36. Direct thrombin inhibitors in acute coronary syndromes: Principal results of a meta-analysis based on individual patients' data. Lancet 2002, 359:294-302. Direct Thrombin Inhibitor Trialists' Collaborative Group.
37. McBane RD, Hassinger NL, Mruk JS, et al. Direct thrombin inhibitors are not equally effective in vivo against arterial thrombosis: In vivo evaluation of DuP714 and argatroban in a porcine angioplasty model and comparison to r-hirudin. Thromb Res 2005, 116:525-532.
38. Greinacher A, Eichler P, Albrecht D, et al. Antihirudin antibodies following low-dose subcutaneous treatment with desirudin for thrombosis prophylaxis after hip-replacement surgery: Incidence and clinical relevance. Blood 2003, 101:2617-2619.
39. Levy J, Kurz M, Whelton A. Lack of clinically significant interactions between the subcutaneously administered direct thrombin inhibitor desirudin and orally administered warfarin upon the international normalized ratio. Presented at: 51st Annual Meeting of the American Society of Hematology; December 5-8, 2009; New Orleans, La. Abstract 22416.
40. Warkentin TE Bivalent direct thrombin inhibitors: Hirudin and bivalirudin. Best Pract Res Clin Haematol 2004, 17:105-125.
41. Braun PJ, Dennis S, Hofsteenge J, Stone SR Use of site-directed mutagenesis to investigate the basis for the specificity of hirudin. Biochemistry 1988, 27:6517-6522.
42. Römisch J, Diehl KH, Hoffmann D, et al. Comparison of in vitro and in vivo properties of rhirudin (HBW 023) and a synthetic analogous peptide. Haemostasis 1993, 23:249-258.
43. Eichler P, Friesen HJ, Lubenow N, et al. Antihirudin antibodies in patients with heparin-induced thrombocytopenia treated with lepirudin: Incidence, effects on aPTT, and clinical relevance. Blood 2000, 96:2373-2378.
44. Gosselin RC, Dager WE, King JH, et al. Effect of direct thrombin inhibitors, bivalirudin, lepirudin, and argatroban, on prothrombin time and INR values. Am J Clin Pathol 2004, 121:593-599.
45. Hijikata-Okunomiya A, Okamoto S, Wanaka K Effect of a synthetic thrombin-inhibitor MD805 on the reaction between thrombin and plasma antithrombin-III. Thromb Res 1990, 59:967-977.
46. Arnold RJ, Kim R, Tang B The cost-effectiveness of argatroban treatment in heparin-induced thrombocytopenia: The effect of early versus delayed treatment. Cardiol Rev 2006, 14:7-13.
47. Frame JN The heparin-induced thrombocytopenia task force model: Implementing quality improvement and economic outcome initiatives. Semin Hematol 2005, 42(Suppl 3):S28-S35.
48. Smythe MA, Koerber JM, Fitzgerald M, Mattson JC The financial impact of heparin-induced thrombocytopenia. Chest 2008, 134:568-573.
49. Lefèvre G, Duval M, Gauron S, et al. Effect of renal impairment on the pharmacokinetics and pharmaco-dynamics of desirudin. Clin Pharmacol Ther 1997, 62:50-59.
50. Nafziger AN, Bertino JS Jr. Desirudin dosing and monitoring in moderate renal impairment [published online ahead of print November 13, 2009]. J Clin Pharmacol.
51. Greinacher A Lepirudin for the treatment of heparin-induced thrombocytopenia. Heparin-Induced Thrombocytopenia 2007, 345-378. Informa Healthcare USA, Inc, New York, NY. 4th ed. T.E. Warkentin, A. Greinacher (Eds.).
52. Guzzi LM, McCollum DA, Hursting MJ Effect of renal function on argatroban therapy in heparin-induced thrombocytopenia. J Thromb Thrombolysis 2006, 22:169-176.
53. Hursting MJ, Verme-Gibboney CN Risk factors for major bleeding in patients with heparin-induced thrombocytopenia treated with argatroban: A retrospective study. J Cardiovasc Pharmacol 2008, 52:561-566.
54. Reddy BV, Grossman EJ, Trevino SA, et al. Argatroban anticoagulation in patients with heparin-induced thrombocytopenia requiring renal replacement therapy. Ann Pharmacother 2005, 39:1601-1605.
55. Arpino PA, Hallisey RK Effect of renal function on the pharmacodynamics of argatroban. Ann Pharmacother 2004, 38:25-29.
56. Eriksson BI, Kälebo P, Ekman S, et al. Direct thrombin inhibition with Rec-hirudin CGP 39393 as prophylaxis of thromboembolic complications after total hip replacement. Thromb Haemost 1994, 72:227-231.