Benefits and risks of aprotinin use during cardiac surgery

Pharmacotherapy

Volumn 28, Issue 1, 2008, Pages 112-124

  Kristeller, Judith L ^a   Roslund, Brian P ^a   Stahl, Russell F ^b  

^a WILKES UNIVERSITY   (United States)

^b P   (United States)

Author keywords

Antifibrinolytic agents; Aprotinin; Blood conservation; Blood transfusion; CABG; Cardiac surgery; Cardiopulmonary bypass; Coronary artery bypass grafting

Indexed keywords

AMINOCAPROIC ACID; ANGIOTENSIN 2 RECEPTOR ANTAGONIST; ANTICOAGULANT AGENT; ANTIFIBRINOLYTIC AGENT; ANTIINFLAMMATORY AGENT; APROTININ; CLOPIDOGREL; CREATININE; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; IMMUNOGLOBULIN G; KALLIKREIN; PLACEBO; PROTEINASE ACTIVATED RECEPTOR 1; SERINE PROTEINASE INHIBITOR; THROMBIN; TRANEXAMIC ACID;

ACUTE KIDNEY FAILURE; ANAPHYLAXIS; BLEEDING; BLOOD CONSERVATION; BLOOD TRANSFUSION; BOVINE SPONGIFORM ENCEPHALOPATHY; CARDIOPULMONARY BYPASS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DOSE COMPARISON; DRUG MARKETING; DRUG MECHANISM; DRUG SAFETY; GRAFT PATENCY; HEART INFARCTION; HEART SURGERY; HIGH RISK PATIENT; HUMAN; KIDNEY FAILURE; MORTALITY; NEPHROTOXICITY; NEUROPROTECTION; REVIEW; RISK BENEFIT ANALYSIS; STROKE; SURGICAL MORTALITY; THROMBOSIS; THROMBOSIS PREVENTION;

APROTININ; CARDIAC SURGICAL PROCEDURES; CLINICAL TRIALS, PHASE IV AS TOPIC; HUMANS; RISK ASSESSMENT; SERINE PROTEINASE INHIBITORS;

EID: 38049044907     PISSN: 02770008     EISSN: None     Source Type: Journal    
DOI: 10.1592/phco.28.1.112     Document Type: Review

References (48)

1. Ferraris VA, Ferraris SP, Saha SP, et al. Perioperative blood transfusion and blood conservation in cardiac surgery: the Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists clinical practice guideline. Ann Thorac Surg 2007;83(suppl 5):S27-86.
2. Karkouti K, Beattie WS, Dattilo KM, et al. A propensity score case-control comparison of aprotinin and tranexamic acid in high-transfusion- risk cardiac surgery. Transfusion 2006;46: 327-38.
3. Mangano DT, Tudor IC, Dietzel C. The risk associated with aprotinin in cardiac surgery. N Engl J Med 2006;354:353-65.
4. U.S. Food and Drug Administration. FDA statement regarding new Trasylol data, 2007. Ref type: generic. Available from http://www.fda.gov/bbs/ topics/NEWS/2006/NEW01472.html. Accessed November 13, 2007.
5. U.S. Food and Drug Administration. Aprotinin injection (marketed as Trasylol) information, 2006. Available from www.fda.gov/cder/drug/infopage/ aprolinin/default.htm. Accessed May 4, 2007.
6. Mangano DT, Miao Y, Vuylsteke A, et al. Mortality associated with aprotinin during 5 years following coronary artery bypass graft surgery. JAMA 2007;297:471-9.
7. U.S. Food and Drug Administration. FDA statement regarding marketing suspension of Trasylol. Available from http://www.fda.gov/bbs/topics/ NEWS/2007/NEW01738.html. Accessed November 13, 2007.
8. Ottawa Health Research Institute. Information about the blood conservation using antifibrinolytics in a randomized trial (BART) study. Available from http://www.ohri.ca/newsroom/newsstory.asp?ID=109&status= print. Accessed November 13, 2007.
9. Ferraris VA, Ferraris SP. Limiting excessive postoperative blood transfusion after cardiac procedures: a review. Tex Heart Inst J 1995;22:216-30.
10. Landis RC, Asimakopoulos G, Poullis M, Haskard DO, Taylor KM. The antithrombotic and antiinflammatory mechanisms of action of aprotinin. Ann Thorac Surg 2001;72:2169-75.
11. Mojcik CF, Levy JH. Aprotinin and the systemic inflammatory response after cardiopulmonary bypass. Ann Thorac Surg 2001;71:745-54.
12. Murkin JM. Cardiopulmonary bypass and the inflammatory response: a role for serine protease inhibitors? J Cardiothorac Vasc Anesth 1997;11(2 suppl 1):19-23.
13. Speekenbrink RG, Wildevuur CR, Sturk A, Eijsman L. Low-dose and high-dose aprotinin improve hemostasis in coronary operations. J Thorac Cardiovasc Surg 1996;112:523-30.
14. 1) by intravenous aprotinin during cardiothoracic surgery. Circulation 2004;110:2597-600.
15. Poullis M, Landis RC, Taylor KM. Aprotinin: is it prothrombotic? Perfusion 2001;16:401-9.
16. Tassani P, Augustin N, Barankay A, Braun SL, Zaccaria F, Richter JA. High-dose aprotinin modulates the balance between proinflammatory and anti-inflammatory responses during coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth 2000;14:682-6.
17. Golker CF, Whiteman MD, Gugel KH, et al. Reduction of the infectivity of scrapie agent as a model for BSE in the manufacturing process of Trasylol. Biologicals 1996;24:103-11.
18. Bull DA, Maurer J. Aprotinin and preservation of myocardial function after ischemia-reperfusion injury. Ann Thorac Surg 2003;75:S735-9.
19. Bidstrup BP, Royston D, Sapsford RN, Taylor KM. Reduction in blood loss and blood use after cardiopulmonary bypass with high dose aprotinin (Trasylol). J Thorac Cardiovasc Surg 1989;97:364-72.
20. Lemmer JH Jr, Dilling EW, Morton JR, et al. Aprotinin for primary coronary artery bypass grafting: a multicenter trial of three dose regimens. Ann Thorac Surg 1996;62:1659-67.
21. Levy JH, Pifarre R, Schaff HV, et al. A multicenter, double-blind, placebo-controlled trial of aprotinin for reducing blood loss and the requirement for donor-blood transfusion in patients undergoing repeat coronary artery bypass grafting. Circulation 1995;92:2236-44.
22. Cosgrove DM III, Heric B, Lytle BW, et al. Aprotinin therapy for reoperative myocardial revascularization: a placebo-controlled study. Ann Thorac Surg 1992;54:1031-6.
23. Laupacis A, Fergusson D, for the International Study of Perioperative Transfusion Investigators. Drugs to minimize perioperative blood loss in cardiac surgery: meta-analyses using perioperative blood transfusion as the outcome. Anesth Analg 1997;85:1258-67.
24. Englberger L, Kipfer B, Berdat PA, Nydegger UE, Carrel TP. Aprotinin in coronary operation with cardiopulmonary bypass: does "low-dose" aprotinin inhibit the inflammatory response? Ann Thorac Surg 2002;73:1897-904.
25. Alvarez JM, Jackson LR, Chatwin C, Smolich JJ. Low-dose postoperative aprotinin reduces mediastinal drainage and blood product use in patients undergoing primary coronary artery bypass grafting who are taking aspirin: a prospective, randomized, double-blind, placebo-controlled trial. J Thorac Cardiovasc Surg 2001;122:457-63.
26. Kunt AS, Darcin OT, Aydin S, Demir D, Selli C, Andac MH. Mini-dose pump-prime aprotinin inhibited enhanced fibrinolytic activity and reduced blood loss and transfusion requirements after coronary artery bypass surgery. J Thromb Thrombolysis 2005;19:197-200.
27. Dignan RJ, Law DW, Seah PW, et al. Ultra-low-dose aprotinin decreases transfusion requirements and is cost-effective in coronary operations. Ann Thorac Surg 2001;71:158-63.
28. Hayashida N, Isomura T, Sato T, Maruyama H, Kosuga K, Aoyagi S. Effects of minimal-dose aprotinin on coronary artery bypass grafting. J Thorac Cardiovasc Surg 1997;114:261-9.
29. Kalangos A, Tayyareci G, Pretre R, Di DP, Sezerman O. Influence of aprotinin on early graft thrombosis in patients undergoing myocardial revascularization. Eur J Cardiothorac Surg 1994;8:651-6.
30. Arora RC, Legare JF, Buth KJ, Sullivan JA, Hirsch GM. Identifying patients at risk of intraoperative and postoperative transfusion in isolated CABG: toward selective conservation strategies. Ann Thorac Surg 2004;78:1547-54.
31. Chu MW, Wilson SR, Novick RJ, Stitt LW, Quantz MA. Does clopidogrel increase blood loss following coronary artery bypass surgery? Ann Thorac Surg 2004;78:1536-41.
32. Scott BH, Seifert FC, Glass PS, Grimson R. Blood use in patients undergoing coronary artery bypass surgery: impact of cardiopulmonary bypass pump, hematocrit, gender, age, and body weight. Anesth Analg 2003;97:958-63.
33. Hebert PC, for the Ottawa Health Research Institute. Blood conservation using antifibrinolytics: a randomized trial in a cardiac surgery population - the BART study. Available from www.controlled-trials.com/isrctn/pf/ 15166455. Accessed November 13, 2007.
34. Fergusson D, Glass KC, Hutton B, Shapiro S. Randomized controlled trials of aprotinin in cardiac surgery: could clinical equipoise have stopped the bleeding? Clin Trials 2005;2:218-29.
35. Harder MP, Eijsman L, Roozendaal KJ, van Oeveren W, Wildevuur CR. Aprotinin reduces intraoperative and postoperative blood loss in membrane oxygenator cardiopulmonary bypass. Ann Thorac Surg 1991;51:936-41.
36. Lass M, Welz A, Kochs M, Mayer G, Schwandt M, Hannekum A. Aprotinin in elective primary bypass surgery: graft patency and clinical efficacy. Eur J Cardiothorac Surg 1995;9:206-10.
37. Kristeller JL, Stahl RF, Roslund BP, Roke-Thomas M. Aprotinin use in cardiac surgery patients at low risk for requiring blood transfusion. Pharmacotherapy 2007;27:988-94.
38. D'Ambra MN, Akins CW, Blackstone EH, et al. Aprotinin in primary valve replacement and reconstruction: a multicenter, double-blind, placebo-controlled trial. J Thorac Cardiovasc Surg 1996;112:1081-9.
39. Goldstein DJ, DeRosa CM, Seldomridge JA, Weinberg AD, Oz MC, Smith CR. Is aprotinin indicated for reoperative valvular surgery? J Heart Valve Dis 1997;6:88-92.
40. Kirzner CF, Correia AR, Azevedo OM Jr, et al. Low-dose aprotinin in heart valve reoperations. J Heart Valve Dis 2001;10:222-7.
41. Orchard MA, Goodchild CS, Prentice CR, et al. Aprotinin reduces cardiopulmonary bypass-induced blood loss and inhibits fibrinolysis without influencing platelets. Br J Haematol 1993;85:533-41.
42. van der Linden J, Lindvall G, Sartipy U. Aprotinin decreases postoperative bleeding and number of transfusions in patients on clopidogrel undergoing coronary artery bypass graft surgery: a double-blind, placebo-controlled, randomized clinical trial. Circulation 2005;112(suppl 9):I276-80.
43. Akowuah E, Shrivastava V, Jamnadas B, et al. Comparison of two strategies for the management of antiplatelet therapy during urgent surgery. Ann Thorac Surg 2005;80:149-52.
44. Lindvall G, Sartipy U, van der Linden J. Aprotinin reduces bleeding and blood product use in patients treated with clopidogrel before coronary artery bypass grafting. Ann Thorac Surg 2005;80:922-7.
45. Alderman EL, Levy JH, Rich JB, et al. Analyses of coronary graft patency after aprotinin use: results from the international multicenter aprotinin graft patency experience (IMAGE) trial. J Thorac Cardiovasc Surg 1998;116:716-30.
46. Henry DA, Carless PA, Moxey AJ, et al. Anti-fibrinolytic use for minimizing perioperative allogeneic blood transfusion. Cochrane Database Syst Rev 2007;(4):CD001886.
47. Brown JR, Birkmeyer NJ, O'Connor GT. Meta-analysis comparing the effectiveness and adverse outcomes of antifibrinolytic agents in cardiac surgery. Circulation 2007;115:2801-13.
48. Murkin JM. Attenuation of neurologic injury during cardiac surgery. Ann Thorac Surg 2001;72:S1838-44.