(Circulation. 1995;92:2236-2244.)
© 1995 American Heart Association, Inc.
Articles |
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
From the Department of Anesthesiology, Emory University Hospital, Atlanta, Ga (J.H.L.); the Department of Thoracic and Cardiovascular Surgery, Loyola University Medical Center, Maywood, Ill (R.P.); the Section of Cardiovascular Surgery, Mayo Clinic, Rochester, Minn (H.V.S.); the Department of Anesthesiology, Hahnemann University, Philadelphia, Pa (J.C.H.); Virginia Heart Surgery Associates, Fairfax (R.A.); the Department of Anesthesiology, University of Washington Medical Center, Seattle (B.S.); the Division of Cardiothoracic Surgery, Cornell Medical Center, New York, NY (T.K.R.); the Department of Anesthesiology, University of Michigan Medical Center, Ann Arbor (J.M.); the Division of Cardiothoracic Surgery, Duke University Medical Center, Durham, NC (P.S.); the Department of Surgery, Allegheny General Hospital, Pittsburgh, Pa. (R.E.C.); and Miles Inc Pharmaceutical Division, West Haven, Conn (A.N., S.L.B., R.K.).
Background Aprotinin is a serine protease inhibitor that reduces blood loss and transfusion requirements when administered prophylactically to cardiac surgical patients. To examine the safety and dose-related efficacy of aprotinin, a prospective, multicenter, placebo-controlled trial was conducted in patients undergoing repeat coronary artery bypass graft (CABG) surgery.
Methods and Results Two hundred eighty-seven patients were randomly assigned to receive either high-dose aprotinin, low-dose aprotinin, pump-prime-only aprotinin, or placebo. Drug efficacy was determined by the reduction in donor-blood transfusion up to postoperative day 12 and in postoperative thoracic-drainage volume. The percentage of patients requiring donor–red-blood-cell (RBC) transfusions in the high- and low-dose aprotinin groups was reduced compared with the pump-prime-only and placebo groups (high-dose aprotinin, 54%; low-dose aprotinin, 46%; pump-prime only, 72%; and placebo, 75%; overall P=.001). The number of units of donor RBCs transfused was significantly lower in the aprotinin-treated patients compared with placebo (high-dose aprotinin, 1.6±0.2 U; low-dose aprotinin, 1.6±0.3 U; pump-prime-only, 2.5±0.3 U; and placebo, 3.4±0.5 U; P=.0001). There was also a significant difference in total blood-product exposures among treatment groups (high-dose aprotinin, 2.2±0.4 U; low-dose aprotinin, 3.4±0.9 U; pump-prime-only, 5.1±0.9 U; placebo, 10.3±1.4 U). There were no differences among treatment groups for the incidence of perioperative myocardial infarction (MI).
Conclusions This study demonstrates that high- and low-dose aprotinin significantly reduces the requirement for donor-blood transfusion in repeat CABG patients without increasing the risk for perioperative MI.
Key Words: cardiopulmonary bypass • aprotinin • bleeding • fibrinolysis • surgery
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M. P. Pelletier, S. Solymoss, A. Lee, and R. C.-J. Chiu Negative Reexploration for Cardiac Postoperative Bleeding: Can It Be Therapeutic? Ann. Thorac. Surg., April 1, 1998; 65(4): 999 - 1002. [Abstract] [Full Text] [PDF]
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 R. Pifarre Use of Aprotinin in the Control of Bleeding During Cardiopulmonary Bypass Surgery: Current Status Clinical and Applied Thrombosis/Hemostasis, January 1, 1998; 4(1): 2 - 6. [Abstract] [PDF]
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W. Dietrich, K. Schopf, M. Spannagl, M. Jochum, S. L. Braun, and H. Meisner Influence of High- and Low-Dose Aprotinin on Activation of Hemostasis in Open Heart Operations Ann. Thorac. Surg., January 1, 1998; 65(1): 70 - 77. [Abstract] [Full Text] [PDF]
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R. E. Helm, T. K. Rosengart, M. Gomez, J. D. Klemperer, W. J. DeBois CPP, F. Velasco, J. P. Gold, N. K. Altorki, S. Lang, S. Thomas, et al. Comprehensive Multimodality Blood Conservation: 100 Consecutive CABG Operations Without Transfusion Ann. Thorac. Surg., January 1, 1998; 65(1): 125 - 136. [Abstract] [Full Text] [PDF]
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S. Westaby Aprotinin Fifteen Years Later Seminars in Cardiothoracic and Vascular Anesthesia, November 1, 1997; 1(4): 366 - 375. [Abstract] [PDF]
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N. Hayashida, T. Isomura, T. Sato, H. Maruyama, K. Kosuga, and S. Aoyagi EFFECTS OF MINIMAL-DOSE APROTININ ON CORONARY ARTERY BYPASS GRAFTING J. Thorac. Cardiovasc. Surg., August 1, 1997; 114(2): 261 - 269. [Abstract] [Full Text]
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 R. R. Lazzara, F. E. Kidwell, M. F. Kraemer, J. A. Wood, and A. Starr Reduction in Costs, Blood Products, and Operating Time in Patients Undergoing Open Heart Surgery Arch Surg, August 1, 1997; 132(8): 858 - 861. [Abstract] [PDF]
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W. Dietrich, P. Spath, A. Ebell, and J. A. Richter PREVALENCE OF ANAPHYLACTIC REACTIONS TO APROTININ: ANALYSIS OF TWO HUNDRED FORTY-EIGHT REEXPOSURES TO APROTININ IN HEART OPERATIONS J. Thorac. Cardiovasc. Surg., January 1, 1997; 113(1): 194 - 201. [Abstract] [Full Text]
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P. K. Smith and L. H. Muhlbaier Aprotinin: Safe and Effective Only With the Full-Dose Regimen Ann. Thorac. Surg., December 1, 1996; 62(6): 1575 - 1577. [Full Text]
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J. H. Lemmer Jr, E. W. Dilling, J. R. Morton, J. B. Rich, F. Robicsek, D. L. Bricker, C. B. Hantler, J. G. Copeland III, J. L. Ochsner, P. O. Daily, et al. Aprotinin for Primary Coronary Artery Bypass Grafting: A Multicenter Trial of Three Dose Regimens Ann. Thorac. Surg., December 1, 1996; 62(6): 1659 - 1668. [Abstract] [Full Text]
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M. R. Terrell, J. M. Walenga, M. J. Koza, and R. Pifarre Efficacy of Aprotinin With Various Anticoagulant Agents in Cardiopulmonary Bypass Ann. Thorac. Surg., August 1, 1996; 62(2): 506 - 511. [Abstract] [Full Text]
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J. H. Lemmer Jr., M. T. Metzdorff, A. H. Krause, J. E. Okies, T. A. Molloy, J. G. Hill, W. B. Long, T. R. Winkler, and U. S. Page APROTININ USE IN PATIENTS WITH DIALYSIS-DEPENDENT RENAL FAILURE UNDERGOING CARDIAC OPERATIONS J. Thorac. Cardiovasc. Surg., July 1, 1996; 112(1): 192 - 194. [Full Text]
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