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J Thorac Cardiovasc Surg 2004;128:442-448
© 2004 The American Association for Thoracic Surgery

Surgery for acquired cardiovascular disease

Effect of aprotinin on clinical outcomes in coronary artery bypass graft surgery: A systematic review and meta-analysis of randomized clinical trials

Artyom Sedrakyan, MD, PhDa,b,d,*, Tom Treasure, MD, FRCSb,c, John A. Elefteriades, MD, FACSa

a Yale University School of Medicine, New Haven, Conn, USA
b Royal College of Surgeons of England, London, UK
c Cardiothoracic Unit, Guy's Hospital, London, UK
d London School of Hygiene and Tropical Medicine, London, United Kingdom

Received for publication December 17, 2003; revisions received March 13, 2004; accepted for publication March 29, 2004.

* Address for reprints: Artyom Sedrakyan, MD, PhD, Health Services Research Unit, London School of Hygiene and Tropical Medicine and Clinical Effectiveness Unit, Royal College of Surgeons of England, 35-43 Lincoln's Inn Fields, London WC2A 3PE, United Kingdom
asedrakyan{at}rcseng.ac.uk

OBJECTIVE: Despite proven blood transfusion benefits, aprotinin may be underused in coronary artery bypass grafting. Reluctance to use aprotinin may stem from safety concerns. The current objective was to evaluate clinical outcomes (mortality, myocardial infarction, renal failure, stroke, atrial fibrillation) in patients undergoing coronary artery bypass grafting who receive aprotinin by performing a quantitative overview of published, randomized, controlled trials.

METHODS: MEDLINE, EMBASE, and PHARMLINE (1988-2001) and reference lists of relevant articles were searched for coronary artery bypass grafting studies. Criteria for data inclusion were as follows: (1) random allocation of study treatments, (2) placebo control, (3) enrollment only of patients undergoing coronary artery bypass grafting, (4) no combination with another experimental medication or device, and (5) prophylactic and continuous intraoperative use.

RESULTS: Data from 35 coronary artery bypass grafting trials (n = 3879) confirm that aprotinin reduces transfusion requirements (relative risk 0.61, 95% confidence interval 0.58-0.66) relative to placebo, with a 39% risk reduction. Aprotinin therapy was not associated with increased or decreased mortality (relative risk 0.96, 95% confidence interval 0.65-1.40), myocardial infarction (relative risk 0.85, 95% confidence interval 0.63-1.14), or renal failure (relative risk 1.01, 95% confidence interval 0.55-1.83) risk, but it was associated with a reduced risk of stroke (relative risk 0.53, 95% confidence interval 0.31-0.90) and a trend toward reduced atrial fibrillation (relative risk 0.90, 95% confidence interval 0.78-1.03).

CONCLUSIONS: Aprotinin reduces transfusion requirements. Concerns that aprotinin therapy is associated with increased mortality, myocardial infarction, or renal failure risk is not supported by data from published, randomized, placebo-controlled clinical trials. Evidence for a reduced risk of stroke and a tendency toward reduction of atrial fibrillation occurrence was observed in patients who received aprotinin.




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Review and application of serine protease inhibition in coronary artery bypass graft surgery
Am. J. Health Syst. Pharm., September 15, 2005; 62(18_Supplement_4): S9 - S14.
[Abstract] [Full Text] [PDF]

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J. H. Levy
Overview of clinical efficacy and safety of pharmacologic strategies for blood conservation
Am. J. Health Syst. Pharm., September 15, 2005; 62(18_Supplement_4): S15 - S19.
[Abstract] [Full Text] [PDF]

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A. Sedrakyan
Improving clinical outcomes in coronary artery bypass graft surgery
Am. J. Health Syst. Pharm., September 15, 2005; 62(18_Supplement_4): S19 - S23.
[Abstract] [Full Text] [PDF]

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 Ann. Thorac. Surg.Home page
G. Lindvall, U. Sartipy, and J. van der Linden
Aprotinin Reduces Bleeding and Blood Product Use in Patients Treated With Clopidogrel Before Coronary Artery Bypass Grafting
Ann. Thorac. Surg., September 1, 2005; 80(3): 922 - 927.
[Abstract] [Full Text] [PDF]

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 J. Thorac. Cardiovasc. Surg.Home page
A. Kher, K. K. Meldrum, K. L. Hile, M. Wang, B. M. Tsai, M. W. Turrentine, J. W. Brown, and D. R. Meldrum
Aprotinin improves kidney function and decreases tubular cell apoptosis and proapoptotic signaling after renal ischemia-reperfusion
J. Thorac. Cardiovasc. Surg., September 1, 2005; 130(3): 662 - 662.
[Abstract] [Full Text] [PDF]

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 CirculationHome page
J. van der Linden, G. Lindvall, and U. Sartipy
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, August 30, 2005; 112(9_suppl): I-276 - I-280.
[Abstract] [Full Text] [PDF]

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 CirculationHome page
J. C.J. Sun, M. A. Crowther, T. E. Warkentin, A. Lamy, and K. H.T. Teoh
Should Aspirin Be Discontinued Before Coronary Artery Bypass Surgery?
Circulation, August 16, 2005; 112(7): e85 - e90.
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E. L. Gillespie, K. A. Gryskiewicz, C. M. White, J. Kluger, C. Humphrey, S. Horowitz, and C. I. Coleman
Effect of aprotinin on the frequency of postoperative atrial fibrillation or flutter
Am. J. Health Syst. Pharm., July 1, 2005; 62(13): 1370 - 1374.
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 Eur. J. Cardiothorac. Surg.Home page
L. Englberger and T. Carrel
Reply to Shrivastava and Akowuah
Eur. J. Cardiothorac. Surg., January 1, 2005; 27(1): 177 - 177.
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