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Domenico Pagano
Neil J. Howell
Robert S. Bonser
Timothy R. Graham
Jorge Mascaro
Stephen J. Rooney
Ian C. Wilson
Bruce E. Keogh
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J Thorac Cardiovasc Surg 2008;135:495-502
© 2008 The American Association for Thoracic Surgery

Surgery for Acquired Cardiovascular Disease

Bleeding in cardiac surgery: The use of aprotinin does not affect survival

Domenico Pagano, MD, FRCSa,*, Neil J. Howell, FRCSb, Nick Freemantle, PhDb, David Cunningham, PhDc, Robert S. Bonser, MD, FRCSa, Timothy R. Graham, FRCSa, Jorge Mascaro, FRCSa, Stephen J. Rooney, FRCSa, Ian C. Wilson, MD, FRCSa, Rob Cramb, FRCPathd, Bruce E. Keogh, MD, FRCSe

a Department of Cardiothoracic Surgery, University Hospital Birmingham, Birmingham, United Kingdom
d Department of Clinical Biochemistry, University Hospital Birmingham, Birmingham, United Kingdom
b Health Care Evaluation Group, University of Birmingham, Birmingham, United Kingdom
c NHS Health and Social Services Information Centre, Leeds, United Kingdom
e National Institute for Clinical Outcomes Research, University College London, London, United Kingdom

Received for publication July 20, 2007; revisions received October 16, 2007; accepted for publication November 8, 2007.

* Address for reprints: D. Pagano, MD, FRCS, Department Cardiothoracic Surgery, University Hospital Birmingham, Edgbaston, Birmingham B15 2TH, United Kingdom. (Email: domenico.pagano{at}uhb.nhs.uk).

Objective: The antifibrinolytic drug aprotinin has been the most widely used agent to reduce bleeding and its complications in cardiac surgery. Several randomized trials and meta-analyses have demonstrated it to be effective and safe. However, 2 recent reports from a single database have implicated the use of aprotinin as a risk for postoperative complications and reduced long-term survival.

Methods: In this single-institution observational study involving 7836 consecutive patients (1998–2006), we assessed the safety of using aprotinin in risk reduction strategy for postoperative bleeding.

Results: Aprotinin was used in 44% of patients. Multivariate analysis identified aprotinin use in risk reduction for reoperation for bleeding (odds ratio, 0.51; 95% confidence interval, 0.36–0.72; P = .001) and need for blood transfusion postoperatively (odds ratio, 0.67; 95% confidence interval, 0.57–0.79; P = .0002). The use of aprotinin did not affect in-hospital mortality (odds ratio, 1.03; 95% confidence interval, 0.71–1.49; P = 0.73), intermediate-term survival (median follow-up, 3.4 years; range, 0–8.9 years; hazard ratio, 1.09; 95% confidence interval, 0.93–1.28; P = .30), incidence of postoperative hemodialysis (odds ratio, 1.16; 95% confidence interval, 0.73–1.85; P = .49), and incidence of postoperative renal dysfunction (odds ratio, 0.78; 95% confidence interval, 0.59–1.03; P = .07).

Conclusion: This study demonstrates that aprotinin is effective in reducing bleeding after cardiac surgery, is safe, and does not affect short- or medium-term survival.

Abbreviations and Acronyms CABG = coronary artery bypass grafting; CI = confidence interval; GFR = glomerular filtration rate; KIU = kallikrein inhibitor units


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