The Journal of Thoracic and Cardiovascular Surgery
Volume 135, Issue 3 , Pages 495-502, March 2008

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

  • Domenico Pagano, MD, FRCS

      Affiliations

    • Department of Cardiothoracic Surgery, University Hospital Birmingham, Birmingham, United Kingdom
    • Corresponding Author InformationAddress for reprints: D. Pagano, MD, FRCS, Department Cardiothoracic Surgery, University Hospital Birmingham, Edgbaston, Birmingham B15 2TH, United Kingdom.
  • ,
  • Neil J. Howell, FRCS

      Affiliations

    • Health Care Evaluation Group, University of Birmingham, Birmingham, United Kingdom
  • ,
  • Nick Freemantle, PhD

      Affiliations

    • Health Care Evaluation Group, University of Birmingham, Birmingham, United Kingdom
  • ,
  • David Cunningham, PhD

      Affiliations

    • NHS Health and Social Services Information Centre, Leeds, United Kingdom
  • ,
  • Robert S. Bonser, MD, FRCS

      Affiliations

    • Department of Cardiothoracic Surgery, University Hospital Birmingham, Birmingham, United Kingdom
  • ,
  • Timothy R. Graham, FRCS

      Affiliations

    • Department of Cardiothoracic Surgery, University Hospital Birmingham, Birmingham, United Kingdom
  • ,
  • Jorge Mascaro, FRCS

      Affiliations

    • Department of Cardiothoracic Surgery, University Hospital Birmingham, Birmingham, United Kingdom
  • ,
  • Stephen J. Rooney, FRCS

      Affiliations

    • Department of Cardiothoracic Surgery, University Hospital Birmingham, Birmingham, United Kingdom
  • ,
  • Ian C. Wilson, MD, FRCS

      Affiliations

    • Department of Cardiothoracic Surgery, University Hospital Birmingham, Birmingham, United Kingdom
  • ,
  • Rob Cramb, FRCPath

      Affiliations

    • Department of Clinical Biochemistry, University Hospital Birmingham, Birmingham, United Kingdom
  • ,
  • Bruce E. Keogh, MD, FRCS

      Affiliations

    • National Institute for Clinical Outcomes Research, University College London, London, United Kingdom

Received 20 July 2007; received in revised form 16 October 2007; accepted 8 November 2007.

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.

CTSNet classification: 16, 18

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

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 Neil Howell and Domenico Pagano report lecture fees from Bayer.

PII: S0022-5223(08)00070-6

doi:10.1016/j.jtcvs.2007.11.045

Refers to article:

  • Aprotinin: Twenty-five years of claim and counterclaim

    Stephen Westaby
    The Journal of Thoracic and Cardiovascular Surgery March 2008 (Vol. 135, Issue 3, Pages 487-491)

  • Aprotinin and Cardiac Surgery

    Abe DeAnda
    The Journal of Thoracic and Cardiovascular Surgery March 2008 (Vol. 135, Issue 3, Pages 492-494)

The Journal of Thoracic and Cardiovascular Surgery
Volume 135, Issue 3 , Pages 495-502, March 2008