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

J Thorac Cardiovasc Surg. 2008 Mar;135(3):495-502. doi: 10.1016/j.jtcvs.2007.11.045.

Abstract

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.

MeSH terms

  • Aged
  • Aprotinin / adverse effects
  • Aprotinin / therapeutic use*
  • Blood Loss, Surgical / prevention & control
  • Cardiac Surgical Procedures / adverse effects*
  • Cardiac Surgical Procedures / methods
  • Cardiac Surgical Procedures / mortality
  • Case-Control Studies
  • Cause of Death
  • Confidence Intervals
  • Coronary Artery Bypass / adverse effects
  • Coronary Artery Bypass / methods
  • Coronary Artery Bypass / mortality
  • Female
  • Hemostatics / adverse effects
  • Hemostatics / therapeutic use*
  • Hospital Mortality / trends*
  • Humans
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Odds Ratio
  • Postoperative Hemorrhage / drug therapy
  • Postoperative Hemorrhage / etiology
  • Postoperative Hemorrhage / mortality*
  • Postoperative Hemorrhage / prevention & control*
  • Probability
  • Reference Values
  • Registries
  • Retrospective Studies
  • Risk Assessment
  • Survival Analysis
  • Treatment Outcome

Substances

  • Hemostatics
  • Aprotinin