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The effect of aprotinin on outcome after coronary-artery bypass grafting
Andrew D Shaw1, Mark Stafford-Smith, William D White
1Department of Anesthesiology, Duke University Medical Center, Durham, NC 27516, USA. andrew.shaw@duke.edu
Insights
Aprotinin use in cardiac surgery was linked to worse patient survival and increased kidney damage compared to other treatments. This study highlights potential risks associated with aprotinin in coronary revascularization procedures.
Area of Science:
- Cardiovascular Surgery
- Pharmacology
- Nephrology
Background:
- Recent studies suggest aprotinin may be linked to adverse outcomes in cardiac surgery patients.
- This review examines the clinical experience with aprotinin at Duke University Medical Center.
Purpose of the Study:
- To evaluate the association between aprotinin use and patient outcomes.
- To compare the effects of aprotinin, aminocaproic acid, and no antifibrinolytic therapy on mortality and renal function.
Main Methods:
- A retrospective review of 10,275 patients undergoing coronary revascularization between 1996 and 2005.
- Logistic-regression models were used to predict aprotinin use and analyze long-term survival and renal function decline (serum creatinine levels).
Main Results:
- 13.2% of patients received aprotinin, 66.8% received aminocaproic acid, and 20.0% received no antifibrinolytic therapy.
- Aprotinin use was associated with significantly higher mortality (HR 1.32 vs. no therapy, HR 1.27 vs. aminocaproic acid).
- Aprotinin was also linked to increased serum creatinine levels but not a higher incidence of dialysis.
Conclusions:
- Patients receiving aprotinin experienced higher mortality rates.
- Aprotinin use correlated with greater increases in serum creatinine levels compared to aminocaproic acid or no antifibrinolytic therapy.
Background:
Aprotinin has recently been associated with adverse outcomes in patients undergoing cardiac surgery. We reviewed our experience with this agent in patients undergoing cardiac surgery at Duke University Medical Center.
Methods:
We retrieved data on 10,275 consecutive patients undergoing surgical coronary revascularization at Duke between January 1, 1996, and December 31, 2005. We fit data to a logistic-regression model predicting each patient's likelihood of receiving aprotinin on the basis of preoperative characteristics and to models predicting long-term survival (up to 10 years) and decline in renal function, as measured by increases in serum creatinine levels.
Results:
A total of 1343 patients (13.2%) received aprotinin, 6776 patients (66.8%) received aminocaproic acid, and 2029 patients (20.0%) received no antifibrinolytic therapy. All patients underwent coronary-artery bypass grafting, and 1181 patients (11.5%) underwent combined coronary-artery bypass grafting and valve surgery. In the risk-adjusted model, survival was worse among patients treated with aprotinin, with a main-effects hazard ratio for death of 1.32 (95% confidence interval [CI], 1.12 to 1.55) for the comparison with patients receiving no antifibrinolytic therapy (P=0.003) and 1.27 (95% CI, 1.10 to 1.46) for the comparison with patients receiving aminocaproic acid (P=0.004). As compared with the use of aminocaproic acid or no antifibrinolytic agent, aprotinin use was also associated with a larger risk-adjusted increase in the serum creatinine level (P<0.001) but not with a greater risk-adjusted incidence of dialysis (P=0.56).
Conclusions:
Patients who received aprotinin had a higher mortality rate and larger increases in serum creatinine levels than those who received aminocaproic acid or no antifibrinolytic agent.
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