The effect of aprotinin on outcome after coronary-artery bypass grafting.
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.
Shaw
Andrew D
AD
Department of Anesthesiology, Duke University Medical Center, Durham, NC 27516, USA. andrew.shaw@duke.edu
Stafford-Smith
Mark
M
White
William D
WD
Phillips-Bute
Barbara
B
Swaminathan
Madhav
M
Milano
Carmelo
C
Welsby
Ian J
IJ
Aronson
Solomon
S
Mathew
Joseph P
JP
Peterson
Eric D
ED
Newman
Mark F
MF
D000368:Aged; D000614:Aminocaproates / Q000009:adverse effects / Q000627:therapeutic use; D000933:Antifibrinolytic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D007611:Aprotinin / Q000009:adverse effects* / Q000627:therapeutic use; D016063:Blood Loss, Surgical / Q000517:prevention & control; D015331:Cohort Studies; D001026:Coronary Artery Bypass; D003327:Coronary Disease / Q000601:surgery; D003404:Creatinine / Q000097:blood; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D007668:Kidney / Q000187:drug effects / Q000502:physiology; D007674:Kidney Diseases / Q000139:chemically induced* / Q000628:therapy; D016015:Logistic Models; D008875:Middle Aged; D009026:Mortality; D006435:Renal Dialysis; D012189:Retrospective Studies; D016896:Treatment Outcome
D000614:Aminocaproates; D000933:Antifibrinolytic Agents; D007611:Aprotinin; D003404:Creatinine