Use of aprotinin in cardiac surgery: effectiveness and safety in a population-based study.
OBJECTIVE
The effectiveness and safety of aprotinin use in cardiac surgery have been questioned. More data reflecting everyday clinical practice from large-scale, unselected populations are needed. We compared the effectiveness and safety of aprotinin in cardiac surgery with those of tranexamic acid in a follow-up study using the population-based Danish health-care databases.


METHODS
We identified a total of 3535 patients who underwent cardiac surgery at the Aarhus University Hospital, Skejby, between 1 January 2003 and 31 December 2006; of these, 635 patients were treated with aprotinin and 2900 with tranexamic acid. We used propensity score matching to match aprotinin-treated patients with tranexamic-acid-treated patients in a 1:1 ratio, followed by Poisson regression analysis to compute relative risks (RRs).


RESULTS
Patients treated with aprotinin had more severe preoperative risk profiles than the tranexamic-acid-treated patients. The rates of postoperative drainage and transfusion of red blood cells were similar in the two groups, whereas the aprotinin group received plasma (adjusted RR=1.39; 95% confidence interval (CI): 1.15-1.68) and platelets (adjusted RR=1.47; 95% CI: 1.19-1.81) more frequently than the tranexamic acid group. There were no statistically significant differences in risks of re-operation due to bleeding (adjusted RR=1.22; 95% CI: 0.84-1.78), 30-day mortality (adjusted RR=1.03; 95% CI: 0.69-1.54), acute myocardial infarction (adjusted RR=1.06; 95% CI: 0.69-1.64), stroke (adjusted RR=1.36; 95% CI: 0.75-2.44) or composite major event (adjusted RR=1.14; 95% CI: 0.87-1.50) between the two groups. However, patients who received aprotinin had an increased risk of postoperative dialysis (adjusted RR=1.76; 95% CI: 1.15-2.70).


CONCLUSIONS
Aprotinin treatment was associated with an increased use of plasma and platelet transfusion and an increased risk for postoperative dialysis, but not with other adverse outcomes, including short-term mortality.
Department of Anaesthesia & Intensive Care, Aarhus University Hospital, Skejby, Aarhus, Denmark. cjj@dadlnet.dk
Carl-Johan
CJ
Jakobsen
Flemming
F
Søndergaard
Vibeke E
VE
Hjortdal
Søren P
SP
Johnsen
D058186:Acute Kidney Injury / Q000139:chemically induced / Q000628:therapy; D000368:Aged; D000369:Aged, 80 and over; D007611:Aprotinin / Q000009:adverse effects / Q000627:therapeutic use*; D016913:Blood Component Transfusion; D006348:Cardiac Surgical Procedures; D004341:Drug Evaluation; D004812:Epidemiologic Methods; D005260:Female; D006488:Hemostasis, Surgical / Q000379:methods*; D006490:Hemostatics / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D019990:Perioperative Care / Q000379:methods; D019106:Postoperative Hemorrhage / Q000517:prevention & control; D006435:Renal Dialysis; D014148:Tranexamic Acid / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
D006490:Hemostatics; D014148:Tranexamic Acid; D007611:Aprotinin