TY - JOUR

T1 - Use of aprotinin in cardiac surgery

T2 - effectiveness and safety in a population-based study

AU - Jakobsen, Carl-Johan

AU - Søndergaard, Flemming

AU - Hjortdal, Vibeke E

AU - Johnsen, Søren P

PY - 2009/11

Y1 - 2009/11

N2 - 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.

AB - 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.

KW - Acute Kidney Injury/chemically induced

KW - Aged

KW - Aged, 80 and over

KW - Aprotinin/adverse effects

KW - Blood Component Transfusion

KW - Cardiac Surgical Procedures

KW - Drug Evaluation

KW - Epidemiologic Methods

KW - Female

KW - Hemostasis, Surgical/methods

KW - Hemostatics/adverse effects

KW - Humans

KW - Male

KW - Middle Aged

KW - Perioperative Care/methods

KW - Postoperative Hemorrhage/prevention & control

KW - Renal Dialysis

KW - Tranexamic Acid/adverse effects

KW - Treatment Outcome

U2 - 10.1016/j.ejcts.2009.05.040

DO - 10.1016/j.ejcts.2009.05.040

M3 - Journal article

C2 - 19782573

VL - 36

SP - 863

EP - 868

JO - European Journal of Cardio-thoracic Surgery

JF - European Journal of Cardio-thoracic Surgery

SN - 1010-7940

IS - 5

ER -