Is Aprotinin Back? Retrospective Analysis in a Historical Cohort of CABG Patients

Objectives: After the sale-discontinuation of aprotinin between 2008 and 2013, the antifibrinolytic drug may be used again since 2017. The indication is limited to CABG procedures with ECC. A postauthorization safety trial is running.

Methods: We compared all patients undergoing CABG with more than one arterial graft at our center from 2002 to 2005 (583 patients). The patients were treated with either aprotinin (aprotinin: 247 patients) or tranexamic acid (TXA: 336 patients). Patient characteristics, operative procedure, and postoperative results regarding blood loss, transfusion of blood products were analyzed.

Results: Mean age (63.3 ± 9.2) and BMI (27.6 ± 4.1) did not differ significantly (p >  0.05) between both groups. Percentage of women (22.7 vs. 11.3%), previous myocardial infarction (46.2 vs. 34.8%), emergency procedures (10.5 vs. 2.7%) and redo procedures (7.3 vs. 0.3%) were significantly differently (aprotinin vs. TXA, p < 0.005). In the aprotinin -group patients were treated with ASA (61.9 vs. 8.9%) and Clopidogrel (21.5 vs. 7.1%) until surgery (aprotinin vs. TXA, p < 0.000). Creatin (0.96 ± 0.25 vs. 1.0 ± 0.28 mg/dL) and urea levels (17.8 ± 6.4 vs. 18.5 ± 7.3 mg/dL) were comparable between both groups (aprotinin vs. TXA, p > 0.05).

Mean number of distal anastomoses (3.1 ± 0.8), operation (274 ± 69 min) and ECC-time (113 ± 33 min) were very similar between the groups (aprotinin vs. TXA, p >  0.5). In both groups use of Rima (34.8 vs. 39%) and radial artery (86.2 vs. 81.3%) were comparable (aprotinin vs. TXA, p >  0.1).

Postoperative ventilation time (24.9 hours) and stay at ICU (3.1 days) were not different (aprotinin vs. TXA, p > 0.5), also blood loss during 24 hours (829 ± 552 vs. 897 ± 529 mL, aprotinin vs. TXA, p > 0.1) whereas transfusion requirement differs significantly (total units 2.3 ± 2.6 vs. 1.9 ± 2.5 aprotinin vs. TXA, p = 0.42, FFP units 2.1 ± 3.2 vs. 1.4 ± 2.8 aprotinin vs. TXA, p = 0.005). Reexploration for bleeding shows a trend (8.1 vs. 3.9%, aprotinin vs. TXA, p = 0.064). Hospital mortality was comparable (2.8 vs. 0.9%, aprotinin vs. TXA, p = 0.08). There was no difference in perioperative renal insufficiency (2.0 vs. 2.1%, aprotinin. vs. TXA, p = 0.21) or creatinine level at discharge (1.0 ± 0.51 vs. 1.0 ± 0.5 mg/dL, aprotinin vs. TXA, p = 0.97).

Conclusion: In high-risk patients, aprotinin seems to have a positive influence with regard to bleeding complications. However, the need for blood products was increased compared to TXA. There was no negative influence on postoperative renal function. Whether the use of aprotinin is still justifies remains to be investigated in further studies.