title: The risks associated with aprotinin use: a retrospective study of cardiac cases in Nova Scotia.
abstract: OBJECTIVE
  In light of the concerns about the safety of aprotinin, we wanted to determine if aprotinin use during cardiac surgery was associated with an increased risk of mortality and morbidity compared with the use of tranexamic acid (TXA). We hypothesized that use of aprotinin is associated with a higher risk of adverse outcomes than use of TXA in our patient population.
  
  
  METHODS
  In this retrospective study at a single surgical centre, we examined primary in-hospital outcomes of postoperative mortality, new acute renal failure, and perioperative blood transfusion, and we also investigated secondary outcomes of stroke, infection, and prolonged stay in the intensive care unit (ICU). The effect of the type of antifibrinolytic on outcome was evaluated for aprotinin cases matched 1:1 with TXA cases using propensity score.
  
  
  RESULTS
  This study included 3,340 patients who received antifibrinolytics during cardiac surgery (376 patients received aprotinin and 2,964 patients received TXA). Patients who received aprotinin were more often elderly and female; they were more commonly presented with congestive heart failure, atrial fibrillation, renal failure, and lower hemoglobin, and they underwent complex and/or urgent surgery. In the matched sample, in-hospital mortality was significantly higher in the aprotinin group (10.9%) compared with the TXA group (5.9%), and ICU stay >72 hr was significantly increased in the aprotinin group (30.0%) compared with the TXA group (21.7%). There was no significant difference in blood product administration between the two groups.
  
  
  CONCLUSIONS
  Aprotinin was associated with an increased risk of in-hospital mortality and morbidity following cardiac surgery, and aprotinin was not associated with a decrease in blood product requirements. Continued use of aprotinin in cardiac surgery should follow careful consideration, weighing the demonstrated risks and potential advantages compared with other TXA.
authors.affiliation: Division of Cardiac Surgery, Dalhousie University, Halifax, NS, Canada. robriddell@gmail.com
authors.forename: Robert E G
authors.initials: RE
authors.lastname: Riddell
authors.forename: Karen J
authors.initials: KJ
authors.lastname: Buth
authors.forename: John A
authors.initials: JA
authors.lastname: Sullivan
mesh_terms: D000368:Aged; D000933:Antifibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use; D007611:Aprotinin / Q000009:adverse effects* / Q000627:therapeutic use; D016063:Blood Loss, Surgical / Q000517:prevention & control; D001803:Blood Transfusion; D006348:Cardiac Surgical Procedures / Q000379:methods*; D001026:Coronary Artery Bypass; D005260:Female; D006490:Hemostatics / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009674:Nova Scotia; D057216:Propensity Score; D012189:Retrospective Studies; D012306:Risk; D014148:Tranexamic Acid / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000933:Antifibrinolytic Agents; D006490:Hemostatics; D014148:Tranexamic Acid; D007611:Aprotinin