title: Impact of aprotinin and renal function on mortality: a retrospective single center analysis.
abstract: BACKGROUND
  An estimated up to 7% of high-risk cardiac surgery patients return to the operating room for bleeding. Aprotinin was used extensively as an antifibrinolytic agent in cardiac surgery patients for over 15 years and it showed efficacy in reducing bleeding. Aprotinin was removed from the market by the U.S. Food and Drug Administration after a large prospective, randomized clinical trial documented an increased mortality risk associated with the drug. Further debate arose when a meta-analysis of 211 randomized controlled trials showed no risk of renal failure or death associated with aprotinin. However, only patients with normal kidney function have been studied.
  
  
  METHODS
  In this study, we look at a single center clinical trial using patients with varying degrees of baseline kidney function to answer the question: Does aprotinin increase odds of death given varying levels of preoperative kidney dysfunction?
  
  
  RESULTS
  Based on our model, aprotinin use was associated with a 3.8-fold increase in odds of death one year later compared to no aprotinin use with p-value = 0.0018, regardless of level of preoperative kidney dysfunction after adjusting for other perioperative variables.
  
  
  CONCLUSIONS
  Lessons learned from our experience using aprotinin in the perioperative setting as an antifibrinolytic during open cardiac surgery should guide us in testing future antifibrinolytic drugs for not only efficacy of preventing bleeding, but for overall safety to the whole organism using long-term clinical outcome studies, including those with varying degree of baseline kidney function.
authors: Department of Anesthesiology, The Ohio State University Medical Center, 410 West 10th Avenue, Columbus 43210, USA.
authors: Brian
authors: B
authors: Schloss
authors: Parul
authors: P
authors: Gulati
authors: Lianbo
authors: L
authors: Yu
authors: Mahmoud
authors: M
authors: Abdel-Rasoul
authors: William
authors: W
authors: O'Brien
authors: Jon
authors: J
authors: Von Visger
authors: Hamdy
authors: H
authors: Awad
mesh_terms: D000368:Aged; D000933:Antifibrinolytic Agents / Q000009:adverse effects*; D007611:Aprotinin / Q000009:adverse effects*; D006348:Cardiac Surgical Procedures / Q000401:mortality*; D005260:Female; D006331:Heart Diseases / Q000150:complications / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D051437:Renal Insufficiency / Q000150:complications*; D012189:Retrospective Studies
chemical_list: D000933:Antifibrinolytic Agents; D007611:Aprotinin