Aprotinin revisited

J Thorac Cardiovasc Surg. 2012 Nov;144(5):998-1002. doi: 10.1016/j.jtcvs.2012.06.035. Epub 2012 Jul 15.

Abstract

In 2008, we saw the withdrawal of aprotinin from the US markets after preliminary results from a large, randomized clinical trial in Canada. This drug, a potent antifibrinolytic, was used primarily in complex and/or redo cardiac surgery as an adjunct to decrease postoperative bleeding and complications. The Canadian study raised questions previously brought up in similar studies-does aprotinin increase the risk of mortality and renal failure after cardiac surgery? Recently, a re-review of the Canadian data noted flaws in the study, as well as in the interpretation of the results. The present review revisits the aprotinin controversy.

Publication types

  • Editorial
  • Review

MeSH terms

  • Antifibrinolytic Agents / adverse effects*
  • Aprotinin / adverse effects*
  • Cardiac Surgical Procedures / adverse effects*
  • Cardiac Surgical Procedures / mortality
  • Evidence-Based Medicine
  • Humans
  • Patient Selection
  • Postoperative Hemorrhage / etiology
  • Postoperative Hemorrhage / prevention & control*
  • Randomized Controlled Trials as Topic / methods
  • Renal Insufficiency / chemically induced*
  • Renal Insufficiency / mortality
  • Research Design
  • Risk Assessment
  • Risk Factors
  • Safety-Based Drug Withdrawals
  • Treatment Outcome

Substances

  • Antifibrinolytic Agents
  • Aprotinin