Impact of aprotinin and renal function on mortality: a retrospective single center analysis

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?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.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.Approximately one million cardiac surgeries are performed in the United States every year. Of these, about 200,000 can be classified as complex procedures, such as repeat coronary artery bypass grafting (CABG), valve replacements, and combined CABG with valve repairs/replacements. One of the reasons these procedures are labeled as complex is because they carry a significant increased risk of perioperative bleeding. An estimated 2.98% to 6.96% of high-risk cardiac operation patients return to the operating room due to bleeding [1]. Aprotinin (Bayer Pharmaceutical Corporation, West Haven, Connecticut), an antifibrinolytic agent, has been used extensively since a study showed that it reduced the need for blood transfusions during repeat cardiac surgery [2]. Since then, other clinical trials have confirmed aprotinin's efficacy in reducing the need for blood transfusions during these high-risk cardiac procedures [3,4].The safety of aprotinin was brought into question in 2006 when a study revealed an increased risk of renal failure, myocardial infarction, and stroke [5]. In 2008, aprotinin was removed