Does use of aprotinin decrease the incidence of stroke and neurological complications in adult patients undergoing cardiac surgery?

Abstract

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether aprotinin use was associated with a lower incidence of stroke and neurological complications in adult patients undergoing cardiac surgery. Using the reported search 224 papers were identified on Medline, 722 on Embase and 12 by hand-searching reference lists. Eight papers represented the best evidence on the subject and the author, journal, date and country of publication, patient group studied, study type, relevant outcomes, results and study comments and weaknesses were tabulated. We conclude that there is evidence from three meta-analyses and two more recent RCTs that the use of aprotinin is associated with a decreased incidence of stroke and neurological complications in some patients undergoing cardiac surgery. However, many single studies within these meta-analyses are small and designed to look at other outcomes so are underpowered for neurological outcome. In contrast, however, a recent cohort study has raised concerns about aprotinin, suggesting that its use is associated with a significant increased risk of stroke in uncomplicated CABG surgery. Ideally further large well-constructed RCTs are required to give a definitive answer to this question and determine the most appropriate dose but given recent concerns, data may have to be obtained from large better controlled cohort studies.