Introduction
: We aimed at evaluating aprotinin efficacy and renal, cardiac and neurologic safety after thoracic aortic surgery in a single Center.
Methods
: This retrospective longitudinal study analyses 742 patients (26% female), aged 57 years (SD 15), operated between January 1993 and December 2006. Efficacy and safety were the primary endpoints. Efficacy was defined as perioperative bleeding ≤1200 ml/first 24 h and/or no reintervention for bleeding. Renal adverse events included increased values of creatinine and BUN and/or the initiation of dialysis. Cardiac adverse events included perioperative myocardial infarction, acute LOS, and progression to heart failure. Neurologic adverse events included stroke, transient ischemia and/or clinical neurologic deficits.
Results
: Aprotinin was given to 525 pts. only. Table 1
shows the outcome according to aprotinin administration. Patients receiving aprotinin had higher bleeding, and renal, neurologic adverse events rate (univariate analysis). Cardiac adverse events and perioperative mortality are similar in both groups. However no evidence of effect was left when accounting for possible confounders (urgent surgery, redo procedure, dissection, antiplatelet medication, NYHA class, deep hypothermia, CPB time).
Conclusions
: The influence of aprotinin shown at univariable analyis, disappeared when controlling for a series of potential confounders in a multivariable analysis. A randomized control clinical trial would have better answered the question as whether aprotinin has a beneficial therapeutic effect together with a high safety. However, this sample size allowed controlling the effect of the drug for a large series of potential confounders in a multivariate analysis. Thus we were able to elicit a lack of association of aprotinin (ORs close to 1 and narrow 95% CIs) with both efficacy and adverse events.
Table 1
Pulmonary effects of dexmedetomidine infusion in thoracic aortic surgery under hypothermic circulatory arrest: a randomized placebo-controlled trial