Walkden et al. performed a case–control study comparing two cohorts undergoing adult cardiac surgery in a single tertiary care center. The first cohort underwent surgery prior to aprotinin withdrawal; the second underwent surgery after aprotinin withdrawal. Propensity matching was used to select patients matched for 24 covariates in both groups (n = 3,508). The authors also estimated the effect of aprotinin withdrawal on a subgroup of high-risk patients.
In summary, aprotinin withdrawal was associated with increased complication rates and patient deaths following cardiac surgery. However, as mentioned by the authors, their study does not demonstrate a causal relationship between aprotinin withdrawal and adverse outcomes. Nevertheless, it demonstrates the disparity between frequently cited systematic reviews of randomized trials, results of observational cohort studies that have considered the therapeutic role of aprotinin and our real-world experience of aprotinin withdrawal on patient outcomes.
We agree with these authors when they suggest that this represents sufficient evidence of clinical equipoise to justify further evaluation of aprotinin in appropriately designed and powered multicenter RCTs.
– Charles-Marc Samama