Aprotinin increases mortality as compared with tranexamic acid in cardiac surgery: a meta-analysis of randomized head-to-head trials.

To determine whether aprotinin increases mortality as compared with tranexamic acid in cardiac surgery, we performed a meta-analysis of randomized head-to-head trials. All prospective randomized head-to-head trials of aprotinin vs. tranexamic acid enrolling patients undergoing cardiac surgery were identified using a web-based search engine (PubMed). For each study, data regarding mortality in both the aprotinin and tranexamic acid groups were used to generate risk ratios (RRs) and 95% confidence intervals (CIs). Study-specific estimates were combined using inverse variance-weighted averages of logarithmic RRs in random-effects models. Our search identified nine trials (eight trials included in the previous meta-analysis and the blood conservation using antifibrinolytics in a randomized trial [BART] study). Seven trials were composed of low-risk patients (n=1291) and two trials consisted of low-risk patients (n=1628). Pooled analysis of the nine trials demonstrated a statistically significant 45% increase in mortality with aprotinin relative to tranexamic acid therapy (RR, 1.45; 95% CI, 1.00 [1.0002]-2.11; P=0.05 [0.0499]). The present meta-analysis of updated all randomized head-to-head trials, the best evidence, demonstrated a statistically significant increase in mortality with aprotinin relative to tranexamic acid therapy in cardiac surgery.