title: Aprotinin increases mortality as compared with tranexamic acid in cardiac surgery: a meta-analysis of randomized head-to-head trials.
abstract: 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.
authors.affiliation: Department of Cardiovascular Surgery, Shizuoka Medical Center, 762-1 Nagasawa, Shimizu-cho, Sunto-gun, Shizuoka 411-8611, Japan. kfgth973@ybb.ne.jp
authors.forename: Hisato
authors.initials: H
authors.lastname: Takagi
authors.forename: Hideaki
authors.initials: H
authors.lastname: Manabe
authors.forename: Norikazu
authors.initials: N
authors.lastname: Kawai
authors.forename: Shin-nosuke
authors.initials: SN
authors.lastname: Goto
authors.forename: Takuya
authors.initials: T
authors.lastname: Umemoto
mesh_terms: D000933:Antifibrinolytic Agents / Q000009:adverse effects*; D007611:Aprotinin / Q000009:adverse effects*; D016063:Blood Loss, Surgical / Q000401:mortality / Q000517:prevention & control*; D001803:Blood Transfusion; D006348:Cardiac Surgical Procedures / Q000009:adverse effects / Q000401:mortality*; D003257:Consumer Product Safety; D019317:Evidence-Based Medicine; D006801:Humans; D016017:Odds Ratio; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D014148:Tranexamic Acid / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D000933:Antifibrinolytic Agents; D014148:Tranexamic Acid; D007611:Aprotinin