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

Department of Cardiovascular Surgery, Shizuoka Medical Center, 762-1 Nagasawa, Shimizu-cho, Sunto-gun, Shizuoka 411-8611, Japan

*Corresponding author. Tel.: +81-55-975-2000; fax: +81-55-975-2725.

E-mail address: kfgth973{at}ybb.ne.jp (H. Takagi).

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.

Key Words: Aprotinin; Tranexamic acid; Cardiac surgery; Meta-analysis; Randomized head-to-head trial

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				I. Koniari, E. Apostolakis, and M. Martha eComment: A comparison of the safety of aprotinin and tranexamic acid in cardiac surgery Interactive CardioVascular and Thoracic Surgery, July 1, 2009; 9(1): 101 - 101. [Full Text] [PDF]