Safety of low-dose aprotinin in coronary artery bypass graft surgery: a single-centre investigation in 2,436 patients in Germany.
BACKGROUND
The antifibrinolytic agent aprotinin is used to limit blood loss in cardiac surgery. In a recently performed multicentre observational study, the use of aprotinin was dose-dependently associated with a higher risk of renal failure and cardiovascular events.


OBJECTIVE
Therefore, the aim of this study was to evaluate the impact of low-dose aprotinin (2 million kallikrein-inhibitor units) on safety variables in a large single-centre investigation in patients who underwent coronary artery bypass graft (CABG) surgery.


METHODS
Clinical outcome variables such as renal failure, myocardial infarction, gastrointestinal failure, neurological complications and in-hospital mortality were assessed in 2,436 CABG surgery patients, whereof 1,162 patients received low-dose aprotinin perioperatively and 1,274 patients did not receive aprotinin. Statistical analysis was performed using multivariable logistic regression.


RESULTS
In patients receiving aprotinin, the odds ratios of experiencing one of the aforementioned adverse events were not significantly different from the patients who did not receive aprotinin (p = 0.136-0.288). Moreover, the need for rethoracotomy did not differ between the two groups (p = 0.129). However, the use of low-dose aprotinin reduced the risk of peri- and postoperative use of packed red blood cells by 39% and was associated with a mean reduction in postoperative blood loss of 201 mL compared with patients who did not receive aprotinin (p < 0.001). Mean total blood loss in the aprotinin group and the control group was 875 mL (standard deviation [SD]: 757 mL) and 1,105 mL (SD: 867 mL), respectively (p < 0.001). In a sub-analysis in 2,049 patients undergoing their first cardiac surgery and undergoing CABG using the internal mammary artery, efficacy and safety data of aprotinin were similar to the results of the entire study cohort of 2,436 patients.


CONCLUSIONS
Our data indicate that low-dose aprotinin efficiently reduces blood loss and does not adversely affect relevant safety variables in CABG surgery.
Kluth
Mario
M
Institute for Anaesthesiology, Heart Center North-Rhine Westfalia, Ruhr University Bochum, Bad Oeynhausen, Germany. mario.kluth@gmx.de
Lueth
Jan U
JU
Zittermann
Armin
A
Lanzenstiel
Markus
M
Koerfer
Reiner
R
Inoue
Kazuo
K
D000368:Aged; D007611:Aprotinin / Q000009:adverse effects*; D001026:Coronary Artery Bypass; D005260:Female; D006490:Hemostatics / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies
D006490:Hemostatics; D007611:Aprotinin