Bleeding in cardiac surgery: the use of aprotinin does not affect survival.
OBJECTIVE
The antifibrinolytic drug aprotinin has been the most widely used agent to reduce bleeding and its complications in cardiac surgery. Several randomized trials and meta-analyses have demonstrated it to be effective and safe. However, 2 recent reports from a single database have implicated the use of aprotinin as a risk for postoperative complications and reduced long-term survival.


METHODS
In this single-institution observational study involving 7836 consecutive patients (1998-2006), we assessed the safety of using aprotinin in risk reduction strategy for postoperative bleeding.


RESULTS
Aprotinin was used in 44% of patients. Multivariate analysis identified aprotinin use in risk reduction for reoperation for bleeding (odds ratio, 0.51; 95% confidence interval, 0.36-0.72; P = .001) and need for blood transfusion postoperatively (odds ratio, 0.67; 95% confidence interval, 0.57-0.79; P = .0002). The use of aprotinin did not affect in-hospital mortality (odds ratio, 1.03; 95% confidence interval, 0.71-1.49; P = 0.73), intermediate-term survival (median follow-up, 3.4 years; range, 0-8.9 years; hazard ratio, 1.09; 95% confidence interval, 0.93-1.28; P = .30), incidence of postoperative hemodialysis (odds ratio, 1.16; 95% confidence interval, 0.73-1.85; P = .49), and incidence of postoperative renal dysfunction (odds ratio, 0.78; 95% confidence interval, 0.59-1.03; P = .07).


CONCLUSIONS
This study demonstrates that aprotinin is effective in reducing bleeding after cardiac surgery, is safe, and does not affect short- or medium-term survival.
Pagano
Domenico
D
Department of Cardiothoracic Surgery, University Hospital Birmingham, Birmingham, United Kingdom. domenico.pagano@uhb.nhs.uk
Howell
Neil J
NJ
Freemantle
Nick
N
Cunningham
David
D
Bonser
Robert S
RS
Graham
Timothy R
TR
Mascaro
Jorge
J
Rooney
Stephen J
SJ
Wilson
Ian C
IC
Cramb
Rob
R
Keogh
Bruce E
BE
D000368:Aged; D007611:Aprotinin / Q000009:adverse effects / Q000627:therapeutic use*; D016063:Blood Loss, Surgical / Q000517:prevention & control; D006348:Cardiac Surgical Procedures / Q000009:adverse effects* / Q000379:methods / Q000401:mortality; D016022:Case-Control Studies; D002423:Cause of Death; D016001:Confidence Intervals; D001026:Coronary Artery Bypass / Q000009:adverse effects / Q000379:methods / Q000401:mortality; D005260:Female; D006490:Hemostatics / Q000009:adverse effects / Q000627:therapeutic use*; D017052:Hospital Mortality / Q000639:trends*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D019106:Postoperative Hemorrhage / Q000188:drug therapy / Q000209:etiology / Q000401:mortality* / Q000517:prevention & control*; D011336:Probability; D012016:Reference Values; D012042:Registries; D012189:Retrospective Studies; D018570:Risk Assessment; D016019:Survival Analysis; D016896:Treatment Outcome
D006490:Hemostatics; D007611:Aprotinin