Originally Published: The
New England Journal of Medicine
Study Title: "The Risk Associated with Aprotinin in
Cardiac Surgery"
Study Authors:
The following institutions and persons coordinated the Multicenter
Study of Perioperative Ischemia Epidemiology II (McSPI EPI-II)
study: Study Chairman — D. Mangano; Senior Editors — J. Levin and L.
Saidman; Study Design and Analysis Center, IREF — P. Barash, M.
Brual, C. Dietzel, A. Herskowitz, Y. Miao, T. Titov, and I.C. Tudor;
Editorial/Administrative Group — D. Beatty, I. Lei, and B. Xavier.
Abstract
"BACKGROUND
The majority of patients undergoing surgical treatment for
ST-elevation myocardial infarction receive antifibrinolytic therapy
to limit blood loss. This approach appears counterintuitive to the
accepted medical treatment of the same condition — namely,
fibrinolysis to limit thrombosis. Despite this concern, no
independent, large-scale safety assessment has been undertaken.
METHODS
In this observational study involving 4374 patients undergoing
revascularization, we prospectively assessed three agents (aprotinin
[1295 patients], aminocaproic acid [883], and tranexamic acid [822])
as compared with no agent (1374 patients) with regard to serious
outcomes by propensity and multivariable methods. (Although
aprotinin is a serine protease inhibitor, here we use the term
antifibrino-lytic therapy to include all three agents.)
RESULTS
In propensity-adjusted, multivariable logistic regression (C-index,
0.72), use of aprotinin was associated with a doubling in the risk
of renal failure requiring dialysis among patients undergoing
complex coronary-artery surgery (odds ratio, 2.59; 95 percent
confidence interval, 1.36 to 4.95) or primary surgery (odds ratio,
2.34; 95 percent confidence interval, 1.27 to 4.31). Similarly, use
of aprotinin in the latter group was associated with a 55 percent
increase in the risk of myocardial infarction or heart failure
(P<0.001) and a 181 percent increase in the risk of stroke or
encephalopathy (P = 0.001). Neither aminocaproic acid nor tranexamic
acid was associated with an increased risk of renal, cardiac, or
cerebral events. Adjustment according to propensity score for the
use of any one of the three agents as compared with no agent yielded
nearly identical findings. All the agents reduced blood loss.
CONCLUSIONS
The association between aprotinin and serious end-organ damage
indicates that continued use is not prudent. In contrast, the less
expensive generic medications aminocaproic acid and tranexamic acid
are safe alternatives."
Complete Study [PDF]
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