Aprotinin During Coronary Artery Bypass Grafting: Worth the Risk?

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Aprotinin During Coronary Artery Bypass Grafting: Worth the Risk?

Two observational studies sharpen safety concerns about an agent that had been widely used.

The use of aprotinin reduces blood loss in patients undergoing cardiac surgery, but results of a prominent study published in 2006 (Journal Watch Cardiology Mar 9 2006) indicated that it may also increase the risk for death. In November 2007, Bayer HealthCare, the drug’s manufacturer, temporarily suspended marketing of the drug worldwide. Two new studies of the real-world use of aprotinin provide additional information about its safety.

In the first study, researchers made use of the Premier Perspective Comparative Database, a repository of hospital administrative data that includes charges for medications. In a cohort of 78,199 patients undergoing coronary artery bypass surgery from January 2003 through March 2006, 42% received aprotinin. In a multivariable analysis, aprotinin was associated with an increased 7-day mortality risk compared with aminocaproic acid (relative risk, 1.78; 95% confidence interval, 1.56–2.02).

The second study was a 10-year, single-site investigation of patients undergoing bypass surgery from January 1996 through December 2005. In all, 1343 patients received aprotinin, 6776 received aminocaproic acid, and 2029 received no antifibrinolytic therapy. The risk for death was significantly increased by about 30% in the aprotinin group, compared with the other two groups. These investigators also found an age interaction: The mortality risk was highest for the youngest patients.

Comment: These observational studies lend additional support to concerns about the safety of aprotinin. The burden of demonstrating safety now rests squarely with the manufacturer.

— Harlan M. Krumholz, MD, SM

Published in Journal Watch Cardiology February 20, 2008