Safety Concerns About Aprotinin

Prompted by troubling observational findings, the FDA has issued a public health advisory about aprotinin use in coronary-artery surgery.

Concerns about bleeding associated with elective coronary-artery surgery have led to the widespread use of lysine analogues (aminocaproic acid and tranexamic acid) and serine protease inhibition (with aprotinin; Trasylol) to reduce bleeding risk. However, safety concerns about these agents persist.

Now, in a multinational, nonrandomized, prospective study not sponsored by industry, researchers studied 4374 patients (80% men) scheduled for coronary-artery surgery with cardiopulmonary bypass: 1295 received aprotinin, 883 aminocaproic acid, 822 tranexamic acid, and 1374 no antifibrinolytic treatment (control). Outcome analyses, in which controls served as the reference group, were adjusted for multiple potential confounders, including patients’…

Reviewing Author

Harlan M. Krumholz, MD, SM