Use of the blood-saving drug aprotinin (Trasylol) during coronary bypass surgery significantly increases the risk of death, according to data from two large studies.
Patients treated with aprotinin had an almost a two-fold greater mortality compared with patients given aminocaproic acid during heart surgery, Sebastian Schneeweiss, M.D., Sc.D., of Harvard, and colleagues, reported in the Feb. 21 issue of The New England Journal of Medicine.
A second study in the NEJM by a Duke-led group revealed about a 30% higher mortality risk with aprotinin versus aminocaproic acid (Amicar) or no antifibrinolytic therapy.
“Characteristics of neither the patients nor the surgeons explain the [mortality] difference, which persisted through several approaches to control confounding,” Dr. Schneeweiss and co-authors concluded.
Evidence of an increased mortality hazard adds to adverse effects documented in a report two weeks ago in The Lancet that implicated aprotinin in renal dysfunction among patients undergoing cardiac surgery.