Last year 246 000 Americans received aprotinin during coronary artery surgery. Aprotinin reduces bleeding and has been licensed for use during coronary artery surgery since 1993 in the United States. More recently, aprotinin has been linked to renal toxicity; cardiovascular, cerebrovascular, and pulmonary vascular side effects; and now deaths. In a prospective study of 4374 patients having coronary artery surgery, those given aprotinin were significantly more likely to die during the next five years than those who received no antifibrinolytic agent (223/1072 (20.8%) v 128/1009 (12.7%); adjusted hazard ratio for death 1.48, 95% CI 1.19 to 1.85). The alternative agents tranexamic acid (1.07, 0.8 to 1.45) and aminocaproic acid (1.03, 0.8 to 1.33) were not associated with any excess deaths.
The study used data from a registry of patients who had their surgery at one of 62 sites in North and South America, Europe, Asia, and the Middle East. The authors did their best to adjust for the inevitable differences between people who do and do not receive aprotinin, and they are fairly convinced that the drug is unsafe. The excess deaths persisted through various different analyses and even seemed to be dose related. As two safe, effective, and cheap alternatives exist, cardiac surgeons should probably think twice before using aprotinin, the authors conclude.