More Evidence of Danger From Heart Surgery Drug

Anti-bleeding agent Trasylol tied to increased death, complications, studies find

By Ed Edelson
HealthDay Reporter

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WEDNESDAY, Feb. 20 HealthDay News) -- Two new studies confirm an increased incidence of death and kidney damage among people given Trasylol (aprotinin), a drug used to reduce bleeding during coronary artery bypass surgeries.

The studies suggest the drug raises patients' risks over both the short- and long-term.

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Trasylol's German maker, Bayer AG, suspended marketing in the United States last November after preliminary results of a Canadian trial revealed problems with the medication.

"There continues to be an association between aprotinin and higher death rates and kidney damage," said Dr. Andrew Shaw, an associate professor of anesthesiology at Duke University and the lead author of one of the reports in the Feb. 21 issue of the New England Journal of Medicine.

The study he led looked at more than 10,000 people who underwent coronary artery bypass surgery. The death rate was 32 percent higher among the 1,343 people who got Trasylol as compared to the 2,029 who received no medication to limit their bleeding. The mortality rate for those taking Trasylol was also 27 percent higher than those given aminocaproic acid, a different medication used to limit bleeding.

One important facet of the study is that the follow-up period was as long as 10 years, Shaw said. Trasylol was put on the market in the United States in 1993.

The study also confirmed the incidence of kidney damage by precise measurements of serum creatinine, a kidney-related protein, Shaw said. "There does appear to be an association between continued use of aprotinin and reduced kidney function," he said.

The second study, led by physicians at Harvard Medical School and Brigham and Women's Hospital, used data on more than 78,000 coronary bypass surgery cases, comparing results when either Trasylol or aminocaproic acid was used.

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