Study confirms Aprotinin (Trasylol) drug increases cardiac surgery death rate

Study information on the use of the drug used for cardiac bypass surgery, which is now off the market...BD

The largest study to date of a controversial cardiac surgery drug shows it increases death rates and damages kidney function, according Duke University Medical Center researchers.

Aprotinin, a drug used to limit bleeding, was temporarily suspended from marketing in the U.S. in November 2007 after a small Canadian study was stopped because similar findings were discovered. The drug, Trasylol, is manufactured by Baylor AG.
"We're not surprised by the results," says Dr. Andrew Shaw, an associate professor in Duke Medicine's department of anesthesiology and the lead author of the paper which appears in the February 21 edition of the New England Journal of Medicine. "It's what we expected to find." Of the 10,275 patients studied, 1343 patients (13.2%) received aprotinin, 6776 patients (66.8%) received aminocaproic acid (another drug used to limit bleeding) and 2029 patients (20.0%) received no therapy. All patients underwent coronary-artery bypass surgery (CABG), and 1181 of them also underwent valve surgery. Patients who received either aminocaproic acid or no therapy did not have high rates of death or poor kidney function seen in the aprotinin group.