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February 21, 2008 New England Journal of Medicine, The effect of Trasylol (aprotinin) on outcome after coronary-artery bypass grafting (CABG) -- The Duke Study.

The effect of aprotinin on outcome after coronary-artery bypass grafting, N Engl J Med. 2008 Feb 21;358(8):784-93.

In 2006, a study published in the New England Journal of Medicine linked Trasylol use during heart surgery with an increased the risk of heart attack, stroke, kidney damage, renal failure, and death.

In response, researchers at Duke University reviewed the cases of over 10,000 patients who underwent coronary-artery bypass graft (CABG) surgery at Duke University Medical Center between January 1, 1996 and December 31, 2005. The purpose of the study was to look for an association between Trasylol (aprotinin) use and adverse outcomes including those reported in the 2006 study (heart attack, stroke, kidney damage, renal failure, and death.)

The Duke Study found that the 30-day death rate of patients given Trasylol during coronary-artery bypass grafting (CABG) surgery is nearly 250% higher than CABG patients given another anti-bleeding drug or no drug at all. The study also linked Trasylol with an increased risk of kidney damage and impaired kidney function.

“We’re not surprised by the results,” says Dr. Andrew Shaw, Associate Professor of Medicine at Duke and lead author of the study. “It’s what we expected to find.”