A new Canadian study has found that Aprotinin, a drug used to prevent blood loss during heart surgery, increased the risk of death by almost 50 percent.
Germany's Bayer makes the drug, known by the brand name Trasylol, and temporarily took it off the market in October 2007, on advice of an independent Data Safety and Monitoring Board which detected a trend toward increased mortality in one arm of the triple-blinded study.
"The trial, published in the New England Journal of Medicine, shows that approximately six per cent of patients who received aprotinin died within 30 days of surgery compared to four per cent of patients who received tranexamic acid or aminocaproic acid," the authors said in a statement.
"These three drugs have been routinely used in heart surgery for more than a decade, but this is the first trial to rigorously compare them in a meaningful setting with meaningful clinical outcomes," said Dr. Dean Fergusson, senior scientist on the study. "The results demonstrate the great value of and the need for independent academic clinical trials."
"Overall, our study supports the use of tranexamic acid or aminocaproic acid over aprotinin during high-risk heart surgery," stressed Dr. Paul Hebert, BART Co-Principal Investigator and Critical Care Physician. "I've treated many patients with complications from heart surgery so I know how important these results are to patients, to their families and to health care providers."
The trial, dubbed BART (Blood Conservation using Antifibrinolytics in a Randomized Trial), was done on 2,000 patients who had undergone heart surgery, in 19 Canadian hospitals.