A trial of three drugs routinely used to prevent blood loss during heart surgery has found that one of them causes a 50% increase in the risk of death.
The study of more than 2,000 high-risk cardiac surgery patients compared aprotinin with two other drugs – tranexamic acid and aminocaproic acid.
The trial, published in the New England Journal of Medicine, shows that approximately 6% of patients who received aprotinin died within 30 days of surgery, compared with 4% of patients given one of the other two drugs.
BART (Blood Conservation using Antifibrinolytics in a Randomized Trial) is one of the largest heart surgery trials ever conducted and was led by senior scientists at the Ottawa Health Research Institute, Canada.
“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 A Fergusson, BART Co-Principal Investigator and Senior Scientist.
Aprotinin was suspended from the market last October pending analysis of the final results of the trial. These results show that although aprotinin appeared to decrease some of the consequences of massive bleeding, these benefits were outweighed by the risks.
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New England Journal of Medicine