Analysis in CMAJ counters criticisms of pivotal BART trial

October 15, 2014

In a paper published by CMAJ, Drs. Dean Fergusson, Brian Hutton and colleagues refute three major criticisms of the BART trial, criticisms that were used as justification to bring aprotinin back on the market with revised warnings in Canada and in Europe. Aprotinin, used to control bleeding in cardiac surgery, was withdrawn worldwide in 2007 after the early termination of the Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART), which showed an increased risk of death for cardiac patients on the drug, compared with available and less costly alternatives. The results of the BART trial were published in the New England Journal of Medicine in 2008. Read the CMAJ release.

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