Cardiac surgery patients may be at risk because of the decision by Health Canada and the European Medicines Agency to reintroduce the use of aprotinin after its withdrawal from the worldwide market in 2007, assert the authors of a previous major trial that found a substantially increased risk of death associated with the drug. In an analysis in CMAJ (Canadian Medical Association Journal), the authors refute three major criticisms of the trial made by the regulatory bodies.
Aprotinin, used to control bleeding in cardiac surgery, was withdrawn worldwide in 2007 after the early termination of the Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART), which showed an increase in risk of death for cardiac patients on the drug. The results of the BART trial were published in the New England Journal of Medicine in 2008.
"This analysis is about setting the record straight and refuting the inaccurate and unclear criticisms made against the BART trial regarding the way it was conducted and its final results reported," says Dean Fergusson, senior scientist and director of the Clinical Epidemiology Program at the Ottawa Hospital Research Institute and a professor at the University of Ottawa. "We want to reassure all those involved in BART, including physicians, nurses, patients and families, that it was a pivotal, well-designed and well-conducted trial."
Aprotinin is still unavailable for use in the United States.
"We consider that the prudent regulatory response to uncertainty would have been to mandate a second large trial comparing aprotinin to an active agent to either refute or confirm results from the BART," the authors conclude.