Bayer Trasylol study halted

The multi-center blood conservation using antifibrinolytics (BART) trial was comparing the efficacy and safety of the use of aprotinin (Trasylol), aminocaproic acid and tranexamic acid in approximately 3000 high-risk cardiac surgical patients undergoing either re-operation for coronary heart bypass graft (CABG) or aortic valve replacement, or combined valves or valve/CABG procedures.

However, a letter from the BART data safety monitoring board said that the planned periodic data analysis indicated reduced bleeding but also an increase in all-cause mortality (that almost reached conventional statistical significance for 30-day mortality) for patients in the aprotinin treatment arm compared to patients who received either aminocaproic acid or tranexamic acid. Data have not, as yet, been shared with Bayer, the company said.

Bayer has informed the FDA, Health Canada and other health authorities around the world. Bayer has also been informed that data will now be collected from all centers throughout Canada and data analysis will be undertaken by those conducting the BART study, a process that is expected to take between four and eight weeks.

Guidance from Bayer includes a recommendation that physicians use Trasylol only in accordance with approved product labeling. Trasylol is indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion.

Additionally, when deciding to prescribe Trasylol, Bayer said that physicians should also take into consideration that the BART Trial has been halted due to an increase in all-cause mortality in patients in the aprotinin treatment arm compared to patients who received either aminocaproic acid or tranexamic acid.