TRASYLOL (aprotinin), antihaemorrhagic

SURGERY - Update

Opinions on drugs - Posted on May 11 2017

Re-assessment of the actual benefit

TRASYLOL has marketing authorisation as a preventive treatment to reduce bleeding and transfusion needs in adults at high risk of major bleeding who are undergoing isolated coronary artery bypass surgery under cardiopulmonary bypass (CPB) (i.e. coronary artery bypass surgery not combined with any other cardiovascular surgical procedure).
A study comparing TRASYLOL with tranexamic acid in a wider population than that specified in the current marketing authorisation for TRASYLOL was stopped prematurely because of a suspected increased risk of mortality in the aprotinin group versus tranexamic acid. However, this study did not find any difference in efficacy or safety between TRASYLOL and tranexamic acid.
A meta-analysis did not demonstrate any advantage from using aprotinin over tranexamic acid in the marketing authorisation population.
This is a 1^st-line medicine essentially for patients at high risk of major bleeding, i.e. primarily patients on dual antiplatelet therapy that cannot be stopped without risk up to 5 days before isolated coronary artery bypass surgery on CPB.