Challenging ticagrelor's claimed reduction in the rate of definite stent thrombosis versus clopidogrel: insights from the FDA reports.

Ticagrelor has been promoted to reduce the rate of definite stent thrombosis compared to clopidogrel from the The Platelet Inhibition and Patient Outcomes (PLATO) trial. However, several issues prevent this statement from being accurate, (1) stent thrombosis was an exploratory endpoint in PLATO--cases were retrospectively and prospectively adjudicated, (2) Sampling/ascertainment bias most likely lead to these conclusions, (3) Stent thromboses were not confirmed by an angiographic core lab (a requirement by the ARC definition for 'definite stent thrombosis'), (4) The integrity of the mortality and MI data from the PLATO trial have recently been challenged. A statement that ticagrelor reduces definite stent thrombosis versus clopidogrel cannot be justified.