BACKGROUND
Ticagrelor is an oral, reversible, direct-acting inhibitor of the adenosine diphosphate receptor P2Y12 that was tested against clopidogrel in the PLATO trial. Remarkably for the oral antiplatelet agents, PLATO Investigators reported that ticagrelor reduced death from vascular causes (4.0% vs. 5.1%, P = 0.001) and death from any cause (4.5%, vs. 5.9% P<0.001).1 Such a strong mortality benefit was surprising because of opposite death counts in the Phase II DISPERSE studies, the mismatch between reasonable myocardial infarction and very high death rates in PLATO, the inverse US outcomes, the unusually delayed timing of benefit, the last minute change of trial governance from the TIMI Group to the sponsor, the late introduction of electronic clinical research forms (eCRF),2 and some striking “errors” revealed by the FDA, including for example, a clopidogrel patient who was reported dead but later experienced non-fatal bleeding.3 However, until now, no hard evidence of misreported death records with definite proof was publicly available. As of today, ticagrelor holds a superiority recommendation over clopidogrel for acute coronary syndromes in European,4Canadian,5 and American 6 guidelines based mostly on the results of the PLATO trial.1