Abstract
Purpose: The FDA-issued PLATO trial dataset revealed that some
primary deaths causes (PDC) were inaccurately reported favoring
ticagrelor. However, the PLATO Investigators operated the shorter death
list of uncertain quality. We compared if PDC match when trial
fatalities were reported to the FDA and by the PLATO investigators.
Method : The FDA list contains precisely detailed 938 PLATO
deaths, while shorter investigators dataset consists of 905 deaths. We
matched 4 vascular (sudden, post-MI, heart failure and stroke), and 3
non-vascular (cancer, sepsis and suicide) PDC between death lists.
Results: There were more sudden deaths in the shorter list than
in the FDA dataset (161 vs.138; p<0.03), post-AMI (373 vs.178;
p<0.001) but fewer heart failure deaths (73 vs.109; p=0.02).
Stroke numbers match well (39 vs. 37; p=NS) with only 2 ticagrelor cases
removed. Cancer matched well (32 vs.31; p=NS), and sepsis cases were
identical (30 vs. 30; P=NS). However, 2 extra clopidogrel suicides in
the shorter list are impossible to comprehend.
Conclusions: The PLATO trial PDC were mismatched between FDA
and Investigators sets. We are kindly asking the ticagrelor sponsor
or/and concerned PLATO Investigators to clarify the PDC dataset match.
Key Words Clinical trial, ticagrelor, clopidogrel, cause of
death, mortality