Academic Editors: Mattia Galli and Domenico D’Amario
Background: The PLATO trial data set reported to the FDA
(DRFDA) revealed that some primary deaths causes (PDC) were inaccurately reported
favoring ticagrelor. Trial Investigators (DRTI) received different data set with
more ticagrelor mortality advantage. We compared these two death lists for the
match in PDC. Methods and Results: The DRFDA contains 938
deaths, while the DRTI contains 905. We matched “vascular”, “non-vascular”,
“unknown”, “missed”, and “other” causes of death between DRFDA and DRTI.
The DRFDA used 14 vascular, 9 non-vascular, 1 unknown and 1 other PDC codes,
while the DRTI used 14 but different vascular, 14 non-vascular but no unknown or
other PDC codes. We observed a significant mismatch for the PDC codes between the
DRFDA and DRTI data sets. Most DRFDA deaths were vascular (n = 677), fewer
non-vascular (n = 159) and unexpectedly many unknown (n = 95) or other (n = 7)
PDC. Surprisingly, the shorter DRTI contains more vascular (n = 795), fewer
non-vascular (n = 110), but no unknown, other, or missed causes. There were more
sudden deaths in DRTI than in DRFDA (161 vs. 138; p