Key result
The PLATO Investigators dataset reported more sudden (161 vs 138; P<0.03) and post-MI deaths (373 vs 178; P<0.001), but fewer heart failure deaths (73 vs 109; P=0.02) compared to the FDA dataset.
Why the study?
The FDA-issued PLATO trial dataset revealed that some primary death causes were inaccurately reported favoring ticagrelor, while PLATO investigators operated a shorter death list of uncertain quality.
Do the primary death causes match between the FDA-issued PLATO trial dataset and the PLATO Investigators dataset?
Do the primary death causes match between the FDA-issued PLATO trial dataset and the PLATO Investigators dataset?
Significant discrepancies exist in the reporting of primary death causes between the FDA and investigator datasets for the PLATO trial, raising questions about data accuracy.
Discrepancies in PLATO death classifications warrant caution interpreting trial mortality data; leaves open questions on dataset accuracy requiring independent verification.
PURPOSE: The FDA-issued PLATO trial dataset revealed that some primary death causes (PDCs) were inaccurately reported favouring 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 four vascular (sudden, post-MI, heart failure and stroke), and three 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 < .03) and post-AMI (373 vs 178; P < .001) but fewer heart failure deaths (73 vs 109; P = .02). Stroke numbers match well (39 vs 37; P = NS) with only two ticagrelor cases removed. Cancer matched well (32 vs 31; P = NS), and sepsis cases were identical (30 vs 30; P = NS). However, two extra clopidogrel suicides in the shorter list are impossible to comprehend. CONCLUSIONS: The PLATO trial PDCs 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.
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Serebruany et al. (2021) studied Primary death causes in the PLATO trial (n=938). PLATO Investigators dataset vs. FDA-issued dataset was evaluated on Match of primary death causes between datasets. The PLATO Investigators dataset reported more sudden (161 vs 138; P<0.03) and post-MI deaths (373 vs 178; P<0.001), but fewer heart failure deaths (73 vs 109; P=0.02) compared to the FDA dataset.
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