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The FDA and PLATO investigators death lists: Call for a match
  • Victor Serebruany,
  • Jean-Francois Tanguay,
  • Thomas Marciniak
Victor Serebruany
Johns Hopkins University
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Jean-Francois Tanguay
Montreal Heart Institute
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Thomas Marciniak
Retired from FDA
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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.

Peer review status:ACCEPTED

08 Jan 2021Submitted to International Journal of Clinical Practice
09 Jan 2021Submission Checks Completed
09 Jan 2021Assigned to Editor
11 Jan 2021Reviewer(s) Assigned
19 Jan 2021Review(s) Completed, Editorial Evaluation Pending
26 Jan 20211st Revision Received
28 Jan 2021Submission Checks Completed
28 Jan 2021Assigned to Editor
28 Jan 2021Reviewer(s) Assigned
01 Feb 2021Review(s) Completed, Editorial Evaluation Pending
18 Feb 2021Editorial Decision: Accept