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Expert OpinionApril 24, 2018, Volume 137, Issue 17

JOURNAL：Circulation. Article Link

Impact of the US Food and Drug Administration–Approved Sex-Specific Cutoff Values for High-Sensitivity Cardiac Troponin T to Diagnose Myocardial Infarction

MR Gimenez, P Badertscher, R Twerenbold et al. Keywords: myocardial infarction; troponin

ABSTRACT

In patients presenting with suspected myocardial infarction (MI), beyond the presence or absence of MI, 4 clinical variables seem to affect high-sensitivity cardiac troponin (hs-cTn) concentrations: age, renal dysfunction, time from chest pain onset, and sex.1 Among the 4 variables, sex has received the most attention, resulting in uncertainty about the need to abandon the 1 overall cutoff in favor of sex-specific cutoffs for hs-cTn in the diagnosis of MI.2,3 For high-sensitivity cardiac troponin T (hs-cTnT), the only hs-cTn assay approved by the US Food and Drug Administration (FDA) until now, this does not seem necessary when applying 99th percentiles of healthy individuals, as done outside the United States. With these cutoffs, only a very small percentage (<1%) of women were reclassified as having MI.2 The FDA-approved use of hs-cTnT differs in using the 99th percentile upper reference limit determined in a reference population matched to the age of patients presenting with suspected MI to the emergency department. As a consequence, the FDA-approved 1 overall (19 ng/L) and sex-specific (women, 14 ng/L; men, 22 ng/L) 99th percentiles are higher compared with the 99th percentiles used outside the United States.

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