Abstract
STUDY OBJECTIVE:We determine the accuracy of high-sensitivity cardiac troponin I (hs-cTnI),
European-derived, rapid, acute myocardial infarction, rule-out/rule-in algorithms
applied to a US emergency department (ED) population. METHODS:Adults presenting to
the ED with suspected acute myocardial infarction were included. Plasma samples collected
at baseline and between 40 and 90 minutes and 2 and 3 hours later were analyzed in
core laboratories using the Siemens Healthineers hs-cTnI assays. Acute myocardial
infarction diagnosis was independently adjudicated. The sensitivity, specificity,
and negative and positive predictive values for rapid acute myocardial infarction
rule-out/rule-in using European algorithms and 30-day outcomes are reported. RESULTS:From
29 US medical centers, 2,113 subjects had complete data for the 0/1-hour algorithm
analyses. With the Siemens Atellica Immunoassay hs-cTnI values, 1,065 patients (50.4%)
were ruled out, with a negative predictive value of 99.7% and sensitivity of 98.7%
(95% confidence interval 99.2% to 99.9% and 96.3% to 99.6%, respectively), whereas
265 patients (12.6%) were ruled in, having a positive predictive value of 69.4% and
specificity of 95.7% (95% confidence interval 63.6% to 74.7% and 94.7% to 96.5%, respectively).
The remaining 783 patients (37.1%) were classified as having continued evaluations,
with an acute myocardial infarction incidence of 5.6% (95% confidence interval 4.2%
to 7.5%). The overall 30-day risk of death or postdischarge acute myocardial infarction
was very low in the ruled-out patients but was incrementally increased in the other
groups (rule-out 0.2%; continued evaluations 2.1%; rule-in 4.8%). Equivalent results
were observed in the 0/2- to 3-hour analyses and when both algorithms were applied
to the hs-cTnI ADVIA Centaur measurements. CONCLUSION:The European rapid rule-out/rule-in
acute myocardial infarction algorithm hs-cTnI cut points can be harmonized with a
demographically and risk-factor diverse US ED population.
Published Version (Please cite this version)
10.1016/j.annemergmed.2019.12.008
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