Key result
New hs-cTnI assay using gender-specific thresholds and 3-hour changes achieves ~98% NPV for NSTEMI rule-out.
Why the study?
Does a new high-sensitivity cardiac troponin I assay using gender-specific thresholds and absolute 3-hour changes improve the diagnosis of NSTEMI in patients with chest pain?
Observational (n=1,560)
Does a new high-sensitivity cardiac troponin I assay using gender-specific thresholds and absolute 3-hour changes improve the diagnosis of NSTEMI in patients with chest pain?
A new high-sensitivity cardiac troponin I assay provides excellent rule-out for NSTEMI, and absolute 3-hour changes are superior to relative changes for rule-in, with gender-specific differences.
Supports excellent NSTEMI rule-out with gender-specific hs-cTnI thresholds; leaves open prospective validation before clinical adoption.
BACKGROUND: The determination of cardiac troponin is essential for diagnosing myocardial infarction. A troponin I assay has recently been developed that provides the highest analytical sensitivity to date. METHODS: The analysis included 1560 patients with chest pain, of whom 1098 were diagnosed with non-coronary chest pain, 189 with unstable angina pectoris and 273 with non-ST-segment elevation myocardial infarction. The troponin I concentration was determined on admission (0 hours) and 3 hours later. The diagnostic algorithm incorporated troponin I elevation above the gender-specific 99th percentile as well as predefined relative or absolute 3-hour changes in the troponin I concentration (delta). RESULTS: The diagnostic criterion of troponin I above the 99th percentile resulted in a negative predictive value of 98.0% and 98.2% in men and women, respectively. For rule-in of non-ST-segment elevation myocardial infarction, the use of absolute deltas yielded higher positive predictive values and sensitivities compared to relative deltas. With detection rates of about 85% and 82% in men and women, respectively, non-ST-segment elevation myocardial infarction was diagnosed with a positive predictive value close to 84% in men and 80% in women. CONCLUSIONS: The investigational troponin I assay provides an excellent non-ST-segment elevation myocardial infarction rule out. With gender-specific differences, the application of absolute changes in troponin concentration was superior to relative changes to rule in patients with non-ST-segment elevation myocardial infarction.
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Schofer et al. (2016) conducted an observational in Chest pain (n=1,560). High-sensitivity cardiac troponin I assay was evaluated on Detection of non-ST-segment elevation myocardial infarction. A new high-sensitivity cardiac troponin I assay using gender-specific 99th percentiles and absolute 3-hour changes provided excellent NSTEMI rule-out with NPVs of 98.0% in men and 98.2% in women.
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