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Articles |
1
Department of Medicine, Brigham and Womens Hospital, Boston, MA 02115.
2
Department of Laboratory Medicine, Childrens Hospital,
Boston, MA 02115.
3
Department of Pathology, Brigham and Womens Hospital, Boston, MA 02115.
a Address correspondence to this author at: Cardiovascular Division, Brigham and Womens Hospital, 75 Francis St., Boston, MA 02115. Fax 617-975-0990; e-mail damorrow{at}bics.bwh.harvard.edu
Background: Significant analytic variability exists between the multiple assays for cardiac troponin I (cTnI) approved for clinical use. Until adequate cTnI standardization is possible, an evidence-based approach evaluating each assay at specific thresholds appears warranted.
Methods: We examined the efficacy of three cTnI assays for predicting death, myocardial infarction (MI), or the composite of death, MI, or urgent revascularization at 43 days among patients with non-ST-elevation acute coronary syndromes enrolled in the Thrombolysis In Myocardial Infarction (TIMI) 11B study.
Results: Six hundred eighty-one patients with serum samples
obtained at baseline and/or 1224 h had cTnI determined using all
three assays. Baseline cTnI was
0.1 µg/L for 368, 395, and 418
patients with the Bayer Immuno 1TM, ACS:180®,
and Dimension® RxL assays, respectively. Correlation
coefficients for the RxL with the ACS:180 and Bayer Immuno 1 results
were 0.89 (P = 0.0001) and 0.87
(P = 0.0001), with a coefficient of 0.92
(P = 0.0001) for the ACS:180 and Bayer Immuno 1
assays. Patients with cTnI
0.1 µg/L were at increased risk for
death or MI by 43 days (relative risk, 2.23.0; P
<0.0006), regardless of the assay used. This prognostic capacity
persisted among those with creatine kinase MB isoenzyme concentrations
within the reference interval. Moreover, cTnI was the strongest
multivariate predictor of death, MI, or urgent revascularization with
adjusted odds ratios of 2.12.9 (P <0.0006).
Conclusion: This study demonstrates the prognostic efficacy of three independently developed cTnI assays at a threshold of 0.1 µg/L for the prediction of adverse clinical outcomes among patients with non-ST-elevation acute coronary syndromes.
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