Clinical Investigation
Acute Ischemic Heart Disease
Improved diagnostic and prognostic performance of a new high-sensitive troponin T assay in patients with acute coronary syndrome

https://doi.org/10.1016/j.ahj.2011.04.007Get rights and content

Background

In the present study, we aimed to analyze the diagnostic and prognostic potential of a newly developed high-sensitive troponin T assay and compared these results with those of a contemporary troponin T assay in 2 distinct patient cohorts, one including patients with evident ACS and the other one including patients with general chest pain.

Methods and Results

For this study, we analyzed data from 2 independent patient cohorts, the Bad Nauheim ACS registry and the Prognosis in Acute Coronary Syndromes registry, with a total of 2,506 patients. On admission, clinical data have been recorded, and a single measurement of troponin T has been performed with a contemporary assay (TnT) and a new high-sensitive troponin T assay (hsTnT). Clinical follow-up has been obtained after 6 months. The diagnostic value of hsTnT was superior to TnT (area under the receiver operating characteristic curve 0.949 vs 0.929, P = .016). Specifically, in TnT-negative patients, hsTnT provided strong diagnostic information (area under the receiver operating characteristic curve of 0.81, P < .001). Furthermore, hsTnT provided independent prognostic power for mortality within 6 months in both cohorts, which was superior to that of the contemporary TnT assay.

Conclusion

Troponin T measured with a newly developed hsTnT provides better diagnostic and prognostic information and, therefore, should be implemented as a standard test in clinical routine.

Section snippets

Background

Myocardial infarction is an acute and life-threatening clinical manifestation of coronary artery disease and is the major cause of death in developed countries. Immediate diagnosis, risk stratification, and initiation of a specific therapy are of foremost importance to improve clinical outcome in patients presenting with symptoms suggestive for an acute coronary syndrome (ACS).1

The measurement of cardiac troponins (cTn) plays a central role for the diagnosis of acute myocardial infarction (AMI)

Patients

We analyzed data from 2 independent patient cohorts, the Bad Nauheim ACS registry and the Prognosis in Acute Coronary Syndromes (PACS) registry, with a total of 2,506 patients. Both cohorts were different, with the Bad Nauheim ACS registry comprising a high-risk cohort with confirmed ACS, and the PACS registry, a lower-risk chest pain cohort.12, 13 Accordingly, we analyzed both populations separately.

The Bad Nauheim ACS registry included consecutive patients (n = 1,023) from April 2003 until

Results

A total of 2,506 patients were analyzed, 1,023 from the Bad Nauheim ACS registry and 1,483 patients from the PACS registry.

Baseline data of both cohorts are depicted in Table I. Patient's characteristics regarding gender, age, and presence of conventional risk factors were similar in both groups. However, in the PACS cohort, the diagnosis of myocardial infarction was less frequent, as well as the finding of TnT (>30 pg/mL) or hsTnT (>14 pg/mL) elevation as compared with that in the Bad Nauheim

Discussion

The main findings of this study were, first, an improved diagnostic accuracy of TnT when measured with the hsTnT assay, specially in patients presenting early after the onset of symptoms; second, a high diagnostic accuracy of the high-sensitive troponin assay in patients who are troponin T negative with the contemporary assay; and third, an incremental prognostic value of the high-sensitive assay, allowing improved risk stratification also in patients with negative troponin T levels on

Conclusion

Troponin T measured with a newly developed high-sensitive troponin T assay provides better diagnostic information for the diagnosis of an AMI in patients with symptoms suggestive for an ACS, particularly, very early after the onset of symptoms. Furthermore, the prognostic information derived from the high-sensitive troponin testing is superior to the contemporary troponin test. The implementation of this new assay into clinical routine therefore allows earlier and improved decision making.

Disclosures

Michael Weber, Lecture fees by Roche Diagnostics and Abbott Diagnostics.

Oscar Bazzino, No disclosures.

Jose Luis Navarro Estrada, No disclosures.

Raul de Miguel, No disclosures.

Simon Salzberg, No disclosures.

Juan J. Fuselli, No disclosures.

Christoph Liebetrau, No disclosures.

Mariella Woelken, No disclosures.

Helge Moellmann, No disclosures.

Holger Nef, No disclosures.

Christian Hamm, Lecture fees by Roche Diagnostics and Abbott Diagnostics, Advisory Board Abbott Diagnostics.

Acknowledgements

The Bad Nauheim ACS registry was funded by a grant from the Kerckhoff-Stiftung, Bad Nauheim Germany. The PACS study was funded by a grant from Sanofi Aventis (Buenos Aires, Argentina). Roche Diagnostics (Mannheim, Germany) provided the assays for measurement of troponin T and high-sensitive troponin T free of charge. No other extramural funding was used to support this work.

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