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Coronary artery disease
Original research article
Novel high-sensitivity cardiac troponin I assay in patients with suspected acute coronary syndrome
  1. Andrew R Chapman1,
  2. Takeshi Fujisawa1,
  3. Kuan Ken Lee1,
  4. Jack Patrick Andrews1,
  5. Atul Anand1,
  6. Dennis Sandeman1,
  7. Amy V Ferry1,
  8. Stacey Stewart1,
  9. Lucy Marshall1,
  10. Fiona E Strachan1,
  11. Alasdair Gray2,3,
  12. David E Newby1,
  13. Anoop S V Shah1,
  14. Nicholas L Mills1,4
  1. 1 BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK
  2. 2 Department of Emergency Medicine, Royal Infirmary of Edinburgh, Edinburgh, UK
  3. 3 EMERGE Research Group, Royal Infirmary of Edinburgh, Edinburgh, UK
  4. 4 Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK
  1. Correspondence to Dr Andrew R Chapman, BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh EH16 4SB, UK; a.r.chapman{at}ed.ac.uk

Abstract

Background High-sensitivity cardiac troponin assays enable the early risk stratification of patients with suspected acute coronary syndrome to identify those at low risk of myocardial infarction or cardiac death. We evaluated the performance of a novel high-sensitivity cardiac troponin I assay in early rule out pathways.

Methods In 1920 patients with suspected acute coronary syndrome, cardiac troponin was measured using the Siemens Atellica high-sensitivity cardiac troponin I assay (99th centile: 34 ng/L women, 53 ng/L men). We evaluated three pathways which use either low risk-stratification thresholds of cardiac troponin (High-SensitivityTroponin in the Evaluation of patients with Acute Coronary Syndrome (High-STEACS) and the European Society of Cardiology (ESC) 1 hour pathway) or the 99th centile diagnostic threshold (ESC 3 hour pathway) to rule out myocardial infarction.

Results The primary outcome of myocardial infarction or cardiac death at 30 days occurred in 14.4% (277/1920). The High-STEACS pathway ruled out 63% of patients (1218/1920), with five missed events for a negative predictive value (NPV) of 99.5% (95% CI (CI) 99.1% to 99.8%). Similar performance was observed for the ESC 1 hour pathway with an NPV of 99.0% (97.6% to 99.8%). In contrast, the ESC 3 hour pathway ruled out 65% of patients (1248/1920), but missed 25 events for an NPV of 98.0% (97.1% to 98.7%).

Conclusions A novel high-sensitivity cardiac troponin I assay can safely identify patients at low risk of myocardial infarction or cardiac death. Diagnostic pathways that use low cardiac troponin concentrations for risk stratification miss fewer events than those that rely on the 99th centile to rule out myocardial infarction.

Trial registration NCT1852123.

  • acute coronary syndromes

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/heartjnl-2018-314093

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    Footnotes

    • Contributors ARC and NLM were responsible for the concept, analysis and drafting of the manuscript, and take responsibility for the integrity of the data. All authors were involved in delivery of this clinical trial, contributed to analysis of the data and provided important critical revision of the manuscript.

    • Funding The High-STEACS trial was funded by the British Heart Foundation (SP/12/10/29922 and PG/15/51/31596), and this analysis was supported by Siemens Healthcare Diagnostics . NLM and ARC are supported by the Butler Senior Clinical Research Fellowship (FS/16/14/32023) and a Clinical Research Training Fellowship (FS/16/75/32533), respectively, from the British Heart Foundation.

    • Competing interests ASVS and ARC have received honoraria from Abbott Diagnostics. NLM has received honoraria or consultancy from Abbott Diagnostics, Roche Diagnostics, Siemens Healthcare Diagnostics and Singulex.

    • Patient consent Not required.

    • Ethics approval This clinical trial was registered (NCT:01852123), approved by the National Research Ethics Committee, and conducted in accordance with the Declaration of Helsinki.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement Data can be made available to others for the purposes of reproducing the results or for further analysis through a data sharing agreement.

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