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Observational Study
. 2018 Feb 1;3(2):104-111.
doi: 10.1001/jamacardio.2017.4625.

Efficacy of High-Sensitivity Troponin T in Identifying Very-Low-Risk Patients With Possible Acute Coronary Syndrome

W Frank Peacock  1 , Brigette M Baumann  2 , Deborah Bruton  3 , Thomas E Davis  4 , Beverly Handy  5 , Christopher W Jones  2 , Judd E Hollander  6 , Alexander T Limkakeng  7 , Abhi Mehrotra  8 , Martin Than  9 , Andre Ziegler  10 , Carina Dinkel  11
Affiliations
Observational Study

Efficacy of High-Sensitivity Troponin T in Identifying Very-Low-Risk Patients With Possible Acute Coronary Syndrome

W Frank Peacock et al. JAMA Cardiol. .

Erratum in

  • Error in Methods Section.
    [No authors listed] [No authors listed] JAMA Cardiol. 2018 Sep 1;3(9):898. doi: 10.1001/jamacardio.2018.2503. JAMA Cardiol. 2018. PMID: 30090946 Free PMC article. No abstract available.

Abstract

Importance: Physicians need information on how to use the first available high-sensitivity troponin (hsTnT) assay in the United States to identify patients at very low risk for 30-day adverse cardiac events (ACE).

Objective: To determine whether a negative hsTnT assay at 0 and 3 hours following emergency department presentation could identify patients at less than 1% risk of a 30-day ACE.

Design, setting, and participants: A prospective, observational study at 15 emergency departments in the United States between 2011 and 2015 that included individuals 21 years and older, presenting to the emergency department with suspected acute coronary syndrome. Of 1690 eligible individuals, 15 (no cardiac troponin T measurement) and 320 (missing a 0-hour or 3-hour sample) were excluded from the analyses.

Exposures: Serial hsTnT measurements (fifth-generation Roche Elecsys hsTnT assay).

Main outcomes and measures: Serial blood samples from each patient were collected after emergency department presentation (once identified as a potential patient with acute coronary syndrome) and 3 hours, 6 to 9 hours, and 12 to 24 hours later. Adverse cardiac events were defined as myocardial infarction, urgent revascularization, or death. The upper reference level for the hsTnT assay, defined as the 99th percentile, was established as 19 ng/L in a separate healthy US cohort. Patients were considered ruled out for acute myocardial infarction if their hsTnT level at 0 hours and 3 hours was less than the upper reference level. Gold standard diagnoses were determined by a clinical end point committee. Evaluation of assay clinical performance for acute myocardial infarction rule-out was prespecified; the hypothesis regarding 30-day ACE was formulated after data collection.

Results: In 1301 healthy volunteers (50.4% women; median age, 48 years), the upper reference level was 19 ng/L. In 1600 patients with suspected acute coronary syndrome (48.4% women; median age, 55 years), a single hsTnTlevel less than 6 ng/L at baseline had a negative predictive value for AMI of 99.4%. In 974 patients (77.1%) with both 0-hour and 3-hour hsTnT levels of 19 ng/L or less, the negative predictive value for 30-day ACE was 99.3% (95% CI, 99.1-99.6). Using sex-specific cutpoints, C statistics for women (0.952) and men (0.962) were similar for acute myocardial infarction.

Conclusions and relevance: A single hsTnT level less than 6 ng/L was associated with a markedly decreased risk of AMI, while serial levels at 19 ng/L or less identified patients at less than 1% risk of 30-day ACE.

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Conflict of interest statement

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Peacock reports grants from Roche Inc during the conduct of the study; grants and personal fees from Roche Inc and Alere Inc; and personal fees from Abbott Inc, Beckman Inc, and Prevencio Inc outside the submitted work. Dr Baumann reports grants from Roche during the conduct of the study (payment for enrollment of patients in this investigation to cover salary support of research coordinator). Ms Bruton reports previous employment with Roche Diagnostics. Dr Handy reports funding from Roche Diagnostics to support laboratory personnel and supplies for the study (study design and statistical analysis), during the conduct of the study and has participated in other studies with Roche Diagnostics in which funding to support laboratory personnel and supplies (study design and statistical analysis) was provided for the study outside the submitted work. Dr Jones reports grants from Roche Diagnostics Inc during the conduct of the study and grants from Janssen and AstraZeneca outside the submitted work. Dr Hollander reports grants from Roche during the conduct of the study and grants from Alere, Siemens, Roche, and Trinity outside the submitted work. Dr Limkakeng reports grants from Roche Diagnostics International Ltd during the conduct of the study; consultancy from ZS Pharma and Biomerieux; and grants/grants pending from Roche Diagnostics, Abbott Laboratories, Bristol Meyers Squibb, Siemens Healthcare, Department of Defense/Henry Jackson Foundation, and Janssen Pharmaceuticals outside the submitted work. Dr Mehrotra reports sponsored research from Roche during the conduct of the study. Dr Than reports grants and personal fees from Abbott and Roche (funding for clinical trials, payment for speaking, and funding for education), grants from Beckman (funding for clinical trials, funding for education), and personal fees from Alere (payment for speaking and funding for education) outside the submitted work. Dr Ziegler reports employment with Roche Diagnostics during the conduct of the study. Ms Dinkel reports employment by Roche Diagnostics. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Standards for Reporting Diagnostic Accuracy Studies Diagrams
A, Myocardial infarction (MI); B, Thirty-day adverse cardiovascular events (ACE; myocardial infarction, urgent revascularization, or cardiac death). CEC indicates clinical events committee; cTnT, cardiac troponin T.
Figure 2.
Figure 2.. Subgroup Analysis of Patients With Baseline and 3-Hour High-Sensitivity Troponin (hsTnT) Level of 19 ng/L or Less
Negative predictive values (NPVs) are presented for clinical events, committee-adjudicated myocardial infarction (MI) diagnosis (A), and the occurrence of cardiac events or death within 30 days (B). PPV indicates positive predictive value.
Figure 3.
Figure 3.. Influence of the Cutoff Point on Diagnostic Performance
See this image and copyright information in PMC

Comment in

References

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