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Classification of patients with acute chest pain by analytical benchmarks and subsequent management recommendations - A comparison of three highly-sensitivity troponin assays in the ROMICAT trials

Session Cardiac troponins and other biomarkers in acute coronary syndromes

Speaker Julia Karady

Event : ESC Congress 2019

  • Topic : coronary artery disease, acute coronary syndromes, acute cardiac care
  • Sub-topic : Acute Coronary Syndromes: Biomarkers
  • Session type : Rapid Fire Abstracts

Authors : J Karady (Boston,US), T Mayrhofer (Boston,US), M Ferencik (Portland,US), JE Udelson (Boston,US), JL Fleg (Bethesda,US), WF Peacock (Houston,US), JL Januzzi Jr (Boston,US), JT Nagurney (Boston,US), WF Koenig (Munich,DE), U Hoffmann (Boston,US)

Authors:
J Karady1 , T Mayrhofer1 , M Ferencik2 , JE Udelson3 , JL Fleg4 , WF Peacock5 , JL Januzzi Jr6 , JT Nagurney7 , WF Koenig8 , U Hoffmann1 , 1Massachusetts General Hospital, Cardiac MR PET CT Program - Boston - United States of America , 2Oregon Health & Science University, Knight Cardiovascular Institute - Portland - United States of America , 3Tufts Medical Center, Department of Medicine - Boston - United States of America , 4National Heart, Lung, and Blood Institute, Division of Cardiovascular Sciences - Bethesda - United States of America , 5Baylor College of Medicine, Department of Emergency Medicine - Houston - United States of America , 6Massachusetts General Hospital, Division of Cardiology - Boston - United States of America , 7Massachusetts General Hospital, Department of Emergency Medicine - Boston - United States of America , 8Technical University of Munich, Deutsches Herzzentrum München - Munich - Germany ,

On behalf: Cardiac MR PET CT Program, Massachusetts General Hospital - Harvard Medical School

Citation:

Background: Concordance of different highly-sensitive troponin (hsTn) assays in stratifying acute chest pain (ACP) patients according to analytical benchmarks and subsequent emergency department (ED) management recommendations are unknown.

Methods: We included patients enrolled in the ROMICAT (Rule Out Myocardial Infarction/Ischemia Using Computer-Assisted Tomography) I and II trials (n=624; 39.1% female; 52.8±10.0 years), who presented to the ED and were referred to further non-invasive diagnostic testing. In ROMICAT I, blood was obtained at 4 hours, and in ROMICAT II at ED presentation, and at 2 and 4 hours and was tested with three state-of-the-art hsTn assays (Roche Diagnostics, Elecsys 2010; Abbott ARCHITECT i2000SR; Siemens Diagnostics, HsVista). In a per sample analysis, we compared the concordance of assays for analytic benchmarks (below the level of detection (LOD)/LOD to 99th percentile/99th percentile to myocardial infarction (MI)/above MI). In a per patient analysis of serial hsTn testing in ROMICAT II, we determined concordance of management recommendations (rule out/observe/rule in) based on 2015ESC guidelines, results of coronary CT angiography and stress myocardial perfusion, and adjudicated endpoints of ACS.

Results: Overall, only 34.4% (353/1027) of samples were classified into the same benchmark category by all assays (table 1). In a per patient analysis, all assays agreed on the same of management recommendation in 25.3% (49/242) patients after the 1st hsTn, mostly driven by differences in discharge (6.6%, 21.1%, and 61.2%; respectively; all p<0.001). The concordance of management recommendations improved significantly to 67.4% (163/242; p<0.001) after the 2nd hsTn measurement but the final agreement for "observe" and "rule in" remained limited (13/90 and 5/18). Among patients in whom discharge was recommended, at least 18.8% (range: 18.8–21.0% across assays) had a positive imaging/stress test and at least 2.9% (range: 2.9–3.4%) had ACS. 

Conclusion: Differences in hsTn assay concordance for analytical benchmarks and subsequent ED management recommendations in patients with ACP are substantial raising concerns about the lack of uniform management. 

<LOD

LOD - 99th%tile*

99th%tile* - AMI**

AMI**<

Roche Elecsys , n (%)

578 (56.3)

328 (31.9)

95 (9.3)

26 (2.5)

Abbott ARCHITECT, n (%)

176 (17.1)

788 (76.7)

14 (1.7)

49 (4.8)

Siemens Vista, n (%)

96 (9.4)

861 (83.9)

33 (3.2)

37 (3.6)

Classification of measurements from three hsTn assays in 1027 samples of patients with ACP according to analytical benchmarks. *assay specific 99th percentiles; **as per ESC 2015 guidelines.

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