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Diagnostic accuracy of a novel ultra-sensitive cardiac troponin I assay compared to high-sensitivity cardiac troponin T and I for the early diagnosis of myocardial infarction

Session Poster Session 3

Speaker Raphael Twerenbold

Event : ESC Congress 2018

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

Authors : R Twerenbold (Basel,CH), M Rubini Gimenez (Basel,CH), J Boeddinghaus (Basel,CH), T Nestelberger (Basel,CH), C Puelacher (Basel,CH), P Badertscher (Basel,CH), J Du Fay De Lavallaz (Basel,CH), D Wussler (Basel,CH), N Kozhuharov (Basel,CH), O Miro (Barcelona,ES), FJ Martin-Sanchez (Madrid,ES), B Morawiec (Katowice,PL), D Keller (Zurich,CH), T Reichlin (Basel,CH), C Mueller (Basel,CH)

Authors:
R. Twerenbold1 , M. Rubini Gimenez1 , J. Boeddinghaus1 , T. Nestelberger1 , C. Puelacher1 , P. Badertscher1 , J. Du Fay De Lavallaz1 , D. Wussler1 , N. Kozhuharov1 , O. Miro2 , F.J. Martin-Sanchez3 , B. Morawiec4 , D. Keller5 , T. Reichlin1 , C. Mueller1 , 1University Hospital Basel - Basel - Switzerland , 2Hospital Clinic de Barcelona - Barcelona - Spain , 3Hospital Clinic San Carlos - Madrid - Spain , 4Medical University of Silesia, Cardiology department - Katowice - Poland , 5University Hospital Zurich - Zurich - Switzerland ,

Citation:
European Heart Journal ( 2018 ) 39 ( Supplement ), 552

Background: Cardiac troponin plays a major role in the early diagnosis of myocardial infarction (MI). It remains unclear, whether the analytical superiority of a novel ultra-sensitive cardiac troponin I (us-cTnI) assay translates into clinical superiority when compared to high-sensitivity cardiac troponin (hs-cTn) T/I assays.

Purpose: We aimed to directly compare the diagnostic accuracy of a novel us-cTnI assay with a hs-cTnT and a hs-cTnI assay for the early diagnosis of MI.

Methods: In a prospective international multicentre diagnostic study enrolling patients presenting with suspected MI to the ED, us-cTnI-Clarity, hs-cTnT-Elecsys and hs-cTnI-Architect was determined at baseline and serially thereafter. Patients presenting with STEMI were excluded. Final diagnoses were centrally adjudicated by two independent cardiologists including all clinical information twice: first, using serial high-sensitivity (hs)-cTnT-Elecsys (primary analysis) and second, using hs-cTnI-Architect (secondary analysis) measurements in addition to the clinically used (hs)-cTnT/I. Primary objective was the direct comparison of the diagnostic accuracy, as quantified by the area under the receiver-operating-characteristic curve (AUC), of us-cTnI-Clarity with the two established hs-cTn assays (hs-cTnT-Elecsys, hs-cTnI-Architect).

Results: Among 2470 recruited patients, MI was the final diagnosis in 413 (17%). The diagnostic accuracy of measurements obtained at ED presentation, as quantified by AUCs, was 0.94 (95% CI, 0.93–0.95) for us-cTnI-Clarity and comparable to hs-cTnT-Elecsys (0.94; 95% CI, 0.93–0.95; p=0.367), and superior to hs-cTnI-Architect (0.93; 95% CI, 0.92–0.94; p=0.009; Figure 1A). Among patients presenting to the ED within 2h after chest pain onset (551/2470, 22%), the AUC was 0.92 (95% CI, 0.89–0.95) for us-cTnI-Clarity compared with 0.90 (95% CI, 0.86–0.93) for hs-cTnT-Elecsys and 0.90 (95% CI, 0.87–0.93) for hs-cTnI-Architect, respectively (p=0.118 and p=0.165 for respective direct comparisons; Figure 1B). Highly comparable findings were obtained when using the second final adjudicated diagnosis including hs-cTnI-Architect.

Conclusion: The diagnostic accuracy of the novel us-cTnI-Clarity assay for MI is very high and overall comparable to the two well-established hs-cTn assays.

Figure 1

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