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One-hour rule-out and rule-in of acute myocardial infarction using a novel ultra-sensitive cardiac troponin I assay

Session Poster Session 7

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), J Boeddinghaus (Basel,CH), T Nestelberger (Basel,CH), M Rubini Gimenez (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 , J. Boeddinghaus1 , T. Nestelberger1 , M. Rubini Gimenez1 , 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 ), 1368-1369

Background: The European Society of Cardiology suggests the use of a 0/1h-algorithm for rapid rule-out and rule-in of acute myocardial infarction (AMI) based on high-sensitivity cardiac troponin (hs-cTn).

Purpose: We aimed to derive and validate a new 0/1h-algorithm for a novel ultra-sensitive cTnI assay, providing 10x higher analytical performance compared to hs-cTnT/I.

Methods: In a prospective international multicentre diagnostic study enrolling patients presenting with suspected AMI to the ED, us-cTnI was determined at baseline and after one hour using Singulex Clarity us-cTnI. Patients presenting with STEMI were excluded. The final diagnosis was centrally adjudicated by two independent cardiologists using all available data including coronary angiography, echocardiography, follow-up data, and serial measurements of hs-cTnT (but not hs-cTnI). The us-cTnI 0/1h-algorithm, incorporating measurements performed at baseline and absolute changes within 1 hour, was derived in a randomly selected sample of 987 patients (derivation sample) using classification and regression tree (CART) analysis, and then validated in the remaining 987 patients (validation sample).

Results: AMI was the final diagnosis in 17% of the 1974 recruited patients. After applying the us-cTnI 0/1h-algorithm developed in the derivation cohort to the validation cohort, 56% of patients could be classified as “rule-out”, 16% as “rule-in”, and 29% as “observe” (Figure 1). Direct rule-out based on the baseline us-cTnI-concentration was feasible in 23%. In the validation cohort, the derived rule-out strategy resulted in a negative predictive value for AMI of 99.6% (95% confidence interval (CI), 98.6–99.9%) and a sensitivity of 98.8% (95% CI, 95.9–99.9%) while the derived rule-in strategy resulted in a positive predictive value for AMI of 79.7% (95% CI, 73.3–84.9%) and a specificity of 96.2% (95% CI, 94.6–97.4%).

Conclusion: Using a simple algorithm incorporating baseline us-cTnI concentrations and their absolute changes within the first hour, measured with a novel us-cTnI assay, allows very safe rule-out as well as accurate rule-in of AMI in more than two patients out of three presenting with suspected AMI.

Figure 1

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