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Validation of a novel high-sensitivity cardiac troponin i assay for early diagnosis of acute myocardial infarction
Authors : J Boeddinghaus (Basel,CH), R Twerenbold (Basel,CH), T Nestelberger (Basel,CH), L Koechlin (Basel,CH), D Wussler (Basel,CH), K Wildi (Basel,CH), C Puelacher (Basel,CH), J Du Fay De Lavallaz (Basel,CH), M Rubini Gimenez (Basel,CH), JE Walter (Basel,CH), T Zimmermann (Basel,CH), O Miro (Barcelona,ES), FJ Martin-Sanchez (Madrid,ES), DI Keller (Zurich,CH), C Mueller (Basel,CH)
J. Boeddinghaus1
,
R. Twerenbold1
,
T. Nestelberger1
,
L. Koechlin1
,
D. Wussler1
,
K. Wildi1
,
C. Puelacher1
,
J. Du Fay De Lavallaz1
,
M. Rubini Gimenez1
,
J.E. Walter1
,
T. Zimmermann1
,
O. Miro2
,
F.J. Martin-Sanchez3
,
D.I. Keller4
,
C. Mueller1
,
1University Hospital Basel, Cardiovascular Research Institute Basel (CRIB) - Basel - Switzerland
,
2Hospital Clinic de Barcelona, Emergency Department - Barcelona - Spain
,
3Hospital Clinic San Carlos, Emergency Department - Madrid - Spain
,
4University Hospital Zurich, Emergency Department - Zurich - Switzerland
,
On behalf: Advantageous Predictors of Acute Coronary Syndrome Evaluation (APACE)
Background: The novel high-sensitivity cardiac troponin I (hs-cTnI)-Vitros assay was developed recently. Before its possible implementation into routine clinical care for triage of chest pain patients, its performance needs clinical validation.
Purpose: To clinically validate hs-cTnI-Vitros and to derive and validate an assay-specific 0/1h-algorithm following the European Society of Cardiology (ESC) recommendations.
Methods: In a prospective international multicentre study (12 centres in 5 European countries) we enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI). Final diagnoses were centrally adjudicated by two independent cardiologists including all clinical information including cardiac imaging twice: first, using serial hs-cTnT (Elecsys, primary analysis) and second, using hs-cTnI (Architect, secondary analysis) measurements in addition to the clinically used (hs)-cTn. Hs-cTnI-Vitros was measured at presentation and at 1h in a blinded fashion. Primary objective was direct comparison of diagnostic accuracy as quantified by the area under the receiver-operating-characteristic curve (AUC) of hs-cTnI-Vitros versus the two established hs-cTn assays (hs-cTnT-Elecsys, hs-cTnI-Architect). Secondary objectives included the derivation and validation of a hs-cTnI-Vitros specific 0/1h-algorithm.
Results: AMI was the adjudicated final diagnosis in 158/1231 (13%) patients. The AUC at presentation for hs-cTnI-Vitros was 0.95 (95% CI, 0.93–0.96), and significantly higher as hs-cTnT-Elecsys (0.94 [95% CI, 0.92–0.95; p=0.01]) and hs-cTnI-Architect (0.92 [95% CI, 0.90–0.94; p<0.001]). Applying the derived hs-cTnI-Vitros 0/1h-algorithm (derivation cohort n=519) to the validation cohort (n=520), 53% of patients were ruled-out (sensitivity 100% [95% CI, 98.6–100]), and 14% of patients were ruled-in (specificity 95.6% [95% CI, 93.4–97.2]). Patients ruled-out by the 0/1h-algorithm had a survival rate of 99.8% at 30-days and 98.7% at 2-years. Findings were confirmed in the secondary analyses using the adjudication including serial measurements of hs-cTnI (Architect).
Conclusions: The novel hs-cTnI-Vitros assay has even higher diagnostic accuracy as the current gold-standards hs-cTnT and hs-cTnI. The hs-cTnI-Vitros specific 0/1h-algorithms allows a safe rule-out and accurate rule-in of AMI in about 70% of patients within 1h after presentation to the ED.
In line with the ESC mission, newly presented content is made available to all for a limited time (4 months for ESC Congress, 3 months for other events). ESC Professional Members, Association Members (Ivory & above) benefit from year-round access to all the resources from their respective Association, and to all content from previous years. Fellows of the ESC (FESC), and Professionals in training or under 40 years old, who subscribed to a Young Combined Membership package benefit from access to all ESC 365 content from all events, all editions, all year long. Find out more about ESC Memberships here.
ESC 365 is supported by Bayer, Boehringer Ingelheim and Lilly Alliance, Bristol-Myers Squibb and Pfizer Alliance, Novartis Pharma AG and Vifor Pharma in the form of educational grants. The sponsors were not involved in the development of this platform and had no influence on its content.
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