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Multicenter evaluation of a 1h-algorithm in the diagnosis of myocardial infarction using
high-sensitivity cardiac Troponin T
Christian Mueller, Evangelos Giannitsis, Michael Christ, Jorge Ordóñez-Llanos, Christopher R. deFilippi, James K. McCord, Richard Body, Mauro Panteghini, Tomas Jernberg, Mario Plebani, Franck Verschuren, John K.
French, Robert H. Christenson, Silvia Weiser, Garnet Bendig, Peter Dilba, Bertil Lindahl,
for the TRAPID-AMI Investigators
High sensitivity cardiac Troponin T assay for RAPID rule-out of Acute Myocardial Infarction
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Disclosures
• Swiss National Science Foundation
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• Critical for timely initiation of evidence based therapies, but still an unmet need in many patients
• Delayed “rule-in” morbidity + mortality
• Delayed “rule-out” time in ED + costs patient anxiety
• 3 key tools: History incl. chest pain characteristics
ECG
cTn
Background: Early diagnosis of AMI
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• Critical for timely initiation of evidence based therapies, but still an unmet need in many patients
• Delayed “rule-in” morbidity + mortality
• Delayed “rule-out” time in ED + costs patient anxiety
• 3 key tools: History incl. chest pain characteristics
ECG
hs-cTn
Background: Early diagnosis of AMI
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0h 1h 2h 3h 4h 5h 6h 7h
ECG
1.Rule-in
2.Rule-out
cTn cTn
ESC 2011: hs-cTn hs-cTn
TRAPID-AMI: hs-cTnT hs-cTnT
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APACE: hs-cTnT 1h-algorithm
Reichlin T, et al. Arch Intern Med 2012
600 ptsNPV 100%95% CI 99-100%
150 ptsPPV 76%95% CI 69-82%
Mmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmm
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APACE: hs-cTnT 1h-algorithm
Reichlin T, et al. Arch Intern Med 2012
Aim of TRAPID-AMI: to prospectively validate the hs-cTnT 1h-algorithm
491 Patients (56%)NPV 100%95% CI 99-100%
169 Patients (19%)PPV 76%95% CI 69-82%
212 Patients (24%)Prevalence of AMI 9%
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12 sites on 3 continents
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• TRAPID-AMI ≈ APACE
• Prospective diagnostic study in the ED
• Inclusion: acute chest pain suggestive of AMI
onset < 6h (<12h in APACE)
written informed consent
First blood draw <45min since presentation
• Exclusion: terminal kidney failure on dialysis
Trauma
DC or defibrillation prior to inclusion
CABG <1month or AMI <3 weeks
• Blinded measurement of hs-cTnT at 0h+1h
Methods II
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• Final diagnosis: central adjudication by two independent cardiologists according to the universial definition of MI using all information including serial cTnI-ultra (hs-cTnT in APACE)
• Primary endpoint: NPV for AMI
• Secondary endpoints: PPV for AMI, ….
• Follow-up: 30d mortality
• Sample size calculation: based on APACE
761 patients in rule-out zone, 1233 patients overall
Methods III
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Results
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Results
95% CI 98.2-99.7% 95% CI 70.4-83.0%
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Subgroups:
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Results
0.1%
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• ED patients vs general practitioner (pre-test probability)
• Observational diagnostic study. Physicians were blinded to the investigational hs-cTnT results and patients were not managed based on these results.
• May underestimate the true NPV of the hs-cTnT 1h-algo due to enrichment with early presenters
• Performance in patients on dialysis is unknown
Limitations
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• The hs-cTnT 1h-algorithm performs well for early rule-out as well as rule-in of AMI.
• Effectiveness (% rule-out/in) and safety (NPV & 30d-mortality in rule-out, PPV in rule-in ≈ APACE.
• Clinical implication: Used in conjunction with all other clinical information including ECG, the hs-cTnT 1h-algorithm will be a safe and effective approach to substantially reduce time to diagnosis in ≈75% of acute chest pain patients.
Conclusions