for the TRAPID-AMI Investigators

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Presentation transcript:

for the TRAPID-AMI Investigators 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 Sponsored by 1

Disclosures Swiss National Science Foundation . ..

Background: Early diagnosis of AMI 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 Einthoven aus Holland Nobelpreis für Physiologie und Medizin 1924

Background: Early diagnosis of AMI 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 Einthoven aus Holland Nobelpreis für Physiologie und Medizin 1924

Rule-in Rule-out 0h 1h 2h 3h 4h 5h 6h 7h ECG cTn cTn ESC 2011: hs-cTn hs-cTn TRAPID-AMI: hs-cTnT hs-cTnT

APACE: hs-cTnT 1h-algorithm Mmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmm 600 pts NPV 100% 95% CI 99-100% 150 pts PPV 76% 95% CI 69-82% Reichlin T, et al. Arch Intern Med 2012

APACE: hs-cTnT 1h-algorithm 491 Patients (56%) NPV 100% 95% CI 99-100% 212 Patients (24%) Prevalence of AMI 9% 169 Patients (19%) PPV 76% 95% CI 69-82% Aim of TRAPID-AMI: to prospectively validate the hs-cTnT 1h-algorithm Reichlin T, et al. Arch Intern Med 2012

12 sites on 3 continents

Methods II 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 Einthoven aus Holland Nobelpreis für Physiologie und Medizin 1924

Methods III 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 Einthoven aus Holland Nobelpreis für Physiologie und Medizin 1924

Results Einthoven aus Holland Nobelpreis für Physiologie und Medizin 1924

Einthoven aus Holland Nobelpreis für Physiologie und Medizin 1924

Results 95% CI 98.2-99.7% 95% CI 70.4-83.0% Einthoven aus Holland Nobelpreis für Physiologie und Medizin 1924 95% CI 98.2-99.7% 95% CI 70.4-83.0%

Subgroups: Einthoven aus Holland Nobelpreis für Physiologie und Medizin 1924

Results 0.1% Einthoven aus Holland Nobelpreis für Physiologie und Medizin 1924 0.1%

Limitations 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 Einthoven aus Holland Nobelpreis für Physiologie und Medizin 1924

Conclusions 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. Einthoven aus Holland Nobelpreis für Physiologie und Medizin 1924