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  1. Multicenter evaluation of a 1h-algorithm in the diagnosis of myocardial infarction using high-sensitivity cardiac Troponin T Christian Mueller, EvangelosGiannitsis, 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, BertilLindahl, for the TRAPID-AMI Investigators High sensitivity cardiac Troponin T assay for RAPID rule-out of Acute Myocardial Infarction Sponsoredby

  2. Disclosures Swiss National Science Foundation . . ..

  3. 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

  4. 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

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

  6. 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

  7. APACE: 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%) Prevalenceof AMI 9% Aimof TRAPID-AMI: toprospectivelyvalidatethehs-cTnT 1h-algorithm Reichlin T, et al. Arch Intern Med 2012

  8. 12 sites on 3 continents

  9. 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

  10. 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

  11. Results

  12. Results 95% CI 98.2-99.7% 95% CI 70.4-83.0%

  13. Subgroups:

  14. Results 0.1%

  15. 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

  16. 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.