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Silvia Valbuena LópezHiSTORIC Trial
HIGH SENSITIVITY CARDIAC TROPONIN
AT PRESENTATION TO RULE-OUT
MYOCARDIAL INFARCTION (HISTORIC):
A STEPPED-WEDGE CLUSTER-
RANDOMIZED CONTROLLED TRIAL
Silvia Valbuena LópezHiSTORIC Trial
BACKGROUND
• New hsTn test offer an oportunity to improve diagnosis in patients with chest pain
• High sensitivity troponins are now measurable in the majority of men and women
• Diagnosis thereshold and algorhythms need to be optimized and prospectively tested
• The main strength of hsTn is to rule MI out, rather tan to rule it in
Silvia Valbuena López
METHODS
HiSTORIC Trial
Silvia Valbuena López
METHODS
HiSTORIC Trial
Silvia Valbuena López
METHODS
HiSTORIC Trial
• Aim  to evaluate the safety and efficacy of implementing the High-STEACS early rule-out pathway
in consecutive patients with suspected ACS
• 1 year follow-up
• Multicenter, prospective, randomized. Pragmatic design
Standard of care  rule-out if hs-TnI <99th centile at presentation (>6h) or serial testing after 6-12h
Silvia Valbuena López
METHODS
HiSTORIC Trial
• Coprimary endpoints
- Length of stay (efficacy)
- MI or cardiac death 30 days after discharge (safety)
• Secondary efficacy endpoint  proportion discharged from emergency
department
• Secondary safety endpoint after 1 year  MI, cardiac death, all-cause death,
unplanned revascularization, re-attendance for any reason
Silvia Valbuena López
RESULTS
HiSTORIC Trial
Silvia Valbuena López
RESULTS
HiSTORIC Trial
Silvia Valbuena López
RESULTS
HiSTORIC Trial
No increase in adverse events at 30 days or 1 year
Silvia Valbuena López
LIMITATIONS
HiSTORIC Trial
• High rate of reattendance and high rate of all-cause death ???
• Standard of care protocol indicates repeating hsTnI after 6-12h  artificial
prolongation of emergency department stay
Silvia Valbuena López
CONCLUSIONS
HiSTORIC Trial
• En una amplia cohorte de pacientes consecutivos el estudio demostró que una vía de
early rule-out, basada en un doble umbral de riesgo, no sólo es más eficaz si no también
segura
• Su implementación redujo el tiempo de estancia en urgencias y aumentó la proporción de
pacientes dados de alta desde urgencias
• Todo ello sin observase un aumento en los eventos adversos ni a los 30 días ni al año

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HiSTORIC Trial

  • 1. Silvia Valbuena LópezHiSTORIC Trial HIGH SENSITIVITY CARDIAC TROPONIN AT PRESENTATION TO RULE-OUT MYOCARDIAL INFARCTION (HISTORIC): A STEPPED-WEDGE CLUSTER- RANDOMIZED CONTROLLED TRIAL
  • 2. Silvia Valbuena LópezHiSTORIC Trial BACKGROUND • New hsTn test offer an oportunity to improve diagnosis in patients with chest pain • High sensitivity troponins are now measurable in the majority of men and women • Diagnosis thereshold and algorhythms need to be optimized and prospectively tested • The main strength of hsTn is to rule MI out, rather tan to rule it in
  • 5. Silvia Valbuena López METHODS HiSTORIC Trial • Aim  to evaluate the safety and efficacy of implementing the High-STEACS early rule-out pathway in consecutive patients with suspected ACS • 1 year follow-up • Multicenter, prospective, randomized. Pragmatic design Standard of care  rule-out if hs-TnI <99th centile at presentation (>6h) or serial testing after 6-12h
  • 6. Silvia Valbuena López METHODS HiSTORIC Trial • Coprimary endpoints - Length of stay (efficacy) - MI or cardiac death 30 days after discharge (safety) • Secondary efficacy endpoint  proportion discharged from emergency department • Secondary safety endpoint after 1 year  MI, cardiac death, all-cause death, unplanned revascularization, re-attendance for any reason
  • 9. Silvia Valbuena López RESULTS HiSTORIC Trial No increase in adverse events at 30 days or 1 year
  • 10. Silvia Valbuena López LIMITATIONS HiSTORIC Trial • High rate of reattendance and high rate of all-cause death ??? • Standard of care protocol indicates repeating hsTnI after 6-12h  artificial prolongation of emergency department stay
  • 11. Silvia Valbuena López CONCLUSIONS HiSTORIC Trial • En una amplia cohorte de pacientes consecutivos el estudio demostró que una vía de early rule-out, basada en un doble umbral de riesgo, no sólo es más eficaz si no también segura • Su implementación redujo el tiempo de estancia en urgencias y aumentó la proporción de pacientes dados de alta desde urgencias • Todo ello sin observase un aumento en los eventos adversos ni a los 30 días ni al año