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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
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