Coronary disease & ACSRandomised controlled trial

Safety and efficacy of the 0/1 h pathway for myocardial infarction in the emergency department: an international, pragmatic, stepped-wedge, cluster-randomised, controlled trial

LancetPublished

  • Stepped-wedge cluster-randomised controlled trial
  • international
  • pragmatic
  • masked-endpoint
  • non-inferiority (safety)
  • superiority (efficacy)
  • 19 hospitals in ten countries

Authors' conclusion

Implementation of the 0/1 h pathway met the prespecified non-inferiority criterion for the 30-day composite safety outcome but did not shorten emergency department length of stay compared with the 0/3 h pathway.

Study context

Population
Consecutive adults presenting to the ED with acute non-traumatic chest discomfort and suspected MI
Participants
67,624 patient presentations
Comparison
0/1 h vs 0/3 h high-sensitivity cardiac troponin pathway
  • 0/1 hn = 31,160
  • 0/3 hn = 36,464reference
Primary endpoint
Coprimary: safety = death from any cause or new type 1 MI within 30 days; efficacy = ED length of stay
Follow-up
30 days (safety)

Primary result

As reported in the abstract

0/1 h vs 0/3 hAdjusted odds ratio (95% CI)P value
death or new type 1 MI at 30 days
0.93(0.77–1.13)
P = 0.0004for non-inferiority
ED length of stay
ratio of adjusted median times 1.00 (95% CI 0.97–1.02); two-sided p=0.65

Original publication

Safety and efficacy of the 0/1 h pathway for myocardial infarction in the emergency department: an international, pragmatic, stepped-wedge, cluster-randomised, controlled trial. Lancet. Published 29 August 2026. doi:10.1016/s0140-6736(26)01654-5

Summarised from the published abstract; every number is checked against it