PRospective Evaluation of the European Society of Cardiology 0/1-hour Algorithm's Safety and Efficacy for Triage of Patients With Suspected Myocardial Infarction (PRESC1SE-MI)

doi:10.1016/s0140-6736(26)01654-5

PRESC1SE-MI

Paziente / Popolazione Intervento / Esposizione Confronto Esito

In 67,624 emergency presentations with suspected myocardial infarction, the ESC 0/1-hour troponin algorithm was non-inferior to the 0/3-hour algorithm for death or type 1 myocardial infarction at 30 days, and length of stay.

N

67.624pazienti

Disegno

International, investigator-initiated, pragmatic, stepped-wedge, cluster-randomised, controlled trial with masked (blinded) endpoint adjudication at 19 hospitals in ten countries; hospitals using the ESC 0/3-hour pathway (blood draws 0 h and 3 h) as standard care were randomised to implement the ESC 0/1-hour pathway (blood draws 0 h and 1 h) after 6 months (early implementation) or 12 months (late implementation); consecutive adults with acute non-traumatic chest discomfort and suspected myocardial infarction enrolled Dec 1, 2020–Dec 31, 2024; 30-day follow-up; non-inferiority for safety (margin OR 1.3) and superiority for efficacy; full analysis set

Esito

Co-primary — (1) composite of all-cause death or type 1 myocardial infarction within 30 days of the index presentation (safety); (2) length of stay in the emergency department, from presentation to discharge or transfer (efficacy)

Rilevanza

2Importante — uno dei diversi pilastri.

RisultatoSafety: death from any cause or new type 1 myocardial infarction within 30 days in 454/36 464 (1.2%) with the 0/3-hour pathway vs 341/31 160 (1.1%) with the 0/1-hour pathway (adjusted OR 0.93, 95% CI 0.77-1.13; p = 0.0004 for non-inferiority, margin OR 1.3). Efficacy: median emergency department length of stay 309 min (IQR 203-470) vs 309 min (207-474); ratio of adjusted median times 1.00 (95% CI 0.97-1.02), two-sided p = 0.65 — non-inferior for safety, no reduction in length of stay.

Boeddinghaus J, Bima P, Crisanti L, et al. 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. 2026; published online Aug 29. doi:10.1016/S0140-6736(26)01654-5 10.1016/s0140-6736(26)01654-5

Discussione e critica

The 0/1-hour algorithm is safe in hospitals that had not yet adopted it — and it saves no time. The second troponin arrived two hours earlier and the patient still left the department at the same minute, which locates the bottleneck downstream of the diagnosis: staffing, beds, local workflow. Two findings deserve caution rather than a headline: new type 1 infarction was more frequent on the fast pathway (OR 1.55) while death was less frequent (OR 0.84), a divergence the investigators themselves call unexplained, and the event rate came in at 1.2% against the 3% assumed, so the safety margin rests on fewer events than planned.