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.

The evaluation of patients with suspected myocardial infarction relies on serial measurements of high-sensitivity cardiac troponin. We aimed to evaluate the safety and efficacy of implementing the guideline-recommended 0/1 h pathway, compared with a 0/3 h pathway, in hospitals that had not yet adopted the newer strategy. PRESC1SE-MI was an international, pragmatic, stepped-wedge, cluster-randomised, controlled, masked-endpoint trial at 19 hospitals in ten countries. The study included consecutive adults presenting to the emergency department with acute non-traumatic chest discomfort and suspected myocardial infarction. Hospitals using a 0/3 h pathway (blood draws at 0 h and 3 h) as standard care were randomly allocated to implement the 0/1 h pathway (blood draws at 0 h and 1 h) after 6 months (early implementation) or 12 months (late implementation). The trial was designed to test the non-inferiority of the 0/1 h pathway for safety and its superiority for efficacy. The non-inferiority margin was set at an odds ratio of 1·3. Analyses were done in the full analysis set. The coprimary safety outcome was a composite of death from any cause or new type 1 myocardial infarction within 30 days, and the coprimary efficacy outcome was emergency department length of stay. This trial is registered with ClinicalTrials.gov, NCT05649384, and is active but no longer enrolling. Between Dec 1, 2020, and Dec 31, 2024, 71 983 consecutive patient presentations were screened, of which 67 624 (93·9%) met the eligibility criteria and comprised the full analysis set. Median age was 59 years (IQR 46-73); 29 954 (44·3%) patient presentations were in female patients and 37 670 (55·7%) were in male patients. 13 753 (22·2%) of 62 060 patient presentations with available data were in patients with known coronary artery disease, and 5855 (8·7%) patient presentations had an adjudicated index diagnosis of myocardial infarction. Overall, 36 464 patient presentations were managed with a 0/3 h pathway and 31 160 with the 0/1 h pathway. Death from any cause or new type 1 myocardial infarction occurred in 454 (1·2%) patient presentations in the 0/3 h group and in 341 (1·1%) patient presentations in the 0/1 h group (adjusted odds ratio 0·93 [95% CI 0·77-1·13]; p non-inferiority =0·0004). The median emergency department length of stay was 309 min (IQR 203-470) in the 0/3 h pathway and 309 min (207-474) in the 0/1 h pathway (ratio of adjusted median times 1·00 [95% CI 0·97-1·02]; two-sided p=0·65). 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. In this setting, implementation of the 0/1 h pathway alone should therefore not be expected to improve emergency department throughput. Swiss National Science Foundation, Swiss Heart Foundation, University Hospital Basel, University of Basel, Foundation for Cardiovascular Research Basel, Fondazione Ricerca Molinette, Idorsia, and Roche.