- Design
- Pragmatic randomised non-inferiority implementation trial
- Population
- 3,543 adults with suspected acute coronary syndrome in two emergency departments
- Primary outcome
- Discharge within four hours; 30-day major adverse cardiac events for safety
- Effect
- Discharge 21.8% vs 19.2% (p=0.07); sensitivity 93.7% vs 89.5%, non-inferior
MACROS2 randomised 3,543 patients with suspected acute coronary syndrome at two North-West England emergency departments to the European Society of Cardiology 0/1-hour high-sensitivity troponin pathway or a 0/3-hour pathway, with an independent assay used for adjudication.
The faster pathway did not translate into faster discharge: 21.8% of patients left within four hours on the 0/1-hour pathway against 19.2% on 0/3-hour, not a significant difference. The 0/1-hour pathway was non-inferior for safety, with a sensitivity of 93.7% against 89.5%, but both pathways were less safe than observational studies had suggested. Laboratory turnaround of about 81 minutes and system constraints absorbed the theoretical time saving.
The lesson is operational. A shorter sampling interval only helps if the laboratory and the department can act on the earlier result; where turnaround is slow, moving to 0/1-hour sampling alone will not clear the department faster.
- Pragmatic randomised trial of 3,543 patients with suspected ACS across two emergency departments.
- Discharge within four hours was similar: 21.8% with 0/1-hour versus 19.2% with 0/3-hour (not significant).
- The 0/1-hour pathway was non-inferior for safety (sensitivity 93.7% versus 89.5%).
- Both pathways were less safe than earlier observational data implied.
- Laboratory turnaround of about 81 minutes was the main bottleneck, not the sampling interval.
Why it matters
The efficiency case for 0/1-hour sampling rests on fast turnaround that many real departments do not have.
The statistics, in plain English
Non-inferiority here means the 0/1-hour pathway was no worse than 0/3-hour within a pre-set 3% margin, not that it was better. A sensitivity of 93.7% means roughly 6 in 100 true events were missed at discharge, a reminder that neither pathway is perfectly safe.
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