High-sensitivity cardiac troponin (hs-cTn) assays are central to accelerated diagnostic pathways (ADPs) for suspected acute coronary syndrome (ACS), with current guidelines favoring 0/1-hour algorithms over traditional 0/3-hour strategies despite limited randomized implementation data. A pragmatic randomized implementation trial published in the Journal of the American College of Cardiology compared the efficiency and safety of the European Society of Cardiology (ESC) 0/1-hour pathway with a 0/3-hour hs-cTn pathway in patients presenting with suspected ACS.
The study enrolled adults presenting with suspected ACS to two major emergency departments in North-West England. The primary efficiency endpoint was the proportion of patients discharged within 4 hours of presentation. The primary safety endpoint was 30-day major adverse cardiac events (MACE), including type 1 myocardial infarction, cardiovascular death, and urgent coronary revascularization among patients discharged without ACS.
Findings
- Among 13,983 screened patients, 3,543 patients with suspected ACS were enrolled and randomized.
- Median turnaround time for central laboratory hs-cTnT results was 81 minutes (IQR: 69-101 minutes).
- The proportion of patients discharged within 4 hours did not differ significantly between the 0/1-hour and 0/3-hour pathways (21.8% vs 19.2%; p = 0.07).
- The ESC 0/1-hour pathway met criteria for noninferior safety compared with the 0/3-hour pathway.
- The absolute difference in sensitivity was +4.2% in favor of the 0/1-hour pathway (1-sided 97.5% CI: −2.5).
- Sensitivity for 30-day safety outcomes was 93.7% (95% CI: 88.4%-97.1%) for the 0/1-hour pathway and 89.5% (95% CI: 82.7%-94.3%) for the 0/3-hour pathway.
The findings suggest that the ESC 0/1-hour hs-cTn pathway did not significantly improve early discharge rates compared with the 0/3-hour strategy in real-world practice.