High-Sensitivity Cardiac Troponin on Presentation to Rule Out Myocardial Infarction: A Stepped-Wedge Cluster
Atul Anand1, Kuan Ken Lee1, Andrew R Chapman1
1BHF Centre for Cardiovascular Science (A.A., K.K.L., A.R.C., A.V.F., P.D.A., F.E.S., K.A.A.F., D.E.N., A.S.V.S., N.L.M.), University of Edinburgh, United Kingdom.s.
Insights
An early rule-out pathway for myocardial infarction using high-sensitivity troponin assays significantly reduced hospital stays and admissions. While 30-day safety noninferiority wasn't met, no increase in cardiac events occurred at 1 year.
Area of Science:
- Cardiology
- Emergency Medicine
- Clinical Trials
Background:
- High-sensitivity cardiac troponin assays allow earlier rule-out of myocardial infarction.
- The safety and efficacy of early rule-out strategies remain uncertain.
- Investigated an early rule-out pathway for acute coronary syndrome patients.
Purpose of the Study:
- To determine the safety and efficacy of an early rule-out pathway for myocardial infarction in patients with suspected acute coronary syndrome.
- To assess the impact on length of stay and 30-day safety outcomes (myocardial infarction or cardiac death).
Main Methods:
- Stepped-wedge cluster randomized controlled trial across 7 Scottish hospitals.
- Included 31,492 patients presenting with suspected acute coronary syndrome.
- Coprimary outcomes: length of stay and 30-day safety; 1-year follow-up for safety and secondary outcomes.
Main Results:
- Length of stay reduced from 10.1 to 6.8 hours; proportion of discharged patients increased from 50% to 71%.
- 30-day safety noninferiority was not demonstrated (P=0.068), but observed differences favored the early rule-out pathway (0.4% vs 0.3%).
- At 1 year, no significant difference in cardiac events, hospital reattendance, or all-cause mortality was observed.
Conclusions:
- Early rule-out pathway for myocardial infarction reduces length of stay and hospital admissions.
- No increase in cardiac events at 1 year, despite not meeting 30-day safety noninferiority.
- Adoption of this pathway offers significant benefits for patients and healthcare providers.
Background:
High-sensitivity cardiac troponin assays enable myocardial infarction to be ruled out earlier, but the safety and efficacy of this approach is uncertain. We investigated whether an early rule-out pathway is safe and effective for patients with suspected acute coronary syndrome.
Methods:
We performed a stepped-wedge cluster randomized controlled trial in the emergency departments of 7 acute care hospitals in Scotland. Consecutive patients presenting with suspected acute coronary syndrome between December 2014 and December 2016 were included. Sites were randomized to implement an early rule-out pathway where myocardial infarction was excluded if high-sensitivity cardiac troponin I concentrations were <5 ng/L at presentation. During a previous validation phase, myocardial infarction was ruled out when troponin concentrations were <99th percentile at 6 to 12 hours after symptom onset. The coprimary outcome was length of stay (efficacy) and myocardial infarction or cardiac death after discharge at 30 days (safety). Patients were followed for 1 year to evaluate safety and other secondary outcomes.
Results:
We enrolled 31 492 patients (59±17 years of age [mean±SD]; 45% women) with troponin concentrations <99th percentile at presentation. Length of stay was reduced from 10.1±4.1 to 6.8±3.9 hours (adjusted geometric mean ratio, 0.78 [95% CI, 0.73-0.83]; P<0.001) after implementation and the proportion of patients discharged increased from 50% to 71% (adjusted odds ratio, 1.59 [95% CI, 1.45-1.75]). Noninferiority was not demonstrated for the 30-day safety outcome (upper limit of 1-sided 95% CI for adjusted risk difference, 0.70% [noninferiority margin 0.50%]; P=0.068), but the observed differences favored the early rule-out pathway (0.4% [57/14 700] versus 0.3% [56/16 792]). At 1 year, the safety outcome occurred in 2.7% (396/14 700) and 1.8% (307/16 792) of patients before and after implementation (adjusted odds ratio, 1.02 [95% CI, 0.74-1.40]; P=0.894), and there were no differences in hospital reattendance or all-cause mortality.
Conclusions:
Implementation of an early rule-out pathway for myocardial infarction reduced length of stay and hospital admission. Although noninferiority for the safety outcome was not demonstrated at 30 days, there was no increase in cardiac events at 1 year. Adoption of this pathway would have major benefits for patients and health care providers. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03005158.
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