Implementation of high-sensitivity cardiac troponin assays and Universal Definition recommendations did not change the rate of myocardial infarction or cardiovascular death (HR 1.00; 95% CI 0.82-1.21).
RCT (n=48,282)
stepped-wedge cluster
Does the implementation of high-sensitivity cardiac troponin assays and the Universal Definition of Myocardial Infarction improve clinical outcomes in patients with suspected acute coronary syndrome?
Implementing high-sensitivity troponin assays increases the detection of myocardial injury and infarction but does not necessarily improve clinical outcomes or significantly change management.
Hazard Ratio: 1 (95% CI 0.82–1.21)
BACKGROUND: The introduction of more sensitive cardiac troponin assays has led to increased recognition of myocardial injury in acute illnesses other than acute coronary syndrome. The Universal Definition of Myocardial Infarction recommends high-sensitivity cardiac troponin testing and classification of patients with myocardial injury based on pathogenesis, but the clinical implications of implementing this guideline are not well understood. METHODS: In a stepped-wedge cluster randomized, controlled trial, we implemented a high-sensitivity cardiac troponin assay and the recommendations of the Universal Definition in 48 282 consecutive patients with suspected acute coronary syndrome. In a prespecified secondary analysis, we compared the primary outcome of myocardial infarction or cardiovascular death and secondary outcome of noncardiovascular death at 1 year across diagnostic categories. RESULTS: Implementation increased the diagnosis of type 1 myocardial infarction by 11% (510/4471), type 2 myocardial infarction by 22% (205/916), and acute and chronic myocardial injury by 36% (443/1233) and 43% (389/898), respectively. Compared with those without myocardial injury, the rate of the primary outcome was highest in those with type 1 myocardial infarction (cause-specific hazard ratio HR 5.64 95% CI, 5.12-6.22), but was similar across diagnostic categories, whereas noncardiovascular deaths were highest in those with acute myocardial injury (cause specific HR 2.65 95% CI, 2.33-3.01). Despite modest increases in antiplatelet therapy and coronary revascularization after implementation in patients with type 1 myocardial infarction, the primary outcome was unchanged (cause specific HR 1.00 95% CI, 0.82-1.21). Increased recognition of type 2 myocardial infarction and myocardial injury did not lead to changes in investigation, treatment or outcomes. CONCLUSIONS: Implementation of high-sensitivity cardiac troponin assays and the recommendations of the Universal Definition of Myocardial Infarction identified patients at high-risk of cardiovascular and noncardiovascular events but was not associated with consistent increases in treatment or improved outcomes. Trials of secondary prevention are urgently required to determine whether this risk is modifiable in patients without type 1 myocardial infarction. CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.gov. Unique identifier: NCT01852123.
Chapman et al. (Mon,) conducted a rct in suspected acute coronary syndrome (n=48,282). High-sensitivity cardiac troponin assay and Universal Definition recommendations vs. Pre-implementation was evaluated on Myocardial infarction or cardiovascular death (HR 1.00, 95% CI 0.82-1.21). Implementation of high-sensitivity cardiac troponin assays and Universal Definition recommendations did not change the rate of myocardial infarction or cardiovascular death (HR 1.00; 95% CI 0.82-1.21).