Implementation of high-sensitivity cardiac troponin and risk of myocardial infarction or death at 5 years: stepped-wedge, cluster-randomised controlled trial

Kuan Ken Lee, Dimitrios Doudesis, Amy Ferry, Andrew R Chapman, Dorien Kimenai, Takeshi Fujisawa, Anda Bulgara, Matthew Lowry, Caelan Taggart, Stacey Stewart, Ryan Wereski, Chris Tuck, Fiona Strachan, David E Newby, Atul Anand, Anoop S V Shah, Nicholas L Mills

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Abstract / Description of output

Abstract
Objective: To evaluate the impact of implementing a high-sensitivity cardiac troponin I assay on long-term outcomes in patients with suspected acute coronary syndrome
Design: Secondary observational analysis of a stepped-wedge cluster-randomised controlled trial.
Setting: Ten secondary and tertiary care centres
Participants: Consecutive patients with suspected acute coronary syndrome (n=48,282; 47% women) were included in this trial. Myocardial injury was defined as any high-sensitivity cardiac troponin I concentration >99th centile of 16 ng/L in women and 34 ng/L in men.
Intervention: Hospital sites were randomly allocated to early (n=5 hospitals) or late (n=5 hospitals) implementation of a high-sensitivity cardiac troponin I assay with sex-specific diagnostic thresholds.
Main Outcome Measures: Subsequent myocardial infarction or death at 5 years.
Results: Overall, 10,360 patients had cardiac troponin concentrations greater than the 99th centile of whom 1,771 (17%) were reclassified by the high-sensitivity assay. The 5-year incidence of subsequent myocardial infarction or death before and after implementation of the high-sensitivity assay was 29% (5,588/18,978) versus 26% (7,591/29,304), respectively, in all patients (adjusted hazard ratio [aHR] 0.97 [95% CI 0.93 to 1.01]), and 63% (456/720) versus 54% (567/1,051) in those reclassified by the high-sensitivity assay (aHR 0.82 [0.72-0.94]). Following implementation, a reduction in subsequent myocardial infarction or death was observed in patients with non-ischemic myocardial injury (aHR 0·83 [0·75-0·91]), but not in those with type 1 or type 2 myocardial infarction (aHR 0·92 [0·83-1·01] and 0·98 [0·84-1·14]).
Conclusions: In patients with suspected acute coronary syndrome, implementation of a high-sensitivity cardiac troponin assay reduced the risk of subsequent myocardial infarction or death at 5 years in those reclassified by the high-sensitivity assay. Improvements in outcome were greatest in patients with non-ischemic myocardial injury suggesting a broader benefit beyond the identification of myocardial infarction.
Original languageEnglish
JournalThe BMJ
Publication statusPublished - 27 Nov 2023

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