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Randomized Controlled Trial
. 2023 Nov 27:383:e075009.
doi: 10.1136/bmj-2023-075009.

Implementation of a high sensitivity cardiac troponin I assay and risk of myocardial infarction or death at five years: observational analysis of a stepped wedge, cluster randomised controlled trial

Kuan Ken Lee  1 , Dimitrios Doudesis  1   2 , Amy V Ferry  1 , Andrew R Chapman  1 , Dorien M Kimenai  1 , Takeshi Fujisawa  1 , Anda Bularga  1 , Matthew T H Lowry  1 , Caelan Taggart  1 , Stacey Schulberg  1 , Ryan Wereski  1 , Chris Tuck  1 , Fiona E Strachan  2 , David E Newby  1 , Atul Anand  1 , Anoop S V Shah  1   3 , Nicholas L Mills  4   2 ; High-STEACS Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Implementation of a high sensitivity cardiac troponin I assay and risk of myocardial infarction or death at five years: observational analysis of a stepped wedge, cluster randomised controlled trial

Kuan Ken Lee et al. BMJ. .

Abstract

Objective: To evaluate the impact of implementing a high sensitivity assay for cardiac troponin I on long term outcomes in patients with suspected acute coronary syndrome.

Design: Secondary observational analysis of a stepped wedge, cluster randomised controlled trial.

Setting: 10 secondary and tertiary care centres in Scotland, UK.

Participants: 48 282 consecutive patients with suspected acute coronary syndrome. Myocardial injury was defined as any high sensitivity assay result for cardiac troponin I >99th centile of 16 ng/L in women and 34 ng/L in men.

Intervention: Hospital sites were randomly allocated to either 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 measure: The main outcome was myocardial infarction or death at five years.

Results: 10 360 patients had cardiac troponin concentrations greater than the 99th centile, of whom 1771 (17.1%) were reclassified by the high sensitivity assay. The five year incidence of subsequent myocardial infarction or death before and after implementation of the high sensitivity assay was 29.4% (5588/18 978) v 25.9% (7591/29 304), respectively, in all patients (adjusted hazard ratio 0.97, 95% confidence interval 0.93 to 1.01), and 63.0% (456/720) v 53.9% (567/1051), respectively, in those reclassified by the high sensitivity assay (0.82, 0.72 to 0.94). After implementation of the high sensitivity assay, a reduction in subsequent myocardial infarction or death was observed in patients with non-ischaemic myocardial injury (0.83, 0.75 to 0.91) but not in those with type 1 or type 2 myocardial infarction (0.92, 0.83 to 1.01 and 0.98, 0.84 to 1.14).

Conclusions: Implementation of a high sensitivity cardiac troponin I assay in the assessment of patients with suspected acute coronary syndrome was associated with a reduced risk of subsequent myocardial infarction or death at five years in those reclassified by the high sensitivity assay. Improvements in outcome were greatest in patients with non-ischaemic myocardial injury, suggesting a broader benefit beyond the identification of myocardial infarction.

Trial registration: ClinicalTrials.gov NCT01852123.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: this study was supported by the British Heart Foundation.; KKL has received honorariums from Abbott Diagnostics; ASVS has received speaker fees from Abbott Diagnostics; and NLM has received honorariums or consultancy fees from Abbott Diagnostics, Roche Diagnostics, Siemens Healthineers, LumiraDx, and Psyros Diagnostics. All other authors declare no financial relationships with any organisations that might have an interest in the submitted work in the previous three years and no other relationships or activities that could appear to have influenced the submitted work.

Figures

Fig 1
Fig 1
Outcomes at five years in all patients before and after implementation of a high sensitivity cardiac troponin I assay. Forest plot shows the number (percentage) of patients in the standard care and implementation phases, and the hazard ratios for implementation versus standard care for the primary and secondary outcomes adjusted for hospital site, season, age, sex, and comorbidities (diabetes mellitus, previous myocardial infarction, and previous cerebrovascular disease). Whiskers represent 95% confidence intervals
Fig 2
Fig 2
Cumulative incidence of myocardial infarction or all cause death in all patients stratified by index diagnosis of type 1 myocardial infarction (log rank test P=0.006), type 2 myocardial infarction (log rank test P=0.70), and non-ischaemic myocardial injury (log rank test P<0.001) during standard care and following implementation of a high sensitivity cardiac troponin I assay
See this image and copyright information in PMC

Comment in

References

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