Sex-specific effects of implementing a high-sensitivity troponin I assay in patients with suspected acute coronary syndrome: results from SWEDEHEART registry
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Key result
Implementation of a high-sensitivity troponin I assay with sex-specific thresholds increased the incidence of acute myocardial infarction diagnosis but did not significantly reduce the risk of major adverse cardiovascular events (HR 0.91, 95% CI 0.80-1.03).
Why the study?
Using hs-cTn assays with sex-specific 99th percentiles may improve management of patients with suspected AMI, but the impact of transitioning from conventional assays required investigation.
Does implementing a high-sensitivity troponin I assay with sex-specific thresholds improve clinical management and reduce major adverse cardiovascular events in patients with suspected acute coronary syndrome?
Population
Patients with suspected ACS admitted to Swedish coronary care units (females, n = 4,819/males, n = 7,670)
Comparison
Periods before vs after implementation of hs-cTnI assay using sex-specific 99th percentiles
Design
Registry-based observational study
Authors
Discussion
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Member takes
Implication
Adoption of sex-specific hs-cTnI thresholds raised AMI diagnoses without improving management or prognosis; leaves open net clinical benefit in routine care.
Study Design
Type
Observational (n=12,489)
Multicenter
Yes
Structured PICO
Does implementing a high-sensitivity troponin I assay with sex-specific thresholds improve clinical management and reduce major adverse cardiovascular events in patients with suspected acute coronary syndrome?
P
Population
12,489 patients (39% female) with suspected acute coronary syndrome admitted to Swedish coronary care units, comparing periods before and after implementation of a high-sensitivity troponin I assay.
E
Exposure
Implementation of high-sensitivity cardiac troponin I (hs-cTnI) assay with sex-specific 99th percentiles (female 16 ng/L, male 34 ng/L).
C
Comparator
Historical control period using conventional cardiac troponin (cTn) assays.
O
Outcome
Composite of major adverse cardiovascular events (MACE: all-cause mortality, readmissions for non-fatal AMI, heart failure, and ischemic stroke).composite
Main Result
Hazard Ratio: 0.91 (95% CI 0.8–1.03)
Absolute Event Rate: 8.9% vs 6.6%
p-value: p=0.126
Implementing a high-sensitivity troponin I assay with sex-specific thresholds increased AMI diagnoses but did not significantly alter clinical management or reduce major adverse cardiovascular events.
Limitations
- Only the hs-cTnI assay from Abbott was studied, limiting generalizability to other assays.
- Observational design makes it difficult to separate the effects of changing to a high-sensitivity assay from the use of sex-specific thresholds.
- Selection bias may be present as patients with troponin levels above the AMI threshold determined with the high-sensitivity assay are enriched with less sick patients.
- Generalization to emergency department patients should be done with caution as the study focused on CCU admissions.
- Potential sex referral bias at the cardiac emergency unit.
- Only peak troponin levels were registered, preventing investigation of temporal troponin changes.
- No standardized rule-in/rule-out algorithm for diagnosis of AMI was applied across hospitals.
- Difficult to disentangle the degree to which introduction of sex-specific thresholds versus lowering diagnostic threshold to 99th percentile contributed to changes
- Temporal management trends may explain divergence between periods rather than the assay itself
Cite This Study
Kimenai et al. (2020) conducted an observational in Suspected acute coronary syndrome (n=12,489). High-sensitivity cardiac troponin I (hs-cTnI) assay with sex-specific thresholds vs. Conventional cardiac troponin (cTn) assay was evaluated on Major adverse cardiovascular events (MACE) (HR 0.91, 95% CI 0.80-1.03, p=0.126). Implementation of a high-sensitivity troponin I assay with sex-specific thresholds increased the incidence of acute myocardial infarction diagnosis but did not significantly reduce the risk of major adverse cardiovascular events (HR 0.91, 95% CI 0.80-1.03).
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