Article Text
Abstract
Objective Validation studies of the 2019 European Society of Cardiology pretest probability model (ESC-PTP) for coronary artery disease (CAD) report that 35%–40% of patients have low pretest probability (ESC-PTP 5% to <15%). Acoustic detection of coronary stenoses could potentially improve clinical likelihood stratification. Aims were to (1) investigate the diagnostic performance of an acoustic-based CAD score and (2) study the reclassification potential of a dual likelihood strategy by the ESC-PTP and a CAD score.
Methods Consecutive patients (n=1683) with stable angina symptoms referred for coronary CT angiography (CTA) underwent heart sound analyses by an acoustic CAD-score device. All patients with ≥50% luminal stenosis in any coronary segment at coronary CTA were referred to investigation with invasive coronary angiography (ICA) with fractional flow reserve (FFR).
A predefined CAD-score cut-off ≤20 was used to rule out obstructive CAD.
Results In total, 439 patients (26%) had ≥50% luminal stenosis on coronary CTA. The subsequent ICA with FFR showed obstructive CAD in 199 patients (11.8%). Using the ≤20 CAD-score cut-off for obstructive CAD rule-out, sensitivity was 85.4% (95% CI 79.7 to 90.0), specificity 40.4% (95% CI 37.9 to 42.9), positive predictive value 16.1% (95% CI 13.9 to 18.5) and negative predictive value 95.4% (95% CI 93.4 to 96.9) in all patients. Applying the cut-off in ESC-PTP 5% to <15% patients, 316 patients (48%) were down-classified to very-low likelihood. The obstructive CAD prevalence was 3.5% in this group.
Conclusion In a large contemporary cohort of patients with low CAD likelihood, the additional use of an acoustic rule-out device showed a clear potential to downgrade likelihood and could supplement current strategies for likelihood assessment to avoid unnecessary testing.
Trial registration number NCT03481712.
- coronary artery disease
- diagnostic imaging
- atherosclerosis
Data availability statement
Data are available on reasonable request.
Statistics from Altmetric.com
Data availability statement
Data are available on reasonable request.
Footnotes
Twitter @lostrasmussen, @h_evald, @AshkanEftekhar1
Correction notice This article has been corrected since it was first published to correct author name Evald Høj Christiansen.
Contributors LDR, SW and MB designed the study. LDR and SW enrolled patients. Coronary CTA scans were read by SW, JKJ, HMS, OH. Invasive coronary angiographies were conducted by SRK, JW, EHC, AE, NRH. MN and SES provided statistical support to LDR. All authors have read and commented on the manuscript in detail. LDR is responsible for the overall content as guarantor.
Funding The study was supported by the Health Research Fund of Central Denmark Region, Aarhus University Research Foundation and by an institutional research grant from Acarix, Denmark.
Competing interests SW acknowledges support from the Novo Nordisk Foundation Clinical Emerging Investigator grant (NNF21OC0066981). MB discloses advisory board participation for Novo Nordisk, AstraZeneca, Pfizer, Boeringer Ingelheim, Bayer, Sanofi, Novartis, Amgen, CLS-Behring and Acarix. The remaining authors have nothing to declare.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
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