Prospective Validation of a Biomarker-Based Rule Out Strategy for Functionally Relevant Coronary Artery Disease
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Prospective Validation of a Biomarker-Based Rule Out Strategy for Functionally Relevant Coronary Artery Disease. / Walter, Joan E; Honegger, Ursina; Puelacher, Christian; Mueller, Deborah; Wagener, Max; Schaerli, Nicolas; Strebel, Ivo; Twerenbold, Raphael; Boeddinghaus, Jasper; Nestelberger, Thomas; Sazgary, Lorraine; Marbot, Stella; du Fay de Lavallaz, Jeanne; Kaiser, Christoph; Osswald, Stefan; Wild, Damian; Rentsch, Katharina; Zellweger, Michael; Reichlin, Tobias; Mueller, Christian.
In: CLIN CHEM, Vol. 64, No. 2, 02.2018, p. 386-395.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Prospective Validation of a Biomarker-Based Rule Out Strategy for Functionally Relevant Coronary Artery Disease
AU - Walter, Joan E
AU - Honegger, Ursina
AU - Puelacher, Christian
AU - Mueller, Deborah
AU - Wagener, Max
AU - Schaerli, Nicolas
AU - Strebel, Ivo
AU - Twerenbold, Raphael
AU - Boeddinghaus, Jasper
AU - Nestelberger, Thomas
AU - Sazgary, Lorraine
AU - Marbot, Stella
AU - du Fay de Lavallaz, Jeanne
AU - Kaiser, Christoph
AU - Osswald, Stefan
AU - Wild, Damian
AU - Rentsch, Katharina
AU - Zellweger, Michael
AU - Reichlin, Tobias
AU - Mueller, Christian
N1 - © 2017 American Association for Clinical Chemistry.
PY - 2018/2
Y1 - 2018/2
N2 - BACKGROUND: This study aimed to prospectively advance a rule-out strategy for functionally significant coronary artery disease (CAD) by use of high-sensitivity cardiac troponin I (hs-cTnI) from bench to bedside, by application of a 3-step approach: validation in serum, correlation in plasma, and application on a clinical platform.METHODS: Patients without known CAD referred for rest/stress myocardial perfusion single-photon emission tomography/computer tomography (MPI-SPECT/CT) were assigned to 3 consecutive cohorts: validation, correlation, and application. Functionally relevant CAD was adjudicated with the use of expert interpretation of MPI-SPECT/CT and, if available, coronary angiography. In the validation cohort resting hs-cTnI was measured in serum before stress testing with the research Erenna system, in serum and plasma in the correlation cohort with the research Erenna system, and in plasma in the application cohort with the clinical Clarity system.RESULTS: Overall, functionally relevant CAD was adjudicated in 21% (304/1478) of patients. In the validation cohort (n = 613), hs-cTnI concentrations were significantly higher in patients with functionally relevant CAD (median 2.8 ng/L vs 1.9 ng/L, P < 0.001) as compared to patients without functionally relevant CAD and allowed a rule out with 95% sensitivity in 14% of patients. In the correlation cohort (n = 606), hs-cTnI concentrations in serum and plasma strongly correlated (Spearman r = 0.921) and had similar diagnostic accuracy as quantified by the area under the receiver operating characteristic curve (0.686 vs 0.678, P = 0.425). In the application cohort (n = 555), very low hs-cTnI plasma concentrations (< 0.5 ng/L) ruled out functionally relevant CAD with 95% sensitivity in 10% of patients.CONCLUSIONS: A single resting plasma hs-cTnI measurement can safely rule out functionally relevant CAD in around 10% of patients without known CAD.
AB - BACKGROUND: This study aimed to prospectively advance a rule-out strategy for functionally significant coronary artery disease (CAD) by use of high-sensitivity cardiac troponin I (hs-cTnI) from bench to bedside, by application of a 3-step approach: validation in serum, correlation in plasma, and application on a clinical platform.METHODS: Patients without known CAD referred for rest/stress myocardial perfusion single-photon emission tomography/computer tomography (MPI-SPECT/CT) were assigned to 3 consecutive cohorts: validation, correlation, and application. Functionally relevant CAD was adjudicated with the use of expert interpretation of MPI-SPECT/CT and, if available, coronary angiography. In the validation cohort resting hs-cTnI was measured in serum before stress testing with the research Erenna system, in serum and plasma in the correlation cohort with the research Erenna system, and in plasma in the application cohort with the clinical Clarity system.RESULTS: Overall, functionally relevant CAD was adjudicated in 21% (304/1478) of patients. In the validation cohort (n = 613), hs-cTnI concentrations were significantly higher in patients with functionally relevant CAD (median 2.8 ng/L vs 1.9 ng/L, P < 0.001) as compared to patients without functionally relevant CAD and allowed a rule out with 95% sensitivity in 14% of patients. In the correlation cohort (n = 606), hs-cTnI concentrations in serum and plasma strongly correlated (Spearman r = 0.921) and had similar diagnostic accuracy as quantified by the area under the receiver operating characteristic curve (0.686 vs 0.678, P = 0.425). In the application cohort (n = 555), very low hs-cTnI plasma concentrations (< 0.5 ng/L) ruled out functionally relevant CAD with 95% sensitivity in 10% of patients.CONCLUSIONS: A single resting plasma hs-cTnI measurement can safely rule out functionally relevant CAD in around 10% of patients without known CAD.
KW - Aged
KW - Biomarkers/blood
KW - Coronary Artery Disease/blood
KW - Exercise Test
KW - Female
KW - Humans
KW - Male
KW - Middle Aged
KW - Multimodal Imaging
KW - Prognosis
KW - Prospective Studies
KW - Sensitivity and Specificity
KW - Tomography, Emission-Computed, Single-Photon
KW - Tomography, X-Ray Computed
KW - Troponin I/blood
U2 - 10.1373/clinchem.2017.277210
DO - 10.1373/clinchem.2017.277210
M3 - SCORING: Journal article
C2 - 29038153
VL - 64
SP - 386
EP - 395
JO - CLIN CHEM
JF - CLIN CHEM
SN - 0009-9147
IS - 2
ER -
