Analytical and clinical evaluation of a novel high-sensitivity assay for measurement of soluble ST2 in human plasma — The Presage™ ST2 assay

Dieplinger, Benjamin; Januzzi, James L.; Steinmair, Martin; Gabriel, Christian; Poelz, Werner; Haltmayer, Meinhard; Mueller, Thomas

doi:10.1016/j.cca.2009.08.010

Cited by 214 publications

(182 citation statements)

References 28 publications

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“…The median sST2 plasma concentrations of our present evaluation of patients with stable CAD (19.4 ng/mL) are markedly increased compared with median concentrations we previously reported in healthy blood donors (11.1 ng/mL) (23 ), and are similar to the results of several previous studies on patients with coronary artery disease, by use of the same Presage™ ST2 assay. Median sST2 concentrations of 28.4 ng/mL at baseline were observed, followed by a subsequent decrease to 21.8 ng/mL after 72 h in patients with non-ST-elevation acute coronary syndromes from the GUSTO IV (Global Use of Strategies to Open Occluded Coronary Arteries in Acute Coronary Syndromes) substudy on inflammatory markers (7 ).…”

Section: Discussionsupporting

confidence: 90%

Increased Soluble ST2 Predicts Long-term Mortality in Patients with Stable Coronary Artery Disease: Results from the Ludwigshafen Risk and Cardiovascular Health Study

et al. 2014

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BACKGROUND Soluble suppression of tumorigenicity 2 (sST2) has emerged as a strong prognostic biomarker in patients with heart failure and myocardial infarction. The aim of this study was to evaluate the long-term prognostic value of sST2 in patients with stable coronary artery disease (CAD). METHODS sST2 plasma concentrations were measured in 1345 patients with stable CAD referred for coronary angiography at a single tertiary care center. The primary endpoint was all-cause mortality. RESULTS During a median follow-up time of 9.8 years, 477 (36%) patients died. The median sST2 plasma concentration at baseline was significantly higher among decedents than survivors (21.4 vs 18.5 ng/mL; P < 0.001). In multivariate Cox proportional hazards regression analysis, sST2 was an independent predictor of all-cause mortality (risk ratio 1.16 per 1-SD increase in log-transformed values; 95% CI 1.05–1.29; P = 0.004). In the same multivariate analysis, amino-terminal pro–B-type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac troponin T (hs-cTnT) were also independent predictors, whereas galectin-3 was not. Patients with sST2 in the highest quartile (>24.6 ng/mL) displayed a 2-fold increased risk of death in univariate analysis, which was attenuated but remained significant in a fully adjusted model (risk ratio 1.39; 95% CI 1.10–1.76; P = 0.006). Further analysis showed that the prognostic impact of sST2 was additive to NT-proBNP and hs-cTnT. Using a multibiomarker approach combining these 3 complementary makers, we demonstrated that patients with all 3 biomarkers in the highest quartiles had the poorest outcome. CONCLUSIONS In this cohort of patients with stable CAD, increased sST2 was an independent predictor of long-term all-cause mortality and provided complementary prognostic information to hs-cTnT and NT-proBNP.

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Section: Discussionsupporting

confidence: 90%

Increased Soluble ST2 Predicts Long-term Mortality in Patients with Stable Coronary Artery Disease: Results from the Ludwigshafen Risk and Cardiovascular Health Study

et al. 2014

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“…We also observed lower levels of serum sST2 in healthy females compared to males (t-test, p = 0.02) a fi nding consisting with previous reports [24,25]. Similarly, a signifi cant difference between the two genders in seropositive carrier group was observed (t-test, p = 0.006).…”

Section: Resultssupporting

confidence: 89%

Status of soluble ST2 levels in serum of HTLV-1 infected individuals

Avval

Shomali

Nadri

et al. 2015

Acta Microbiologica et Immunologica Hungarica

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ST2 is a member of IL-1 receptor family expressed on Th2 cells and regulates Th2 responces. The gene of ST2 encodes soluble ST2 (sST2) and the transmembrane ST2 (ST2L) isoforms through alternative mRNA splicing. The discovery of IL33/ ST2 signaling pathway, has drawn a great scientifi c attention to this system. sST2 has been shown to be an indacating factor in various infl ammatory conditions. This study aims to evaluate serum sST2 levels in HTLV-1 infected patients. This study included 49 HTLV-1 seropositive cases of which 14 were sympthomatic. Controls consisted of 30 healthy volunteers. sST2 level was measured using a quantitative ELISA assay and the results of the study groups were compared. Corroborating the previous reports, sST2 was lower in females (P = 0.003). The sST2 levels was slightly increased in HTLV-1 patients, though such increase was not statistically significant (P = 0.91), in addition sST2 level did not correlate signifi cantly to the disease duration (P = 0.78). Despite some other chronic viral infection, HTLV-1 seems not to induce high serum sST2. However owing to relatively high normal variation of sST2 levels and rather small sample size, we stongly recommend further reseach with preferably larger sample size to evalute sST2 in HTLV-1 infected patients.

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“…The FDA‐approved prognostic cutpoint for this assay is 35 ng/mL. References ranges for sST2 have been reported as 8.6 to 49.3 ng/mL in males and 7.2 to 33.5 ng/mL in females29 or 4 to 31 ng/mL in males and 2 to 21 ng/mL in females 25. Analyte stability has been demonstrated for at least 1.5 years from previously frozen samples 30.…”

Section: Methodsmentioning

confidence: 95%

“…Past work from our group and others has shown that sST2 is a powerful prognostic factor in patients with HF with preserved ejection fraction (HFpEF) 20, 21, 22. This may be particularly relevant to older adults, where HFpEF comprises at least 50% of HF and is associated with a high burden of comorbidities, which may be associated with increased sST2 levels 23, 24, 25. We hypothesized that in a community‐based elderly population free of HF, increased sST2 levels will be associated with increased incident HF and increased cardiovascular mortality.…”

Section: Introductionmentioning

confidence: 98%

Soluble ST2 for Prediction of Heart Failure and Cardiovascular Death in an Elderly, Community‐Dwelling Population

Parikh

Seliger

Christenson

et al. 2016

JAHA

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BackgroundSoluble ST2 (sST2), a marker of myocyte stretch and fibrosis, has prognostic value in many cardiovascular diseases. We hypothesized that sST2 levels are associated with incident heart failure (HF), including subtypes of preserved (HFpEF) and reduced (HFrEF) ejection fraction, and cardiovascular death.Methods and ResultsBaseline serum sST2 was measured in 3915 older, community‐dwelling subjects from the Cardiovascular Health Study without prevalent HF. sST2 levels were associated with older age, male sex, black race, traditional cardiovascular risk factors, other biomarkers of inflammation, cardiac stretch, myocardial injury, and fibrosis, and abnormal echocardiographic parameters. In longitudinal analysis, greater sST2 was associated with a higher risk of incident HF and cardiovascular death; however, in multivariate models adjusting for other cardiac risk factors and the cardiac‐specific biomarker, N‐terminal pro–type B natriuretic peptide, these associations were attenuated. In these models, an sST2 level above the US Food and Drug Administration–approved cut‐off value (>35 ng/mL) was significantly associated with incident HF (hazard ratio [HR], 1.20; 95% CI, 1.02–1.43) and cardiovascular death (HR, 1.21; 95% CI, 1.02–1.44), and greater sST2 was continuously associated with cardiovascular death (per 1‐ln increment: HR, 1.24; 95% CI, 1.02–1.50). sST2 was not associated with the HF subtypes of HFpEF and HFrEF in adjusted analysis. Addition of sST2 to existing risk models of HF and cardiovascular death modestly improved discrimination and reclassification into a higher risk.ConclusionsThe predictive value of sST2 for HF of all subtypes and cardiovascular death is modest in an elderly population despite strong cross‐sectional associations with risk factors and underlying cardiac pathology.

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Analytical and clinical evaluation of a novel high-sensitivity assay for measurement of soluble ST2 in human plasma — The Presage™ ST2 assay

Cited by 214 publications

References 28 publications

Increased Soluble ST2 Predicts Long-term Mortality in Patients with Stable Coronary Artery Disease: Results from the Ludwigshafen Risk and Cardiovascular Health Study

Increased Soluble ST2 Predicts Long-term Mortality in Patients with Stable Coronary Artery Disease: Results from the Ludwigshafen Risk and Cardiovascular Health Study

Status of soluble ST2 levels in serum of HTLV-1 infected individuals

Soluble ST2 for Prediction of Heart Failure and Cardiovascular Death in an Elderly, Community‐Dwelling Population

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