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  • Rubini Gimenez, M  (22)
  • 1
    In: European Heart Journal, Oxford University Press (OUP), Vol. 43, No. Supplement_2 ( 2022-10-03)
    Abstract: The presence of accompanying dyspnea is routinely assessed and common in chest pain patients with suspected acute coronary syndromes (ACS), but its impact on differential diagnoses, diagnostic work-up and outcome is incompletely understood. Purpose To determine the association of accompanying dyspnea with diagnoses, diagnostic work-up, and outcome of patients presenting with suspected ACS to the emergency department (ED). Methods We prospectively enrolled unselected patients presenting to the ED with chest pain as the main symptom suggestive of ACS in an international multicenter study. Final diagnoses were adjudicated by two independent cardiologists using all information including cardiac imaging. Patients were stratified by the presence or absence of self-reported dyspnea. The primary diagnostic endpoint was the differential diagnosis. The secondary diagnostic endpoint was the performance of high-sensitivity cardiac troponin (hs-cTn) and the European Society of Cardiology (ESC) 0/1h-algorithms for the diagnosis of myocardial infarction (MI). The primary prognostic endpoint was all-cause mortality at two years. Results Among 6045 patients, 2892/6045 (48%) had accompanying dyspnea. Final diagnoses in patients with versus without dyspnea were different (overall p & lt;0.001), but prevalence of ACS was comparable (MI 22.4% vs. 21.9%, p=0.602, unstable angina 8.7% vs. 7.9%, p=0.291). In contrast, patients with dyspnea more often had cardiac, non-coronary disease (15.3% vs. 10.2%, p & lt;0.001). Diagnostic accuracy of high-sensitivity cardiac troponin (hs-cTn)T/I concentrations at presentation for the diagnosis of MI was high and not affected by the presence of dyspnea (area under the curve 0.89–0.91 in both groups). The ESC 0/1h-algorithms performed excellent in both groups with negative predictive values & gt;99.4%. The presence of dyspnea was associated with all-cause death at two years (hazard ratio [HR] 2.487 [95% CI, 2.001–3.091, p & lt;0.001) and remained an independent predictor after adjustment for covariates at baseline (HR 1.813 [95% CI, 1.453–2.261, p=0.001]). Overall mortality rates were higher in patients with dyspnea at two years (9.0% vs. 3.7%, p & lt;0.001). Conclusion Accompanying dyspnea was not associated with a higher prevalence of ACS but with cardiac, non-coronary disease such as heart failure. While the safety of the diagnostic work-up was not affected, accompanying dyspnea was associated with and an independent predictor for two-year all-cause mortality. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): Swiss Heart Foundation, University of Basel.
    Type of Medium: Online Resource
    ISSN: 0195-668X , 1522-9645
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 2
    In: European Heart Journal, Oxford University Press (OUP), Vol. 39, No. suppl_1 ( 2018-08-01)
    Type of Medium: Online Resource
    ISSN: 0195-668X , 1522-9645
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2018
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  • 3
    In: European Heart Journal, Oxford University Press (OUP), Vol. 42, No. Supplement_1 ( 2021-10-12)
    Abstract: The latest non-ST elevation myocardial infarction (NSTEMI) guidelines from the European Society of Cardiology (ESC) recommend a 3h cardiac troponin determination in patients triaged to the observe-zone of the ESC 0/1h-algorithm; however, no specific cut-off for further triage is endorsed. Purpose To derive and internally, as well as externally, validate a novel 3-hour pathway for the observe-zone of the ESC 0/1h-algorithm. Methods In an ongoing multicentre international diagnostic study, we prospectively enrolled unselected patients presenting to the emergency department with symptoms suggestive of myocardial infarction (MI). Final diagnoses were centrally adjudicated by two independent cardiologists applying the 4th universal definition of MI, based on complete cardiac work-up including cardiac imaging, serial high sensitivity cardiac troponin T (hs-cTnT) sampling and 90-day follow-up information. High sensitivity-cTnT concentrations were measured at presentation and after 1 and 3 hours. The primary outcome was safety, quantified by the sensitivity and NPV for early rule out of NSTEMI. External validation was performed in an independent multicentre international study. Results Among 2076 eligible patients, application of the ESC 0/1h-algorithm triaged 1512 patients (72.8%) to either rule-out or rule-in of NSTEMI, remaining 564 patients (27.2%) in the observe-zone (adjudicated NSTEMI prevalence 120/564 patients, 21.3%). The novel derived 3h-pathway for the observe-zone patients ruled-out NSTEMI with a 3h hs-cTnT concentration & lt;15 ng/L and a 0/3h-hs-cTnT absolute change & lt;4 ng/L, triaging 138 patients (25%) towards rule-out, resulting in a sensitivity of 99.2% (95% CI 96.0–99.9) and a NPV of 99.3% (95% CI 95.4–99.9). A 0/3h-hs-cTnT absolute change ≥6 ng/L ruled-in 63 patients (11.2%), resulting in a specificity of 98% (95% CI 96.2–98.9) and a PPV of 85.7% (95% CI75.0–92.3). The novel 3h-pathway reduced the number of patients in the observe zone by 36%, and the number of T1MI by 50% (Figure 1). Findings were confirmed in both internal and external validation. Conclusions A novel derived pathway combining a 3h hs-cTnT concentration & lt;15 ng/L and a 0/3h absolute change & lt;4 ng/L allowed to very safely rule-out NSTEMI in patients remaining in the observe-zone of the ESC 0/1h-algorithm. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): The Swiss Heart FoundationThe Swiss National Science Foundation Figure 1
    Type of Medium: Online Resource
    ISSN: 0195-668X , 1522-9645
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
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  • 4
    In: European Heart Journal, Oxford University Press (OUP), Vol. 41, No. Supplement_2 ( 2020-11-01)
    Abstract: Clinical risk scores are recommended for formal risk stratification in patients presenting with suspected acute coronary syndrome (ACS). It is unknown, whether these scores still provide additional value in the era of high-sensitivity cardiac troponin (hs-cTn) compared to simple integrated clinical judgment. Purpose To evaluate the diagnostic and prognostic performance of integrated clinical judgment compared to clinical risk scores. Methods We prospectively enrolled patients presenting to the emergency department with symptoms suggestive of ACS such as acute chest discomfort. The primary prognostic endpoint was the composite of 30-day major adverse cardiac events (MACE) including all-cause death, life-threatening arrhythmia, cardiogenic shock, acute myocardial infarction (AMI, including the index event), and urgent coronary revascularization and was adjudicated by two independent cardiologists. The performance of five well-established formal risk scores (T-MACS, HEART, GRACE, TIMI, and EDACS) for the prediction of 30-day MACE was directly compared with simple integrated clinical judgment for the ACS likelihood by the treating ED physician. Integrated clinical judgment was quantified using a visual analogue scale at 90 minutes after patient's presentation to the ED. The primary diagnostic endpoint was index AMI. Results Among 2031 patients, 417/2031 patients (20.5%) had at least one MACE within 30 days. Prognostic accuracy for 30-day MACE quantified by the area under the receiver-operating characteristics curve (AUC) was 0.87 (95% CI 0.85–0.89) for T-MACS, 0.87 (95% CI 0.85–0.89) for HEART, 0.84 (95% CI 0.82–0.86) for GRACE, 0.81 (95% CI 0.79–0.83) for TIMI, 0.75 (95% CI 0.73–0.78) for EDACS, versus 0.89 (95% CI 0.87–0.91) for simple integrated clinical judgment (p & lt;0.01 versus GRACE, TIMI, and EDACS; Figure 1). Similarly, diagnostic accuracy was 0.92 (95% CI 0.90–0.94) for T-MACS, 0.89 (95% CI 0.87–0.90) for HEART, 0.88 (95% CI 0.86–0.89) for GRACE, 0.80 (95% CI 0.78–0.82) for TIMI, 0.74 (95% CI 0.72–0.77) for EDACS, versus 0.89 (95% CI 0.88–0.91) for simple integrated clinical judgment (p & lt;0.01 versus GRACE, TIMI, and EDACS). Conclusion None of the formal clinical risk scores outperformed simple integrated clinical judgment for ACS in the prediction of 30-day MACE or the diagnosis of AMI. Therefore, in the era of hs-cTn testing as part of integrated clinical judgment, clinical risk scores seem to no longer provide incremental value. Figure 1. Diagnostic accuracy for MACE at 30-days Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Swiss National Science Foundation, Swiss Heart Foundation
    Type of Medium: Online Resource
    ISSN: 0195-668X , 1522-9645
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
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  • 5
    In: European Heart Journal, Oxford University Press (OUP), Vol. 43, No. Supplement_2 ( 2022-10-03)
    Abstract: The clinical performance of the novel high-sensitivity cardiac troponin I EXL (hs-cTnI-EXL) assay is unknown so far. Purpose We aimed to validate the clinical performance of the hs-cTnI-EXL assay and to derive and validate an hs-cTnI-EXL-specific 0/1h-algorithm for the early diagnosis of myocardial infarction (MI). Methods This multicenter study included patients presenting to the emergency department with symptoms suggestive of myocardial infarction. Central adjudication of final diagnoses was performed by two independent cardiologists using all clinical information including cardiac imaging twice: first, using serial hs-cTnI-Architect (primary analysis) and second, using serial hs-cTnT-Elecsys (secondary analysis) concentrations in addition to those clinically used (hs)-cTn. Hs-cTnI-EXL was measured at presentation and at 1h. The primary objective was to directly compare diagnostic accuracy quantified by the area under the receiver-operating-characteristic curve (AUC) of hs-cTnI-EXL, hs-cTnI-Architect and hs-cTnT-Elecsys. Secondary objectives included the derivation and validation of an hs-cTnI- EXL-specific 0/1h-algorithm. Results MI was the adjudicated final diagnosis in 204/1454 (14%) patients. At presentation, the AUC for hs-cTnI-EXL was 0.94 (95% CI, 0.93–0.96), being comparable to hs-cTnI-Architect (0.95; 95% CI, 0.93–0.96) and hs-cTnT-Elecsys (0.93; 95% CI, 0.91–0.95; Figure 1). In the derivation cohort (n=813), an optimal hs-cTnI-EXL-0/1h-algorithm was rule-out of MI with & lt;9ng/L if onset of chest pain & gt;3h or & lt;9ng/L & 0h-1h-change & lt;5ng/L, and rule-in with ≥160ng/L or 0h-1h-change ≥100ng/L. In the validation cohort (n=345), this hs-cTnI-EXL-0/1h-algorithm also performed well: rule-out in 56% of patients, negative predictive value 99.5% (95% CI, 97.1–99.9), sensitivity 97.8% (95% CI, 88.7–99.6), rule-in in 9% of patients, positive predictive value 83.3% (95% CI, 66.4–92.7), specificity 98.3% (95% CI, 96.1–99.3; Figure 2). Secondary analyses confirmed the findings using adjudication including serial measurements of hs-cTnT-Elecsys. Conclusions Hs-cTnI-EXL has comparable diagnostic performance to the currently best-validated hs-cTnT/I assays. Funding Acknowledgement Type of funding sources: Foundation. Main funding source(s): Swiss National Foundation, Swiss Heart Foundation
    Type of Medium: Online Resource
    ISSN: 0195-668X , 1522-9645
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 6
    In: European Heart Journal, Oxford University Press (OUP), Vol. 41, No. Supplement_2 ( 2020-11-01)
    Abstract: The European Society of Cardiology (ESC) high sensitivity cardiac troponin T 0/1h-algorithm has substantially improved the management of patients with suspected acute myocardial infarction (AMI) by triaging about 75% of patients to rapid rule-out and/or rapid rule-in. However, about 25% of patients remain in the “observe-zone”, and the optimal management of these patients is unknown. Recently, a pilot single center study with a low prevalence of AMI suggested that an absolute change of less than 7ng/L between the 0h and 3h hs-cTnT concentration would allow to help in the evaluation of patients in the observe-zone and allow triage towards rule-out with very high negative predictive value [NPV]. Purpose To externally validate this suggested modification of the ESC 0/1h-algorithm for early rule out of AMI. Methods In an ongoing multicentre international study, we prospectively enrolled unselected patients presenting to the emergency department with symptoms suggestive of MI. Final diagnoses were centrally adjudicated by two independent cardiologists using all available medical records obtained during clinical care including 90 day follow-up information and cardiac imaging. High sensitivity-cTnT (Elecsys) concentrations were measured at presentation and after 1 and 3 hours. The primary outcome was safety, quantified by the sensitivity and NPV for early rule out of NSTEMI. Results Among 1633 enrolled patients with available 0, 1 and 3h hs-cTnT concentrations, NSTEMI was the adjudicated final diagnosis in 337 (20.6%) patients. The ESC 0/1h-algorithm ruled out 918 (56.2%) patients, with a sensitivity of 98.8% (95% confidence interval [CI], 97.0–99.5) and a NPV of 99.6% (95% CI, 98.9–99.8). A total of 428 patients (26.2%) remained in the observe zone. After applying the suggested 0–3 hour absolute change cut-off criteria of 7ng/L, 393 (92.0%) additional patients from the observe zone were triaged towards ruled out. However, the safety of this triage step was poor with 62 patients with NSTEMI missed, resulting in a sensitivity of 33.3% and a NPV of 84.2% for rule-out. Conclusions The suggested 0/3h absolute change cut-off of 7ng/L for patients remaining in the observe zone of the ESC 0/1h-algorithm does NOT allow safe rule-out of AMI and should therefore NOT be implemented into routine clinical care. Figure 1 Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): Swiss National Science Foundation, the Swiss Heart Foundation, the Stiftung für kardiovaskuläre Forschung Basel, the University of Basel and the University Hospital Basel
    Type of Medium: Online Resource
    ISSN: 0195-668X , 1522-9645
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
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  • 7
    In: European Heart Journal, Oxford University Press (OUP), Vol. 41, No. Supplement_2 ( 2020-11-01)
    Abstract: Recurrence of acute chest pain after percutaneous coronary intervention (PCI) is common. The early detection of acute myocardial infarction (AMI) as a possible cause of acute chest pain can be challenging in patients with a history of PCI due to e.g. pre-existing electrocardiographic abnormalities. It is unknown, whether high-sensitivity cardiac troponin T (hs-cTnT) concentrations and hs-cTnT-based rapid algorithms perform equally well in patients with a history of PCI. Purpose To investigate the impact of prior PCI on the diagnostic performance of hs-cTnT concentrations for early rule-out and rule-in of AMI. Methods In an ongoing multicentre international study, we prospectively enrolled unselected patients presenting to the emergency department (ED) with symptoms suggestive of AMI. Final diagnoses were centrally adjudicated by two independent cardiologists using all available medical records obtained during clinical care including 90 day follow-up information and cardiac imaging. High-sensitivity cTnT concentrations at presentation and after 1h were compared against the adjudicated final diagnosis. Patients were stratified according to the presence or absence of previous PCI. Results Among 5536 patients (1313 with and 4223 without previous PCI), incidence of AMI was significantly higher in patients with previous PCI (26.3% versus 21.4%; p & lt;0.001). Patients with prior PCI and a final diagnoses other than AMI had significantly higher concentrations of hs-cTnT at presentation to the ED (median 9ng/l [IQR 6 to 15.8] vs 5.5ng/l [IQR 3 to 10] ; p & lt;0.001). However, in patients with final adjudicated diagnosis of AMI, hs-TnT concentrations at presentation were lower in patients with previous PCI (median 46ng/l [IQR 23 to 94] vs 55ng/l [IQR 25 to 175] ; p=0.003). The diagnostic accuracy of hs-cTnT was high in patients with history of PCI, but significantly lower compared to patients without PCI (AUC 0.91 [95% CI 0.89–0.92] versus AUC 0.94 [95% CI 0.94–0.95] ; p & lt;0.001, respectively). When applying the ESC 0/1-algorithm among patients with previous history of PCI, the rule out pathway showed also very high safety in patients with a history of PCI (sensitivity 99.2 [95% CI 97.2–99.8] and negative predictive value 99.6 [95% CI 98.5–99.9] ). However, the efficacy of the ESC 0/1h-algorithm for early rule out of NSTEMI was lower in the PCI group compared to no PCI (45.2% vs 65.1%; P & lt;0.001, respectively), triaging more patients to the observe zone (36.8% versus 18.8%; p & lt;0.001). Time to discharge from the ED was significantly longer in patients with prior PCI (334 min vs 290 min; p & lt;0.001). When stratified for index AMI, patients with history of PCI waited longer for a final diagnoses of AMI (285 vs 217 min; p & lt;0.001). Conclusions History of PCI impacts on the diagnostic performance of hs-cTnT. Although the ESC 0/1h-algorithm still performs very safe when applied to patients with a history of PCI, its efficacy is significantly reduced. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): Swiss National Science Foundation, the Swiss Heart Foundation, the KTI, the Stiftung für kardiovaskuläre Forschung Basel the University of Basel and the University Hospital Basel
    Type of Medium: Online Resource
    ISSN: 0195-668X , 1522-9645
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
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  • 8
    In: European Heart Journal, Oxford University Press (OUP), Vol. 40, No. Supplement_1 ( 2019-10-01)
    Abstract: Lately, the novel high-sensitivity cardiac troponin I (hs-cTnI) Access assay was developed. Its clinical performance in patients presenting with chest pain to the emergency department (ED) is unknown. Purpose To clinically validate the novel hs-cTnI-Access assay and to derive and validate an assay specific 0/1h-algorithm accordingly to the European Society of Cardiology (ESC) recommendations. Methods In a prospective international multicentre study we enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI). Final diagnoses were centrally adjudicated by two independent cardiologists including all clinical information including cardiac imaging twice: first, using serial hs-cTnT (Elecsys, primary analysis) and second, using hs-cTnI (Architect, secondary analysis) measurements in addition to the clinically used (hs)-cTn. Hs-cTnI-Access was measured at presentation and at 1h. Primary objective was a direct comparison of diagnostic accuracy as quantified by the area under the receiver-operating-characteristic curve (AUC) of hs-cTnI-Access versus the two established hs-cTn assays (hs-cTnT-Elecsys, hs-cTnI-Architect). Secondary objectives included the derivation and internal validation of an hs-cTnI-Access specific 0/1h-algorithm. Results AMI was the adjudicated final diagnosis in 243/1579 (15.4%) patients. The AUC at presentation for hs-cTnI-Access was 0.95 (95% CI, 0.94–0.96), significantly higher as hs-cTnI-Architect (0.92 [95% CI, 0.91–0.94; p 〈 0.001]), and comparable to hs-cTnT-Elecsys (0.94 [95% CI, 0.93–0.95; p=0.12] ) Applying the derived hs-cTnI-Access 0/1h-algorithm (derivation cohort n=686) to the internal validation cohort (n=680), 60% of patients were ruled-out (sensitivity 98.9% [95% CI, 94.3–99.8]), and 15% of patients were ruled-in (specificity 95.9% [95% CI, 94.0–97.2] ). Patients ruled-out by the 0/1h-algorithm had a survival rate of of 100% after 30-days and 98.4% after two years of follow up. Findings were confirmed in the secondary analyses using the adjudication including serial measurements of hs-cTnI (Architect). Performance of the 0/1h-algorithm Conclusions Diagnostic accuracy of the novel hs-cTnI-Access assay is excellent and at least comparable to the two established hs-cTn assays. The assay-specific 0/1h-algorithm allows a safe rule-out and accurate rule-in of MI in about 75% of patients within 1-hour after presentation to the ED. Survival of patients ruled-out by the 0/1h-algorithm was very high. Acknowledgement/Funding Swiss National Science Foundation, the Swiss Heart Foundation, the KTI, the European Union, the Stiftung für kardiovaskuläre Forschung Basel
    Type of Medium: Online Resource
    ISSN: 0195-668X , 1522-9645
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2019
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  • 9
    In: European Heart Journal, Oxford University Press (OUP), Vol. 43, No. Supplement_2 ( 2022-10-03)
    Abstract: Clinical practice guidelines assume that both cardiac troponin (cTn) T and cTnI concentrations reflect identical pathophysiological processes and are equally effective in the detection of myocardial injury. However, there are differences between cTnT and cTnI that have been reported. Purpose The aim of this study was to directly compare the diagnostic performance of high-sensitivity cardiac troponin (hs-cTn) T versus hs-cTnI for the early diagnosis of acute myocardial infarction (MI). Methods In a prospective multicentre study, diagnostic and prognostic accuracies of hs-cTnT and I were analyzed in consecutive patients presenting to the emergency department with acute chest pain. The final diagnosis was adjudicated by two independent cardiologists using all information pertaining to the individual patient according to the fourth universal definition of MI. Adjudication of the final diagnoses was performed twice: once using serial measurements of hs-cTnT and once using hs-cTnI. Furthermore, the clinical performance of hs-cTnT/I when embedded in the European Society of Cardiology (ESC) 0/1h-algorithm was assessed. Results Among 5087 consecutive patients (median [Interquartile range, IQR] age 61 [49.0, 74.0] years, 33.2% female), 951 (18.7%) and 901 patients (17.7%) had an adjudicated final diagnosis of non-ST-segment elevation myocardial infarction (NSTEMI) when using serial measurements of hs-cTnT and hs-cTnI for adjudication, respectively. Diagnostic accuracy was very high for both hs-cTnT and hs-cTnI and comparable when using hs-cTnT for adjudication (hs-cTnT: area under the curve [AUC] 0.93 [95% CI 0.92–0.94] versus hs-cTnI AUC 0.93 [95% CI 0.92–0.94]; p=0.891). However, when using serial measurements of hs-cTnI for adjudication, diagnostic accuracy was significantly higher for hs-cTnI (AUC 0.93 [95% CI 0.92–0.94] versus AUC 0.94 [95% CI 0.94–0.95], p & lt;0.001; Figure 1). This was confirmed in subgroup analyses including early presenter (≤3h), patients with renal failure, known coronary artery disease and elderly (≥70 years). However, both assays performed excellent with very high safety for rule-out and high accuracy for rule-in MI when embedded in the ESC 0/1h-algorithm. Prognostic accuracies for 730-day all-cause mortality and cardiovascular death were significantly higher for hs-cTnT compared to hs-cTnI (Figure 2). Conclusions While there seem to be differences between hs-cTnT and hs-cTnI in their diagnostic and prognostic performance, clinical relevance needs to be further evaluated since both assays performed excellent when embedded in their respective early triage algorithms. Funding Acknowledgement Type of funding sources: Foundation. Main funding source(s): Swiss National Foundation, Swiss Heart Foundation
    Type of Medium: Online Resource
    ISSN: 0195-668X , 1522-9645
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 10
    In: European Heart Journal, Oxford University Press (OUP), Vol. 43, No. Supplement_2 ( 2022-10-03)
    Abstract: It is unclear which patients, after rule-out of non-ST elevation myocardial infarction (NSTEMI) with the European Society of Cardiology (ESC) 0/1h-algorithms, require further objective anatomical or functional cardiac testing and which do not. Purpose To test the safety and efficacy of the no-objective-testing (NOT)-rules after NSTEMI rule-out by the well-validated ESC 0/1h-algorithms. Methods We prospectively enrolled adult patients presenting with acute chest pain to 12 emergency departments (ED) in five European countries in an international, prospective, diagnostic multicenter study. The final diagnosis of major adverse cardiovascular events (MACE), defined as nonfatal acute coronary syndromes (NSTEMI or unstable angina) or cardiovascular death was centrally adjudicated by two independent cardiologists applying the 4th Universal Definition of myocardial infarction using all information including cardiac imaging and serial measurements of high-sensitivity cardiac troponin (hs-cTn) T/I. The primary endpoints were the safety and efficacy of the NOT-rules for the rule-out of MACE within 30-days follow-up including index events. Secondary endpoints included MACE within 365 and 730 days. Results Among 4804 and 4569 eligible patients with available 0h and 1h hs-cTnT-Elecsys or hs-cTnI-Architect concentrations, 2783 (58%) and 2252 (49%) patients were eligible for application of the NOT-rules after rule-out of NSTEMI by the respective ESC hs-cTnT/I-0/1h-algorithm. The first rule (weighted score including age, sex, cardiovascular risk factors, previous MI or known coronary artery disease (CAD), nitrate use) identified 26% of patients, had a sensitivity of 100% (95% CI 98.3–100%), a negative predictive value (NPV) of 100% (95% CI, n.c.) for hs-cTnT-Elecsys and 99.4% (95% CI 96.7–99.9%) and 99.8% (95% CI 98.8–99.9%) for hs-cTnI-Architect, respectively. The dichotomized second (age & lt;50y, no previous MI or known CAD, & lt;3 risk factors, no nitrate use) and even simpler third rule (nitrate use omitted) both identified 31% of patients with 99.5% (95% CI 97.4–99.9%) sensitivity and a NPV of 99.9% (95% CI 99.2–99.9%) for hs-cTnT-Elecsys. Sensitivities were 98.8% (95% CI 95.7–99.9%) and NPV 99.7% (95% CI 98.9–99.9%) for hs-cTnI-Architect. High safety was confirmed with consistently very high sensitivities and NPV for 365-day and 2-year MACE. Conclusion All three NOT-rules performed very well for rule-out of MACE. The third NOT-rule best balanced feasibility, safety and efficacy by identifying nearly one out of three patients as low-risk, who may not require further cardiac testing. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): Swiss Heart Foundation, University of Basel.
    Type of Medium: Online Resource
    ISSN: 0195-668X , 1522-9645
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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