Abstract
High-sensitivity cardiac troponin (hs-cTn) assays have been used clinically in many countries throughout the world for years and complement detailed clinical assessment and the ...electrocardiogram in the early diagnosis of myocardial infarction (MI). High-sensitivity cardiac troponin assays for the first time allow to precisely quantify cardiomyocyte injury around the 99th percentile and thereby substantially increase the accuracy for MI already for blood draws obtained at presentation to the emergency department (ED). Higher diagnostic accuracy at ED presentation enabled the development and extensive validation of early hs-cTn-based diagnostic algorithms, which substantially reduced the time required for safe rule-out or rule-in of MI.
The European Society of Cardiology (ESC) recommends the 0/1-h algorithm for rapid triage of patients with suspected non–ST-segment elevation myocardial infarction (MI). However, its impact on patient ...management and safety when routinely applied is unknown.
This study sought to determine these important real-world outcome data.
In a prospective international study enrolling patients presenting with acute chest discomfort to the emergency department (ED), the authors assessed the real-world performance of the ESC 0/1-h algorithm using high-sensitivity cardiac troponin T embedded in routine clinical care and its associated 30-day rates of major adverse cardiac events (MACE) (the composite of cardiovascular death and MI).
Among 2,296 patients, non–ST-segment elevation MI prevalence was 9.8%. In median, 1-h blood samples were collected 65 min after the 0-h blood draw. Overall, 94% of patients were managed without protocol violations, and 98% of patients triaged toward rule-out did not require additional cardiac investigations including high-sensitivity cardiac troponin T measurements at later time points or coronary computed tomography angiography in the ED. Median ED stay was 2 h and 30 min. The ESC 0/1-h algorithm triaged 62% of patients toward rule-out, and 71% of all patients underwent outpatient management. Proportion of patients with 30-day MACE were 0.2% (95% confidence interval: 03% to 0.5%) in the rule-out group and 0.1% (95% confidence interval: 0% to 0.2%) in outpatients. Very low MACE rates were confirmed in multiple subgroups, including early presenters.
These real-world data document the excellent applicability, short time to ED discharge, and low rate of 30-day MACE associated with the routine clinical use of the ESC 0/1-h algorithm for the management of patients presenting with acute chest discomfort to the ED.
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Reply Nestelberger, Thomas; Boeddinghaus, Jasper; Badertscher, Patrick ...
Journal of the American College of Cardiology,
03/2018, Letnik:
71, Številka:
11
Journal Article
The European Society of Cardiology recommends a 0/1-hour algorithm for rapid rule-out and rule-in of non-ST-segment elevation myocardial infarction using high-sensitivity cardiac troponin (hs-cTn) ...concentrations irrespective of renal function. Because patients with renal dysfunction (RD) frequently present with increased hs-cTn concentrations even in the absence of non-ST-segment elevation myocardial infarction, concern has been raised regarding the performance of the 0/1-hour algorithm in RD.
In a prospective multicenter diagnostic study enrolling unselected patients presenting with suspected non-ST-segment elevation myocardial infarction to the emergency department, we assessed the diagnostic performance of the European Society of Cardiology 0/1-hour algorithm using hs-cTnT and hs-cTnI in patients with RD, defined as an estimated glomerular filtration rate <60 mL/min/1.73 m
, and compared it to patients with normal renal function. The final diagnosis was centrally adjudicated by 2 independent cardiologists using all available information, including cardiac imaging. Safety was quantified as sensitivity in the rule-out zone, accuracy as the specificity in the rule-in zone, and efficacy as the proportion of the overall cohort assigned to either rule-out or rule-in based on the 0- and 1-hour sample.
Among 3254 patients, RD was present in 487 patients (15%). The prevalence of non-ST-segment elevation myocardial infarction was substantially higher in patients with RD compared with patients with normal renal function (31% versus 13%,
<0.001). Using hs-cTnT, patients with RD had comparable sensitivity of rule-out (100.0% 95% confidence interval {CI}, 97.6-100.0 versus 99.2% 95% CI, 97.6-99.8;
=0.559), lower specificity of rule-in (88.7% 95% CI, 84.8-91.9 versus 96.5% 95% CI, 95.7-97.2;
<0.001), and lower overall efficacy (51% versus 81%,
<0.001), mainly driven by a much lower percentage of patients eligible for rule-out (18% versus 68%,
<0.001) compared with patients with normal renal function. Using hs-cTnI, patients with RD had comparable sensitivity of rule-out (98.6% 95% CI, 95.0-99.8 versus 98.5% 95% CI, 96.5-99.5;
=1.0), lower specificity of rule-in (84.4% 95% CI, 79.9-88.3 versus 91.7% 95% CI, 90.5-92.9;
<0.001), and lower overall efficacy (54% versus 76%,
<0.001; proportion ruled out, 18% versus 58%,
<0.001) compared with patients with normal renal function.
In patients with RD, the safety of the European Society of Cardiology 0/1-hour algorithm is high, but specificity of rule-in and overall efficacy are decreased. Modifications of the rule-in and rule-out thresholds did not improve the safety or overall efficacy of the 0/1-hour algorithm.
URL: https://www.clinicaltrials.gov. Unique identifier: NCT00470587.
Until now, high-sensitivity cardiac troponin (hs-cTn) assays were mainly developed for large central laboratory platforms.
This study aimed to assess the clinical performance of a point-of-care ...(POC)-hs-cTnI assay in patients with suspected myocardial infarction (MI).
This study enrolled patients presenting to the emergency department with symptoms suggestive of MI. Two cardiologists centrally adjudicated the final diagnosis using all clinical data including cardiac imaging. The primary objective was to directly compare diagnostic accuracy of POC-hs-cTnI-TriageTrue versus best-validated central laboratory assays. Secondary objectives included the derivation and validation of a POC-hs-cTnI-TriageTrue–specific 0/1-h algorithm.
MI was the adjudicated final diagnosis in 178 of 1,261 patients (14%). The area under the curve (AUC) for POC-hs-cTnI-TriageTrue at presentation was 0.95 (95% confidence interval CI: 0.93 to 0.96) and was at least comparable to hs-cTnT-Elecsys (AUC: 0.94; 95% CI: 0.93 to 0.96; p = 0.213) and hs-cTnI-Architect (AUC: 0.92; 95% CI: 0.90 to 0.93; p < 0.001). A single cutoff concentration <3 ng/l at presentation identified 45% of patients at low risk with a negative predictive value (NPV) of 100% (95% CI: 99.4% to 100%). A single cutoff concentration >60 ng/l identified patients at high risk with a positive predictive value (PPV) of 76.8% (95% CI: 68.9% to 83.6%). The 0/1-h algorithm ruled out 55% of patients (NPV: 100%; 95% CI: 98.8% to 100%), and ruled in 18% of patients (PPV: 76.8%; 95% CI: 67.2% to 84.7%). Ruled-out patients had cumulative event rates of 0% at 30 days and 1.6% at 2 years. This study confirmed these findings in a secondary analysis including hs-cTnI-Architect for central adjudication.
The POC-hs-cTnI-TriageTrue assay provides high diagnostic accuracy in patients with suspected MI with a clinical performance that is at least comparable to that of best-validated central laboratory assays. (Advantageous Predictors of Acute Coronary Syndromes Evaluation Study APACE; NCT00470587)
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