Clinical Evaluation of a New High-Sensitivity Cardiac Troponin I Assay for Diagnosis and Risk Assessment of Patients with Suspected Acute Myocardial Infarction

Abstract

<b><i>Introduction:</i></b> Current assays based on the 0-hour/1-hour (0-/1-h) algorithm using high-sensitivity cardiac troponin (hs-cTn) are limited to only Abbott Architect hs-cTnI, Siemens Vista hs-cTnI, and Roche Elecsys hs-cTnT. <b><i>Objective:</i></b> This study aimed to evaluate this new hs-cTnI assay, LumipulsePresto hs Troponin I, for diagnosis of acute myocardial infarction (AMI) on admission and on 0-/1-h algorithm to stratify AMI patients precisely. <b><i>Methods:</i></b> This prospective cohort study included 442 patients with suspected non-ST-elevation myocardial infarction in three hospitals in Japan and Taiwan from June 2016 to January 2019. We enrolled patients presenting to the emergency department with symptoms suggestive of AMI and collected blood samples on admission and 1 hour later. Two independent cardiologists centrally adjudicated final diagnoses; all clinical information was reviewed twice: first, using serial hs-cTnT (Roche-Elecsys, primary analysis) and Lumipulse Presto Lumipulse Presto, second, using the Lumipulse Presto hs-cTnI measurements. At first, we compared diagnostic accuracy quantified using receiver operating characteristic (ROC) curves for AMI. Then, we evaluated major adverse cardiovascular events (cardiac death, AMI) in the rule-out group according to a 0-hour/1-hour algorithm at the 30-day follow-up. <b><i>Results:</i></b> Diagnostic accuracy at presentation by the ROC curve for AMI was very high and similar for the LumipulsePresto hs-cTnI and hs-cTnT,(area under the curve [AUC]: LumipulsePresto hs-cTnI, 0.89, 95% confidence interval [CI] 0.86–0.93; hs-cTnT, 0.89, 95% CI 0.85–0.93; <i>p</i> = 0.82). In early presenters, the LumipulsePresto hs-cTnI appeared to maintain the diagnostic performance of hs-cTn for patients with <3 h (AUC: LumipulsePresto hs-cTnI, 0.87, 95% CI 0.81–0.92; hs-cTnT, 0.86, 95% CI 0.80–0.92; <i>p</i> = 0.81). The algorithm using the LumipulsePresto hs-cTnI ruled out AMI in 200 patients with negative predictive value and sensitivity of 100% (95% CI 97.3%–100%) and 100% (95% CI 92.7%–100%), respectively, in the rule-out group. <b><i>Conclusion:</i></b> Diagnostic accuracy and clinical utility of the novel LumipulsePresto hs-cTnI assay are high and comparable with the established hs-cTn assays.

An international, stepped wedge, cluster-randomized trial investigating the 0/1-h algorithm in suspected acute coronary syndrome in Asia: the rational of the DROP-Asian ACS study

“…Unstable angina will be diagnosed in patients with typical ischemic symptoms at rest or minor exercise with no evidence of acute myocardial necrosis (normal or elevated hs-cTnT levels without any relevant change during serial sampling). Vasospastic angina pectoris was diagnosed in patients with no obvious coronary stenosis, in which an ECG revealed ST elevation, or there was angiographic evidence of a coronary artery spasm that was released after the intracoronary administration of 1 mg of nitroglycerin [18,26,27]. Noncardiac chest pain was diagnosed based on the absence of findings from laboratory tests, ECG, and chest radiography at the 30-day follow-up.…”

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“…The AUC value of BNP and NT-proBNP in predicting ischemic heart failure was 0.770 and 0.754, respectively [ 23 – 25 ]. The AUC value was 0.87–0.95 in the case of hs-cTI in suspected acute myocardial infarction [ 26 , 27 ]. CK-MB had an AUC of 0.84, and myoglobin had an AUC of 0.79 in the early diagnosis of myocardial infarction in patients with chest pain [ 28 ].…”