Masayuki Shiozaki1, Kenji Inoue2, Satoru Suwa3, Chien-Chang Lee4, Shuo-Ju Chiang5, Akihiro Sato1, Kentaro Fukuda1, Naozumi Kubota1, Hiroshi Tamura1, Yasumasa Fujiwara1, Kentaro Yamaguchi6, Tomoaki Sato6, Masataka Sumiyoshi1, Hiroyuki Daida7. 1. Department of Cardiology, Juntendo University Nerima Hospital, Tokyo, Japan. 2. Department of Cardiology, Juntendo University Nerima Hospital, Tokyo, Japan, inouelsbm@gmail.com. 3. Department of Cardiology, Juntendo University Shizuoka Hospital, Shizuoka, Japan. 4. Department of Emergency Medicine, National Taiwan University Hospital, Taipei, Taiwan. 5. Division of Cardiology, Department of Internal Medicine, Taipei City Hospital Yangming Branch, Taipei, Taiwan. 6. Fujirebio Inc., Tokyo, Japan. 7. Department of Cardiology, Juntendo University School of Medicine, Tokyo, Japan.
Abstract
INTRODUCTION: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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; p = 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; p = 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. CONCLUSION: Diagnostic accuracy and clinical utility of the novel LumipulsePresto hs-cTnI assay are high and comparable with the established hs-cTn assays.
INTRODUCTION: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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; p = 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; p = 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. CONCLUSION: Diagnostic accuracy and clinical utility of the novel LumipulsePresto hs-cTnI assay are high and comparable with the established hs-cTn assays.
Authors: Russell V Luepker; Fred S Apple; Robert H Christenson; Richard S Crow; Stephen P Fortmann; David Goff; Robert J Goldberg; Mary M Hand; Allan S Jaffe; Desmond G Julian; Daniel Levy; Teri Manolio; Shanthi Mendis; George Mensah; Andrzej Pajak; Ronald J Prineas; K Srinath Reddy; Veronique L Roger; Wayne D Rosamond; Eyal Shahar; A Richey Sharrett; Paul Sorlie; Hugh Tunstall-Pedoe Journal: Circulation Date: 2003-11-10 Impact factor: 29.690
Authors: Johannes Tobias Neumann; Nils Arne Sörensen; Tjark Schwemer; Francisco Ojeda; Rafael Bourry; Vanessa Sciacca; Sarina Schaefer; Christoph Waldeyer; Christoph Sinning; Thomas Renné; Martin Than; William Parsonage; Karin Wildi; Nataliya Makarova; Renate B Schnabel; Ulf Landmesser; Christian Mueller; Louise Cullen; Jaimi Greenslade; Tanja Zeller; Stefan Blankenberg; Mahir Karakas; Dirk Westermann Journal: JAMA Cardiol Date: 2016-07-01 Impact factor: 14.676
Authors: Kristian Thygesen; Joseph S Alpert; Allan S Jaffe; Bernard R Chaitman; Jeroen J Bax; David A Morrow; Harvey D White Journal: Circulation Date: 2018-11-13 Impact factor: 29.690
Authors: J H Pope; T P Aufderheide; R Ruthazer; R H Woolard; J A Feldman; J R Beshansky; J L Griffith; H P Selker Journal: N Engl J Med Date: 2000-04-20 Impact factor: 91.245
Authors: Fred S Apple; Allan S Jaffe; Paul Collinson; Martin Mockel; Jordi Ordonez-Llanos; Bertil Lindahl; Judd Hollander; Mario Plebani; Martin Than; M H M Chan Journal: Clin Biochem Date: 2014-09-07 Impact factor: 3.281
Authors: John W Pickering; Jaimi H Greenslade; Louise Cullen; Dylan Flaws; William Parsonage; Sally Aldous; Peter George; Andrew Worster; Peter A Kavsak; Martin P Than Journal: Circulation Date: 2016-10-17 Impact factor: 29.690