TY - JOUR
T1 - Single High-Sensitivity Point-of-Care Whole-Blood Cardiac Troponin i Measurement to Rule Out Acute Myocardial Infarction at Low Risk
AU - SAMIE Investigators
AU - Apple, Fred S.
AU - Smith, Stephen W.
AU - Greenslade, Jaimi H.
AU - Sandoval, Yader
AU - Parsonage, William
AU - Ranasinghe, Isuru
AU - Gaikwad, Niranjan
AU - Schulz, Karen
AU - Stephensen, Laura
AU - Schmidt, Christian W.
AU - Okeson, Brynn
AU - Cullen, Louise
AU - Brownlee, Emily
AU - Fincher, Gavin
AU - Hall, Emma
AU - Hancock, Rebecca
AU - Gangathimmaiah, Vinay
AU - Hamilton-Craig, Christian
AU - Hobbins-King, Andrew
AU - Keijzers, Gerben
AU - Bayat, Maryam Khorramshahi
AU - McCormick, Ellyse
AU - Mahmoodi, Ehsan
AU - Perez, Siegfried
AU - Staib, Andrew
AU - Zournazi, Anna
AU - Than, Martin
N1 - Funding Information:
This work was supported in part by unrestricted grants from Siemens Healthineers (Dr Apple) and the Hennepin Healthcare Research Institute (Dr Apple).
Publisher Copyright:
© 2022 Lippincott Williams and Wilkins. All rights reserved.
PY - 2022/10/31
Y1 - 2022/10/31
N2 - Background: High-sensitivity cardiac troponin (hs-cTn) laboratory assays are used to rule out myocardial infarction (MI) on presentation, but prolonged result turnaround times can delay patient management. Our primary aim was to identify patients at low risk of index MI using a rapid point-of-care (POC) whole-blood hs-cTnI assay at presentation with potential early patient discharge. Methods:Consecutive patients presenting to the emergency department from 2 prospective observational studies with suspected acute coronary syndrome were enrolled. A POC hs-cTnI assay (Atellica VTLi) threshold using whole blood at presentation, which resulted in a negative predictive value of ≥99.5% and sensitivity of >99% for index MI, was derived (SEIGE [Safe Emergency Department Discharge Rate]) and validated with plasma (SAMIE [Suspected Acute Myocardial Infarction in Emergency]). Event adjudications were established with hs-cTnI assay results from routine clinical care. The primary outcome was MI at 30 days. Results:A total of 1086 patients (8.1% with MI) were enrolled in a US derivation cohort (SEIGE) and 1486 (5.5% MI) in an Australian validation cohort (SAMIE). A derivation whole-blood POC hs-cTnI concentration of <4 ng/L provided a sensitivity of 98.9% (95% CI, 93.8%-100%) and negative predictive value of 99.5% (95% CI, 97.2%-100%) for ruling out MI. In the validation cohort, the sensitivity was 98.8% (95% CI, 93.3%-100%), and negative predictive value was 99.8% (95% CI, 99.1%-100%); 17.8% and 41.8%, respectively, were defined as low risk for discharge. The 30-day adverse cardiac events were 0.1% (n=1) for SEIGE and 0.8% (n=5) for SAMIE. Conclusions: A POC whole-blood hs-cTnI assay permits accessible, rapid, and safe exclusion of MI and may expedite discharge from the emergency department. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04772157. URL: https://www.australianclinicaltrials.gov.au/anzctr_feed/form; Unique identifier: 12621000053820.
AB - Background: High-sensitivity cardiac troponin (hs-cTn) laboratory assays are used to rule out myocardial infarction (MI) on presentation, but prolonged result turnaround times can delay patient management. Our primary aim was to identify patients at low risk of index MI using a rapid point-of-care (POC) whole-blood hs-cTnI assay at presentation with potential early patient discharge. Methods:Consecutive patients presenting to the emergency department from 2 prospective observational studies with suspected acute coronary syndrome were enrolled. A POC hs-cTnI assay (Atellica VTLi) threshold using whole blood at presentation, which resulted in a negative predictive value of ≥99.5% and sensitivity of >99% for index MI, was derived (SEIGE [Safe Emergency Department Discharge Rate]) and validated with plasma (SAMIE [Suspected Acute Myocardial Infarction in Emergency]). Event adjudications were established with hs-cTnI assay results from routine clinical care. The primary outcome was MI at 30 days. Results:A total of 1086 patients (8.1% with MI) were enrolled in a US derivation cohort (SEIGE) and 1486 (5.5% MI) in an Australian validation cohort (SAMIE). A derivation whole-blood POC hs-cTnI concentration of <4 ng/L provided a sensitivity of 98.9% (95% CI, 93.8%-100%) and negative predictive value of 99.5% (95% CI, 97.2%-100%) for ruling out MI. In the validation cohort, the sensitivity was 98.8% (95% CI, 93.3%-100%), and negative predictive value was 99.8% (95% CI, 99.1%-100%); 17.8% and 41.8%, respectively, were defined as low risk for discharge. The 30-day adverse cardiac events were 0.1% (n=1) for SEIGE and 0.8% (n=5) for SAMIE. Conclusions: A POC whole-blood hs-cTnI assay permits accessible, rapid, and safe exclusion of MI and may expedite discharge from the emergency department. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04772157. URL: https://www.australianclinicaltrials.gov.au/anzctr_feed/form; Unique identifier: 12621000053820.
UR - http://www.scopus.com/inward/record.url?scp=85144589899&partnerID=8YFLogxK
U2 - 10.1161/CIRCULATIONAHA.122.061148
DO - 10.1161/CIRCULATIONAHA.122.061148
M3 - Article
C2 - 36314160
AN - SCOPUS:85144589899
SN - 0009-7322
VL - 146
SP - 1918
EP - 1929
JO - Circulation
JF - Circulation
IS - 25
ER -