Rapid Acute Coronary Syndrome Evaluation Over One Hour With High-Sensitivity Cardiac Troponin I: A United States-Based Stepped-Wedge, Randomized Trial - 16/06/24

Doi : 10.1016/j.annemergmed.2024.04.024

Joseph Miller, MD ^a, Bernard Cook, PhD ^a, Chaun Gandolfo, DO ^b, Nicholas L. Mills, MD ^c, Simon Mahler, MD ^d, Phillip Levy, MD ^e, Sachin Parikh, MD ^b, Seth Krupp, MD ^a, Khaled Nour, MD ^b, Howard Klausner, MD ^a, Ryan Gindi, MD ^b, Aaron Lewandowski, MD ^f, Michael Hudson, MD ^b, Giuseppe Perrotta, MD ^a, Bryan Zweig, MD ^b, David Lanfear, MD ^b, Henry Kim, MD ^b, Shooshan Dangoulian, PhD ^e, Amy Tang, PhD ^a, Erika Todter, MS ^a, Altaf Khan, MS ^a, Catriona Keerie, MSc ^c, Shane Bole, BS ^a, Hashem Nasseredine, MD ^a, Ahmed Oudeif, MD ^a, Elian Abou Asala, MD ^a, Mustafa Mohammed, DO ^a, Ahmed Kazem, DO ^a, Kelly Malette, MD ^a, Gulmohar Singh-Kucukarslan, MA ^a, Nicole Xu, BS ^e, Sophie Wittenberg, BS ^e, Thayer Morton, DO ^a, Satheesh Gunaga, DO ^g, Ziad Affas, MD ^h, Kutiba Tabbaa, MD ^h, Parth Desai, BS ^e, Ayman Alsaadi, MD ^a, Shazil Mahmood, MD ^a, Andrew Schock, MD ^a, Nicholas Konowitz, MD ^a, Joshua Fuchs, DO ^a, Kate Joyce, MD ^a, Lance Shamoun, MD ^d, Jacob Babel, DO ^c, Andrew Broome, MD ^d, Geoffrey Digiacinto, DO ^g, Elizabeth Shaheen, MD ^g, Gale Darnell, MD ^▪, Gregory Muller, MD ^g, Gerard Heath, MD ^a, Gust Bills, DO ^f, Jason Vieder, DO ^a, Steven Rockoff, DO ^f, Brian Kim, MD ⁱ, Anthony Colucci, DO ^h, Elizabeth Plemmons, MD ^g, James McCord, MD ^b,^⁎
for the
RACE-IT Research Group
^a Henry Ford Hospital, Detroit, MI
^b Heart and Vascular Institute Henry Ford Health, Detroit, MI
^c The Usher Institute, University of Edinburgh, Edinburgh, UK
^d Wake Forest University School of Medicine Winston-Salem, NC
^e Wayne State University School of Medicine, Detroit, MI
^f Henry Ford West Bloomfield Hospital, West Bloomfield, MI, USA
^g Henry Ford Wyandotte Hospital Wyandotte, MI
^h Henry Ford Macomb Hospital, Clinton Township, MI
ⁱ Henry Ford Allegiance Hospital, Jackson, MI

^∗Corresponding Author.

Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Sunday 16 June 2024

Abstract

Study objective

The real-world effectiveness and safety of a 0/1-hour accelerated protocol using high-sensitivity cardiac troponin (hs-cTn) to exclude myocardial infarction (MI) compared to routine care in the United States is uncertain. The objective was to compare a 0/1-hour accelerated protocol for evaluation of MI to a 0/3-hour standard care protocol.

Methods

The RACE-IT trial was a stepped-wedge, randomized trial across 9 emergency departments (EDs) that enrolled 32,609 patients evaluated for possible MI from July 2020 through April 2021. Patients undergoing high-sensitivity cardiac troponin I testing with concentrations less than or equal to 99th percentile were included. Patients who had MI excluded by the 0/1-hour protocol could be discharged from the ED. Patients in the standard care protocol had 0- and 3-hour troponin testing and application of a modified HEART score to be eligible for discharge. The primary endpoint was the proportion of patients discharged from the ED without 30-day death or MI.

Results

There were 13,505 and 19,104 patients evaluated in the standard care and accelerated protocol groups, respectively, of whom 19,152 (58.7%) were discharged directly from the ED. There was no significant difference in safe discharges between standard care and the accelerated protocol (59.5% vs 57.8%; adjusted odds ratio (aOR)=1.05, 95% confidence interval [CI] 0.95 to 1.16). At 30 days, there were 90 deaths or MIs with 38 (0.4%) in the standard care group and 52 (0.4%) in the accelerated protocol group (aOR=0.84, 95% CI 0.43 to 1.68).

Conclusion

A 0/1-hour accelerated protocol using high-sensitivity cardiac troponin I did not lead to more safe ED discharges compared with standard care.

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Plan

Introduction

Background

Importance

Goals of This Investigation

Materials and Methods

Study Design and Population

Randomization and Intervention

Study Outcomes

Statistical Analysis

Results

Study Sites and Population

Primary and Secondary Outcomes

Effectiveness of the 0/1-Hour Protocol

Limitations

Discussion

	Supervising editor: Steve Goodacre, PhD. Specific detailed information about possible conflict of interest for individual editors is available at editors.
	Please see page XX for the Editor’s Capsule Summary of this article.
	Author contributions: JiMc, JoMi, BC, NM, SM, PL, and SK conceived the study, and designed the trial. SP, KN, HK, RG, AL, MH, GP, BZ, DL, and HK adjudicated endpoints (myocardial infarction and death). SD, AT, ET, and CK provided statistical advice on study design and analyzed the data. All other authors were involved with either data collection or assisting in the implementation of the new protocol. JiMc drafted the manuscript and all authors contributed to its revision. JiMc takes responsibility for the paper as a whole. JoMi takes final responsibility of the data in the manuscript.
	Data sharing statement: Deidentified data and a data dictionary are available on reasonable request.
	Authorship: All authors attest to meeting the four ICMJE.org authorship criteria: (1) Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND (2) Drafting the work or revising it critically for important intellectual content; AND (3) Final approval of the version to be published; AND (4) Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
	Funding and support: By Annals’ policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). Joseph Miller reports the following: Beckman Coulter, Research Support and Consulting; Siemens, Consulting; and AstraZeneca, Consulting. Bernard Cook reports the following: Abbott, Research Support; Beckman Coulter, Research Support and Consulting; and Roche, Research Support. David Lanfear reports the following: Abbott Laboratories, Amgen, Astra Zeneca, Cytokinetics, DCRI (CONNECT-HF), Illumina, Janssen, Lilly, Martin Pharmaceuticals, Ortho Diagnostics, Otsuka, Somalogic, Vicardia. Simon Mahler reports the following: funding/support from Roche Diagnostics, Abbott Laboratories, Ortho Clinical Diagnostics, Siemens, Grifols, Pathfast, Quidel, and HRSA (1H2ARH399760100). In addition, Simon Mahler is an advisor for Roche Diagnostics, Abbott Laboratories, Genetesis, Quidel, Inflammatix, Radiometer, and Amgen and the Chief Medical Officer for Impathiq Inc. Phillip Levy is the past chair of the American College of Cardiology (ACC) Accreditation Oversight Committee and a current member of the ACC NCDR Oversight Committee and the NCDR Chest Pain/MI Registry Publications Committee; he was also Vice chair for the ACC/AHA Chest Pain Guidelines. Dr. Levy has served as a consultant for Quidel, Siemens, Roche Diagnostics, Ortho Diagnostics, Beckman Coulter, Pathfast, and the Baim Institute. James McCord reports the following: Roche, Research Support; Abbott, Research Support; Siemens, Research Support and Consulting; and Beckman Coulter, Research Support and Consulting. Nicholas Mills has received honoraria or consultancy from Abbott Diagnostics, Roche Diagnostics, Siemens Healthineers, and Lumira Dx, and the University of Edinburgh has received research grants from Abbott Diagnostics and Siemens Healthineers supported by Chair, Program and Research Excellence Awards (CH/F/21/90010, RG/20/10/34966, RE/18/5/34216) from the British Heart Foundation. The other coauthors report no disclosures.
	Trial registration number: NCT04488913