Rapid Acute Coronary Syndrome Evaluation Over One Hour With High-Sensitivity Cardiac Troponin I: A United States-Based Stepped-Wedge, Randomized Trial
Joseph Miller, Bernard Cook, Chaun M. Gandolfo, Nicholas L. Mills, Simon A. Mahler, Phillip D. Levy, Sachin Parikh, Seth Krupp, Khaled Nour, Howard Klausner, Ryan Gindi, Aaron Lewandowski, Michael Hudson, Giuseppe Perrotta, Bryan Zweig, David E. Lanfear, Henry Kim, Shooshan Dangoulian, Amy Tang, Erika Todter, Altaf Khan, Catriona Keerie, Shane Bole, Hashem Nasseredine, Ahmed Oudeif, Elian Abou Asala, Mustafa Mohammed, Ahmed Kazem, Kelly Malette, Gulmohar Singh-Kucukarslan, Nicole Y. Xu, Sophie Wittenberg, Thayer Morton, Satheesh Gunaga, Ziad Affas, Kutiba Tabbaa, Parth Desai, Ayman Alsaadi, Shazil Mahmood, Andrew Schock, Nicholas Konowitz, J. Fuchs, Kate Joyce, Lance Shamoun, Jacob Babel, A Broomé, G V DiGiacinto, Elizabeth Shaheen, Gale Darnell, Gregory Muller, Gerard Heath, Gust Bills, Jason Vieder, Steven Rockoff, Brian Kim, Anthony Colucci, Elizabeth Plemmons, James McCord
Abstract
Study objectiveThe 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.MethodsThe 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.ResultsThere 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).ConclusionA 0/1-hour accelerated protocol using high-sensitivity cardiac troponin I did not lead to more safe ED discharges compared with standard care. 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. 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. 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). A 0/1-hour accelerated protocol using high-sensitivity cardiac troponin I did not lead to more safe ED discharges compared with standard care.