A randomized trial of a 1-hour Troponin T protocol in suspected acute coronary syndromes. The rapid assessment of possible acute coronary syndrome in the Emergency Department with high-sensitivity Troponin T study (RAPID-TnT)

Derek Chew, Kristina Lambrakis, Andrew Blyth, Anil Seshadri, Michael J.R. Edmonds, Tom Briffa, Louise A. Cullen, Stephen Quinn, Jonathan Karnon, Anthony Chuang, Adam J. Nelson, Deborah Wright, Matthew Horsfall, Erin Morton, John K. French, Cynthia Papendick

Research output: Contribution to journalArticle

Abstract

BACKGROUND: High-sensitivity troponin assays promise earlier discrimination of myocardial infarction. Yet, the benefits and harms of this improved discriminatory performance when incorporated within rapid testing protocols, with respect to subsequent testing and clinical events, has not been evaluated in an in-practice patient-level randomized study. This multicenter study evaluated the noninferiority of a 0/1-hour high-sensitivity cardiac troponin T (hs-cTnT) protocol in comparison with a 0/3-hour masked hs-cTnT protocol in patients with suspected acute coronary syndrome presenting to the emergency department (ED). METHODS: Patients were randomly assigned to either a 0/1-hour hs-cTnT protocol (reported to the limit of detection [<5 ng/L]) or masked hs-cTnT reported to ≤29 ng/L evaluated at 0/3-hours (standard arm). The 30-day primary end point was all-cause death and myocardial infarction. Noninferiority was defined as an absolute margin of 0.5% determined by Poisson regression. RESULTS: In total, 3378 participants with an emergency presentation were randomly assigned between August 2015 and April 2019. Ninety participants were deemed ineligible or withdrew consent. The remaining participants received care guided either by the 0/1-hour hs-cTnT protocol (n=1646) or the 0/3-hour standard masked hs-cTnT protocol (n=1642) and were followed for 30 days. Median age was 59 (49-70) years, and 47% were female. Participants in the 0/1-hour arm were more likely to be discharged from the ED (0/1-hour arm: 45.1% versus standard arm: 32.3%, P<0.001) and median ED length of stay was shorter (0/1-hour arm: 4.6 [interquartile range, 3.4-6.4] hours versus standard arm: 5.6 (interquartile range, 4.0-7.1) hours, P<0.001). Those randomly assigned to the 0/1-hour protocol were less likely to undergo functional cardiac testing (0/1-hour arm: 7.5% versus standard arm: 11.0%, P<0.001). The 0/1-hour hs-cTnT protocol was not inferior to standard care (0/1-hour arm: 17/1646 [1.0%] versus 16/1642 [1.0%]; incidence rate ratio, 1.06 [ 0.53-2.11], noninferiority P value=0.006, superiority P value=0.867), although an increase in myocardial injury was observed. Among patients discharged from ED, the 0/1-hour protocol had a negative predictive value of 99.6% (95% CI, 99.0-99.9%) for 30-day death or myocardial infarction. CONCLUSIONS: This in-practice evaluation of a 0/1-hour hs-cTnT protocol embedded in ED care enabled more rapid discharge of patients with suspected acute coronary syndrome. Improving short-term outcomes among patients with newly recognized troponin T elevation will require an evolution in management strategies for these patients. CLINICAL TRIAL REGISTRATION: URL: https://www.anzctr.org.au. Unique identifier: ACTRN12615001379505.

LanguageEnglish
Pages1543-1556
Number of pages14
JournalCirculation
Volume140
Issue number19
DOIs
Publication statusPublished - 5 Nov 2019
Externally publishedYes

Keywords

  • acute coronary syndrome
  • chest pain
  • clinical trial
  • myocardial infarction
  • troponin

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Chew, Derek ; Lambrakis, Kristina ; Blyth, Andrew ; Seshadri, Anil ; Edmonds, Michael J.R. ; Briffa, Tom ; Cullen, Louise A. ; Quinn, Stephen ; Karnon, Jonathan ; Chuang, Anthony ; Nelson, Adam J. ; Wright, Deborah ; Horsfall, Matthew ; Morton, Erin ; French, John K. ; Papendick, Cynthia. / A randomized trial of a 1-hour Troponin T protocol in suspected acute coronary syndromes. The rapid assessment of possible acute coronary syndrome in the Emergency Department with high-sensitivity Troponin T study (RAPID-TnT). In: Circulation. 2019 ; Vol. 140, No. 19. pp. 1543-1556.
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title = "A randomized trial of a 1-hour Troponin T protocol in suspected acute coronary syndromes. The rapid assessment of possible acute coronary syndrome in the Emergency Department with high-sensitivity Troponin T study (RAPID-TnT)",
abstract = "BACKGROUND: High-sensitivity troponin assays promise earlier discrimination of myocardial infarction. Yet, the benefits and harms of this improved discriminatory performance when incorporated within rapid testing protocols, with respect to subsequent testing and clinical events, has not been evaluated in an in-practice patient-level randomized study. This multicenter study evaluated the noninferiority of a 0/1-hour high-sensitivity cardiac troponin T (hs-cTnT) protocol in comparison with a 0/3-hour masked hs-cTnT protocol in patients with suspected acute coronary syndrome presenting to the emergency department (ED). METHODS: Patients were randomly assigned to either a 0/1-hour hs-cTnT protocol (reported to the limit of detection [<5 ng/L]) or masked hs-cTnT reported to ≤29 ng/L evaluated at 0/3-hours (standard arm). The 30-day primary end point was all-cause death and myocardial infarction. Noninferiority was defined as an absolute margin of 0.5{\%} determined by Poisson regression. RESULTS: In total, 3378 participants with an emergency presentation were randomly assigned between August 2015 and April 2019. Ninety participants were deemed ineligible or withdrew consent. The remaining participants received care guided either by the 0/1-hour hs-cTnT protocol (n=1646) or the 0/3-hour standard masked hs-cTnT protocol (n=1642) and were followed for 30 days. Median age was 59 (49-70) years, and 47{\%} were female. Participants in the 0/1-hour arm were more likely to be discharged from the ED (0/1-hour arm: 45.1{\%} versus standard arm: 32.3{\%}, P<0.001) and median ED length of stay was shorter (0/1-hour arm: 4.6 [interquartile range, 3.4-6.4] hours versus standard arm: 5.6 (interquartile range, 4.0-7.1) hours, P<0.001). Those randomly assigned to the 0/1-hour protocol were less likely to undergo functional cardiac testing (0/1-hour arm: 7.5{\%} versus standard arm: 11.0{\%}, P<0.001). The 0/1-hour hs-cTnT protocol was not inferior to standard care (0/1-hour arm: 17/1646 [1.0{\%}] versus 16/1642 [1.0{\%}]; incidence rate ratio, 1.06 [ 0.53-2.11], noninferiority P value=0.006, superiority P value=0.867), although an increase in myocardial injury was observed. Among patients discharged from ED, the 0/1-hour protocol had a negative predictive value of 99.6{\%} (95{\%} CI, 99.0-99.9{\%}) for 30-day death or myocardial infarction. CONCLUSIONS: This in-practice evaluation of a 0/1-hour hs-cTnT protocol embedded in ED care enabled more rapid discharge of patients with suspected acute coronary syndrome. Improving short-term outcomes among patients with newly recognized troponin T elevation will require an evolution in management strategies for these patients. CLINICAL TRIAL REGISTRATION: URL: https://www.anzctr.org.au. Unique identifier: ACTRN12615001379505.",
keywords = "acute coronary syndrome, chest pain, clinical trial, myocardial infarction, troponin",
author = "Derek Chew and Kristina Lambrakis and Andrew Blyth and Anil Seshadri and Edmonds, {Michael J.R.} and Tom Briffa and Cullen, {Louise A.} and Stephen Quinn and Jonathan Karnon and Anthony Chuang and Nelson, {Adam J.} and Deborah Wright and Matthew Horsfall and Erin Morton and French, {John K.} and Cynthia Papendick",
year = "2019",
month = "11",
day = "5",
doi = "10.1161/CIRCULATIONAHA.119.042891",
language = "English",
volume = "140",
pages = "1543--1556",
journal = "Circulation",
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Chew, D, Lambrakis, K, Blyth, A, Seshadri, A, Edmonds, MJR, Briffa, T, Cullen, LA, Quinn, S, Karnon, J, Chuang, A, Nelson, AJ, Wright, D, Horsfall, M, Morton, E, French, JK & Papendick, C 2019, 'A randomized trial of a 1-hour Troponin T protocol in suspected acute coronary syndromes. The rapid assessment of possible acute coronary syndrome in the Emergency Department with high-sensitivity Troponin T study (RAPID-TnT)', Circulation, vol. 140, no. 19, pp. 1543-1556. https://doi.org/10.1161/CIRCULATIONAHA.119.042891

A randomized trial of a 1-hour Troponin T protocol in suspected acute coronary syndromes. The rapid assessment of possible acute coronary syndrome in the Emergency Department with high-sensitivity Troponin T study (RAPID-TnT). / Chew, Derek; Lambrakis, Kristina; Blyth, Andrew; Seshadri, Anil; Edmonds, Michael J.R.; Briffa, Tom; Cullen, Louise A.; Quinn, Stephen; Karnon, Jonathan; Chuang, Anthony; Nelson, Adam J.; Wright, Deborah; Horsfall, Matthew; Morton, Erin; French, John K.; Papendick, Cynthia.

In: Circulation, Vol. 140, No. 19, 05.11.2019, p. 1543-1556.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A randomized trial of a 1-hour Troponin T protocol in suspected acute coronary syndromes. The rapid assessment of possible acute coronary syndrome in the Emergency Department with high-sensitivity Troponin T study (RAPID-TnT)

AU - Chew, Derek

AU - Lambrakis, Kristina

AU - Blyth, Andrew

AU - Seshadri, Anil

AU - Edmonds, Michael J.R.

AU - Briffa, Tom

AU - Cullen, Louise A.

AU - Quinn, Stephen

AU - Karnon, Jonathan

AU - Chuang, Anthony

AU - Nelson, Adam J.

AU - Wright, Deborah

AU - Horsfall, Matthew

AU - Morton, Erin

AU - French, John K.

AU - Papendick, Cynthia

PY - 2019/11/5

Y1 - 2019/11/5

N2 - BACKGROUND: High-sensitivity troponin assays promise earlier discrimination of myocardial infarction. Yet, the benefits and harms of this improved discriminatory performance when incorporated within rapid testing protocols, with respect to subsequent testing and clinical events, has not been evaluated in an in-practice patient-level randomized study. This multicenter study evaluated the noninferiority of a 0/1-hour high-sensitivity cardiac troponin T (hs-cTnT) protocol in comparison with a 0/3-hour masked hs-cTnT protocol in patients with suspected acute coronary syndrome presenting to the emergency department (ED). METHODS: Patients were randomly assigned to either a 0/1-hour hs-cTnT protocol (reported to the limit of detection [<5 ng/L]) or masked hs-cTnT reported to ≤29 ng/L evaluated at 0/3-hours (standard arm). The 30-day primary end point was all-cause death and myocardial infarction. Noninferiority was defined as an absolute margin of 0.5% determined by Poisson regression. RESULTS: In total, 3378 participants with an emergency presentation were randomly assigned between August 2015 and April 2019. Ninety participants were deemed ineligible or withdrew consent. The remaining participants received care guided either by the 0/1-hour hs-cTnT protocol (n=1646) or the 0/3-hour standard masked hs-cTnT protocol (n=1642) and were followed for 30 days. Median age was 59 (49-70) years, and 47% were female. Participants in the 0/1-hour arm were more likely to be discharged from the ED (0/1-hour arm: 45.1% versus standard arm: 32.3%, P<0.001) and median ED length of stay was shorter (0/1-hour arm: 4.6 [interquartile range, 3.4-6.4] hours versus standard arm: 5.6 (interquartile range, 4.0-7.1) hours, P<0.001). Those randomly assigned to the 0/1-hour protocol were less likely to undergo functional cardiac testing (0/1-hour arm: 7.5% versus standard arm: 11.0%, P<0.001). The 0/1-hour hs-cTnT protocol was not inferior to standard care (0/1-hour arm: 17/1646 [1.0%] versus 16/1642 [1.0%]; incidence rate ratio, 1.06 [ 0.53-2.11], noninferiority P value=0.006, superiority P value=0.867), although an increase in myocardial injury was observed. Among patients discharged from ED, the 0/1-hour protocol had a negative predictive value of 99.6% (95% CI, 99.0-99.9%) for 30-day death or myocardial infarction. CONCLUSIONS: This in-practice evaluation of a 0/1-hour hs-cTnT protocol embedded in ED care enabled more rapid discharge of patients with suspected acute coronary syndrome. Improving short-term outcomes among patients with newly recognized troponin T elevation will require an evolution in management strategies for these patients. CLINICAL TRIAL REGISTRATION: URL: https://www.anzctr.org.au. Unique identifier: ACTRN12615001379505.

AB - BACKGROUND: High-sensitivity troponin assays promise earlier discrimination of myocardial infarction. Yet, the benefits and harms of this improved discriminatory performance when incorporated within rapid testing protocols, with respect to subsequent testing and clinical events, has not been evaluated in an in-practice patient-level randomized study. This multicenter study evaluated the noninferiority of a 0/1-hour high-sensitivity cardiac troponin T (hs-cTnT) protocol in comparison with a 0/3-hour masked hs-cTnT protocol in patients with suspected acute coronary syndrome presenting to the emergency department (ED). METHODS: Patients were randomly assigned to either a 0/1-hour hs-cTnT protocol (reported to the limit of detection [<5 ng/L]) or masked hs-cTnT reported to ≤29 ng/L evaluated at 0/3-hours (standard arm). The 30-day primary end point was all-cause death and myocardial infarction. Noninferiority was defined as an absolute margin of 0.5% determined by Poisson regression. RESULTS: In total, 3378 participants with an emergency presentation were randomly assigned between August 2015 and April 2019. Ninety participants were deemed ineligible or withdrew consent. The remaining participants received care guided either by the 0/1-hour hs-cTnT protocol (n=1646) or the 0/3-hour standard masked hs-cTnT protocol (n=1642) and were followed for 30 days. Median age was 59 (49-70) years, and 47% were female. Participants in the 0/1-hour arm were more likely to be discharged from the ED (0/1-hour arm: 45.1% versus standard arm: 32.3%, P<0.001) and median ED length of stay was shorter (0/1-hour arm: 4.6 [interquartile range, 3.4-6.4] hours versus standard arm: 5.6 (interquartile range, 4.0-7.1) hours, P<0.001). Those randomly assigned to the 0/1-hour protocol were less likely to undergo functional cardiac testing (0/1-hour arm: 7.5% versus standard arm: 11.0%, P<0.001). The 0/1-hour hs-cTnT protocol was not inferior to standard care (0/1-hour arm: 17/1646 [1.0%] versus 16/1642 [1.0%]; incidence rate ratio, 1.06 [ 0.53-2.11], noninferiority P value=0.006, superiority P value=0.867), although an increase in myocardial injury was observed. Among patients discharged from ED, the 0/1-hour protocol had a negative predictive value of 99.6% (95% CI, 99.0-99.9%) for 30-day death or myocardial infarction. CONCLUSIONS: This in-practice evaluation of a 0/1-hour hs-cTnT protocol embedded in ED care enabled more rapid discharge of patients with suspected acute coronary syndrome. Improving short-term outcomes among patients with newly recognized troponin T elevation will require an evolution in management strategies for these patients. CLINICAL TRIAL REGISTRATION: URL: https://www.anzctr.org.au. Unique identifier: ACTRN12615001379505.

KW - acute coronary syndrome

KW - chest pain

KW - clinical trial

KW - myocardial infarction

KW - troponin

UR - http://www.scopus.com/inward/record.url?scp=85074553429&partnerID=8YFLogxK

U2 - 10.1161/CIRCULATIONAHA.119.042891

DO - 10.1161/CIRCULATIONAHA.119.042891

M3 - Article

VL - 140

SP - 1543

EP - 1556

JO - Circulation

T2 - Circulation

JF - Circulation

SN - 0009-7322

IS - 19

ER -