Late Outcomes of the RAPID-TnT Randomized Controlled Trial: 0/1-Hour High-Sensitivity Troponin T Protocol in Suspected ACS.

acute coronary syndrome diagnostic testing high-sensitivity troponin myocardial infarction randomized trial

Journal

Circulation
ISSN: 1524-4539
Titre abrégé: Circulation
Pays: United States
ID NLM: 0147763

Informations de publication

Date de publication:
13 07 2021
Historique:
pubmed: 18 5 2021
medline: 30 12 2021
entrez: 17 5 2021
Statut: ppublish

Résumé

High-sensitivity troponin assays are increasingly being adopted to expedite evaluation of patients with suspected acute coronary syndromes. Few direct comparisons have examined whether the enhanced performance of these assays at low concentrations leads to changes in care that improves longer-term outcomes. This study evaluated late outcomes of participants managed under an unmasked 0/1-hour high-sensitivity cardiac troponin T (hs-cTnT) protocol compared with a 0/3-hour masked hs-cTnT protocol. We conducted a multicenter prospective patient-level randomized comparison of care informed by unmasked 0/1-hour hs-cTnT protocol (reported to <5 ng/L) versus standard practice masked hs-cTnT testing (reported to ≤29 ng/L) assessed at 0/3 hours and followed participants for 12 months. Participants included were those presenting to metropolitan emergency departments with suspected acute coronary syndromes, without ECG evidence of coronary ischemia. The primary end point was time to all-cause death or myocardial infarction using Cox proportional hazards models adjusted for clustering within hospitals. Between August 2015 and April 2019, we randomized 3378 participants, of whom 108 withdrew, resulting in 12-month follow-up for 3270 participants (masked: 1632; unmasked: 1638). Among these, 2993 (91.5%) had an initial troponin concentration of ≤29 ng/L. Deployment of the 0/1-hour hs-cTnT protocol was associated with reductions in functional testing. Over 12-month follow-up, there was no difference in invasive coronary angiography (0/1-hour unmasked: 232/1638 [14.2%]; 0/3-hour masked: 202/1632 [12.4%]; Unmasked hs-cTnT reporting deployed within a 0/1-hour protocol did not reduce ischemic events over 12-month follow-up. Changes in practice associated with the implementation of this protocol may be associated with an increase in death and myocardial infarction among those with newly identified troponin elevations. Registration: URL: https://www.anzctr.org.au; Unique identifier: ACTRN12615001379505.

Sections du résumé

BACKGROUND
High-sensitivity troponin assays are increasingly being adopted to expedite evaluation of patients with suspected acute coronary syndromes. Few direct comparisons have examined whether the enhanced performance of these assays at low concentrations leads to changes in care that improves longer-term outcomes. This study evaluated late outcomes of participants managed under an unmasked 0/1-hour high-sensitivity cardiac troponin T (hs-cTnT) protocol compared with a 0/3-hour masked hs-cTnT protocol.
METHODS
We conducted a multicenter prospective patient-level randomized comparison of care informed by unmasked 0/1-hour hs-cTnT protocol (reported to <5 ng/L) versus standard practice masked hs-cTnT testing (reported to ≤29 ng/L) assessed at 0/3 hours and followed participants for 12 months. Participants included were those presenting to metropolitan emergency departments with suspected acute coronary syndromes, without ECG evidence of coronary ischemia. The primary end point was time to all-cause death or myocardial infarction using Cox proportional hazards models adjusted for clustering within hospitals.
RESULTS
Between August 2015 and April 2019, we randomized 3378 participants, of whom 108 withdrew, resulting in 12-month follow-up for 3270 participants (masked: 1632; unmasked: 1638). Among these, 2993 (91.5%) had an initial troponin concentration of ≤29 ng/L. Deployment of the 0/1-hour hs-cTnT protocol was associated with reductions in functional testing. Over 12-month follow-up, there was no difference in invasive coronary angiography (0/1-hour unmasked: 232/1638 [14.2%]; 0/3-hour masked: 202/1632 [12.4%];
CONCLUSIONS
Unmasked hs-cTnT reporting deployed within a 0/1-hour protocol did not reduce ischemic events over 12-month follow-up. Changes in practice associated with the implementation of this protocol may be associated with an increase in death and myocardial infarction among those with newly identified troponin elevations. Registration: URL: https://www.anzctr.org.au; Unique identifier: ACTRN12615001379505.

Identifiants

pubmed: 33998255
doi: 10.1161/CIRCULATIONAHA.121.055009
doi:

Substances chimiques

Troponin T 0

Banques de données

ANZCTR
['ACTRN12615001379505']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

113-125

Commentaires et corrections

Type : CommentIn
Type : CommentIn
Type : CommentIn

Auteurs

Kristina Lambrakis (K)

College of Medicine and Public Health, Flinders University of South Australia, Adelaide (K.L., A.B., A.S., A.C., E.K., E.M., J.K., D.P.C.).
South Australian Department of Health, Adelaide (K.L., C.P., A.B., A.S., M.J.R.E., A.C., E.K., A.J.N., D.W., M.H., D.P.C.).

Cynthia Papendick (C)

South Australian Department of Health, Adelaide (K.L., C.P., A.B., A.S., M.J.R.E., A.C., E.K., A.J.N., D.W., M.H., D.P.C.).
School of Medicine, University of Adelaide, Australia (C.P., A.J.N.).

John K French (JK)

Department of Cardiology, Liverpool Hospital, University of New South Wales, Sydney, Australia (J.K.F.).

Stephen Quinn (S)

Department of Statistics, Data Science and Epidemiology (S.Q.), Swinburne University of Technology, Melbourne, Australia.

Andrew Blyth (A)

College of Medicine and Public Health, Flinders University of South Australia, Adelaide (K.L., A.B., A.S., A.C., E.K., E.M., J.K., D.P.C.).
South Australian Department of Health, Adelaide (K.L., C.P., A.B., A.S., M.J.R.E., A.C., E.K., A.J.N., D.W., M.H., D.P.C.).

Anil Seshadri (A)

College of Medicine and Public Health, Flinders University of South Australia, Adelaide (K.L., A.B., A.S., A.C., E.K., E.M., J.K., D.P.C.).
South Australian Department of Health, Adelaide (K.L., C.P., A.B., A.S., M.J.R.E., A.C., E.K., A.J.N., D.W., M.H., D.P.C.).

Michael J R Edmonds (MJR)

South Australian Department of Health, Adelaide (K.L., C.P., A.B., A.S., M.J.R.E., A.C., E.K., A.J.N., D.W., M.H., D.P.C.).

Anthony Chuang (A)

College of Medicine and Public Health, Flinders University of South Australia, Adelaide (K.L., A.B., A.S., A.C., E.K., E.M., J.K., D.P.C.).
South Australian Department of Health, Adelaide (K.L., C.P., A.B., A.S., M.J.R.E., A.C., E.K., A.J.N., D.W., M.H., D.P.C.).

Ehsan Khan (E)

College of Medicine and Public Health, Flinders University of South Australia, Adelaide (K.L., A.B., A.S., A.C., E.K., E.M., J.K., D.P.C.).
South Australian Department of Health, Adelaide (K.L., C.P., A.B., A.S., M.J.R.E., A.C., E.K., A.J.N., D.W., M.H., D.P.C.).

Adam J Nelson (AJ)

South Australian Department of Health, Adelaide (K.L., C.P., A.B., A.S., M.J.R.E., A.C., E.K., A.J.N., D.W., M.H., D.P.C.).
School of Medicine, University of Adelaide, Australia (C.P., A.J.N.).

Deborah Wright (D)

South Australian Department of Health, Adelaide (K.L., C.P., A.B., A.S., M.J.R.E., A.C., E.K., A.J.N., D.W., M.H., D.P.C.).

Matthew Horsfall (M)

South Australian Department of Health, Adelaide (K.L., C.P., A.B., A.S., M.J.R.E., A.C., E.K., A.J.N., D.W., M.H., D.P.C.).

Erin Morton (E)

College of Medicine and Public Health, Flinders University of South Australia, Adelaide (K.L., A.B., A.S., A.C., E.K., E.M., J.K., D.P.C.).

Jonathan Karnon (J)

College of Medicine and Public Health, Flinders University of South Australia, Adelaide (K.L., A.B., A.S., A.C., E.K., E.M., J.K., D.P.C.).

Tom Briffa (T)

School of Population and Global Health, University of Western Australia, Perth (T.B.).

Louise A Cullen (LA)

Emergency and Trauma Centre, Royal Brisbane and Women's Hospital, Australia (L.A.C.).
School of Public Health, Queensland University of Technology, Brisbane, Australia (L.A.C.).
School of Medicine, University of Queensland, Brisbane, Australia (L.A.C.).

Derek P Chew (DP)

College of Medicine and Public Health, Flinders University of South Australia, Adelaide (K.L., A.B., A.S., A.C., E.K., E.M., J.K., D.P.C.).
South Australian Health and Medical Research Institute, Adelaide (D.P.C.).
South Australian Department of Health, Adelaide (K.L., C.P., A.B., A.S., M.J.R.E., A.C., E.K., A.J.N., D.W., M.H., D.P.C.).

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