Rule-out of non-ST-segment elevation acute coronary syndrome by a single, pre-hospital troponin measurement: a randomized trial.


Journal

European heart journal
ISSN: 1522-9645
Titre abrégé: Eur Heart J
Pays: England
ID NLM: 8006263

Informations de publication

Date de publication:
14 05 2023
Historique:
received: 12 10 2022
revised: 28 12 2022
accepted: 25 01 2023
medline: 15 5 2023
pubmed: 10 2 2023
entrez: 9 2 2023
Statut: ppublish

Résumé

Patients with suspected non-ST-segment elevation acute coronary syndrome (NSTE-ACS) are routinely transferred to the emergency department (ED). A clinical risk score with point-of-care (POC) troponin measurement might enable ambulance paramedics to identify low-risk patients in whom ED evaluation is unnecessary. The aim was to assess safety and healthcare costs of a pre-hospital rule-out strategy using a POC troponin measurement in low-risk suspected NSTE-ACS patients. This investigator-initiated, randomized clinical trial was conducted in five ambulance regions in the Netherlands. Suspected NSTE-ACS patients with HEAR (History, ECG, Age, Risk factors) score ≤3 were randomized to pre-hospital rule-out with POC troponin measurement or direct transfer to the ED. The sample size calculation was based on the primary outcome of 30-day healthcare costs. Secondary outcome was safety, defined as 30-day major adverse cardiac events (MACE), consisting of ACS, unplanned revascularization or all-cause death. : A total of 863 participants were randomized. Healthcare costs were significantly lower in the pre-hospital strategy (€1349 ± €2051 vs. €1960 ± €1808) with a mean difference of €611 [95% confidence interval (CI): 353-869; P < 0.001]. In the total population, MACE were comparable between groups [3.9% (17/434) in pre-hospital strategy vs. 3.7% (16/429) in ED strategy; P = 0.89]. In the ruled-out ACS population, MACE were very low [0.5% (2/419) vs. 1.0% (4/417)], with a risk difference of -0.5% (95% CI -1.6%-0.7%; P = 0.41) in favour of the pre-hospital strategy. Pre-hospital rule-out of ACS with a POC troponin measurement in low-risk patients significantly reduces healthcare costs while incidence of MACE was low in both strategies. Clinicaltrials.gov identifier NCT05466591 and International Clinical Trials Registry Platform id NTR 7346.

Identifiants

pubmed: 36755110
pii: 7031792
doi: 10.1093/eurheartj/ehad056
pmc: PMC10182886
doi:

Substances chimiques

Troponin 0
Biomarkers 0

Banques de données

ClinicalTrials.gov
['NCT05466591']

Types de publication

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

Langues

eng

Sous-ensembles de citation

IM

Pagination

1705-1714

Commentaires et corrections

Type : CommentIn

Informations de copyright

© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.

Déclaration de conflit d'intérêts

Conflict of interest C.C. reports a grant from ZonMw (The Netherlands Organisation for Health Research and Development) and consulting fees from AstraZeneca and Xenikos BV; R.R.J.v.K. reports honoraria grants from Bayer and Novartis, P.D. reports grants from Philips, Abbott and AstraZeneca and consulting fees from Philips; N.v.R. reports grants from Abbott, Philips, Medtronic and Biotronik and speaker fees from Microport, Abbott, Rainmed and Bayer. The other authors have no conflicts of interest.

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Auteurs

Cyril Camaro (C)

Department of Cardiology, Radboud University Medical Centre, P.O. Box 9101, Geert Grooteplein Zuid 10, 6525 GA Nijmegen, Gelderland, The Netherlands.

Goaris W A Aarts (GWA)

Department of Cardiology, Radboud University Medical Centre, P.O. Box 9101, Geert Grooteplein Zuid 10, 6525 GA Nijmegen, Gelderland, The Netherlands.

Eddy M M Adang (EMM)

Department of Health Evidence, Radboud Institute for Health Sciences, Geert Grooteplein 21, 6525 EZ Nijmegen, Gelderland, The Netherlands.

Roger van Hout (R)

Ambulance Service, Safety region Gelderland-Zuid, Professor Bellefroidstraat 11, 6525 AG Nijmegen, Gelderland, The Netherlands.

Gijs Brok (G)

Ambulance Service, Safety region Gelderland-Zuid, Professor Bellefroidstraat 11, 6525 AG Nijmegen, Gelderland, The Netherlands.

Anouk Hoare (A)

Ambulance Service, Witte Kruis, Ringveste 7A, 3992 DD Houten, Utrecht, The Netherlands.

Laura Rodwell (L)

Department of Health Evidence, Radboud Institute for Health Sciences, Geert Grooteplein 21, 6525 EZ Nijmegen, Gelderland, The Netherlands.

Frank de Pooter (F)

Ambulance Service, Witte Kruis, Ringveste 7A, 3992 DD Houten, Utrecht, The Netherlands.

Walter de Wit (W)

Ambulance Service, Witte Kruis, Ringveste 7A, 3992 DD Houten, Utrecht, The Netherlands.

Gilbert E Cramer (GE)

Department of Cardiology, Radboud University Medical Centre, P.O. Box 9101, Geert Grooteplein Zuid 10, 6525 GA Nijmegen, Gelderland, The Netherlands.

Roland R J van Kimmenade (RRJ)

Department of Cardiology, Radboud University Medical Centre, P.O. Box 9101, Geert Grooteplein Zuid 10, 6525 GA Nijmegen, Gelderland, The Netherlands.

Peter Damman (P)

Department of Cardiology, Radboud University Medical Centre, P.O. Box 9101, Geert Grooteplein Zuid 10, 6525 GA Nijmegen, Gelderland, The Netherlands.

Eva Ouwendijk (E)

General Practitioner Centre Nijmegen and Boxmeer, Weg door Jonkerbos 108, 6532 SZ Nijmegen, Gelderland, The Netherlands.

Martijn Rutten (M)

Scientific Centre for Quality of Healthcare (IQ Healthcare), Radboud University Medical Centre, Kapittelweg 54, 6525 EP Nijmegen, Gelderland, The Netherlands.

Erwin Zegers (E)

Department of Cardiology, Canisius Wilhelmina Hospital, Weg door Jonkerbos 100, 6532 SZ Nijmegen, Gelderland, The Netherlands.

Robert-Jan M van Geuns (RM)

Department of Cardiology, Radboud University Medical Centre, P.O. Box 9101, Geert Grooteplein Zuid 10, 6525 GA Nijmegen, Gelderland, The Netherlands.

Marc E R Gomes (MER)

Department of Cardiology, Canisius Wilhelmina Hospital, Weg door Jonkerbos 100, 6532 SZ Nijmegen, Gelderland, The Netherlands.

Niels van Royen (N)

Department of Cardiology, Radboud University Medical Centre, P.O. Box 9101, Geert Grooteplein Zuid 10, 6525 GA Nijmegen, Gelderland, The Netherlands.

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