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Randomized Controlled Trial
. 2023 May 14;44(19):1705-1714.
doi: 10.1093/eurheartj/ehad056.

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

Cyril Camaro  1 , Goaris W A Aarts  1 , Eddy M M Adang  2 , Roger van Hout  3 , Gijs Brok  3 , Anouk Hoare  4 , Laura Rodwell  2 , Frank de Pooter  4 , Walter de Wit  4 , Gilbert E Cramer  1 , Roland R J van Kimmenade  1 , Peter Damman  1 , Eva Ouwendijk  5 , Martijn Rutten  6 , Erwin Zegers  7 , Robert-Jan M van Geuns  1 , Marc E R Gomes  7 , Niels van Royen  1
Affiliations
Randomized Controlled Trial

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

Cyril Camaro et al. Eur Heart J. .

Abstract

Aims: 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.

Methods and results: 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.

Conclusion: 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.

Trial registration: Clinicaltrials.gov identifier NCT05466591 and International Clinical Trials Registry Platform id NTR 7346.

Keywords: Acute coronary syndrome; HEART score; Point-of-care troponin; Pre-hospital triage; Risk stratification.

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Conflict of interest statement

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.

Figures

Structured Graphical Abstract
Structured Graphical Abstract
ACS, acute coronary syndrome; CI, confidence interval; ED, emergency department; MACE, major adverse cardiac events; NSTE-ACS, non-ST-elevation acute coronary syndrome; POC, point-of-care
Figure 1
Figure 1
Flow chart of recruitment and participants. ED, emergency department; HEAR score, History Electrocardiogram Age Risk factors score; IC, informed consent; POC, point-of-care.
Figure 2
Figure 2
Median on-scene time and time to availability. ED, emergency department.
Figure 3
Figure 3
MACE at 30 days. MACE, major adverse cardiac events; ED, emergency department; ACS, acute coronary syndrome.
See this image and copyright information in PMC

Comment in

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