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

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

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.

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.

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

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.

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