ARTICA RCT primary outcome

• Main Author: Camaro, C (Radboudumc) ORCID=0000-0001-6170-8318
• Other Authors: Aarts, G.W.A. (Radboudumc Nijmegen) ORCID=0000-0003-4912-295X, Researcher, van Royen, Prof.dr NIELS (Radboudumc) ORCID=0000-0001-6136-8640, ProjectLeader, Camaro, C. (Radboudumc) ORCID=0000-0001-6170-8318, RightsHolder
• Format: Dataset
• Language: English
• Published: 2019
• Subjects: Cardiovascular disorders; Point-of-care troponin; Risk stratification; Acute coronary syndrome; HEART score; Pre-hospital triage; Mace; artica
• Online Access: http://nbn-resolving.org/urn:nbn:nl:ui:13-uo-ck3s; https://easy.dans.knaw.nl/ui/datasets/id/easy-dataset:324120

BACKGROUND: 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 major adverse cardiac events was low in both strategies