Department of Cardiology, Radboud University Medical Centre, P.O. Box 9101, Geert Grooteplein Zuid 10, 6525 GA Nijmegen, Gelderland, The Netherlands.
Department of Health Evidence, Radboud Institute for Health Sciences, Geert Grooteplein 21, 6525 EZ Nijmegen, Gelderland, The Netherlands.
Eur Heart J. 2023 May 14;44(19):1705-1714. doi: 10.1093/eurheartj/ehad056.
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.
疑似非 ST 段抬高型急性冠状动脉综合征（NSTE-ACS）患者通常被转至急诊科（ED）。一种具有即时检测（POC）肌钙蛋白检测的临床风险评分可能使救护车护理人员能够识别出低风险患者，这些患者无需进行 ED 评估。目的是评估在低危疑似 NSTE-ACS 患者中使用 POC 肌钙蛋白检测进行院前排除策略的安全性和医疗保健成本。
这是一项由研究者发起的、在荷兰五个救护车区域进行的随机临床试验。HEAR（病史、心电图、年龄、危险因素）评分≤3 的疑似 NSTE-ACS 患者被随机分为院前排除策略（使用 POC 肌钙蛋白检测）或直接转至 ED。样本量计算基于主要结局 30 天医疗保健成本。次要结局为安全性，定义为 30 天内主要不良心脏事件（MACE），包括 ACS、计划外血运重建或全因死亡。共纳入 863 名患者进行随机分组。院前策略的医疗保健成本显著降低（€1349±€2051 比 €1960±€1808），平均差异为 €611（95%CI：353-869；P<0.001）。在总人群中，两组之间的 MACE 无差异[院前策略组 3.9%（17/434），ED 策略组 3.7%（16/429）；P=0.89]。在排除 ACS 的人群中，MACE 发生率非常低[0.5%（2/419）比 1.0%（4/417）]，院前策略的风险差异为-0.5%（95%CI-1.6%-0.7%；P=0.41）。
在低危患者中，使用 POC 肌钙蛋白检测进行院前 ACS 排除可显著降低医疗保健成本，同时两种策略的 MACE 发生率均较低。
Clinicaltrials.gov 标识符 NCT05466591 和国际临床试验注册平台 id NTR 7346。
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