高危急性冠状动脉综合征患者动态心电图监测的评估：MONITOR ACS-Epic 13随机试验
Evaluation of ambulatory electrocardiographic monitoring of patients after high-risk acute coronary syndrome: the MONITOR ACS-Epic 13 randomized trial.
作者信息
De La Torre Hernandez Jose M, Exposito Victor, Gonzalez Enriquez Susana, Rodriguez Entem Felipe, Margarida Adrian, García Camarero Tamara, Veiga Gabriela, Sainz Laso Fermin, Lee Dae-Hyun, Gil Ongay Aritz, Barrera Sergio, Catoya Santiago, Garilleti Celia, Hernandez Rigoberto, Obregon Cristina, Olalla Juan J
机构信息
Cardiology Division, Hospital Universitario Marques de Valdecilla, IDIVAL, Santander, Spain.
出版信息
Front Cardiovasc Med. 2025 Aug 18;12:1646175. doi: 10.3389/fcvm.2025.1646175. eCollection 2025.
AIMS
Patients with acute coronary syndrome (ACS) may experience adverse events during follow-up. Previous trials have shown that asymptomatic arrhythmias preceded these adverse events in a substantial proportion of patients. Ambulatory remote monitoring may allow early detection of electrocardiographic alterations with therapeutic and prognostic implications. This study aims to evaluate the efficacy of remote monitoring in this population.
METHODS AND RESULTS
This is a single-center, randomized controlled trial designed to evaluate the efficacy of 12-month monitoring of high-risk patients after ACS. High risk was defined by a GRACE score over 118 and a CHADS-VASc score over 2. In the intervention arm, two different systems were implemented: an implantable loop recorder in all patients and a portable mobile ECG system in those suitable. The primary endpoint was detection rates for atrial fibrillation/flutter, ventricular arrhythmias, and advanced conduction abnormalities. A total of 150 patients (estimated sample size) were included. Baseline clinical characteristics were comparable. The primary endpoint was achieved in 21.3% of the patients in the monitoring group and only in 2.7% in the control group ( = 0.0005). The combined diagnosis of atrial fibrillation/flutter was significantly more frequent in the monitoring group (10.6% vs. 1.3%, = 0.016). The incidence of death, myocardial infarction, or stroke at 12 months was 9.3% in the control group and 5.3% in the monitoring group ( = 0.34).
CONCLUSIONS
Ambulatory monitoring of high-risk patients after ACS shows a significantly higher detection of ECG-clinically relevant findings as compared with a control group. This was not translated into a difference in 1-year MACE, though the study was clearly underpowered for these clinical endpoints.
CLINICAL TRIAL REGISTRATION
https://clinicaltrials.gov/study/NCT03940066?tab=history&a=3NCT03940066, identifier: NCT03940066.
目的
急性冠状动脉综合征（ACS）患者在随访期间可能会发生不良事件。既往试验表明，相当一部分患者在这些不良事件发生之前出现过无症状性心律失常。动态远程监测可能有助于早期发现具有治疗和预后意义的心电图改变。本研究旨在评估远程监测在该人群中的疗效。
方法与结果
这是一项单中心随机对照试验，旨在评估ACS后高危患者12个月监测的疗效。高危定义为GRACE评分超过118分且CHADS-VASc评分超过2分。在干预组中，实施了两种不同的系统：所有患者均植入可植入式环路记录器，适合的患者使用便携式移动心电图系统。主要终点是房颤/房扑、室性心律失常和高级传导异常的检测率。共纳入150例患者（估计样本量）。基线临床特征具有可比性。监测组21.3%的患者达到主要终点，而对照组仅为2.7%（P = 0.0005）。监测组房颤/房扑的联合诊断明显更常见（10.6%对1.3%，P = 0.016）。对照组12个月时死亡、心肌梗死或中风的发生率为9.3%，监测组为5.3%（P = 0.34）。
结论
与对照组相比，ACS后高危患者的动态监测显示出心电图临床相关发现的检测率显著更高。尽管该研究对于这些临床终点的检验效能明显不足，但这并未转化为1年主要不良心血管事件（MACE）的差异。
临床试验注册
https://clinicaltrials.gov/study/NCT03940066?tab=history&a=3NCT03940066，标识符：NCT03940066。
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