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心脏植入式电子设备检测无症状性心房颤动:NOAH 和 ARTESiA 试验后抗凝治疗的决策如何?

Detection of subclinical atrial fibrillation with cardiac implanted electronic devices: What decision making on anticoagulation after the NOAH and ARTESiA trials?

机构信息

Cardiology Division, Department of Biomedical, Metabolic and Neural Sciences, Italy University of Modena and Reggio Emilia, Policlinico di Modena, Modena, Italy.

Cardiology Division, Department of Biomedical, Metabolic and Neural Sciences, Italy University of Modena and Reggio Emilia, Policlinico di Modena, Modena, Italy.

出版信息

Eur J Intern Med. 2024 May;123:37-41. doi: 10.1016/j.ejim.2024.01.002. Epub 2024 Jan 27.

Abstract

Atrial fibrillation (AF) may be asymptomatic and the extensive monitoring capabilities of cardiac implantable electronic devices (CIEDs) revealed asymptomatic atrial tachi-arrhythmias of short duration (minutes-hours) occurring in patients with no prior history of AF and without AF detection at a conventional surface ECG. Both the terms "AHRE" (Atrial High-Rate Episodes) and subclinical AF were used in a series of prior studies, that evidenced the association with an increased risk of stroke. Two randomized controlled studies were planned in order to assess the risk-benefit profile of anticoagulation in patients with AHRE/subclinical AF: the NOAH and ARTESiA trials. The results of these two trials (6548 patients enrolled, overall) show that the risk of stroke/systemic embolism associated with AHRE/subclinical AF is in the range of 1-1.2 % per patient-year, but with an important proportion of severe/fatal strokes occurring in non-anticoagulated patients. The apparent discordance between ARTESiA and NOAH results may be approached by considering the related study-level meta-analysis, which highlights a consistent reduction of ischemic stroke with oral anticoagulants vs. aspirin/placebo (relative risk [RR] 0.68, 95 % CI 0.50-0.92). Oral anticoagulation was found to increase major bleeding (RR 1.62, 95 % CI 1.05-2.5), but no difference was found in fatal bleeding (RR 0.79, 95 % CI 0.37-1.69). Additionally, no difference was found in cardiovascular death or all-cause mortality. Taking into account these results, clinical decision-making for patients with AHRE/subclinical AF at risk of stroke, according to CHADS-VASc, can now be evidence-based, considering the benefits and related risks of oral anticoagulants, to be shared with appropriately informed patients.

摘要

心房颤动(AF)可能是无症状的,心脏植入式电子设备(CIEDs)的广泛监测能力揭示了没有 AF 既往史且常规体表心电图未检测到 AF 的患者发生的无症状、短时间(数分钟至数小时)的心房快速性心律失常。在一系列先前的研究中,使用了术语“AHRE”(心房高频事件)和亚临床 AF,这些研究证明了与增加中风风险有关。两项随机对照研究旨在评估 AHRE/亚临床 AF 患者抗凝治疗的风险效益:NOAH 和 ARTESiA 试验。这两项试验(共纳入 6548 例患者)的结果表明,与 AHRE/亚临床 AF 相关的中风/全身性栓塞风险为每位患者每年 1-1.2%,但在未接受抗凝治疗的患者中发生严重/致命性中风的比例较高。ARTESiA 和 NOAH 结果之间的明显差异可以通过考虑相关的研究水平荟萃分析来解决,该分析强调了口服抗凝剂与阿司匹林/安慰剂相比可一致降低缺血性中风(相对风险 [RR] 0.68,95%置信区间 [CI] 0.50-0.92)。口服抗凝剂可增加主要出血(RR 1.62,95% CI 1.05-2.5),但致命性出血无差异(RR 0.79,95% CI 0.37-1.69)。此外,心血管死亡或全因死亡率无差异。考虑到这些结果,根据 CHADS-VASc,现在可以对有中风风险的 AHRE/亚临床 AF 患者的临床决策进行基于证据的评估,考虑到口服抗凝剂的益处和相关风险,并与适当知情的患者共享。

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