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揭示不明原因卒中患者短期监测之外的心房颤动:来自不明原因卒中与潜在心房颤动试验的 3 年结果。

Uncovering Atrial Fibrillation Beyond Short-Term Monitoring in Cryptogenic Stroke Patients: Three-Year Results From the Cryptogenic Stroke and Underlying Atrial Fibrillation Trial.

机构信息

From the Department of Cardiology, Hospital Klinikum Coburg, Teaching Hospital of the University of Würzburg, Coburg, Germany (J.B.); Department of Medicine, Population Health Research Institute, McMaster University, Hamilton, ON, Canada (C.A.M.); Department of Cardiac Intensive Care, Institute of Cardiology, Catholic University of the Sacred Heart, Rome, Italy (T.S.); Department of Neurology, Institute of Neurology, Università Campus Bio-Medico, Rome, Italy (V.D.L.); Department of Neurology & Stroke Center, University Hospital Essen, Essen, Germany (H.-C.D.); Davee Department of Neurology (R.A.B.) and Bluhm Cardiovascular Institute (R.S.P.), Northwestern University Feinberg School of Medicine, Chicago, IL; University of Kansas Medical Center, Kansas City, KS (M.R.); Departments of Diagnostics and Monitoring Research (P.D.Z.) and Statistics (S.L.), Medtronic, Mounds View, MN; and Bluhm Cardiovascular Institute, Northwestern University Feinberg School of Medicine, Chicago, IL (R.S.P.).

出版信息

Circ Arrhythm Electrophysiol. 2016 Jan;9(1):e003333. doi: 10.1161/CIRCEP.115.003333.

Abstract

BACKGROUND

Atrial fibrillation (AF) can be a cause of previously diagnosed cryptogenic stroke. However, AF can be paroxysmal and asymptomatic, thereby making detection with routine ECG methods difficult. Oral anticoagulation is highly effective in reducing recurrent stroke in patients with AF, but its initiation is dependent on the detection of AF. Cryptogenic Stroke and Underlying Atrial Fibrillation (CRYSTAL AF) is the first randomized study to report the detection of AF in cryptogenic stroke patients using continuous long-term monitoring via insertable cardiac monitors (ICM).

METHODS AND RESULTS

Patients with prior cryptogenic stroke were randomized to control (n=220) or ICM (n=221) and followed for ≤36 months. Cumulative AF detection rates in the ICM arm increased progressively during this period (3.7%, 8.9%, 12.4%, and 30.0% at 1, 6, 12, and 36 months, respectively), but remained low in the control arm (3.0% at 36 months). This resulted in oral anticoagulation prescription in 94.7% of ICM patients with AF detected at 6 months, 96.6% at 12 months, and 90.5% at 36 months. Among ICM patients with AF detected, the median time to AF detection was 8.4 months, 81.0% of first AF episodes were asymptomatic, and 94.9% had at least 1 day with >6 minutes of AF.

CONCLUSIONS

Three-year monitoring by ICM in cryptogenic stroke patients demonstrated a significantly higher AF detection rate compared with routine care. Given the frequency of asymptomatic first episodes and the long median time to detection, these findings highlight the limitations of using traditional AF detection methods. The majority of patients with AF were prescribed oral anticoagulation therapy.

CLINICAL TRIAL REGISTRATION

Clinicaltrials.gov; Unique identifier: NCT00924638.

摘要

背景

心房颤动(AF)可能是先前诊断为隐源性中风的原因。然而,AF 可能是阵发性和无症状的,因此使用常规心电图方法很难检测到。口服抗凝剂在降低 AF 患者复发性中风方面非常有效,但它的启动取决于 AF 的检测。隐源性中风和潜在心房颤动(CRYSTAL AF)是第一项使用可植入心脏监测器(ICM)进行连续长期监测以报告隐源性中风患者 AF 检测的随机研究。

方法和结果

先前患有隐源性中风的患者被随机分配至对照组(n=220)或 ICM 组(n=221),并随访≤36 个月。在此期间,ICM 臂中的累积 AF 检测率逐渐增加(分别为 1、6、12 和 36 个月时为 3.7%、8.9%、12.4%和 30.0%),但对照组仍较低(36 个月时为 3.0%)。这导致在 6 个月时检测到 AF 的 94.7%的 ICM 患者、12 个月时的 96.6%和 36 个月时的 90.5%开具了口服抗凝剂处方。在检测到 AF 的 ICM 患者中,AF 的中位检测时间为 8.4 个月,首次 AF 发作中 81.0%为无症状,94.9%有至少 1 天的 AF 时间超过 6 分钟。

结论

在隐源性中风患者中进行为期 3 年的 ICM 监测显示,AF 检测率明显高于常规护理。鉴于无症状首发事件的频率和中位检测时间较长,这些发现突出了使用传统 AF 检测方法的局限性。大多数 AF 患者被开处了口服抗凝治疗。

临床试验注册

Clinicaltrials.gov;唯一标识符:NCT00924638。

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