隐匿性脑卒中与潜在的心房颤动。

Cryptogenic stroke and underlying atrial fibrillation.

机构信息

From the Catholic University of the Sacred Heart, Institute of Cardiology (T.S.), and Institute of Neurology, Campus Bio-Medico University (V.D.L.) - both in Rome; the Department of Neurology and Stroke Center, University Hospital Essen, Essen (H.-C.D.), and Hospital Klinikum Coburg, Teaching Hospital of the University of Würzburg, Coburg (J.B.) - both in Germany; Bluhm Cardiovascular Institute (R.S.P.) and Davee Department of Neurology (R.A.B.), Northwestern University Feinberg School of Medicine, Chicago; Population Health Research Institute, McMaster University, Hamilton, ON, Canada (C.A.M.); University of Kansas Medical Center, Kansas City (M.M.R.); the KU Leuven Department of Neurosciences, the VIB-Vesalius Research Center, and the Department of Neurology, University Hospitals Leuven - all in Leuven, Belgium (V.T.); Medtronic, Mounds View, MN (T.R., K.L.); and Medtronic, Maastricht, the Netherlands (F.B.).

出版信息

N Engl J Med. 2014 Jun 26;370(26):2478-86. doi: 10.1056/NEJMoa1313600.

DOI:10.1056/NEJMoa1313600

PMID:24963567

Abstract

BACKGROUND

Current guidelines recommend at least 24 hours of electrocardiographic (ECG) monitoring after an ischemic stroke to rule out atrial fibrillation. However, the most effective duration and type of monitoring have not been established, and the cause of ischemic stroke remains uncertain despite a complete diagnostic evaluation in 20 to 40% of cases (cryptogenic stroke). Detection of atrial fibrillation after cryptogenic stroke has therapeutic implications.

METHODS

We conducted a randomized, controlled study of 441 patients to assess whether long-term monitoring with an insertable cardiac monitor (ICM) is more effective than conventional follow-up (control) for detecting atrial fibrillation in patients with cryptogenic stroke. Patients 40 years of age or older with no evidence of atrial fibrillation during at least 24 hours of ECG monitoring underwent randomization within 90 days after the index event. The primary end point was the time to first detection of atrial fibrillation (lasting >30 seconds) within 6 months. Among the secondary end points was the time to first detection of atrial fibrillation within 12 months. Data were analyzed according to the intention-to-treat principle.

RESULTS

By 6 months, atrial fibrillation had been detected in 8.9% of patients in the ICM group (19 patients) versus 1.4% of patients in the control group (3 patients) (hazard ratio, 6.4; 95% confidence interval [CI], 1.9 to 21.7; P<0.001). By 12 months, atrial fibrillation had been detected in 12.4% of patients in the ICM group (29 patients) versus 2.0% of patients in the control group (4 patients) (hazard ratio, 7.3; 95% CI, 2.6 to 20.8; P<0.001).

CONCLUSIONS

ECG monitoring with an ICM was superior to conventional follow-up for detecting atrial fibrillation after cryptogenic stroke. (Funded by Medtronic; CRYSTAL AF ClinicalTrials.gov number, NCT00924638.).

摘要

背景

目前的指南建议对缺血性脑卒中患者至少进行 24 小时的心电图（ECG）监测，以排除心房颤动。然而，尚未确定最有效的监测持续时间和类型，尽管在 20%至 40%的病例（隐匿性卒中）中进行了全面的诊断评估，但缺血性卒中的病因仍不确定。隐匿性卒中后发现心房颤动具有治疗意义。

方法

我们进行了一项随机对照研究，纳入了 441 例患者，以评估植入式心脏监测器（ICM）的长期监测与常规随访（对照组）相比，是否更有效地检测隐匿性卒中患者的心房颤动。年龄在 40 岁及以上且在至少 24 小时的 ECG 监测期间无证据表明存在心房颤动的患者，在指数事件后 90 天内进行随机分组。主要终点是 6 个月内首次检测到持续时间超过 30 秒的心房颤动的时间。次要终点之一是 12 个月内首次检测到心房颤动的时间。根据意向治疗原则进行数据分析。

结果

在 6 个月时，ICM 组有 8.9%（19 例）的患者检测到心房颤动，而对照组有 1.4%（3 例）（风险比，6.4；95%置信区间[CI]，1.9 至 21.7；P<0.001）。在 12 个月时，ICM 组有 12.4%（29 例）的患者检测到心房颤动，而对照组有 2.0%（4 例）（风险比，7.3；95%CI，2.6 至 20.8；P<0.001）。