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大血管病变或小血管病变引起的卒中患者中房颤的预测因素:STROKE AF 随机临床试验的预先指定的二次分析。

Predictors of Atrial Fibrillation in Patients With Stroke Attributed to Large- or Small-Vessel Disease: A Prespecified Secondary Analysis of the STROKE AF Randomized Clinical Trial.

机构信息

Department of Neurology, Massachusetts General Hospital, Boston.

Department of Neurology, Weill Cornell Medicine, New York, New York.

出版信息

JAMA Neurol. 2023 Jan 1;80(1):99-103. doi: 10.1001/jamaneurol.2022.4038.

Abstract

IMPORTANCE

The Stroke of Known Cause and Underlying Atrial Fibrillation (STROKE AF) trial found that approximately 1 in 8 patients with recent ischemic stroke attributed to large- or small-vessel disease had poststroke atrial fibrillation (AF) detected by an insertable cardiac monitor (ICM) at 12 months. Identifying predictors of AF could be useful when considering an ICM in routine poststroke clinical care.

OBJECTIVE

To determine the association between commonly assessed risk factors and poststroke detection of new AF in the STROKE AF cohort monitored by ICM.

DESIGN, SETTING, AND PARTICIPANTS: This was a prespecified analysis of a randomized (1:1) clinical trial that enrolled patients between April 1, 2016, and July 12, 2019, with primary follow-up through 2020 and mean (SD) duration of 11.0 (3.0) months. Eligible patients were selected from 33 clinical research sites in the US. Patients had an index stroke attributed to large- or small-vessel disease and were 60 years or older or aged 50 to 59 years with at least 1 additional stroke risk factor. A total of 496 patients were enrolled, and 492 were randomly assigned to study groups (3 did not meet inclusion criteria, and 1 withdrew consent). Patients in the ICM group had the index stroke within 10 days before insertion. Data were analyzed from October 8, 2021, to January 28, 2022.

INTERVENTIONS

ICM monitoring vs site-specific usual care (short-duration external cardiac monitoring).

MAIN OUTCOMES AND MEASURES

The ICM device automatically detects AF episodes 2 or more minutes in length; episodes were adjudicated by an expert committee. Cox regression multivariable modeling included all parameters identified in the univariate analysis having P values <.10. AF detection rates were calculated using Kaplan-Meier survival estimates.

RESULTS

The analysis included the 242 participants randomly assigned to the ICM group in the STROKE AF study. Among 242 patients monitored with ICM, 27 developed AF (mean [SD] age, 66.6 [9.3] years; 144 men [60.0%]; 96 [40.0%] women). Two patients had missing baseline data and exited the study early. Univariate predictors of AF detection included age (per 1-year increments: hazard ratio [HR], 1.05; 95% CI, 1.01-1.09; P = .02), CHA2DS2-VASc score (per point: HR, 1.54; 95% CI, 1.15-2.06; P = .004), chronic obstructive pulmonary disease (HR, 2.49; 95% CI, 0.86-7.20; P = .09), congestive heart failure (CHF; with preserved or reduced ejection fraction: HR, 6.64; 95% CI, 2.29-19.24; P < .001), left atrial enlargement (LAE; HR, 3.63; 95% CI, 1.55-8.47; P = .003), QRS duration (HR, 1.02; 95% CI, 1.00-1.04; P = .04), and kidney dysfunction (HR, 3.58; 95% CI, 1.35-9.46; P = .01). In multivariable modeling (n = 197), only CHF (HR, 5.06; 95% CI, 1.45-17.64; P = .05) and LAE (HR, 3.32; 1.34-8.19; P = .009) remained significant predictors of AF. At 12 months, patients with CHF and/or LAE (40 of 142 patients) had an AF detection rate of 23.4% vs 5.0% for patients with neither (HR, 5.1; 95% CI, 2.0-12.8; P < .001).

CONCLUSIONS AND RELEVANCE

Among patients with ischemic stroke attributed to large- or small-vessel disease, CHF and LAE were associated with a significantly increased risk of poststroke AF detection. These patients may benefit most from the use of ICMs as part of a secondary stroke prevention strategy. However, the study was not powered for clinical predictors of AF, and therefore, other clinical characteristics may not have reached statistical significance.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02700945.

摘要

重要性

已知病因和潜在心房颤动(STROKE AF)试验发现,大约 1/8 名近期归因于大或小血管疾病的缺血性中风患者在 12 个月时通过可植入心脏监测器(ICM)检测到中风后心房颤动(AF)。当考虑在常规中风后临床护理中使用 ICM 时,识别 AF 的预测因素可能会很有用。

目的

确定 STROKE AF 队列中常见评估风险因素与通过 ICM 检测到的中风后新发 AF 之间的关联。

设计、地点和参与者:这是一项预先指定的随机(1:1)临床试验的分析,纳入了 2016 年 4 月 1 日至 2019 年 7 月 12 日期间在美国 33 个临床研究地点选择的患者,主要随访时间截至 2020 年,平均(SD)随访时间为 11.0(3.0)个月。入选患者的指数性中风归因于大或小血管疾病,年龄为 60 岁或以上,或年龄为 50 至 59 岁,且至少有 1 个其他中风危险因素。共有 496 名患者入组,其中 492 名被随机分配到研究组(3 名不符合纳入标准,1 名退出了同意书)。ICM 组患者在插入前 10 天内发生了指数性中风。数据分析于 2021 年 10 月 8 日至 2022 年 1 月 28 日进行。

干预措施

ICM 监测与特定部位的常规护理(短时间外部心脏监测)。

主要结果和测量

ICM 设备自动检测持续时间至少 2 分钟的 AF 发作;发作由专家委员会裁决。多变量 Cox 回归模型包括单变量分析中所有 P 值<.10 的参数。使用 Kaplan-Meier 生存估计计算 AF 检测率。

结果

该分析包括 STROKE AF 研究中随机分配到 ICM 组的 242 名参与者。在 242 名接受 ICM 监测的患者中,27 例发生 AF(平均年龄[SD],66.6[9.3]岁;144 例男性[60.0%];96 例女性[40.0%])。两名患者有基线数据缺失,提前退出研究。AF 检测的单变量预测因素包括年龄(每增加 1 岁:风险比[HR],1.05;95%CI,1.01-1.09;P=0.02)、CHA2DS2-VASc 评分(每增加 1 分:HR,1.54;95%CI,1.15-2.06;P=0.004)、慢性阻塞性肺疾病(HR,2.49;95%CI,0.86-7.20;P=0.09)、充血性心力衰竭(有或无射血分数保留或降低:HR,6.64;95%CI,2.29-19.24;P<.001)、左心房扩大(HR,3.63;95%CI,1.55-8.47;P=0.003)、QRS 持续时间(HR,1.02;95%CI,1.00-1.04;P=0.04)和肾功能障碍(HR,3.58;95%CI,1.35-9.46;P=0.01)。在多变量建模(n=197)中,只有心力衰竭(HR,5.06;95%CI,1.45-17.64;P=0.05)和左心房扩大(HR,3.32;95%CI,1.34-8.19;P=0.009)仍然是 AF 的显著预测因素。在 12 个月时,患有心力衰竭和/或左心房扩大(142 名患者中的 40 名)的患者 AF 检测率为 23.4%,而无心力衰竭和左心房扩大的患者为 5.0%(HR,5.1;95%CI,2.0-12.8;P<.001)。

结论和相关性

在归因于大或小血管疾病的缺血性中风患者中,心力衰竭和左心房扩大与中风后 AF 检测的风险显著增加相关。这些患者可能最受益于将 ICM 作为二级卒中预防策略的一部分。然而,该研究未针对 AF 的临床预测因素进行加权,因此,其他临床特征可能未达到统计学意义。

试验注册

ClinicalTrials.gov 标识符:NCT02700945。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82d4/9664367/b48d2de07a6b/jamaneurol-e224038-g001.jpg

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