长期连续心脏监测与常规护理对大血管或小血管病变引起的卒中患者心房颤动检出率的影响：STROKE-AF 随机临床试验。
Effect of Long-term Continuous Cardiac Monitoring vs Usual Care on Detection of Atrial Fibrillation in Patients With Stroke Attributed to Large- or Small-Vessel Disease: The STROKE-AF Randomized Clinical Trial.
机构信息
Davee Department of Neurology, Feinberg School of Medicine of Northwestern University, Chicago, Illinois.
Department of Neurology, Weill Cornell Medicine, New York, New York.
出版信息
JAMA. 2021 Jun 1;325(21):2169-2177. doi: 10.1001/jama.2021.6470.
IMPORTANCE
Patients with ischemic stroke attributed to large- or small-vessel disease are not considered at high risk for atrial fibrillation (AF), and the AF incidence rate in this population is unknown.
OBJECTIVES
To determine whether long-term cardiac monitoring is more effective than usual care for AF detection in patients with stroke attributed to large- or small-vessel disease through 12 months of follow-up.
DESIGN, SETTING, AND PARTICIPANTS: The STROKE-AF trial was a randomized (1:1), multicenter (33 sites in the US) clinical trial that enrolled 496 patients between April 2016 and July 2019, with primary end point follow-up through August 2020. Eligible patients were aged 60 years or older or aged 50 to 59 years with at least 1 additional stroke risk factor and had an index stroke attributed to large- or small-vessel disease within 10 days prior to insertable cardiac monitor (ICM) insertion.
INTERVENTIONS
Patients randomized to the intervention group (n = 242) received ICM insertion within 10 days of the index stroke; patients in the control group (n = 250) received site-specific usual care consisting of external cardiac monitoring, such as 12-lead electrocardiograms, Holter monitoring, telemetry, or event recorders.
MAIN OUTCOMES AND MEASURES
Incident AF lasting more than 30 seconds through 12 months.
RESULTS
Among 492 patients who were randomized (mean [SD] age, 67.1 [9.4] years; 185 [37.6%] women), 417 (84.8%) completed 12 months of follow-up. The median (interquartile range) CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke or transient ischemic attack, vascular disease, age 65 to 74 years, sex category) score was 5 (4-6). AF detection at 12 months was significantly higher in the ICM group vs the control group (27 patients [12.1%] vs 4 patients [1.8%]; hazard ratio, 7.4 [95% CI, 2.6-21.3]; P < .001). Among the 221 patients in the ICM group who received an ICM, 4 (1.8%) had ICM procedure-related adverse events (1 site infection, 2 incision site hemorrhages, and 1 implant site pain).
CONCLUSIONS AND RELEVANCE
Among patients with stroke attributed to large- or small-vessel disease, monitoring with an ICM compared with usual care detected significantly more AF over 12 months. However, further research is needed to understand whether identifying AF in these patients is of clinical importance.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02700945.
重要性
归因于大血管或小血管疾病的缺血性脑卒中患者不被认为具有较高的心房颤动（AF）风险，并且该人群中的 AF 发生率尚不清楚。
目的
通过 12 个月的随访，确定长期心脏监测在检测归因于大血管或小血管疾病的脑卒中患者的 AF 方面是否比常规护理更有效。
设计、地点和参与者：STROKE-AF 试验是一项随机（1:1）、多中心（美国 33 个地点）临床试验，于 2016 年 4 月至 2019 年 7 月期间纳入 496 名患者，主要终点随访至 2020 年 8 月。符合条件的患者年龄在 60 岁或以上，或年龄在 50 至 59 岁之间，至少有 1 个额外的卒中危险因素，在插入可植入心脏监测器（ICM）前 10 天内发生归因于大血管或小血管疾病的指数性脑卒中。
干预措施
随机分配至干预组（n=242）的患者在指数性脑卒中后 10 天内接受 ICM 插入；对照组（n=250）的患者接受特定部位的常规护理，包括外部心脏监测，如 12 导联心电图、动态心电图监测、遥测或事件记录器。
主要结局和测量指标
通过 12 个月的随访，检测到持续 30 秒以上的 AF 发作。
结果
在 492 名随机患者（平均[标准差]年龄，67.1[9.4]岁；185[37.6%]为女性）中，有 417 名（84.8%）完成了 12 个月的随访。中位数（四分位距）CHA2DS2-VASc（充血性心力衰竭、高血压、年龄≥75 岁、糖尿病、卒中和短暂性脑缺血发作、血管疾病、65 岁至 74 岁、性别）评分 5 分（4-6 分）。与对照组相比，ICM 组在 12 个月时 AF 的检测率显著更高（27 例[12.1%] vs 4 例[1.8%]；风险比，7.4[95%置信区间，2.6-21.3]；P<0.001）。在接受 ICM 的 221 名 ICM 组患者中，有 4 名（1.8%）发生了与 ICM 程序相关的不良事件（1 例部位感染、2 例切口出血和 1 例植入部位疼痛）。
结论和相关性
在归因于大血管或小血管疾病的脑卒中患者中，与常规护理相比，使用 ICM 监测在 12 个月内更能显著检测到 AF。然而，仍需要进一步的研究来了解在这些患者中识别 AF 是否具有临床意义。
试验注册
ClinicalTrials.gov 标识符：NCT02700945。
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