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
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
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DOI：
10.1001/jama.2021.6470
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发表时间：
2021-06-01
影响因子：
120.7
通讯作者：
Schwamm, Lee H.
中科院分区：
文献类型：
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作者：
Bernstein, Richard A.;Kamel, Hooman;Schwamm, Lee H.
重要性 因大血管或小血管疾病引起的缺血性卒中患者不被认为是房颤 (AF) 的高危人群，并且该人群的 AF 发病率未知。 目的 通过 12 个月的随访，确定长期心脏监测是否比常规护理更有效地检测因大血管或小血管疾病引起的卒中患者。 设计、设置和参与者 STROKE-AF 试验这是一项随机 (1:1)、多中心（美国 33 个中心）临床试验，在 2016 年 4 月至 2019 年 7 月期间入组了 496 名患者，主要终点随访至 2020 年 8 月。符合条件的患者年龄为 60 岁或以上，或年龄为 50 至 59 岁，至少有 1 个额外的中风危险因素，并且在插入式心脏监测仪 (ICM) 前 10 天内发生过因大血管或小血管疾病导致的中风。干预措施 随机分配到干预组的患者 (n = 242) 在中风发生后 10 天内接受 ICM 植入；对照组患者 (n = 250) 接受特定部位的常规护理，包括外部心脏监测，例如 12 导联心电图、动态心电图监测、遥测或事件记录仪。 主要结果和措施 AF 事件持续超过 30 秒至 12 个月。 结果 在 492 名随机分组的患者中（平均 [SD] 年龄，67.1 [9.4] 岁；185 名患者） [37.6%] 女性），417 名 (84.8%) 完成了 12 个月的随访。中位（四分位距）CHA(2)DS(2)-VASc（充血性心力衰竭、高血压、年龄 >= 75 岁、糖尿病、中风或短暂性脑缺血发作、血管疾病、年龄 65 至 74 岁、性别类别）评分为 5 (4-6)。 ICM 组 12 个月时的 AF 检出率显着高于对照组（27 名患者 [12.1%] vs 4 名患者 [1.8%]；风险比，7.4 [95% CI，2.6-21.3]；P
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 trialwas 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) CHA(2)DS(2)-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