丹麦哥本哈根大学Jesper H Svendsen团队研究了植入式环路记录仪检测心房颤动预防高危人群卒中的效果。相关论文于2021年8月29日发表在《柳叶刀》杂志上。
目前尚不清楚筛查房颤并在发现房颤后进行抗凝治疗是否可以预防卒中。使用植入式环路记录器（ILR）的连续心电图监测可有助于发现无症状的房颤发作。该研究旨在确定房颤筛查和抗凝药物的使用是否可以预防高危人群卒中。
研究组在丹麦的四个中心进行了一项随机对照试验，招募年龄在70-90岁、无房颤、至少有一项额外中风危险因素（如高血压、糖尿病、既往中风或心力衰竭）的患者。将其按1：3随机分配接受ILR监测或常规护理（对照组）。在ILR组，如果房颤发作持续6分钟或更长时间，建议进行抗凝治疗。主要结局是首次卒中或全身动脉栓塞的时间。
2014年1月31日至2016年5月17日，研究组共招募6004人，其中1501人（25.0%）接受ILR监测，4503人（75.0%）接受常规护理。平均年龄为74.7岁，2837名（47.3%）为女性，5444名（90.7%）为高血压患者。没有受试者失去随访。在64.5个月的中位随访期间，共有1027名参与者被诊断为房颤：其中ILR组1501人中有477人（31.8%），显著高于对照组（4503人中有550人，12.2%）。
共有1036名参与者开始口服抗凝剂治疗：其中ILR组有445名（29.7%），对照组有591名（13.1%），组间差异显著；共有318名参与者发生主要结局（315例卒中，3例全身动脉栓塞）：ILR组67例（4.5%），对照组251例（5.6%），组间差异不显著；221名参与者出现大出血：ILR组65例（4.3%），对照组156例（3.5%），组间差异不显著。
研究结果表明，在有卒中危险因素的个体中，ILR筛查导致房颤检出率和抗凝启动率增加三倍，但卒中或全身动脉栓塞的风险没有显著降低。
附：英文原文
Title: Implantable loop recorder detection of atrial fibrillation to prevent stroke (The LOOP Study): a randomised controlled trial
Author: Jesper H Svendsen, Sren Z Diederichsen, Sren Hjberg, Derk W Krieger, Claus Graff, Christian Kronborg, Morten S Olesen, Jonas B Nielsen, Anders G Holst, Axel Brandes, Ketil J Haugan, Lars Kber
Issue&Volume: 2021-08-29
Abstract:
Background
It is unknown whether screening for atrial fibrillation and subsequent treatment with anticoagulants if atrial fibrillation is detected can prevent stroke. Continuous electrocardiographic monitoring using an implantable loop recorder (ILR) can facilitate detection of asymptomatic atrial fibrillation episodes. We aimed to investigate whether atrial fibrillation screening and use of anticoagulants can prevent stroke in individuals at high risk.
Methods
We did a randomised controlled trial in four centres in Denmark. We included individuals without atrial fibrillation, aged 70–90 years, with at least one additional stroke risk factor (ie, hypertension, diabetes, previous stroke, or heart failure). Participants were randomly assigned in a 1:3 ratio to ILR monitoring or usual care (control) via an online system in permuted blocks with block sizes of four or eight participants stratified according to centre. In the ILR group, anticoagulation was recommended if atrial fibrillation episodes lasted 6 min or longer. The primary outcome was time to first stroke or systemic arterial embolism. This study is registered with ClinicalTrials.gov, NCT02036450.
Findings
From Jan 31, 2014, to May 17, 2016, 6205 individuals were screened for inclusion, of whom 6004 were included and randomly assigned: 1501 (25·0%) to ILR monitoring and 4503 (75·0%) to usual care. Mean age was 74·7 years (SD 4·1), 2837 (47·3%) were women, and 5444 (90·7%) had hypertension. No participants were lost to follow-up. During a median follow-up of 64·5 months (IQR 59·3–69·8), atrial fibrillation was diagnosed in 1027 participants: 477 (31·8%) of 1501 in the ILR group versus 550 (12·2%) of 4503 in the control group (hazard ratio [HR] 3·17 [95% CI 2·81–3·59]; p<0·0001). Oral anticoagulation was initiated in 1036 participants: 445 (29·7%) in the ILR group versus 591 (13·1%) in the control group (HR 2·72 [95% CI 2·41–3·08]; p<0·0001), and the primary outcome occurred in 318 participants (315 stroke, three systemic arterial embolism): 67 (4·5%) in the ILR group versus 251 (5·6%) in the control group (HR 0·80 [95% CI 0·61–1·05]; p=0·11). Major bleeding occurred in 221 participants: 65 (4·3%) in the ILR group versus 156 (3·5%) in the control group (HR 1·26 [95% CI 0·95–1·69]; p=0·11).
Interpretation
In individuals with stroke risk factors, ILR screening resulted in a three-times increase in atrial fibrillation detection and anticoagulation initiation but no significant reduction in the risk of stroke or systemic arterial embolism. These findings might imply that not all atrial fibrillation is worth screening for, and not all screen-detected atrial fibrillation merits anticoagulation.
DOI: 10.1016/S0140-6736(21)01698-6
Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01698-6/fulltext
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