Background

Atrial fibrillation is a leading cause of ischaemic stroke. Early detection of atrial fibrillation can enable anticoagulant therapy to reduce ischaemic stroke and mortality. In this randomised study in an older population, we aimed to assess whether systematic screening for atrial fibrillation could reduce mortality and morbidity compared with no screening.

Methods

STROKESTOP was a multicentre, parallel group, unmasked, randomised controlled trial done in Halland and Stockholm in Sweden. All 75–76-year-olds residing in these two regions were randomly assigned (1:1) to be invited to screening for atrial fibrillation or to a control group. Participants attended local screening centres and those without a history of atrial fibrillation were asked to register intermittent electrocardiograms (ECGs) for 14 days. Treatment with oral anticoagulants was offered if atrial fibrillation was detected or untreated. All randomly assigned individuals were followed up in the intention-to-treat analysis for a minimum of 5 years for the primary combined endpoint of ischaemic or haemorrhagic stroke, systemic embolism, bleeding leading to hospitalisation, and all-cause death. This trial is registered with ClinicalTrials.gov, NCT01593553.

Findings

From March 1, 2012, to May 28, 2014, 28 768 individuals were assessed for eligibility and randomly assigned to be invited to screening (n=14 387) or the control group (n=14 381). 408 individuals were excluded from the intervention group and 385 were excluded from the control group due to death or migration before invitation. There was no loss to follow-up. Of those invited to screening, 7165 (51·3%) of 13 979 participated. After a median follow-up of 6·9 years (IQR 6·5–7·2), significantly fewer primary endpoint events occurred in the intervention group (4456 [31·9%] of 13 979; 5·45 events per 100 years [95% CI 5·52–5·61]) than in the control group (4616 [33·0%] of 13 996; 5·68 events per 100 years [5·52–5·85]; hazard ratio 0·96 [95% CI 0·92–1·00]; p=0·045).

Interpretation

Screening for atrial fibrillation showed a small net benefit compared with standard of care, indicating that screening is safe and beneficial in older populations.

Funding

Stockholm County Council, the Swedish Heart & Lung Foundation, King Gustav V and Queen Victoria's Freemasons' Foundation, the Klebergska Foundation, the Tornspiran Foundation, the Scientific Council of Halland Region, the Southern Regional Healthcare Committee, the Swedish Stroke Fund, Carl Bennet AB, Boehringer Ingelheim, Bayer, and Bristol Myers Squibb–Pfizer.

中文翻译：

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心房颤动系统筛查 (STROKESTOP) 的临床结果：一项多中心、平行组、无掩蔽、随机对照试验

背景

心房颤动是缺血性卒中的主要原因。早期发现心房颤动可以使抗凝治疗能够降低缺血性卒中和死亡率。在这项针对老年人群的随机研究中，我们旨在评估与不进行筛查相比，系统筛查房颤是否可以降低死亡率和发病率。

方法

STROKESTOP 是在瑞典的哈兰德和斯德哥尔摩进行的一项多中心、平行组、无掩蔽、随机对照试验。居住在这两个地区的所有 75-76 岁的人都被随机分配 (1:1) 被邀请参加房颤筛查或对照组。参与者参加了当地筛查中心，没有房颤病史的参与者被要求登记间歇性心电图 (ECG) 14 天。如果检测到心房颤动或未经治疗，则提供口服抗凝剂治疗。对于缺血性或出血性卒中、全身性栓塞、出血导致住院和全因死亡的主要综合终点，所有随机分配的个体都在意向治疗分析中进行了至少 5 年的随访。该试验已在 ClinicalTrials.gov 注册，

发现

从 2012 年 3 月 1 日到 2014 年 5 月 28 日，对 28 768 名个体进行了资格评估，并随机分配到筛选组（n=14 387）或对照组（n=14 381）。408 人被排除在干预组之外，385 人在被邀请前因死亡或迁移而被排除在对照组之外。随访没有损失。在受邀参加筛选的人中，13 979 人中有 7165 人 (51·3%) 参加。中位随访 6·9 年（IQR 6·5–7·2）后，干预组发生的主要终点事件显着减少（13 979 人中有 4456 [31·9%]；每 100 人中有 5·45 次事件）年 [95% CI 5·52–5·61]) 比对照组 (4616 [33·0%] of 13 996；每 100 年 5·68 起事件 [5·52–5·85]；风险比0·96 [95% CI 0·92–1·00]；p=0·045)。

解释

与标准护理相比，心房颤动筛查的净收益很小，表明筛查对老年人群是安全且有益的。

资金

斯德哥尔摩郡议会、瑞典心肺基金会、古斯塔夫五世国王和维多利亚女王的共济会基金会、Klebergska 基金会、Tornspiran 基金会、哈兰地区科学委员会、南部地区医疗保健委员会、瑞典中风基金会、Carl Bennet AB 、勃林格殷格翰、拜耳和百时美施贵宝-辉瑞。