Karolinska Institutet, Department of Medicine, Karolinska University Hospital Huddinge, Stockholm, Sweden.
Karolinska Institutet, Department of Clinical Sciences, Division of Cardiovascular Medicine, Danderyd University Hospital, Stockholm, Sweden.
Lancet. 2021 Oct 23;398(10310):1498-1506. doi: 10.1016/S0140-6736(21)01637-8. Epub 2021 Aug 29.
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.
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.
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).
Screening for atrial fibrillation showed a small net benefit compared with standard of care, indicating that screening is safe and beneficial in older populations.
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.
心房颤动是缺血性中风的主要原因。早期发现心房颤动可以使抗凝治疗降低缺血性中风和死亡率。在这项针对老年人群的随机研究中，我们旨在评估系统筛查心房颤动是否可以降低死亡率和发病率，与不筛查相比。
STROKESTOP 是一项多中心、平行组、非盲、随机对照试验，在瑞典的哈兰和斯德哥尔摩进行。所有 75-76 岁居住在这两个地区的人被随机分配（1:1）邀请进行心房颤动筛查或对照组。参与者参加当地筛查中心，没有心房颤动病史的人被要求登记 14 天的间歇性心电图（ECG）。如果发现或未治疗心房颤动，将提供口服抗凝剂治疗。所有随机分配的个体均按意向治疗进行至少 5 年的最低随访，主要联合终点为缺血性或出血性中风、全身性栓塞、导致住院的出血和全因死亡。这项试验在 ClinicalTrials.gov 注册，NCT01593553。
从 2012 年 3 月 1 日至 2014 年 5 月 28 日，对 28768 人进行了资格评估，并随机分配邀请进行筛查（n=14387）或对照组（n=14381）。由于死亡或移民，408 名干预组患者和 385 名对照组患者在邀请前被排除。没有随访损失。在被邀请进行筛查的 13979 人中，有 7165 人（51.3%）参加了筛查。中位随访 6.9 年（IQR 6.5-7.2）后，干预组主要终点事件明显减少（13979 例中有 4456 例[31.9%]；每 100 年发生 5.45 例[95%CI 5.52-5.61]），而对照组（13996 例中有 4616 例[33.0%]；每 100 年发生 5.68 例[5.52-5.85]；风险比 0.96[95%CI 0.92-1.00]；p=0.045）。
与标准治疗相比，心房颤动筛查显示出较小的净获益，表明筛查在老年人群中是安全且有益的。
斯德哥尔摩郡议会、瑞典心脏和肺基金会、古斯塔夫五世和维多利亚女王共济会基金会、克莱伯格基金会、托恩斯皮兰基金会、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、卡尔贝内特 AB、勃林格殷格翰、拜耳和百时美施贵宝-辉瑞。
