Scripps Research Translational Institute, La Jolla, CA, United States of America.
Healthagen, LLC, Chicago, IL, United States of America.
PLoS One. 2021 Oct 5;16(10):e0258276. doi: 10.1371/journal.pone.0258276. eCollection 2021.
Atrial fibrillation (AF) is common, often without symptoms, and is an independent risk factor for mortality, stroke and heart failure. It is unknown if screening asymptomatic individuals for AF can improve clinical outcomes.
mSToPS was a pragmatic, direct-to-participant trial that randomized individuals from a single US-wide health plan to either immediate or delayed screening using a continuous-recording ECG patch to be worn for two weeks and 2 occasions, ~3 months apart, to potentially detect undiagnosed AF. The 3-year outcomes component of the trial was designed to compare clinical outcomes in the combined cohort of 1718 individuals who underwent monitoring and 3371 matched observational controls. The prespecified primary outcome was the time to first event of the combined endpoint of death, stroke, systemic embolism, or myocardial infarction among individuals with a new AF diagnosis, which was hypothesized to be the same in the two cohorts but was not realized.
Over the 3 years following the initiation of screening (mean follow-up 29 months), AF was newly diagnosed in 11.4% (n = 196) of screened participants versus 7.7% (n = 261) of observational controls (p<0.01). Among the screened cohort with incident AF, one-third were diagnosed through screening. For all individuals whose AF was first diagnosed clinically, a clinical event was common in the 4 weeks surrounding that diagnosis: 6.6% experienced a stroke,10.2% were newly diagnosed with heart failure, 9.2% had a myocardial infarction, and 1.5% systemic emboli. Cumulatively, 42.9% were hospitalized. For those diagnosed via screening, none experienced a stroke, myocardial infarction or systemic emboli in the period surrounding their AF diagnosis, and only 1 person (2.3%) had a new diagnosis of heart failure. Incidence rate of the prespecified combined primary endpoint was 3.6 per 100 person-years among the actively monitored cohort and 4.5 per 100 person-years in the observational controls.
At 3 years, screening for AF was associated with a lower rate of clinical events and improved outcomes relative to a matched cohort, although the influence of earlier diagnosis of AF via screening on this finding is unclear. These observational data, including the high event rate surrounding a new clinical diagnosis of AF, support the need for randomized trials to determine whether screening for AF will yield a meaningful protection from strokes and other clinical events.
The mHealth Screening To Prevent Strokes (mSToPS) Trial is registered on ClinicalTrials.gov with the identifier NCT02506244.
心房颤动（AF）很常见，通常无症状，是死亡、中风和心力衰竭的独立危险因素。目前尚不清楚对无症状个体进行 AF 筛查是否能改善临床结局。
mSToPS 是一项实用的、直接针对参与者的试验，该试验将来自美国一个单一健康计划的个体随机分为立即或延迟筛查，使用连续记录的心电图贴片佩戴两周，两次，相隔约 3 个月，以潜在地检测未诊断的 AF。该试验的 3 年结果部分旨在比较接受监测的 1718 名个体和 3371 名匹配观察性对照者的综合队列中的临床结局。预设的主要结局是新诊断为 AF 的个体中死亡、中风、全身性栓塞或心肌梗死联合终点的首次事件时间，据推测这两个队列的结局相同，但并未实现。
在筛查开始后的 3 年内（平均随访 29 个月），筛查组中有 11.4%（n=196）的个体新诊断出 AF，而观察对照组中有 7.7%（n=261）（p<0.01）。在筛查队列中出现新发 AF 的个体中，有三分之一是通过筛查诊断的。对于所有首次临床诊断为 AF 的个体，在诊断后的 4 周内常见临床事件：6.6%发生中风，10.2%新诊断为心力衰竭，9.2%发生心肌梗死，1.5%发生全身性栓塞。累计有 42.9%的人住院。对于通过筛查诊断的患者，在 AF 诊断期间，没有发生中风、心肌梗死或全身性栓塞，只有 1 人（2.3%）新诊断为心力衰竭。主动监测队列的预定联合主要终点发生率为每 100 人年 3.6 例，观察对照组为每 100 人年 4.5 例。
3 年后，与匹配队列相比，AF 筛查与较低的临床事件发生率和改善的结局相关，尽管通过筛查更早诊断 AF 对这一发现的影响尚不清楚。这些观察性数据，包括新诊断为 AF 时周围的高事件率，支持需要进行随机试验来确定筛查 AF 是否能提供预防中风和其他临床事件的有意义的保护。
mHealth Screening To Prevent Strokes（mSToPS）试验在 ClinicalTrials.gov 上注册，标识符为 NCT02506244。
