Screening for atrial fibrillation using a 14-day continuous ECG monitor in patients ≥70 years did not reduce stroke hospitalizations compared to usual care (HR 1.10; 95% CI 0.69-1.75).
RCT (n=11,905)
1:1
Yes
Hazard Ratio: 1.1 (95% CI 0.69–1.75)
Absolute Event Rate: 0.7% vs 0.6%
BACKGROUND Atrial fibrillation (AF) often remains undiagnosed, and it independently raises the risk of ischemic stroke, which is largely reversible by oral anticoagulation. Although randomized trials using longer term screening approaches increase identification of AF, no studies have established that AF screening lowers stroke rates. OBJECTIVES To address this knowledge gap, the GUARD-AF (Reducing Stroke by Screening for Undiagnosed Atrial Fibrillation in Elderly Individuals) trial screened participants in primary care practices using a 14-day continuous electrocardiographic monitor to determine whether screening for AF coupled with physician/patient decision-making to use oral anticoagulation reduces stroke and provides a net clinical benefit compared with usual care. METHODS GUARD-AF was a prospective, parallel-group, randomized controlled trial designed to test whether screening for AF in people aged ≥70 years using a 14-day single-lead continuous electrocardiographic patch monitor could identify patients with undiagnosed AF and reduce stroke. Participants were randomized 1:1 to screening or usual care. The primary efficacy and safety outcomes were hospitalization due to all-cause stroke and bleeding, respectively. Analyses used the intention-to-treat population. RESULTS Enrollment began on December 17, 2019, and involved 149 primary care sites across the United States. The COVID-19 pandemic led to premature termination of enrollment, with 11,905 participants in the intention-to-treat population. Median follow-up was 15.3 months (Q1-Q3: 13.8-17.6 months). Median age was 75 years (Q1-Q3: 72-79 years), and 56.6% were female. The risk of stroke in the screening group was 0.7% vs 0.6% in the usual care group (HR: 1.10; 95% CI: 0.69-1.75). The risk of bleeding was 1.0% in the screening group vs 1.1% in the usual care group (HR: 0.87; 95% CI: 0.60-1.26). Diagnosis of AF was 5% in the screening group and 3.3% in the usual care group, and initiation of oral anticoagulation after randomization was 4.2% and 2.8%, respectively. CONCLUSIONS In this trial, there was no evidence that screening for AF using a 14-day continuous electrocardiographic monitor in people ≥70 years of age seen in primary care practice reduces stroke hospitalizations. Event rates were low, however, and the trial did not enroll the planned sample size.(Reducing Stroke by Screening for Undiagnosed Atrial Fibrillation in Elderly Individuals GUARD-AF; NCT04126486).
“If asymptomatic AF is the proverbial 'needle in the haystack,' identifying those at risk of stroke is akin to 'finding the right needle in the haystack'—a notably more challenging task. The current trial provides reassuring data that the stroke risk in screen-detected AF is low.”
Lópes et al. (2024) conducted an RCT in Undiagnosed Atrial Fibrillation (n=11,905). Screening for AF using a 14-day continuous electrocardiographic monitor vs. Usual care was evaluated on Hospitalization due to all-cause stroke (HR 1.10, 95% CI 0.69-1.75). Screening for atrial fibrillation using a 14-day continuous ECG monitor in patients ≥70 years did not reduce stroke hospitalizations compared to usual care (HR 1.10; 95% CI 0.69-1.75).