Abstract
Introduction: Screening for atrial fibrillation before symptoms manifested and subsequent initiation of oral anticoagulants (OACs), could prevent stroke and death. The most cost-effective strategy to screen atrial fibrillation in high-risk population aged 65 and over remains unknown. Methods: We performed a randomised controlled trial that compares different screening frequencies of 30-second single-lead ECG (AliveCor® Heart Monitor) in the detection of atrial fibrillation in Chinese residents (≥65 years old) in 5 community health centres in Shanghai. Only participants without atrial fibrillation history and atrial fibrillation rhythm at baseline were eligible for inclusion in the trial. Participants were randomised in a 1:1 ratio into annual (G1) and quarterly screening (G2) groups: the quarterly screening group was further randomised in a 3:1 ratio into subgroups of quarterly screening (G2-1) and quarterly screening PLUS (G2-2, ECG weekly for 1-month then quarterly). The primary outcome was the detection rate of atrial fibrillation. The intention-to-treat analysis was performed for all randomised patients who had at least one ECG recording during follow-up. This trial was registered at ClinicalTrials.gov, number NCT02990741. Results: Between April 17, 2017, and June 26, 2018, a total of 8240 participants were randomised into G1 (n=4120), G2-1 (n=3090) and G2-2 (n=1030), with a mean of 1.6, 3.5 and 5.2 ECG records respectively during a median of 2.1 years follow-up (13,284 person-years). 73 incident cases of atrial fibrillation occurred: 26 in G1 (4.1/1000 person-years) and 47 in G2 (6.7/1000 person-years; hazard ratio with G1, 1.71; 95% confidence interval [CI] 1.06-2.76; P =0.03). 40 incident cases were detected in G2-1 (7.2/1000 person-years; hazard ratio with G1, 1.83; 95% CI 1.12-3.00; P =0.02) and 7 in G2-2 (4.8/1000 person-years; hazard ratio with G1, 1.24; 95% CI 0.54-2.86; P =0.61). No significant difference was noted between G2-1 and G2-2 (hazard ratio with G2-1, 0.68; 95% CI 0.30-1.52; P =0.35). Conclusions: Quarterly 30-second single-lead ECG screening significantly increased the detection rate of incident atrial fibrillation, additional weekly screening in the first month did not yield added predictive value.
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