mSToPS: Active Screening For AFib Using ECG Patch Associated With Significant Improvement in Outcomes at Three Years

Active screening for atrial fibrillation (AFib) using a wearable ECG patch was associated with a significant improvement in clinical outcomes and safety at three years compared with routine care, according to results from the mSToPS trial present Nov. 16 during AHA 2020.

Steven R. Steinhubl, MD, FACC, et al., analyzed data from 5,089 participants, 1,718 of whom underwent active monitoring and 3,371 of whom were observational controls based on age-, sex- and CHA2DS2-VASc-matching (mean age 73 years; 40.5% female; median baseline CHA2DS2-VASc was 3).

The trial’s primary outcome was the time to first event of the combined endpoint of death, stroke, systemic embolism, or myocardial infarction via claims and membership data among those with an AFib diagnosis at any time during the three-year study period, and within the entire cohort. The primary safety endpoint was the incidence rate of hospitalization for a primary bleeding diagnosis.

Results showed AFib was newly diagnosed in 11.4% (n=196) of those in the actively monitored group, compared with 7.7% (n=261) in the observational control group (p<0.01). The incidence of the combined primary endpoint was significantly lower among the patients in the actively monitored cohort, whether newly diagnosed or within the entire cohort, compared with routine care. Additionally, the rate of hospitalization for bleeding was also significantly lower in the actively monitored group overall (0.32 vs. 0.71 per 100 person-years, Adjusted Hazard Ratio 0.47, p=0.01).

Despite limitations of the study, including use of claims data for endpoints, low overall use of anticoagulants in both cohorts (<50%), and treatment decisions left to the discretion of the individual health care provider, researchers note their finding suggest possible benefits of active monitoring in high-risk AFib patients without symptoms. However, they caution that "independent replication of these findings is required in order to be confident" that such aggressive monitoring is warranted.

Keywords: AHA Annual Scientific Sessions, AHA20, Atrial Fibrillation, Stroke, Telemedicine


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