3-year Clinical Outcomes in a Nationwide, Randomized, Pragmatic Clinical Trial of Atrial Fibrillation Screening - Mhealth Screening to Prevent Strokes (mstops)
Author Block: Steven R Steinhubl, Jill Waalen, Scripps Res Translational Inst, Lajolla, CA; Anirudh Sanyal, Alison M Edwards, Healthagen, Chicago, IL; Lauren M Ariniello, Gail S Ebner, Katie Baca-Motes, Scripps Res Translational Inst, Lajolla, CA; Robert A Zambon, Janssen Pharmaceuticals, Titusville, NJ; Troy Sarich, Johnson & Johnson, New Brunswick, NJ; Eric J. J Topol, Scripps Res, La Jolla, CA
Disclosure Block: S.R.Steinhubl: Other; Modest; DynoSense, EasyG, Livongo, Otsuka, Research Grant; Significant; Janssen. E.J.Topol: None. J.Waalen: None. A.Sanyal: Employment; Significant; Healthagen Outcomes. A.M.Edwards: Employment; Significant; Healthagen, part of the CVS Health family of companies. L.M.Ariniello: None. G.S.Ebner: None. K.Baca-motes: None. R.A.Zambon: Employment; Significant; Janssen R&D. T.Sarich: Employment; Significant; Johnson & Johnson, Stock Shareholder; Significant; Johnson & Johnson.
Introduction: Routine screening for undiagnosed AF with ECG monitoring is currently not recommended due in part to a lack of data regarding the impact of screening on clinical outcomes.Hypothesis: Identifying individuals with AF through active screening prior to clinical presentation can improve long-term outcomes relative to standard care.Methods: Beginning in November 2016, 1738 participants enrolled in the mSToPS trial and initiated active monitoring with a sensor patch for a median duration of 24.7 days. At the time of enrollment, they were age-, sex- and CHA2DS2-VASc-matched with 3476 observational controls for this pre-specified analysis. Predefined outcome at 3 years 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 a diagnosis of AF at any time during the 3-year analysis period.Results: Mean (SD) age at enrollment was 73.7 years (7.0), 40.5% were female and median (IQR) baseline CHA2DS2-VASc was 3 (2-4). At the end of 3 years, with an overall mean duration of eligible follow-up of 29 months, AF was newly diagnosed in 11.4% (n=196) of those actively monitored versus 7.7% (n=261) in observational controls (p<0.001). Although two-thirds of new diagnoses of AF in the actively monitored cohort occurred clinically over the 3 years, the time to first event of the combined primary endpoint was significantly lower in that cohort (HR 0.56, p<0.01), with significantly lower rates of the individual endpoints of stroke and death.Conclusions: Active screening for AF, as part of a prospective, pragmatic, direct-to-participant, nationwide study, was associated with a significant improvement in clinical outcomes relative to standard-of-care controls, including a decrease in strokes and mortality.