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Zio by iRhythm Detects Previously Undiagnosed Atrial Fibrillation and Helps to Prevent Hospitalizations, Stroke, and Death as a Result
Three-Year Study Results Presented at 2020 American Heart Association Scientific SessionsZio Supports Better Healthcare Utilization Rates and Patient Outcomes
About this update from Irhythm Holdings, Inc.
[{"type":"text","content":"Three-Year Study Results Presented at 2020 American Heart Association Scientific SessionsZio Supports Better Healthcare Utilization Rates and Patient Outcomes With Ambulatory Cardiac Monitoring SAN FRANCISCO, Nov. 16, 2020 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health care solutions company focused on the advancement of cardiac care, today announced the three-year clinical outcomes of the mHealth Screening to Prevent Strokes (mSToPS) study.\n The study evaluated the detection of silent, or previously undiagnosed, atrial fibrillation (AF) in moderate-risk individuals using the FDA-cleared Zio by iRhythm ambulatory monitoring patch. This study is the first siteless, nationwide study of its kind and was led by researchers at the Scripps Research Translational Institute, in partnership with collaborators, Aetna and Janssen Pharmaceuticals. The study aimed to determine if participant-generated data available through a wearable ECG patch could improve the identification of AF relative to routine care and to determine if screening for AF by wearing Zio could improve clinical outcomes at three years after the initiation of screening. mSToPS evaluated the time to this first serious cardiac event, including stroke, systemic embolism, myocardial infarction, or death, via claims and Aetna membership data. At the end of three years after the initial onset of monitoring: AF was newly diagnosed in 11.4% of those actively monitored with Zio versus only 7.7% of the control group (a statistically significant 48% improvement).The trial found the incidence rate of a cardiac event (stroke, myocardial infarction, systemic embolism, or death) was 8.4 per 100 person-years in people diagnosed with AF who underwent active monitoring, compared to the control group incidence rate of 13.8 per 100 person-years (a statistically significant improvement). This data demonstrates Zio’s detection of AF in moderate-risk patients supported the prevention of serious cardiac events after diagnosis.Active monitoring with Zio also led to fewer hospitalizations for bleeding, the primary safety endpoint for the study (incidence rate of 0.32 per 100 person-years versus 0.71 per 100 person-years).Active monitoring also led to fewer total hospitalizations (12.9 versus 18.9 per 100 person-years). Ultimately, the mSToPS study found that...