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.
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 active screening for AF, as part of a prospective, pragmatic, direct-to-participant and nationwide study, was associated with a significant improvement in clinical outcomes and safety at three years relative to routine care. Through research like mSToPS, Zio has been demonstrated to help clinicians detect AF earlier, especially in instances when routine care may not.
The lifetime risk of developing AF is nearly 40%1 for adults over age 55, the monitored demographic in this study. For many individuals, AF is undiagnosed until the time of stroke2 or another serious cardiac event. The American Heart Association published estimates that the annual costs of stroke will nearly double3 by 2030. Early detection of AF lowers the overall rates of cardiac incidents and hospitalizations, and the detection of silent or undiagnosed AF can greatly reduce the cost of healthcare resource utilization and improve patient care.
“Through clinical validation with studies like mSToPS, iRhythm demonstrates the importance of shifting to preventative and more proactive care to catch undiagnosed atrial fibrillation and improve the lives of millions of people,” said Kevin King, CEO of iRhythm. “Zio also helps decrease costs associated with increased healthcare utilization and more significant, potentially life-threatening clinical events. At iRhythm, we are helping to create a new standard of patient care.”
“The three-year results support the clinical value of early screening and targeted detection in moderate-risk populations,” said Steven Steinhubl, MD, Director of Digital Medicine at Scripps Research Translational Institute and principal investigator of the study. “The study validates continued research into how to best monitor high-risk populations and confirms the value in discovering ways we can detect previously undiagnosed AF. It underscores the value of detecting AF as soon as possible to produce better patient outcomes.”
These results were presented at the American Heart Association’s 2020 virtual Scientific Sessions on November 16 at 9:21 a.m. CT by Dr. Steven Steinhubl of the Scripps Research Translational Institute.