SAN FRANCISCO, Dec. 16, 2019 (GLOBE NEWSWIRE) — iRhythm Technologies, Inc. (NASDAQ: IRTC) today announced its participation in a new, randomized, controlled study, GUARD-AF (ReducinG stroke by screening for UndiAgnosed atRial fibrillation in elderly inDividuals), sponsored by the Bristol-Myers Squibb-Pfizer Alliance (the Alliance). The study seeks to determine if earlier detection of atrial fibrillation (AFib) through screening in previously undiagnosed men and women at least 70 years of age in the U.S. ultimately impacts the rate of stroke, compared to usual standard medical care. The screening arm will utilize iRhythm’s Zio® XT service.
iRhythm estimates that more than 10 million Americans are at high risk for a common heart rhythm disorder known as atrial fibrillation. AFib is associated with a five-fold increase in the risk of stroke, with these strokes tending to have more severe consequences.1 Approximately 25 percent of people who have an AFib-related stroke are estimated to die within one month.2 Further, some studies suggest that more than 25 percent of people who have an AFib-related stroke find out they have AFib after a stroke.3
Clinical research is already demonstrating a major unmet need in the market for earlier AFib detection. For example, at the annual meeting of the American College of Cardiology in March 2019, the first phase of the mSToPS study, published in JAMA, showed that patients who were diagnosed with AFib in iRhythm’s Zio service-monitored group had a significantly lower rate of hospitalizations and emergency room visits in the 12 months following initiation than the non-monitored control group.
“iRhythm is excited to participate in the GUARD-AF study with the Alliance,” said Kevin King, president and CEO of iRhythm. “This is an important study to determine whether monitoring of individuals at-risk of AFib can ultimately lead to improved outcomes and decreased rates of stroke. We are pleased to be involved in the study and contributing to this important clinical research in an area of unmet need.”
“Through earlier AFib detection, we’re focused on helping to reduce the number of individuals who suffer an AFib-related stroke,” said Roland Chen, Vice President, Head of Clinical Development, Innovative Medicines, Bristol-Myers Squibb. “With this study, the BMS-Pfizer Alliance intends to help inform clinical practice regarding screening for this common type of heart rhythm condition.”
The GUARD-AF study population (n=52,000) will include men and women at least 70 years of age visiting their primary care physician for usual follow-up care, who are willing to provide consent to participate in the study. Participants will be randomized to receive Zio XT for AFib detection, or to receive usual standard medical care. The primary outcome measures will be stroke and bleeding events leading to hospitalization. A novel, pragmatic aspect of the trial is that outcome events will be ascertained from a healthcare claims database which, although subject to certain limitations, are expected to provide evidence on health outcomes associated with AFib detection intervention that may help inform future guidelines. Enrollment is expected to begin in the coming weeks. More information on the study can be found on www.clinicaltrials.gov under the identifier NCT04126486.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These statements include statements regarding clinical developments and market opportunity. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include risks described in the section entitled “Risk Factors” and elsewhere in the company’s public filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. iRhythm disclaims any obligation to update these forward-looking statements.
About iRhythm Technologies, Inc.
iRhythm is a leading digital health care company redefining the way cardiac arrhythmias are clinically diagnosed. The company combines wearable biosensor devices worn for up to 14 days and cloud-based data analytics with powerful proprietary algorithms that distill data from millions of heartbeats into clinically actionable information. The company believes improvements in arrhythmia detection and characterization have the potential to change clinical management of patients.
1 Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, et al. Heart disease and stroke statistics—2015 update: a report from the American Heart Association. Circulation. 2015;131:e29–e322.
2 Lin HJ, Wolf PA, Kelly-Hayes M, Beiser AS. Stroke severity in AF: Framingham Heart Study. Stroke. 1996; 10:1760-4.
3 Freedman B, Potpara TS, Lip GY. Stroke prevention in atrial fibrillation. Lancet. 2016;388:806–817.
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Leigh Salvo
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investors@irhythmtech.com
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