iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health
care company focused on creating trusted solutions that detect,
predict, and prevent disease, today announced the presentation and
publication of the GUARD-AF (Reducin
G stroke
by screening for
Undi
Agnosed
at
Rial fibrillation in elderly
in
Dividuals) randomized clinical trial at the
European Society of Cardiology (ESC) Congress 2024. The trial was
sponsored by Bristol-Myers Squibb-Pfizer Alliance and iRhythm
provided the Zio XT patch ECG long-term continuous monitoring
(LTCM) monitor used in the interventional (screening) arm of the
study.
GUARD-AF was a prospective, parallel-group, randomized
controlled trial designed to test whether screening for AF in
people aged ≥70 years using an on-label Zio® XT 14-day single-lead
LTCM could identify patients with undiagnosed AF and reduce stroke.
Participants were randomized 1:1 to screening with Zio XT LTCM or
usual care. The primary efficacy and safety outcomes were
hospitalization due to all-cause stroke and bleeding,
respectively.
During a median follow-up of 15 months in 11,905 enrolled
patients from 149 primary care sites in the US (5,952 assigned to
screening), the study found that Zio XT LTCM led to an increase in
new diagnosis of AF vs usual care (5.0 vs 3.3%) through the end of
follow-up. There was no significant difference between groups in
incidence of the primary endpoint of stroke hospitalization,
although event rates were low and the trial was stopped before
achieving enrollment of the planned total of 52,000 patients during
the COVID-19 pandemic2, thereby reducing statistical power.
Findings were presented by Dr. Renato Lopes, Professor of Medicine
at the Duke Clinical Research Institute and Duke University, at the
ESC Congress on September 1 and simultaneously published in two
tandem manuscripts in the Journal of the America College of
Cardiology (JACC)3 and the JACC: Clinical Electrophysiology.4
“Owing in part to the low event rate and truncated enrollment,
the study found no reduction in the rate of stroke,” said Dr.
Lopes. “However, there are some important lessons here. Our study
confirms that AFib is common in older patients and can be
identified with cardiac monitoring in primary care — upstream of
cardiology care, which many patients will not have access to. Most
participants with AFib also had short, infrequent episodes that
would be missed with a pulse check, single ECG, shorter duration of
monitoring. Identification of these short episodes could be a
useful prompt for physicians to more aggressively treat heart
disease risk factors and may reduce the downstream risk of heart
failure, which will be evaluated in future trials.”
The study had several notable implications:
- Screening with Zio XT LTCM led to an increase in diagnosis of
AF over the maximum 2.5 years of follow up vs usual care (5.0% vs
3.3%), an increase in initiation of oral anticoagulation that is
used for prevention of stroke in AF (4.2% vs 2.8%), and no increase
in the rate of hospitalization for bleeding.3
- Primary care-initiated home-based monitoring in an older
population is feasible. GUARD-AF is the largest randomized trial to
evaluate the impact of AF screening with a patch-based ECG monitor
on care delivery in a primary care setting; more than half of
participants enrolled were women.3
- Virtual, home-based diagnostics are feasible. In GUARD-AF, 20%
of participants were enrolled virtually and received the Zio XT
LTCM device by mail for self-application. Wear time and analyzable
time were similar and high in self-applied and clinic-applied
groups3, confirming prior studies and clinical experience with Zio
LTCM service.5
- In the 252 participants with AF detected on 14-day LTCM, most
(88%) had low-burden paroxysmal AF. Of those with detected AF, most
had AF < 1.0% of the time3, suggesting that many patients with
diagnosed AF may miss detection with 12-lead ECG (10 seconds),
smartwatch ECG (30 seconds), or ambulatory monitoring of shorter
duration such as 48 hours. Only 32 of 252 had AF at the start of
the ECG recording.
Additionally, this research underscores how large pragmatic
trials powered by the Zio LTCM service are feasible at scale.
iRhythm’s clinical research services have supported over 100
prospective studies at nearly 500 sites in over 40,000
participants.
“These findings support the totality of evidence that
undiagnosed AFib is common and can be found with Zio’s 14-day
long-term monitoring — even when it is not likely to be found with
point-of-care ECGs or short-term monitors due to the short,
infrequent episodes in the early stages of atrial fibrillation,”
said Mintu Turakhia MD, iRhythm’s Chief Medical and Scientific
Officer and EVP, Product Innovation. “iRhythm’s undiagnosed
arrhythmia pilot programs leverage many features seen in GUARD-AF,
such as virtual enrollment and self-applied patches at home. These
programs, as well as ongoing clinical trials, such as AMALFI6, and
those in development will have longer follow-up or assess a wider
range of outcomes, including heart failure, which occurs in
one-third of patients with AFib, along with cardiovascular
hospitalization, health care utilization, and costs.”
Also at ESC, Evangelos Hytopoulos, PhD, iRhythm’s Sr. Director
of Data Science, presented separate work performed in collaboration
with Scripps Research, New insights from the ECG: screening and
prediction7, that used machine learning on ECG signal of 14-days of
patch-based monitoring without AF to successfully predict episodes
of AF in the subsequent year. The research presented is part of a
scientific study only and is not part of any commercial product
offering in any market.
About iRhythm Technologies, Inc.iRhythm is a
leading digital health care company that creates trusted solutions
that detect, predict, and prevent disease. Combining wearable
biosensors and cloud-based data analytics with powerful proprietary
algorithms, iRhythm distills data from millions of heartbeats into
clinically actionable information. Through a relentless focus on
patient care, iRhythm’s vision is to deliver better data, better
insights, and better health for all. To learn more about iRhythm,
go to iRhythmtech.com.
Forward-Looking StatementsThis 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.
iRhythm Contact Information
Investor Relations ContactStephanie
Zhadkevichinvestors@irhythmtech.com
Media ContactKassandra
Perryirhythm@highwirepr.com
1 The Zio XT Patch is a prescription-only, single patient use,
continuously recording ECG monitor that can be worn up to 14 days.
It is indicated for use on patients who may be asymptomatic or who
may suffer from transient symptoms such as palpitations, shortness
of breath, dizziness, light-headedness, pre-syncope, syncope,
fatigue, or anxiety. 2 Singer DE, et al. American Heart Journal.
2022 Jul:249:76-85. doi: 10.1016/j.ahj.2022.04.005.3 Lopes RD, et
al. J Am Coll Cardiol. 2024.4 Singer DE, et al. JACC Clin
Electrophysiol. 2024.5 Goergen JA, et al. Heart Rhythm. 2023
Mar;20(3):407-413. doi: 10.1016/j.hrthm.2022.11.020.6 About
AMALFI https://www.amalfitrial.org/about 7 M Gadaleta, et
al, Predicting 1-year atrial fibrillation risk from a patch-based
ambulatory ECG monitoring without atrial fibrillation, European
Society of Cardiology (ESC) 2024 Congress, August 30 – September 2,
London.
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