DUBLIN, June 7, 2021 /PRNewswire/ -- Medtronic plc
(NYSE:MDT), the global leader in medical technology, today
announced clinical trial results from the STROKE AF trial
demonstrating the superiority of the Reveal LINQ™ Insertable
Cardiac Monitor (ICM) to detect abnormal heartbeats, otherwise
known as atrial fibrillation (AF), in both large and small vessel
stroke patients compared to standard of care. The findings were
published in the June 1, 2021 issue
of the Journal of the American Medical Association
(JAMA).
Stroke impacts more than 795,000 people every year. More than
87% of strokes are ischemic strokes, which occur when vessels that
allow blood to flow to the brain are blocked.1 AF is a
major risk factor for ischemic stroke. In fact, there is a
five-fold increase in ischemic stroke risk for AF patients.
The STROKE AF study evaluated 496 patients2,
including 284 large vessel and 208 small vessel stroke patients.
The findings demonstrated Reveal LINQ ICM was superior to the
standard of care for AF detection:
- At 12 months, AF was detected in 12.1% (or one in eight)
patients in the ICM arm compared to 1.8% in the standard of care
arm (HR=7.41; p<0.001). This equates to a greater than
seven-fold increase in detecting AF in the ICM arm.
- 78% of patients who had AF would have been missed if only
monitored for 30 days.3
- Median time to detection of AF was 99 days.
- Rates of AF detection in the ICM arm were similar between
patients with index strokes due to small vessel versus large vessel
disease (12.6% compared to 11.7% respectively; p=0.74).
- At 12 months, 96.3% of first AF episodes were asymptomatic in
ICM arm.
- The majority (55.5%) of patients with AF detected had an
episode lasting more than one hour.
"STROKE AF showed that many patients with large vessel or small
vessel stroke actually have AF, which is challenging to find using
standard cardiac monitoring," said Richard
Bernstein, M.D., Ph.D., Northwestern Medicine Distinguished
Physician in Vascular Neurology, Medical Director of Telehealth,
and professor of Neurology, Northwestern
University Feinberg School of Medicine. "Our job as
neurologists includes identifying potential causes of future
strokes to adequately protect our patients. AF is a risk that we
can't afford to miss, and without long-term monitoring, we are
missing it."
"The Stroke AF trial shows that long-term monitoring with an ICM
resulted in significantly higher rates of AF detection compared to
routine follow-up at both six months and one year after the
patient's index stroke," said Lee H.
Schwamm, M.D., vice president of Virtual Care and Digital
Health, Mass General Brigham and C. Miller
Fisher chair in Vascular Neurology, Massachusetts General
Hospital. "Preventing recurrent stroke is challenging. I believe
the findings from the STROKE AF study strongly suggest the need to
re-examine the role of ICMs in secondary prevention, go beyond just
the cryptogenic stroke patient, and embrace a broader conceptual
framework that shifts the emphasis away from the cause of the index
stroke and onto future stroke prevention."
STROKE AF is a 1:1, randomized clinical trial, taking place at
33 clinical sites across the U.S. Individuals 60 years and older
with ischemic stroke believed to be due to small vessel disease,
large vessel cervical or intracranial atherosclerosis within the
past 10 days, as well as individuals 50 to 59 years older with
stroke risk factors, were enrolled in the trial. Patients
randomized to the ICM arm were given a Medtronic Reveal LINQ
Insertable Cardiac Monitor. Patients in the control group received
site-specific usual care, consisting of external cardiac monitoring
such as 12-lead ECGs, Holter monitoring, telemetry, or event
recorders. Incidence rates of AF and recurrent stroke will be
compared over a three-year study duration. The study is led by
co-principal investigators, Dr. Bernstein and Dr. Schwamm.
"Medtronic has been an innovative leader in ICM technology for
20 years and has made significant contributions to understanding
the clinical utility of using ICMs in the cryptogenic stroke
population, including publication of the CRYSTAL-AF Study in 2014.
Now with the STROKE AF study, we are able to deepen our
understanding in this additional patient population," said
Rob Kowal, M.D., Ph.D., chief
medical officer of the Cardiovascular Diagnostics and Services
business, which is part of the Cardiovascular Portfolio at
Medtronic. "We believe that prolonged cardiac monitoring with the
Reveal LINQ ICM can assist clinicians as they seek to prevent
secondary strokes among their patients who have suffered an initial
ischemic stroke. Findings from the STROKE AF study clearly validate
the benefits of long-term monitoring for this high-risk population
and have the potential to be practice-changing."
In collaboration with leading clinicians, researchers and
scientists worldwide, Medtronic offers the broadest range of
innovative medical technology for the interventional and surgical
treatment of cardiovascular disease and cardiac arrhythmias. The
company strives to offer products and services of the highest
quality that deliver clinical and economic value to healthcare
consumers and providers around the world.
About Medtronic
Medtronic plc (www.medtronic.com),
headquartered in Dublin, Ireland,
is among the world's largest medical technology, services and
solutions companies – alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 90,000 people worldwide, serving physicians,
hospitals and patients in more than 150 countries. The company is
focused on collaborating with stakeholders around the world to take
healthcare Further, Together.
Any forward-looking statements are subject to risks and
uncertainties such as those described in Medtronic's periodic
reports on file with the Securities and Exchange Commission. Actual
results may differ materially from anticipated results.
1 Virani SS, Alonso A, Benjamin EJ, Bittencourt
MS, Callaway CW, Carson AP, et al.
Heart disease and stroke statistics—2020 update: a report from the
American Heart Associationexternal icon. Circulation.
2020;141(9):e139–e596.
2 A total of 496 patients were enrolled in the
study and 492 were randomized
3 Based on data through 12 months
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