Results from largest randomized TAVR trial to
date presented at TCT 2022
MARLBOROUGH, Mass., Sept. 17,
2022 /PRNewswire/ -- Boston Scientific Corporation
(NYSE:BSX) has announced results from the PROTECTED TAVR clinical
trial evaluating the SENTINEL™ Cerebral Protection System, which is
designed to capture and remove embolic debris stemming from
transcatheter aortic valve replacement (TAVR) before it can reach
the brain and potentially cause a stroke. Outcomes were presented
during a late-breaking clinical science session at the 34th
Transcatheter Cardiovascular Therapeutics (TCT), the annual
scientific symposium of the Cardiovascular Research Foundation, in
Boston, and will be published in
the New England Journal of Medicine.
This randomized trial evaluated periprocedural stroke reduction
and neurologic outcomes in patients with aortic stenosis treated
with either the SENTINEL device to provide cerebral embolic
protection (CEP) during TAVR or TAVR alone. The primary endpoint
was not met, as the data demonstrated a non-significant trend
towards a lower rate of stroke in patients treated with the
SENTINEL device, representing a 21% relative risk reduction in all
stroke through 72 hours or time of hospital discharge (2.3% with
TAVR and CEP vs. 2.9% with TAVR only, P=0.30). Importantly, a
secondary analysis demonstrated a statistically significant 60%
relative risk reduction in disabling stroke through 72 hours or
time of hospital discharge in patients treated with the SENTINEL
device (0.5% with TAVR and CEP vs. 1.3% with TAVR only,
P=0.02).
"Data from the PROTECTED TAVR trial provide the physician
community with evidence that the device plays an important role in
reducing disabling strokes across patient types in those undergoing
TAVR," said Dr. Samir Kapadia,
chairman of the Robert and Suzanne Tomsich Department of
Cardiovascular Medicine, Sydell and Arnold Miller Family Heart,
Vascular & Thoracic Institute, Cleveland Clinic. "We also found
that the rate of vascular complications in this trial was very low,
whether or not the device was used, highlighting the safety of this
technology in TAVR procedures."
While outcomes with TAVR for the treatment of aortic stenosis
have been shown to be comparable to surgery, stroke remains an
important and feared complication of the procedure. Representing
the largest randomized TAVR trial to date, the study enrolled 3,000
patients spanning more than 50 global sites and all surgical risk
levels, with all patients receiving a neurological exam before and
after the procedure. Subgroup analyses demonstrated that the
reduction in disabling stroke with the SENTINEL device was
consistent across patient subgroups, including age, gender,
operative risk, valve type and history of cardiovascular
disease.
"Considering strokes are unpredictable, can occur regardless of
an individual's clinical background and often take a great toll on
a patient's quality-of-life and financial stability, we believe the
data appear to demonstrate a consistent effect from CEP technology
across all patient populations in the trial – supporting the use of
the SENTINEL device as an effective therapy to reduce the risk of
the most debilitating form of stroke for patients undergoing TAVR,"
said Dr. Ian Meredith, global chief
medical officer, Boston Scientific. "We look forward to additional
data on this technology such as from the currently enrolling
PROTECT TAVI trial in the United
Kingdom, which will similarly evaluate TAVR-related stroke
reduction using the SENTINEL device."
Previous clinical trials involving more than 3,500 patients have
demonstrated that the SENTINEL device is safe and effective,
including capture and removal of cerebral embolic debris in 99% of
TAVR cases.1 To date, more than 75,000 patients worldwide have been
protected with this technology.
To learn more about the results of the PROTECTED TAVR trial,
visit www.bostonscientific.com/sentinel.
About Boston Scientific
Boston Scientific transforms lives through innovative medical
solutions that improve the health of patients around the world. As
a global medical technology leader for more than 40 years, we
advance science for life by providing a broad range of high
performance solutions that address unmet patient needs and reduce
the cost of healthcare. For more information, visit
www.bostonscientific.com and connect on Twitter and
Facebook.
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CONTACTS:
Angela Mineo
Media Relations
(763) 955-8325 (office)
Angela.mineo@bsci.com
Lauren Tengler
Investor Relations
(508) 683-4479
BSXInvestorRelations@bsci.com
** Dr. Samir Kapadia has not been
compensated by Boston Scientific Corporation for his work on the
PROTECTED TAVR trial or his quote within this news release.
1 SENTINEL IDE Trial. Data presented at SENTINEL FDA
Advisory Panel, February 23,
2017.
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SOURCE Boston Scientific Corporation