TCT 2023: Medtronic adds to the body of
evidence for Evolut TAVR with late-breaking clinical trial data
from the Evolut Low Risk Trial
DUBLIN and SAN
FRANCISCO, Oct. 24, 2023 /PRNewswire/ -- Medtronic
plc (NYSE:MDT), a global leader in healthcare technology, today
announced four-year results from the Evolut Low Risk Trial.
The Medtronic Evolut™ transcatheter aortic valve replacement
(TAVR) system demonstrated exceptional outcomes and sustained valve
performance, proven by significantly better hemodynamics than
surgical aortic valve replacement (SAVR). Only Evolut TAVR has
reported consistently lower and diverging rates of death or
disabling stroke versus state-of-the-art surgery, at four years.
The data were presented at the 35th Transcatheter
Cardiovascular Therapeutics (TCT) conference, the annual scientific
symposium of the Cardiovascular Research Foundation and
simultaneously published in the Journal of the American College
of Cardiology.
Since the approval of TAVR in low-risk surgical patients, there
is an ongoing need for evidence to better understand the
intermediate and longer-term durability of TAVR devices of
different designs.
"As we see patients in the Evolut Low Risk trial continue to
show positive outcomes and sustained valve performance compared to
surgery out to four years, this helps us establish
intermediate-term evidence for Evolut TAVR and helps define what
this might look like in the long term," said Dr. Michael Reardon, Allison Family Distinguished
Chair of Cardiovascular Research and professor of cardiothoracic
surgery at the Houston Methodist Hospital and principal
investigator of the trial. "These results are not only encouraging,
but pivotal in shaping treatment decisions for low-risk patients
with symptomatic severe aortic stenosis. We are seeing sustained,
excellent valve performance in patients treated with Evolut TAVR,
which ultimately translates into improved outcomes, including
mortality and disabling stroke.1 This intermediate-term
result underscores the belief that valve design matters, and
previously published data points to superior outcomes* and better
design in the Evolut TAVR platform."
The Evolut™ Low Risk Trial was a prospective,
randomized, multicenter, international, noninferiority study to
assess the safety and efficacy of the Evolut TAVR system
compared to surgical aortic valve replacement (SAVR) in low-risk
patients. Low-risk patients, defined in the trial as having a
predicted risk of 30-day mortality <3% per multidisciplinary
local heart team assessment, were randomized to TAVR with a
Medtronic self-expanding, supra-annular Evolut R, PRO, or
CoreValve™ bioprosthesis vs. SAVR. A total of 1,414 patients
underwent attempted implant (730 TAVR; 684 SAVR).
The study showed continued favorable outcomes for Evolut TAVR
compared to SAVR at four years for the primary endpoint of
all-cause mortality or disabling stroke. At four years, a 26%
relative reduction in the hazard (p= 0.05) of death or disabling
stroke with TAVR (10.7%) was seen compared to SAVR (14.1%). The
absolute difference between treatment arms for the primary endpoint
continued to increase over time, representing a clinical benefit
from Evolut TAVR for patients at four years compared to surgery.
The findings also showed the composite of all-cause mortality,
disabling stroke, or aortic valve rehospitalization was 18.0% with
TAVR and 22.4% with SAVR (p=0.04).
"The Medtronic Low Risk data presented today at TCT demonstrates
our continued commitment to generating evidence on our Evolut TAVR
platform and providing treatment options for low-risk symptomatic
severe aortic stenosis patients, a growing patient population,"
said Nina Goodheart, senior vice
president and president of the Structural Heart & Aortic
business within the Cardiovascular Portfolio at Medtronic. "We are
dedicated to supporting advanced, lifelong patient care by
empowering physicians with the latest minimally invasive,
clinically proven technology to best treat their patients."
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc,
headquartered in Dublin, Ireland,
is the leading global healthcare technology company that boldly
attacks the most challenging health problems facing humanity by
searching out and finding solutions. Our Mission — to alleviate
pain, restore health, and extend life — unites a global team of
95,000+ passionate people across more than 150 countries. Our
technologies and therapies treat 70 health conditions and include
cardiac devices, surgical robotics, insulin pumps, surgical tools,
patient monitoring systems, and more. Powered by our diverse
knowledge, insatiable curiosity, and desire to help all those who
need it, we deliver innovative technologies that transform the
lives of two people every second, every hour, every day. Expect
more from us as we empower insight-driven care, experiences that
put people first, and better outcomes for our world. In everything
we do, we are engineering the extraordinary. For more information
on Medtronic (NYSE:MDT), visit www.Medtronic.com and follow
@Medtronic on Twitter and LinkedIn.
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 O'Hair D, Yakubov SJ, Grubb KJ, et al. Structural
valve deterioration after self-expanding transcatheter or surgical
aortic valve implantation in patients at intermediate or high risk.
JAMA Cardiology. 2023;8(2):111.
doi:10.1001/jamacardio.2022.4627
* Versus surgery in high-risk patients on mortality at 1
year2 and vs surgery in low-risk patients on MPG and EOA
at 1 year and KCCQ at 30 days3
2Adams DA, et al. N Eng J Med.
2014;370:1790–1798.
3 Popma JJ, et al. N Engl J Med.
2019;380:1706–1715.
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SOURCE Medtronic plc