New data from largest head-to-head randomized
control TAVR trial demonstrates non-inferior clinical outcomes
and superior valve performance for Evolut TAVR compared to Sapien™
at one year
DUBLIN and ATLANTA, April 7,
2024 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a
global leader in healthcare technology, today announced new data
from the largest head-to-head comparative trial of
transfemoral transcatheter aortic valve replacement (TAVR), were
presented as a late breaking clinical trial at the American College
of Cardiology Annual Scientific Session and simultaneously
published in The New England Journal of Medicine. The
one-year results of the SMall Annuli
Randomized To Evolut or SAPIEN (SMART) Trial in
individuals with aortic stenosis (AS) with small aortic annuli
(SAA) demonstrated noninferior clinical outcomes and superior valve
performance as measured by bioprosthetic valve dysfunction
performance for the Evolut™ TAVR platform compared to the SAPIEN™
platform.
"SMART was launched to better understand how the two most
commonly used TAVR systems perform in patients with small aortic
annuli, and particularly in women who tend to have smaller heart
valves," said Nina Goodheart, senior
vice president and president, Structural Heart & Aortic, which
is part of the Cardiovascular Portfolio at Medtronic. "We continue
to develop evidence to better understand the benefits of our Evolut
TAVR technology in all patients, including patient populations that
are underrepresented, under-diagnosed and under-treated. The
results from the SMART trial demonstrate these benefits in a large
patient population and reinforce our commitment to driving health
equity and engineering the best technology to solve unmet patient
needs."
In addition to being the largest comparative trial of TAVR,
SMART is also the largest TAVR trial to date to enroll primarily
women (87%). Symptomatic severe aortic stenosis can be fatal if
left untreated and the average patient survival is two years
without treatment.1 Despite women's longer life
expectancy, once impacted by severe aortic stenosis they suffer
from higher mortality than men, even after matching for
age.2 Both TAVR and surgical aortic valve replacement
(SAVR) are options for women to treat AS. Due to their smaller
aortic annuli, women can often receive a valve replacement that
does not properly fit their anatomy — highlighting the need for
clinical evidence to inform the best treatment
approaches.3 Additionally, despite prevalence of
chronic conditions associated with AS in women over 65, a new
survey of over 1,000 women announced today found that the majority
have never been referred to a cardiologist.
"As clinicians, we know that tailored approaches are needed to
address the unique presentation of AS in the small annulus patient
population, which is primarily women. Little comparative data
exists to help us with valve selection," said Howard C. Herrmann, M.D., Perelman School of
Medicine at the University of
Pennsylvania, Philadelphia,
Penn., and lead investigator of the SMART Trial. "While we
know women have a greater benefit than men when treated with TAVR
vs SAVR, now for the first time there is definitive data
demonstrating that women have the best valve performance when
treated with the Evolut TAVR system."
The SMART Trial is an international, prospective, multi-center,
randomized (1:1) post-market trial comparing the safety and
performance of self-expanding versus balloon-expandable TAVR in
patients with symptomatic severe AS and SAA. The trial randomized
and treated 716 patients, 87% of which were women, across more than
80 sites worldwide. Eligible patients had a computed tomography
aortic valve annulus area of ≤430 mm2 and suitable
anatomy for transfemoral TAVR with both an Evolut PRO/PRO+/FX or a
SAPIEN 3™/3 Ultra™ valve.
"For patients with heart valve replacements, early bioprosthetic
valve dysfunction can lead to increased risk of serious long term
outcomes including mortality and rehospitalization," added Dr.
Herrmann. "As clinicians, these data further reinforces that not
all valves are the same, and we strongly need to consider valve
performance when determining device selection."
Results demonstrated that the Evolut TAVR platform met both
co-primary endpoints of clinical non-inferiority and hemodynamic
superiority at one year.
- Evolut TAVR met non-inferiority for the clinical outcome
primary endpoint, a composite of all-cause mortality, disabling
stroke, or heart failure rehospitalization at one year (9.4% Evolut
vs. 10.6% SAPIEN, p<0.001 for non-inferiority).
- Evolut TAVR demonstrated superiority for the valve function
primary endpoint, bioprosthetic valve dysfunction through one year
(9.4% Evolut vs. 41.6% SAPIEN, p<0.001 for superiority).
"Medtronic is committed to providing clinicians and patients
with aortic stenosis long-term data to help to inform their
treatment decisions," said Jeffrey
Popma, M.D., vice president and Chief Medical Officer for
the Coronary & Renal Denervation business and the Structural
Heart & Aortic business at Medtronic. "Our prior studies have
shown an important link between valve performance, mortality, and
re-hospitalization at five years. All SMART patients will be
followed for five years to assess the relationship between better
valve performance and improved clinical outcomes in patients with
small annuli."
Analyst and Investor Briefing
Medtronic will host an analyst and investor briefing to discuss the
results from the SMART Trial on Sunday, April 7,
2024, at 10:45 AM EDT. The briefing will feature remarks
from Medtronic management, immediately followed by answering
questions from institutional investors and equity analysts. A live,
listen-only webcast will be available and can be accessed by
clicking on the Events link at
investorrelations.medtronic.com on April 7. An archived
replay will be available on the same webpage later in the
day. This event is not part of the official ACC Scientific
Sessions.
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 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
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.
SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards
Lifesciences Corporation.
1Carabello BA, Paulus WJ. Aortic stenosis. Lancet.
March 14, 2009;373(9667):956-966.
2Am Heart Assoc. 2021;10:e018816. DOI:
10.1161/JAHA.120.018816.
3Lester SJ, Heilbron B, Gin K, Dodek A, Jue J. The
natural history and rate of progression of aortic stenosis. Chest.
April 1998;113(4):1109-1114
Contact:
Ryan Weispfenning
Investor Relations
+1-763-505-4626
Kimberly Powell
Public Relations
+1-202-498-2601
View original content to download
multimedia:https://www.prnewswire.com/news-releases/smart-trial-one-year-data-demonstrates-medtronic-evolut-tavr-platform-as-optimal-treatment-for-severe-aortic-stenosis-in-patients-with-small-annulus-which-is-primarily-women-302109869.html
SOURCE Medtronic plc