CRT 2025 Late Breaking Science features
largest head-to-head randomized control TAVR trial to
primarily enroll women using the two most widely used global TAVR
devices
GALWAY, Ireland and WASHINGTON, March 9,
2025 /PRNewswire/ -- Medtronic plc
(NYSE: MDT), a global leader in healthcare
technology, today released the two-year results of the
SMall Annuli
Randomized To Evolut
or SAPIEN (SMART) Trial, the largest
international head-to-head comparative trial of transfemoral
transcatheter aortic valve replacement (TAVR).
In patients with aortic stenosis and a small aortic
annulus, results showed comparable composite outcome of mortality,
disabling stroke, and heart failure hospitalization, and continued
superior valve performance as measured by bioprosthetic
valve dysfunction (BVD) at two years for
Evolut™ TAVR compared to SAPIEN™.
The late-breaking science was presented at the Cardiovascular
Research Technologies (CRT) 2025 conference in Washington, D.C.
"Valve performance is critical for all patients, but the impact
of poor valve performance is magnified in patients with a small
aortic annulus, who are at risk of receiving a valve that is not
adequate for their cardiac requirements," said Howard C. Herrmann, M.D., Perelman School of
Medicine at the University of
Pennsylvania, and lead investigator of the trial. "The
two-year results highlight the continued superior performance of
the Evolut TAVR valve in these patients. While we would not yet
expect to see a significant difference in the composite clinical
outcomes at this early stage, valve performance provides important
data that operators can use to inform and personalize treatment
decisions to enhance patient outcomes."
The SMART two-year data demonstrated that Evolut TAVR continues
to show significantly less BVD, which can be a predictor of adverse
outcomes1, compared to SAPIEN TAVR. Additional results
demonstrated that Evolut TAVR showed the following relative to
SAPIEN TAVR:
- Five times less prosthetic valve thrombosis (p=0.0048)
- Nine times less hemodynamic structural valve dysfunction
(defined by mean gradient ≥ 20mmHg; p<0.001)
These results build on additional data of Evolut BVD performance
in small and large annulus patients, which will be presented as a
late-breaker at CRT today, and the Evolut BVD pooled analysis by
Dr. Steven Yakobuv published in the Journal of the American College
of Cardiology.
The SMART Trial is an international, prospective, multi-center,
randomized (1:1) post-market trial comparing the safety and
performance of Evolut self-expanding TAVR versus SAPIEN
balloon-expandable TAVR in patients with symptomatic severe aortic
stenosis (AS) and small aortic annulus. The trial, the largest head
to head randomized control trial to primarily enroll women,
randomized and treated 716 patients, 87% of which were women,
across more than 80 sites worldwide.2 Eligible patients
had an aortic valve annulus area of ≤430 mm as measured by
computed tomography, and suitable anatomy for transfemoral TAVR
with both an Evolut PRO/PRO+/FX or a SAPIEN 3™/3 Ultra™ valve.
Patients enrolled in the trial will continue to be followed out to
five years.
"The SMART Trial is a groundbreaking, head-to-head comparison
that, for the first time, highlights how a patient with a small
annulus can benefit from Evolut's differentiated valve design,"
said Kendra J. Grubb, M.D., M.H.A,
M.Sc., vice president and chief medical officer, Structural Heart,
which is part of the Cardiovascular Portfolio at Medtronic. "At two
years, we continue to see superior valve performance that we will
follow to assess long-term outcomes."
About Aortic Stenosis
Aortic stenosis (AS), a
narrowing of the aortic valve, is among the most common of all
valvular heart diseases, impacting 1.5 million in the
U.S.3 Symptomatic severe AS can be fatal if left
untreated and the average patient survival is two years
without treatment.4 Approximately 40% of the total
global market is believed to have a small aortic annulus, requiring
tailored valve selection for their unique anatomy.
About Medtronic
Bold thinking. Bolder actions. We
are Medtronic. Medtronic plc, headquartered in Galway,
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.
1Généreux, P. et al. J Am Coll Cardiol.
2021;77(21):2717-46
2Herrmann HC, Mehran R, Blackman DJ, Bailey S, Mollmann
H, et al. Self-Expanding or Balloon-Expandable TAVR in Patients
with a Small Aortic Annulus. N Engl J Med. 2024 Jun 6;390(21):1959-1971.
3Carabello BA, Paulus WJ. Aortic
stenosis. Lancet. March 14,
2009;373(9667):956-966.
4Lester 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
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