TCT 2021: Intermediate risk TAVR patients demonstrate strong
hemodynamics and stable valve performance at five years
DUBLIN and ORLANDO, Fla., Nov. 5,
2021 /CNW/ -- Medtronic plc (NYSE:MDT), a global
leader in healthcare technology, today unveiled five-year
clinical data from the Surgical Replacement and Transcatheter
Aortic Valve Implantation (SURTAVI) Trial, which was presented as a
Late Breaking Clinical Trial at the 33rd Transcatheter
Cardiovascular Therapeutics (TCT) conference, the annual scientific
symposium of the Cardiovascular Research Foundation. Data from the
trial showed that the hemodynamic (blood flow) benefits of the
Medtronic CoreValve™ and Evolut™ platforms were maintained at five
years with an excellent safety profile and stable valve performance
in patients with symptomatic, severe aortic stenosis who are at an
intermediate risk for open-heart surgery.
At five years, rates of all-cause mortality were similar between
TAVR with the CoreValve/Evolut platform and surgical aortic valve
replacement (SAVR) (30.0% for TAVR versus 28.7% for SAVR; p=0.55),
while rates of disabling stroke were also similar (4.1% for TAVR
versus 5.8% for SAVR, p = 0.12). The TAVR arm continued to
demonstrate durable valve longevity, as evidenced by better mean
aortic valve gradients (8.6 mm Hg vs. 11.2 mm Hg; p<0.001) at
five years. Additionally, valve thrombosis remained low out to five
years for both TAVR and SAVR.
In the study, patients considered to be at intermediate risk for
open-heart surgery had a risk of mortality of ≥ 3 and < 15% at
30 days following the procedure in combination with other
factors.
"TAVR has revolutionized the treatment of aortic stenosis with
more TAVR cases now performed than surgical aortic valve
replacement for this disease. With this shift in treatment,
longer-term, randomized data is increasingly important as we strive
to better understand the lifetime management of these patients,"
said Michael Reardon, M.D.,
professor of cardiothoracic surgery and Allison Family
Distinguished Chair of Cardiovascular Research at Houston Methodist
DeBakey Heart & Vascular Center, principal investigator in the
SURTAVI trial.
The global, prospective, multi-center, randomized SURTAVI Trial
evaluated two early valve generations (CoreValve™, Evolut™ R)
across a variety of valve sizes in 864 intermediate-risk
symptomatic severe aortic stenosis patients. Patients in the TAVR
arm were compared to 796 intermediate-risk patients who were
randomized to open-heart surgery.
"These longer-term outcomes are remarkably similar after TAVR
and surgery in patients with severe aortic stenosis at intermediate
operative risk," said Nicolas Van
Mieghem, M.D., Ph.D., professor of interventional
cardiology, department of cardiology, Thoraxcenter, Erasmus University Medical Center in Rotterdam, The Netherlands, who presented the
data at the meeting. "Additionally, results from this study are
particularly impressive given the TAVR devices evaluated were
first- and second-generation systems."
The Evolut TAVR platform, which includes the Evolut™ R, Evolut™
PRO, Evolut™ PRO+, and newest-generation Evolut™ FX valves, is
indicated for symptomatic severe aortic stenosis patients across
all risk categories (extreme, high, intermediate and low) in the
U.S.
About Medtronic
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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 90,000+ passionate people
across 150 countries. Our technologies and therapies treat 70
health conditions and include cardiac devices, cranial and spinal
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 all. 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.
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SOURCE Medtronic plc