DUBLIN, May 18, 2021 /PRNewswire/ -- Medtronic plc
(NYSE:MDT), the global leader in medical technology, today
announced the complete two-year outcomes from the landmark Evolut
Low Risk Trial comparing the minimally invasive Evolut™
transcatheter aortic valve replacement (TAVR) system to the gold
standard of open-heart surgery in characteristically younger,
healthier aortic stenosis patients. Presented virtually today
as a late-breaking clinical trial at the EuroPCR 2021 e-Course,
results showed the Evolut TAVR platform was non inferior to surgery
for the primary endpoint of all-cause mortality or disabling stroke
at two years (4.3% for TAVR versus 6.3% for surgery; p< 0.0001
for non-inferiority), and trended the same or lower on all critical
events, confirming the earlier Bayesian statistical analysis
presented at the American College of Cardiology (ACC) 68th Annual
Scientific Session in 2019.
"We know that TAVR has an advantage over surgery in certain
near-term outcomes; however, in these low-risk studies, longer term
outcomes are more important than ever. The full two-year data from
the randomized Evolut Low Risk Trial demonstrate that between years
one and two, patients who have undergone TAVR continue to do
exceptionally well with no convergence of the primary outcome
curves," said John Forrest, M.D.,
director of interventional cardiology at the Yale School of Medicine in New Haven, Conn., and principal investigator
in the Evolut Low Risk Trial. "Heart teams can be confident that
low-risk patients who undergo TAVR are doing exceptionally well at
two years. There are some clear differences in secondary outcomes,
and the long-term impact in areas such as hemodynamics, pacemakers,
and prosthesis-patient mismatch will be important to follow."
At two years, results from the study showed there was no
convergence of the divergent Kaplan-Meier curves for death or
disabling stroke between TAVR and surgery, demonstrating that
improved safety shown early on for TAVR was sustained over time. In
addition, results from the study showed:
- Excellent hemodynamic (blood flow) performance for TAVR with
statistically significantly lower mean aortic valve gradient (9.0
mm Hg versus 11.7 mm Hg) and larger effective orifice area than
surgery (2.2 cm2 versus 2.0 cm2) at two
years, (p < 0.001 for both comparisons).
- Numerically lower rates of death in the TAVR arm (3.5% versus
4.4%), heart failure hospitalizations (5.3% versus 7.1%) and
disabling stroke (1.5% versus 2.7%) compared to surgery at two
years.
- Prosthesis-patient mismatch was lower for TAVR compared to
surgery at two years with a difference of 2.1% versus 4.9% in the
severe category (p<0.001).
- Valve thrombosis rates showed no signs of increase and remained
low at two years (0.3% for TAVR versus 0.2% for SAVR).
The global randomized Evolut Low Risk Trial evaluated three
valve generations (CoreValve™, Evolut™ R and Evolut™ PRO valves)
across a variety of valve sizes in more than 700 patients with
severe aortic stenosis deemed to have a low mortality risk with
surgery with a predicted risk of mortality of less than 3%.
"Results from this landmark study reassure us that the positive
outcomes presented using the Bayesian statistical analysis at
ACC.19, before the full two-year outcomes were available, matched
the actual two-year outcomes and thus was an extremely accurate and
scientifically rigorous methodology that researchers can feel
confident about moving forward," said Jeffrey J. Popma, M.D., vice president and chief
medical officer for the Coronary & Renal Denervation business
and the Structural Heart & Aortic business, which are part
of the Cardiovascular Portfolio at Medtronic. "Furthermore, the
Evolut TAVR platform continues to show it is a treatment option
well-suited for lower-risk patients who are living longer and may
be more active."
The Evolut TAVR platform, including the Evolut™ R, Evolut™ PRO
and Evolut PRO+ TAVR Systems, is indicated for symptomatic patients
with severe aortic stenosis across all surgical risk categories
(extreme, high, intermediate and low) in the U.S. and countries
that recognize CE Mark. It is estimated that 165,000 low-risk
patients suffer from severe aortic stenosis per year in the
U.S., Western Europe, and
Japan. If left untreated, it can
cause heart failure in as little as two years.
In collaboration with leading clinicians, researchers and
scientists worldwide, Medtronic offers the broadest range of
innovative medical technology for the interventional and surgical
treatment of cardiovascular disease and cardiac arrhythmias. The
company strives to offer products and services that deliver
clinical and economic value to healthcare consumers and providers
around the world.
About Medtronic
Medtronic plc (www.medtronic.com),
headquartered in Dublin, Ireland,
is among the world's largest medical technology, services and
solutions companies – alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 90,000 people worldwide, serving physicians,
hospitals and patients in more than 150 countries. The company is
focused on collaborating with stakeholders around the world to take
healthcare Further, Together.
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