New data from Medtronic Patient Preference study presented at
TCT 2021; Medtronic adds to its clinical leadership for renal
denervation with launch of the SPYRAL AFFIRM study
DUBLIN and ORLANDO, Fla., Nov. 4, 2021 /CNW/
-- Medtronic plc (NYSE:MDT), a global leader in
healthcare technology, today announced findings from a new study of
the Patient Preferences for the Treatment of Hypertension. The
findings will be presented later today during the "What's Novel in
Interventional Hypertension session" at the 33rd
Transcatheter Cardiovascular Therapeutics (TCT 2021) conference,
the annual scientific symposium of the Cardiovascular Research
Foundation.
Medtronic also announced the initiation of the SPYRAL AFFIRM
study, evaluating the long-term safety, efficacy, and durability of
the Medtronic Symplicity™ Renal Denervation System in real-world
patients with uncontrolled hypertension and comorbidities such as
diabetes, isolated systolic hypertension, and chronic kidney
disease.
Patient Preference in the Treatment of Hypertension:
Interventional Treatments and Standard of Care
For the first
time, new data presented at TCT 2021 quantified United States (U.S.) patient preferences for
considerations of interventional procedures in the treatment of
high blood pressure, including treatment mode, effectiveness and
risks.
The study found that in exchange for treatment risks, patients
on average would require a minimal acceptable benefit of less than
2.5mmHg reduction in office-based systolic blood pressure.
Additionally, on average, patients indicated a tolerance of at
least 20% risk of adverse events (such as a vascular injury or drug
side effects) in exchange for being able to lower their
office-based systolic blood pressure.
These findings suggest that despite the risks of an
intervention, patients may accept lower blood pressure reductions
than those observed in published literature of Medtronic Symplicity
Spyral Renal Denervation procedure1,2. Additionally,
patients may be willing to tolerate risks higher than those
observed in peer-reviewed published studies3 of
Symplicity Spyral.
The study also concluded that blood pressure reduction was the
most important driver of patient preference over all other
attributes like medication burden and treatment (including
interventional treatment-related) risks. When applying this model
to a patient population who is interested in an interventional
procedure without medication, up to 76.5% of patients would be
willing to consider an interventional approach such as RDN if they
achieve a 10mmHg reduction in office-based systolic blood pressure.
Including the maximum acceptable risk of 20%:
- 76.5% of patients would be willing to consider an
interventional approach such as RDN with reductions in office blood
pressure anticipated at 10 mmHg.
- 24.3% of patients would be willing to consider an
interventional approach such as RDN with reductions in office blood
pressure anticipated at 5 mmHg.
- 6.9% of patients would be willing to consider an interventional
approach such as RDN with reductions in office blood pressure
anticipated at 2.5 mmHg, the minimal acceptable benefit.
"This novel, patient preference study is particularly valuable
for a new procedure like renal denervation, because it demonstrates
that for patients, lowering blood pressure, even by a small amount,
is meaningful," said Dr. Michael
Weber, professor of cardiovascular medicine at State University of New York, Downstate Medical
Center. "For the first time, these results give us
quantitative insights into hypertension treatment preferences -
importantly, patients are very open to considering a medical
intervention procedure, such as RDN, with demonstrated improvements
in the control of their high blood pressure."
The study, which was designed based on the FDA Guidance for
Patient Preference Information, surveyed 400 individuals in the
U.S. who have high blood pressure (physician confirmed systolic
office-based blood pressure greater than 140 mmHg), who were on up
to three anti-hypertensive medications and were not previously
involved in a SPYRAL HTN study. The study uses a statistical method
called a discrete choice experiment, often used to compare
individuals' preferences among two or more alternatives.
"The patient preference insights, combined with the breadth of
real world and randomized sham controlled trials we have for renal
denervation, are aligned with the recent clinical consensus from
the European Society of Hypertension, Society for Cardiovascular
Angiography and Interventions, and National Kidney Foundation that
reinforce RDN as a potential treatment option for patients," said
Jason Weidman, senior vice president
and president of the Coronary & Renal Denervation business,
which is part of the Cardiovascular Portfolio at Medtronic.
"Patient preference data will be important to help physicians
understand patients' acceptable benefits and risks related to
minimally invasive procedures for the treatment of
hypertension."
SPYRAL AFFIRM Study Launch
Separately, Medtronic
announced that the first patient was enrolled at Piedmont Heart
Institute in Atlanta, Ga. for the
SPYRAL AFFIRM clinical study. Using a performance goal, this
clinical study will enroll 1,000 real-world patients with
uncontrolled hypertension and associated comorbidities, such as
isolated systolic hypertension, diabetes, and chronic kidney
disease. SPYRAL AFFIRM will follow these patients for three
years. This investigational device exemption trial was approved by
the U.S. Food and Drug Administration (FDA) in June 2021 and will be conducted at 100 sites
globally.
"Through the strong investment in our clinical program, the
AFFIRM study will expand RDN research into a variety of patient
groups," said Weidman. "The AFFIRM clinical study adds to our body
of evidence for RDN and will help us further answer questions about
the use of this procedure in more complex, real world patients such
as those with isolated systolic hypertension, diabetes and chronic
kidney disease."
The SPYRAL AFFIRM clinical study is part of the SPYRAL HTN
Global Clinical Program, adding to the safety and efficacy
data for RDN. Along with the real-world data from the
Global Symplicity Registry,4 when combined
with commercial experience, there have been more than 20,000
procedures performed with Medtronic RDN technology. The clinical
program is backed by the most rigorous and extensive patient
experience studied in the presence2 and
absence1 of medication and in patients with high
baseline cardiovascular risk.4
About the Medtronic Symplicity™ Renal Denervation
System
The Medtronic RDN procedure uses a minimally invasive
procedure that delivers radiofrequency energy to specific nerves
near the kidneys that can become overactive and cause high blood
pressure. Approved for commercial use in more than 60 countries
around the world, the Symplicity Spyral renal denervation system is
limited to investigational use in the
United States, Japan, and
Canada.
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 90,000+ 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 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.
1 Kandzari et al. Effect of renal denervation on
blood pressure in the presence of antihypertensive drugs: 6-month
efficacy and safety results from the SPYRAL HTN-ON MED
proof-of-concept randomised trial. The Lancet, 2018
2 Bӧhm M, Kario K, Kandzari DE, Mahfoud F, Weber
MA, Schmieder RE, et al., SPYRAL HTN-OFF MED Pivotal Investigators.
Efficacy of catheter-based renal denervation in the absence of
antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a
multicentre, randomised, sham-controlled trial. The Lancet 2020;
395:1444–1451.
3 Townsend et al. Review and meta-analysis of
renal artery damage following percutaneous renal denervation with
radiofrequency renal artery ablation. EuroIntervention 2020; 16:
89-96.
4 Mahfoud F, et al. Renal Denervation in
High-Risk Patients with Hypertension. J Am Coll Cardiol. 2020;
75(23): 2879-88.
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