19 / 32
Dr. Boehm explained that the results –
published simultaneously online in
The
Lancet
– provided biological proof of
principle of the efficacy of renal denervation
and will inform the design of a larger, more
definitive trial of the approach.
Dr. Boehm concluded, “The effectiveness
of renal denervation in this study may have
been due to the new procedural approach,
which aimed to achieve complete dener-
vation, and the fact that patients were not
taking antihypertensive medications, which
may have confounded the results of pre-
vious studies.”
He added, “With consistent and significant
drops across ambulatory and office-based
blood pressure – including both systolic and
diastolic measurements – we are confident
to be moving forward with a pivotal trial so
that doctors and patients may have an alter-
native approach to lowering blood pressure.”
In a recent editorial about the study in
The
Lancet
, Michel Azizi, MD, PhD, with the
Paris Descartes University, France, noted
that “More studies are needed with the
Spyral and other catheters and using dif-
ferent technologies (e.g., highly focused
ultrasound), not only to support these pre-
liminary results but also to investigate
whether an escape phenomenon might
occur in hypertension in the long term
(reports exist of renal nerve regrowth after
catheter-based renal denervation in animal
models) and the unknown risk of de-novo
renal artery stenoses associated with the
new catheters.”
PracticeUpdate Editorial Team
COMMENT
By Clyde W Yancy
MD, MSc, MACC,
FAHA, MACP, FHFSA
SPYRAL HTN-OFF MED
T
his intriguing study revisits renal
denervation as a treatment for
hypertension. The prior SYMPLIC-
ITY HTN-3 trial failed to demonstrate
superiority of renal denervation com-
pared with an expertly configured
multidrug regimen for resistant hyper-
tension treated in specialized centers.
The bar for superiority in that trial was
quite high, but the standard of optimized
best medical therapy for hypertension
remains appropriately intact.
In this study of only 80 patients with
documented hypertension but off med-
ical therapy (drug naïve or intolerant),
renal denervation led to a 5-mmHg
difference, which was statistically sig-
nificant. Is this a clinically important
benefit? Not likely. The anticipated
new hypertension guidelines will almost
assuredly target lower blood pressure
goals in some (at higher risk) but not all
patients with hypertension. A 5-mmHg
difference is simply not enough. But,
within a global approach of lifestyle
modification, antihypertensive ther-
apy as tolerated, and careful follow-up,
there may emerge a role for renal den-
ervation in select patients. The more
important observation here is that these
new data resume the discussion regard-
ing adjunctive interventions that may
allow better blood pressure control.
Given the global burden of hyperten-
sion and its important contribution to
cardiovascular disease and stroke, it is
necessary that every treatment option
be fully explored.
The effectiveness of renal denervation in this study may
have been due to the new procedural approach, which
aimed to achieve complete denervation, and the fact that
patients were not taking antihypertensive medications,
which may have confounded the results of
previous studies.“
Michael Boehm,
MD, PhD
© ESC Congress 2017 – European Society of Cardiology
ESC 2017
19
VOL. 2 • NO. 2 • 2017