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CONVERSATIONS with EXPERTS
follow-up, I was impressed to hear my colleague,
Bill O’Neill, stand up and say that SYNERGY was
the best-performing DES he’d ever used in terms of
deliverability, flexibility, profile and conformability.
SYNERGY is a high-performance device—and
I always want to bring my “A game” to the lab.
SYNERGY makes my job easier; I don’t know
what price can be put on that, but I’m glad to have
technology that makes my job easier.
The results you cite range anywhere between 24
hours and 2 years. How do you see SYNERGY
performing long-term?
So far, in EVOLVE II, the incidence of ARC definite/
probable stent thrombosis is zero beyond 6 days (there
was a single “probable” stent thrombosis at day 6).
Frankly, it’s hard to beat zero. This is a very attractive
profile that most interventionists would be very
happy to adopt.
What are considerations you would give to your
peers on choosing to adopt permanent polymers
versus the bioabsorbable polymer?
We have, at this point, gone to SYNERGY as our “goto” workhorse de vice. I don’t see any specific reason
to pick a permanent or durable polymer device.
SYNERGY has the advantages of being lower profile,
more deliverable, more flexible and with zero stent
thrombosis beyond the first 6 days in EVOLVE II.
The FDA has recently voted in support of the
Absorb™ bioresorbable stent. Do you have any
thoughts on this approval?
The ABSORB III trial demonstrated non-inferiority
within a pre-specified, acceptable margin for target
lesion failure (TLF) at 1 year between the Absorb
bioabsorbable vascular scaffold (BVS) and the
XIENCE™, cobalt-chromium, DES.
Absorb “hit the mark,” so to speak, with regard
to non-inferiority for TLF at 1 year. The premise
that Absorb will provide very late benefit (beyond
1 year) compared to XIENCE is tied to the concept
that the metal frame causes mechanical vessel
restraint, which interferes with pulsatility, and
cyclic strain, which are necessary for normal vessel
biology and physiology. The metal frame may also
cause geometric distortion of the vessel, which
alters shear stress and coronary flow velocity,
particularly at the margins of the stented segment,
which may promote restenosis and/or thrombosis.
The “promise” of Absorb BVS (better very-late
outcomes) is yet-to-be proven. ABSORB IV, which is
a randomized trial evaluating 5,000 patients followed
through 5-years with a 1- and 5-year landmark
analysis for TLF, will provide insight into the possible
superiority of BVS compared with XIENCE. The
incidence of TLF events on a per-year basis following
metal platform stents appears to be related to the
metal frame itself. If there is no metal frame, then
outcomes could be better—that’s the premise.
SYNERGY Bioabsorbable Polymer Drug-Eluting Stent
Beyond emerging stent technology, what other
trends in interventional cardiology do you find
promising or challenging?
For the interventional cardiologist, the field has
grown by leaps and bounds—from cerebrovascular
intervention, peripheral vascular intervention,
structural heart disease, trans-catheter valve
replacement and repair.
I have stepped out of my main area of
coronary stent design and development to be
in the transcatheter aortic valve replacement
space. We have developed a large experience,
which includes first-in-man and first-in-the-U.S.
experiences with specific transcatheter heart valve
cost. Often, the individuals who buy the technology
that we use to treat patients are administrators
who aren’t familiar with the devices because they
haven’t had them in their hands—and they certainly haven’t tried to shove them into an artery. So
there has become a disconnect between the practicing physician and the product that they may or may
not want to use. Hospitals, at times, make decisions
based on a few dollars per device that the physicians would not make.
Overall, these are incredibly exciting times to
be an interventional cardiologist. Twenty years
ago, I said that an interventional cardiologist
within cardiology who tried to be a “jack of all
SYNERGY makes our job easier; I don’t know
what price can be put on that, but I’m glad to
have technology that makes my job easier.
technologies. Conversely, I’ve chosen not to do
peripheral vascular intervention, cerebrovascular
intervention, or to-date, MitraClip®, although I am
actively looking at other technologies in the mitral
space, because I think that’s going to be a very
important space. Others in my group have focused
on MitraClip or other areas such as intervention for
pulmonary embolus or deep vein thrombosis and
endovascular aneurysm repair. My concern is that
people who try to “do it all” may end up not being
really good at any of it.
Finally, whatever the sub-specialty, interventionists have additional challenges, such as working
within a hospital system that owns their group.
Doctors need to have choices, based on hands-on
experience and access to medical literature for devices that cannot be solely differentiated based on
trades” would be a master of none. Practice makes
perfect. Volume drives proficiency and efficiency.
Now, I’d say the same thing about being an
interventionist within the field of interventional
cardiology—you need a focused, sub-subspecialization within interventional cardiology
more now than ever before. ■
Dr. Kereiakes is a fellow of the American College
of Cardiology, a fellow of the Society for Cardiac
Angiography, and a practicing interventionalist at the
Christ Hospital Physicians Ohio Heart & Vascular practice
in Cincinnati, OH.
DISCLOSURES: Dr. Kereiakes received no
compensation for his participation. This material was
sponsored by Boston Scientific Corporation.