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CONVERSATION with the EXPERT
EVOLVE II: Results and
Considerations
With Dean J. Kereiakes, MD
Dean J. Kereiakes, MD, has been an
interventional cardiologist for over
twenty-five years. “My area of expertise
and experience has been largely in the
area of coronary stent
design and development,” he said, having
completed more than
25,000 catheterization
laboratory procedures in
the three decades he has
Dean J. Kereiakes, MD
been investigating interventional technologies. He has also participated in over 1,300 clinical research
protocols including, being the national/
international principal investigator on
pivotal trials for U.S. FDA approval of
eight different coronary stents. In this
Conversation with the Expert, Dr. Kereiakes gives insight into the results of the
EVOLVE II clinical trial, current trends in
stent technology, and thoughts on interventional cardiology.
similar for both stent types. What excites me most
is the trend for safety of SYNERGY, compared to the
“best-in-class”, permanent polymer drug-eluting stent
(DES), with respect to lower-stent thrombosis rates.
This is intriguing because we were not comparing
SYNERGY to TAXUS™ or a bare-metal stent, but to
a very-high performance, very safe device, PROMUS
Element Plus. Despite this fact, we still observed a
50% to 85% reduction in stent thrombosis through
What was the intent and purpose of the EVOLVE II
clinical trial?
The intent of EVOLVE II was to demonstrate noninferiority for target lesion failure (TLF) at 1 year
between the SYNERGY Stent™ and the PROMUS
Element™ Plus stent, which is considered “best in
class,” among currently available, drug-eluting stents.
PROMUS Element Plus has a permanent polymer
that elutes everolimus. EVOLVE II was performed
to obtain U.S. Food and Drug Administration (FDA)
regulatory approval for the SYNERGY Stent.
Some may challenge that SYNERGY is no different than permanent polymers. How would you
respond to this?
First, we made we made an important observation
regarding the relative safety of SYNERGY in EVOLVE
II with a 24-hour landmark, wherein there wasn’t a
single definite stent thrombosis among 846 complex
patients treated with SYNERGY beyond the first 24
hours following stent deployment. Using this landmark
based on the premise that definite stent thrombosis is
the most accurate diagnostic level of evidence for stent
thrombosis—and that none were observed beyond
24 hours through 2 years, there is an 84% relative
reduction in stent thrombosis by SYNERGY compared
to “best-in-class” PROMUS Element Plus. The hazard
ratio is 0.16 and the p value is 0.056.
What excites you the most about the results of the
EVOLVE II trial?
The trial achieved its primary endpoint—noninferiority for TLF at 1 year and at 2 years, TLF was
EVOLVE II is not the only data in support of
the relative safety of the SYNERGY Stent versus
permanent polymer-coated devices. The SCAAR
(Swedish Coronary Angiography and Angioplasty
Register) registry recently reported on 83,000 DEStreated patients treated between 2007 and 2015,
of which almost 8,000 were SYNERGY. SYNERGY
treated patients had the lowest rate of definite stent
thrombosis (0.25%) at 1-year follow up compared
Any way you cut the data, a 50% to 85%
reduction in stent thrombosis compared to a
very good, very safe, “best-in-class” device is an
incredible accomplishment.
2 years, depending on how the data are analyzed.
However, any way you cut the data, a 50% to 85%
reduction in stent thrombosis compared to a very
good, very safe, “best-in-class” device is an incredible
accomplishment.
with all other stents included in analysis. Although
not randomized, these are huge numbers of “realworld” patients treated in the same country, at the
same hospitals, with the same doctors with the lowest
rate of definite stent thrombosis. There are additional
data from serial, optical coherence tomography (OCT),
intravascular imaging studies that have evaluated the
degree of stent apposition and stent coverage at 3 and
6 months following stent deployment. SYNERGY
has rates of well over 90% to 95% at 3 months, and
almost 100% by 6 months. These are the highest rates
of healing that we have seen by OCT.
Additionally, EVOLVE II enrolled complex cases.
The average age was 64 years, more than one-third
of patients had an ACS presentation, more than
25% were biomarker (CKMB) positive prior to their
index PCI, 31% had diabetes and 75% had AHA/
ACC B2C complex-lesion morphology. This was a
more complex clinical and angiographic profile of
patients than has ever been included in a regulatory
trial for FDA approval of a new stent in the U.S. At
my ACC 2016 presentation of the EVOLVE II 2-year