JIM Today 2018 - Thursday - page 5

Issue 1 
 22 February 2018 
JIM today
It features the PROBIO passive
coating that seals the metal surface
of the stent and prevents interaction
with the surrounding blood and tis-
sue. Importantly, the surface coating,
a poly-L-lactic acid (PLLA) polymer,
degrades over time. “The degradation
begins immediately, and within 24
months there is a complete degrada-
tion – so in the vessel we are left with
a bare metal stent which is covered
with the PROBIO passive coating,”
said Dr Roguin.
Relaying the key results from
BIOFLOW V, Dr Roguin commented
that procedural success – defined by
<30% residual stenosis of the target
lesion using the assigned stent only,
without an in-hospital major adverse
event – was significantly higher with
Orsiro than with Xience (93.9% vs
90.1%; P=0.019). “This was driven
largely by a higher rate of in-hospital
MI in the Xience group [3.9% vs
6.7%; P=0.029],” he added.
“At 30 days, however, rates of
all-cause mortality, target lesion
revascularisation and stent throm-
bosis were similarly low in both
groups. At 12 months, the primary
endpoint of target lesion failure was
6.2% with Orsiro and 9.6% with
Xience [P=0.04]. The Orsiro group
had numerically but not significantly
lower rates of cardiac death [0.1% vs
0.7%; P=0.115] and clinically driven
target lesion revascularisation [2.0%
vs 2.4%; P=0.686], but target vessel
MI persisted as a significant difference
through 12 months [4.7% vs. 8.3%;
P=0.016]. In multivariable analysis,
the findings remained significant,
and were independent of any base-
line characteristics.”
As Dr Roguin described, the BIO-
FLOW V investigators also conducted
a Bayesian analysis of patients pooled
from previous trials BIOFLOW II and
BIOFLOW IV, incorporating those who
met all inclusion criteria for BIOFLOW
V. Among 2,208 patients, the ob-
served 12-month target lesion failure
rates were 6.3% with Orsiro and
8.9% with Xience, resulting in a dif-
ference of – 2.6% (95% CI 6.7–11.4),
with a probability of noninferiority
of 100%. “A post-hoc superiority
analysis showed a 96.9% probability
that Orsiro was superior to Xience,”
added Dr Roguin.
He concluded: “This is the first
trial that has demonstrated superior
outcomes compared with the Xience
stent, which has served as a bench-
mark for drug-eluting stents.”
1. Kandzari DE, et al. Ultrathin, bioresorbable
polymer sirolimus-eluting stents versus thin,
durable polymer everolimus-eluting stents in
patients undergoing coronary revascularisation
(BIOFLOW V): a randomised trial. The Lancet,
Capturing the benefits of novel
‘pro-healing’ stent design
his afternoon, Roxana Mehran (Icahn
School of Medicine at Mount Sinai,
New York, NY, USA) will introduce
the COMBO Dual Therapy Stent (Orbus-
Neich, Hong Kong), a drug-eluting stent
that also incorporates a novel technology
designed to improve endothelium regenera-
tion and vessel repair.
JIM Today
spoke to Dr Mehran to learn
more about the device, its advantages and
associated data.
Can you talk us through COMBO’s spe-
cial accelerative healing design?
The COMBO stent is a novel device that
combines sirolimus elution from a biode-
gradable polymer with a unique ‘pro-heal-
ing’ technology. This technology consists
of a bio-engineered layer with anti-CD34+
antibodies which capture circulating endothelial
progenitor cells (EPCs). These EPCs bind to the
stent surface, and there they can rapidly differenti-
ate into normal endothelium.
How long does it take to see a
Pre-clinical work with COMBO
showed more endothelial cover-
age with COMBO compared to
single therapy sirolimus-eluting stents after three
and 14 days. Clinical studies report very low stent
thrombosis rates and low in-stent restenosis rates
in up to two years follow-up.
What limitations and challenges in the
stenting field is the device trying to
The dual-therapy stent targets both (late)
in-stent restenosis rates and stent throm-
bosis rates. With rapid endothelialisation, a
shorter duration of dual antiplatelet therapy
(DAPT) might be safe. The aim is that with
healthy endothelial coverage, lower neointi-
mal hyperplasia and neoatherosclerosis can
be achieved.
What are some of the other design
The COMBO stent has a dual helix stent
design (“helical sinusoidal design”), which
also allows for excellent side-branch acces-
sibility. Operators report good deliverability
and trackability of the stent.
The sirolimus dosage on the stent is 5
µg/mm, which is fully eluted by 30 days,
and the polymer is a biodegradable polymer
matrix which has complete degradation
within 90 days.
Let’s look to the data. What trials will
you be discussing at JIM?
The REMEDEE FIM trial (n=183) compared
late lumen loss on OCT at nine months us-
ing COMBO and TAXUS Liberté [Boston Sci-
entific, USA]. The COMBO stent was non-inferior
to the paclitaxel-eluting TAXUS stent. EGO-COM-
BO was another OCT study with 61 all-comers
patients. Strut coverage on OCT was measured at
different time points to gain insight in the healing
pattern of COMBO. Strut coverage at [two, three,
four and five] months was 77.1%, 92.5%, 92.7%
and 94.9% respectively.
DES 1 
Continued on page 6
“The COMBO stent is a novel device
that combines sirolimus elution from a
biodegradable polymer with a unique
‘pro-healing’ technology …
a bio-engineered layer with anti-CD34+
antibodies which capture circulating
endothelial progenitor cells.”
Roxana Mehran
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