JIM Today 2018 - Thursday - page 6

6
JIM today
Issue 1 
Thursday
 22 February 2018
The HARMONEE trial results were presented
at TCT 2017. This non-inferiority trial compared
COMBO with Xience V [Abbott Vascular] in 572 pa-
tients, with one-year target vessel failure set as the
primary endpoint. The non-inferiority endpoint was
met, although the event rates were much lower
than the estimated event rates, therefore the study
was clearly underpowered. The secondary outcome,
superiority of homogenous
tissue strut coverage on
OCT, was met with strut
coverage of 81.2% with
COMBO, versus 68.8%
with Xience.
The Chinese RECOVERY
trial (n=432) compared
COMBO with the Nano
polymer-free stent [Lepu
Medical Technology,
China], a sirolimus-eluting
stent. The primary endpoint
was target lesion failure
(TLF) at one year follow-up. COMBO was shown to
be non-inferior to the Nano polymer-free stent.
The MASCOT registry is the largest, pro-
spective, multicentre registry evaluating clinical
outcomes after COMBO stenting. A total of
2,614 patients were enrolled from 61 global
sites including Asia, Europe, South America and
the Middle East. I’m proud of this study, which
completed one-year follow-up last year. The pri-
mary results were presented at TCT 2017: TLF at
one year was observed in 3.4% of patients, and
definite stent thrombosis occurred in only 0.5%
of patients.
The REDUCE trial is another interesting study
presented at TCT 2017. This investigator-initiated
trial randomised patients presenting with acute
coronary syndrome and treated with COMBO,
along with either the standard 12 months of
DAPT, or three months of DAPT. The primary
endpoint at one year was a composite of bleed-
ing and thrombotic events (all-cause death, MI,
ST, stroke, TVR or bleeding: BARC type II, III and
V). Short-duration DAPT was non-inferior to
standard-duration DAPT in these patients.
What about upcoming studies? Is “SORT OUT
X” going to be important?
Yes, SORT OUT X
1
is a very exciting study! The
research group, led by Dr Jakobsen (Aarhus Uni-
versity Hospital, Skejby,
Denmark), is investigating
clinical outcomes after
COMBO versus Orsiro
(Biotronik, Germany)
stent placement. The
Orsiro stent is a very thin
strut, sirolimus-eluting
stent (single-therapy
stent). This randomised
controlled trial plans to
enrol 3,140 patients, and
enrolment is currently
ongoing. The results of
this study will allow further understanding of the
added value of the pro-healing layer (dual-therapy
stent versus single-therapy stent).
What’s your take-home message on the device
and its future?
The COMBO stent is a new device with an exciting
promise of safer, shorter duration DAPT. Patients
with a high bleeding risk could really benefit from a
stent that does not require the current minimal du-
ration of six-months DAPT. New trials should focus
on patients with high bleeding risk (or high risk of
DAPT cessation), and investigate the best treatment
options for these patients. I believe that we have
to look more at patient characteristics, and move
on to patient-tailored stent and DAPT therapies,
instead of ‘one size fits all’.
References
1. ClinicalTrials.gov. NCT03216733
VenusA-Valve: a perfect fit for the
Chinese population
T
he VenusA-Valve transcath-
eter aortic valve replace-
ment/implantation (TAVR/I)
system, China’s first such system
to treat patients with aortic
stenosis, will be dissected during
this afternoon’s TAVI session in
Room Foscolo.
In April 2017, the VenusA-
Valve was granted marketing
approval by the China Food and
Drug Administration (CFDA)
as a less-invasive treatment for
inoperable and high-risk patients
needing aortic valve replacement.
It marks the first CFDA-approved
TAVR solution for patients
in China.
The need for a solution to aor-
tic stenosis in high-risk patients
has never been more pressing.
With an increasingly aging popu-
lation, heart diseases are on the
rise amongst the elderly popula-
tion in China and beyond. There
are approximately 44 million
Chinese over the age of 75 years,
of which around 1.5 million suffer
from severe aortic stenosis that
has not been treated effectively.
DES 1 
Manzoni 
Thursday 
12:45
TAVI 1 
Foscolo 
Thursday 
12:45
Capturing the benefits of novel
‘pro-healing’ stent design
13.05
The ultraseal LAA experience
Jai-Wun Park
13.15
PFO closure
Iqbal Malik
13.25
Complex LAAC anatomies:
a case-based discussion
Mark Spence
13.55
Ready for prime time to combo
Mitral & LAA?
Giuseppe Tarantini
13.45
Questions & Answers
Main Hall Washington
Chairperson: Martin B. Leon
Co-chairperson: Alexandre C. Abizaid
14.30
LIVE CASES FROM BONN, GERMANY
University Hospital
Commentators: Balbir Singh, Corrado Tamburino,
Hendrik Treede, Ron Waksman,
Alan Yeung
Guest operators: Paul Hsien-Li Kao,
Marco Wainstein
Online factoids relevant to the case presented:
Lorenzo Azzalini (Coordinator), Ozan
Mehemet Demir, Damiano Regazzoli
16.15
Discussing the case
16.30 Coffee break
17.00
LIVE CASES FROM MILAN, ITALY
St. Raffaele Hospital
Commentators: Yaron Almagor, Carlo Briguori,
Lutz Buellesfeld, Ted Feldman,
Giuseppe Tarantini
Online factoids relevant to the case presented:
Lorenzo Azzalini (Coordinator), Ozan
Mehemet Demir, Damiano Regazzoli
18.15
Discussing the case
18.45
Evening Symposium
Room Manzoni
Manage a large discrepancy in vessel
diameters in left main bifurcation
lesions – is a self apposing stent the
answer?
Chairpersons: Bernardo Cortese,
Gennaro Sardella
Discussants: Carlo Briguori, Gioel Gabrio Secco,
Ferdinando Varbella
18.45
Introduction
Gennaro Sardella
18.50
The current role of PCI for Left Main,
the surgical perspective
Guido Gelpi
19.00
Why use a self-apposing stent in Left Main
PCI: anatomic and clinical considerations
Bernardo Cortese
19.10
Discussion
19.15
Case 1: Case presentation
Alessio Lamanna
Case discussion
19.30
Case 2: Case presentation
Paolo Sganzerla
Case discussion
19.45
Case 3: Case presentation
Italo Porto
Case discussion
20.00
Wrap-up
Bernardo Cortese
Continued from page 4
Continued from page 5
“I believe that we have
to look more at patient
characteristics, and move
on to patient-tailored
stent and DAPT therapies,
instead of ‘one size fits all’.”
Roxana Mehran
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