Balões farmacológicos e stents dedicados Balões farmacológicos e

Balões farmacológicos e stents dedicados
no tratamento de lesões em bifurcações
Marco V. Wainstein,, MD DSc.
Director, Cardiovascular Cath Lab
Hospital Moinhos de Vento
Adjunct Professor of Medicine – Federal University of Rio Grande do Sul
Interventional Cardiology
Hospital de Clinicas de Porto Alegre
P t ti l C
Potential
Conflict
fli t off IInterest
t
t

Consultant:: Biotronik, BBraun , Terumo
Consultant

Board Member:
Member: Aesculap-Bbraun

Investigator:: Biotronik
Investigator

Lecturer: Biosensors, BBraun, Terumo, AstraLecturer:
Zeneca

Scientific Support
Support:: Abbott Vascular ,Cordis J&J,
Boston Scientific
S i
ifi
Bifurcation stenting:
Questions to be answered
Types of
bifurcation
s
Two
stents or
one?
Should I
h
have
kissing
k
stents?
What is plaque
shifting?
What
Technique..
IVUS/OCT
…?
Need for treating Bifurcations.
• Bifurcations are a high risk region for the formation of atherosclerotic
plaque.
• >20%
20% off all
ll PCI iinvolve
l ttreatment
t
t off Bif
Bifurcations:
ti
– cannot be avoided!!
• Procedural and clinical success rates are inferior to non-complex
treatments.
Drugs have helped greatly but still not solved the underlying problem.
Restenosis
Simple Strategy
Complex Strategy
MB
2% -7.3%
3.1% - 10%
SB
4% -15%
9% - 21%
Combined
6% - 21.3%
15.4% - 27%
MACE
At 6mths
Simple Strategy
9.6%
Complex Strategy
12.6%
Meta Analysis: Hakeem et al 2009 (BBC,Nordic,Cactus,Colombo,Pan,Ferenc)
Technical Data for SeQuent® Please
SeQuent Please® is a conventional catheter for PTCA
whose balloon section at the distal end is coated with a
homogenous matrix of paclitaxel and contrast media
(iopromide).


Balloon surface paclitaxel load of 3 µg/mm² surface
area

No sustained drug release,
release as in DES,
DES needed - > 10 sec
inflation is sufficient (30 sec are currently
recommended for SeQuent® Please))
DEB Registry
eg st y
(n=2319)
312
13%
Bif
J. Wöhrle, June 2010
(2%, n=31)
DEB Registry
g
y
312
13%
Bif
J. Wöhrle, June 2010
Bifurcation lesions
PEPCAD V
n= 28 pts., pre PCI vs. 9 month: p < 0.001
mm
Late Loss
x 0.38 mm
Late Loss
x 0.21
0 21 mm
p = 0.038
Suggestion for DEB use in
bifurcations




Provisional DES implantation in MB
If SB stenosis > 50% without
dissections: reassess SB and open the
struts with
i h POBA
Kissing-balloon inflations with 2 POBA
Finally, 30-40 sec SB DEB inflation at
nominal pressure using long balloon to
avoid
id geographic
hi miss
i
Ideal Bifurcation Stent Design
Requirements
Simple
Si
l to
deliver.
Coverage of
Full
Bifurcation
Effective at
all angles.
Optimal
D i
Design
< 5% TLR
@12mths
Simple
selection
criteria.
criteria
Design Approach
Fundamentally there exist two design
philosophies:
hil
hi
1 Modified Provisional:
1.
Objective: Provide sidebranch access without main branch compromise.
e.g. BSC petal, Abbott Frontier, Trireme Antares, Stentys.
2. Dedicated devices:
Objective: Provide treatment of the bifurcation segment using an
anatomically considered design.
e.g. Cappella Sideguard, Tryton, Axxess.
1. Modified Provisional:
Pros:
- Simplest design concept.
- Cost effective, single stent for majority.
p
y easy
y to use.
- Conceptually
Cons:
- Deliverability.
-G
Guidewire
d
twist, guidewire
d
b
bias, d
delivery-system
l
rotation.
STENTYS® Technology
• Nitinol, self
self-apposing stent (BMS and DES)
• 6F single
single-wire, rapid exchange, CECE-marking
• Disconnectable
Di
bl struts over ffull
ll llength
h*
Disconnectors
along the stent
Disconnectabl
e
interconnector
* Except the first and last 2mm
Disconnectio
n
17
2. Dedicated Devices:
Pros:
- Effective treatment of entire bifurcation
anatomy.
anatomy
- Minimal main branch impact.
Cons:
- Cost (price and time) since 2 stents required.
- More complex design than modified
provisional.
Cappella Sidebranch Stent
( ti l protection
(ostial
t ti
d
device)
i )
Sideguard address the complexities
associated with ostial and bifurcated lesions
•
•
Precise BE Delivery System
Bare Metal Sidebranch Stent
Peel-away Split Sheath,
Balloon
ll
Expandable
d bl Delivery
l
Self-Expanding
p
g (SE) Stent
Sideguard is a self-expanding, anatomically-shaped stent
Target is a balloon-release delivery system for SE stents
Tryton Side Branch Stent
Sid Branch
Side
B
h
Side Branch Region
Standard Design
Transition Zone
Coverage
Hoop Strength
Main Vessel Region
3 Fronds - Minimal
Coverage
g
Wedding Band
Main Vessel
Cobalt Chromium
Strut Thickness:
0 003”
0.003
Diameter: 2.5 mm
AXXESS PLUS LM System
Flared Distal-End Stent Design
Self Expanding Nitinol Material
6, 8, 10, or 12 mm
flare diameter
4.8F Rx Delivery System
Biolimus A9
antiproliferative
strut coating
Goal: Span Both Vessels




Cover the proximal lesion segment
Cover the ostium of the side branch and distal parent vessel without
compromising access to the side branch
This is accomplished if 2 markers are in 1 branch and 1 is in the other
Provide a convenient placement marker for additional distal stents
Axxess™ Clinical Program
AXXESS
AXXESS
N=43
N=43
N
43
•
•
•
•
France & Germany
Pilot study using bare metal stent Axxess™ Platform
In-segment
g
restenosis at 6 months
6 month follow-up available, study completed
AXXESS
AXXESS
PLUS
PLUS
N=139
N=139
•
•
•
•
Europe, Brazil and New Zealand
FIM Safety and performance evaluation of Axxess™ DES
Axxess cone stent in-stent late loss at 6 months
5 year follow-up available, study completed
DIVERGE
DIVERGE
N=302
N=302
•
•
•
•
Europe, Australia and New Zealand
Evaluated best practices from AXXESS PLUS
MACE at 9 months
3 year follow-up available, follow-up planned up to 5 years
Out-of-Hospital Outcomes
6-MONTH
30
12-MONTH
% of patiients
20
12.9
10
9.8
8.9
7.4
0.7
1.5
0.7
0.8
0.7
1.5
0
MACE*
Any Death
Cardiac
Death
MI
*Defined as any death, MI and ischemia
ischemia--driven TLR. **Ischemia
Ischemia--driven TLR
TLR**
Conclusions
Stenting coronary bifurcations requires more than
deciding to implant 1 or 2 stents
The most important
p
decisions should be taken by
y
examining:
-the clinical setting (age of the patient, general conditions, extent of
ischemia),
-the extent of the disease of both branches,
-their size
size,
- the territory of distribution and
-how confident is the operator
p
with a specific
p
approach
Contemporary use of DEB for
bifurcations




Single-stent
Single
stent provisional strategy usually
regarded as a preferred strategy for
bifurcations
SB restenosis might be a problem in all
bifurcations
DEB can pa
particularly
tic la l indicated for
fo preventing
p e enting
SB restenosis without the disadvantages of
second stent
Future randomized trials are needed to
confirm routine use of DEB in bifurcations
Dedicated stents
Dedicated bifurcation stents address ideally
the specific needs of bifurcation lesions
 Due to the variable anatomy of bifurcation
lesions, variable stent designs or
deployment techniques are most likely
needed
 Dedicated bifurcation DES are needed to
combine the benefits of both technologies
