8th European Bifurcation Club 12-13 October 2012 - · PDF file8th European Bifurcation Club...
Transcript of 8th European Bifurcation Club 12-13 October 2012 - · PDF file8th European Bifurcation Club...
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8th European Bifurcation Club
12-13 October 2012 - Barcelona
Simultaneous inflation of two
drug-eluting balloons for the
treatment of coronary bifurcation
restenosis
Gregory A. Sgueglia, MD, PhD
Ospedale S. Eugenio
Rome, Italy
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percutaneous treatment of coronary
bifurcation restenosis might pose real
challenges to the interventional cardiologist
for two main reasons:
• most often DES restenosis
• multiple stent layers, or uncovered struts
forming a neocarena or jailing the side
branch, thus worsening geometrical
constraints
Framing the problem
Sgueglia J Invasive Cardiol 2011
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DES treatment of DES restenosis
RIBS III
(DES restenosis)
Nin
e m
onth
s b
inary
reste
nosis
(%
)
Alfonso JACC Intv 2012
ISAR-DESIRE 2
(SES restenosis)
Six
-eig
ht
month
s b
inary
reste
nosis
(%
)
Mehilli JACC 2010
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Limits of stent treatment of ISR
Sgueglia J Cardiovasc Med 2011
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Main vessel restenosis Side branch restenosis TLR
Provisional Complex Provisional Complex Provisional Complex
Colombo 1/21 (4.8%) 3/53 (5.7%) 3/21 (14.3%) 12/53 (22.6%) 1/22 (4.58) 6/63 (9.5%)
Pan 1/47 (2.1%) 4/44 (9.1%) 2/47 (4.3%) 6/44 (13.6%) 1/47 (2,1%) 2/44 (4.5%)
Steigen 7/151 (4.6%) 10/155 (6.5%) 29/151 (19.2%) 18/155 (11.6%) 4/207 (1.9%) 2/206 (1.0%)
Ferenc 7/96 (7.3%) 3/96 (3.1%) 9/96 (9.4%) 12/96 (12.5%) 11/101 (10.9%) 9/101 (8.9%)
Colombo 10/150 (6.7%) 7/152 (4.6%) 22/150 (14.7%) 20/152 (13.2%) 11/173 (6.3%) 13/177 (7.3%)
Overall 26/465 (5.6%) 27/500 (5.4%) 65/465 (14.0%) 68/500 (13.6%) 28/550 (5.1%) 32/591 (5.4%)
More on bifurcation restenosis
Sgueglia IJC 2011
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The Drug
• paclitaxel is a highly lipophylic compound
• after short exposure, single-dose remains in cells for days
• at low doses, it arrests cells before they divide
• at low doses, it has less anti-proliferative effect on endothelial cells
Axel Circulation 1997
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dilation catheter
antiproliferative drug
binder/matrix/excipient
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The Matrix
Credit Medrad
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DEB CE mark timeline
First generation
(balloon + paclitaxel)
Second generation
(balloon + binder/matrix/excipient + paclitaxel)
2007 2008 2009 2010 2011 2012
DIOR I
In.Pact
Falcon
Elutax SeQuent
Please
DIOR II
Protégé
Pantera Lux
Danubio
Moxy Primus
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Not all DEB are created equal
• 1,129 pts treated by DEB
• 1° generation ELUTAX
(2 μg/mm2 paclitaxel, no excipient)
• 2° generation SeQuent
Please
(3 μg/mm2 paclitaxel, iopromide
as excipient)
EuroIntervention 2012
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Paclitaxel-eluting stent
DEB’s Advantages
• fast and homogeneous drug transfer to the arterial wall
• highest drug concentration at the time of angioplasty injury
• respect of the vessel anatomy
• lack of persisting inflammatory stimuli
• short duration of dual antiplatelet therapy
Posa CCI 2010
Drug-eluting balloon
Radke EuroIntervention 2011
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p=0.002
Six
-month
late
lum
en loss (
mm
)
Unverdorben Circulation 2006
DEB in BMS restenosis
0.03±0.48 mm
0.74±0.86 mm
p=0.02
Six
-month
late
lum
en loss (
mm
)
0.17±0.42 mm
0.38±0.61 mm
Scheller NEJM 2006
PACCOCATH ISR PEPCAD II
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Wijns EHJ 2010
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p<0.001
Six
-month
late
lum
en loss (
mm
)
1.03±0.77 mm
0.43±0.61 mm
p<0.001
Six
-month
bin
ary
reste
nosis
(%
) 17.2%
61.3%
Rittger JACC 2012
DEB in DES restenosis
DES restenosis: SeQuent Please DEB (72 pts) vs uncoated balloon (38 pts)
PEPCAD-DES
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Six
-nin
e m
on
ths e
vents
(%
)
Stella EuroIntervention 2011
VALENTINES
BMS/DES restenosis: DIOR II DEB (250 pts)
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J Invasive Cardiol 2011
Four cases are described in which an approach
consisting of the simultaneous inflation of two
drug-eluting balloons has been successfully
applied to treat different kinds of bifurcation
restenoses following both provisional and
complex stenting strategies.
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Kissing DEB feasibility and rational
• simultaneous use of two DEB is feasible and
safe with all brand in standard operative
conditions (6F GC, radial access) Sgueglia Cardiovasc Revsc Med 2011
• the advantages of DEB fully apply to the
treatment of bifurcation restenosis, especially
the lack of metallic scaffold and homogenous
drug distribution Sgueglia EuroIntervention 2011
• kissing inflation is recommended to preserve the
geometry of the implanted stent Sgueglia JACC Cardiovasc Intv 2012
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The challenge
M67, effort angina, EST+, one year earlier
mini-crush with two EES (Xience V)
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The solution
Kissing-DEB (DIOR II)
3,5/15 mm x 2
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The result
Final result
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The follow-up
Six months follow-up
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Proximal MV
0,1 or 2
Distal MV
0, 1 or 2
SB
0, 1 or 2
A restenosis involving
the SB only after a PCI
according to the crush
technique is classified
Medina modified classification of
bifurcation restenosis
0 = no restenosis
1 = restenosis following a single-stent procedure
2 = restenosis following a two-stent procedure
Sgueglia IJC 2011
0 ,0 ,2
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Pending issues
1. previous simple technique with “good kissing” or
complex technique
– all should get smooth
2. previous simple technique with no kissing
– the original distal cell could not be available
anymore because of neointimal growth
3. previous simple technique with “bad kissing”
– difficult to anticipate if DEB features could
compensate for inaccurate first procedure
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Credit Foin N
timepoint 2 timepoint 1
Neointimal growth
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Conclusions
• the kissing DEB approach for the
treatment of bifurcation restenosis has a
sound rational
• overall, it appears a straightforward
procedure for the treatment restenosis
following bifurcation treatment according
to virtually any kind of technique
• pending issues prompt further evaluation