Transcript Diapositiva 1

Silingardi R.
Veronesi J.
Gennai S.
University of Modena and Reggio Emilia
Vascular Surgery – Director: prof. Coppi
Where are we
with drug
eluting balloons
and stents for
SFA?
Veronesi J.
[email protected]
University of Modena and Reggio Emilia
PTA and BMS in SFA
12 Months Primary Patency
BMS provides improved patency,
but data are limited for
medium and long lesions
How can we keep SFA open?
DEB
Drug eluting balloon
Local release of
medication into the
vessel wall during
dilatation
DEB
Same Drug - Different Excipients and Coating Techs
DEB vs Standard Balloon
De novo lesions, 6-months LLL in SFA
5 DEB Trials with 6-month LLL Primary Endpoint
DEB vs PTA Meta-analysis
Cassese et al. 2012
• 4 Fem--‐pop trials: Thunder,
FemPac, Levant I, Pacifier
• 433 patients
• DEB at 10.3 months --‐> reduced TLR,
LLL, Restenosis
• All cause mortality unchanged
DEB - Current issues
1. Intermittent claudicatio
2. Costs
3. Calcifications
4. Atherectomy
5. Long Lesions
Fanelli et al
DEB - Our indications
•
•
•
•
•
In-stent restenosis
Femoro-popliteal segment disease
Lesions < 10 cm
No calcified lesions
Young patients
University of Modena and Reggio Emilia
Drug Eluting Stents (DES)
Trials
• SIROCCO I e II (Cordis)
• STRIDES (Abbott)
• Zilver PTX (Cook)
University of Modena and Reggio Emilia
SIROCCO trial
Duda et al.
Sirolimus-Eluting versus Bare Nitinol Stent
for Obstructive Superficial Femoral Artery
Disease: The SIROCCO II Trial
• Trend for greater
efficacy in the
sirolimus-eluting stent
group
• No statistically
significant differences
in any of the variables
STRIDES trial
• TLR after 6 and 12 months was 95% and 80%
• Primary patency after 6 and 12 months
was 94% and 68%
Everolimus-eluting self-expanding nitinol stent
can be successfully implanted in pts with severe PAD
3-Year Effectiveness
Primary Patency
DES (Zilver PTX) vs. PTA
DES – Current issues
• Stent fracture
• Mid- and long-term
results?
• Are costs justified?
DES - Our indications
• Bailout after PTA
• Stent fracture
• Rutherford scale  categories IV°, V°, VI°
corresponded to resting pain, minor
ulcerations and gangrenes
• Young patients
University of Modena and Reggio Emilia
DEB : BTK and ATK
From 2000 to 2012
DEB BTK
DEB BTK
DEB ATK DEB ATK
Dior
(Eurocor)
IN.PACT
Amphirion
(Medtronic)
IN-PACT
Admiral
(Medtronic)
FREEWAY
(Eurocor)
24
15
10
5
28
125
92
72
75
70
71
73
Secondary Patency
at 1 year
80
73
78
80
Follow up (months)
45
14
14
10
Cases (n)
Mean Lesion
Length (mm)
Primary Patency
at 1 year
DES : BTK and ATK
Cases (n)
Primary Patency
at 1 year
Secondary Patency
at 1 year
Follow up
(months)
From 2000 to 2012
DES BTK
DES BTK
DES ATK
Dexamet™
(Biocompatible Abbott Vascular)
Amazonia Pax
(Minvasys)
Zilver PTX
(Cook)
25
68%
10
70%
16
63%
82%
84%
69%
53
30
18
For any questions…
[email protected]
www.chirurgiavascolare.unimore.it
CONCLUSIONS
DEB & DES in SFA
• DEB in SFA has demonstrated (in RCTs) clinical and
morphologic benefits in the mid-term compared with
uncoated balloon
• DES promises improved patency compared with BMS
• Results from different DES trials are controversial
• “Drug-eluting technology” seems to reduce the need
for reinterventions and compensation with costs
• Promising technology with long DEB and drug
bioabsorbable stents is desirable