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Angelo Cioppa, MD
I have the following potential conflicts of interest to report: Research contracts Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s)
X I do not have any potential conflict of interest
Potential conflicts of interest
Angelo Cioppa, MDMontevergine Clinic,
Mercogliano, Italy
Superficial Femoral Artery AngioplastyThe Cardiologist’s Approach
HOW DID I TREAT ?
Treatment Choice
EndovascularEndovascular
Approach/MaterialsJR4 5F +0,035”
Floppy WireJR4 5F +0,035”
Stiff Wire
JR4 5F Pull Back 6F cross-over Sheath
JR4 5F to manage the lesion
0,035” wire passed throught the lesion
• Debulking or ELCA.
• Balloon PTA (standard or DCB).
• Stenting (BMS or DES or Covered).
Treatment Strategy
Mean Lesion Length (cm)
On
e-Y
ear
Pri
ma
ry P
ate
ncy
Bare Nitinol Stent vs POBA12-month Patency RatesRCS and Multicenter Registries
0%
20%
40%
60%
80%
100%
0 5 10 15 20 25 30 35
• More reports exist for using Bare Nitinol Stents in longer lesions compared to POBA
• Throughout the treatment range, Bare Nitinol Stents exhibit patency rates higher than POBA
Superficial Femoral Artery (SFA) is
the “nightmare “ for the Interventionalists.
• Restenosis rate after SFA treatment was reported
between 35-75%.
No data suggest use of primary stent in short SFA lesions
No data suggest use of primary stent in short SFA lesions
Zilver PTX Clinical Trial Cook Zilver stent coated with Paclitaxel Randomized arm (480 pts.) and Registry arm (790 pts.) Mean lesion length 9.7 cm Freedom from TLR (6 months 96%; 24 months ≈ 85 %)
STRIDES Study: A safety and efficacy study DYNALINK-E Everolimus Eluting Peripheral Stent System Prospective, single-arm, non-randomized, multi-center 100 pts. Average lesion length 9 cm 12 month primary patency 69% (freedom from TLR 80%)
SIROCCO SMART Stent versus Sirolimus-eluting SMART Stent Prospective, randomized, multi-center 93 CLI pts. Average lesion length 8.3 cm Patency failure defined as PSV > 100% or no Doppler signal Comparable 24 month primary patency of Sirolimus stent vs bare
(77.1% vs 78.9%)
Drug Eluting Stents in the SFA
LimitationsStent Fractures/compressionDiscordant resultsCosts
Drug Eluting Stent in the SFA
DEB in the SFA
THUNDERPACCOCATH™ vs. PTA vs. PTX in contrast medium
SFAde-novo
6m LLL G.Tepe et al. N Engl J Med 2008;358:689-99
FEMPAC PACCOCATH™ vs.PTA SFA de-novo 6m LLL M.Werk et al. Circulation. 2008;118:1358-1365
LEVANT I MOXY™ vs. PTA SFA de-novo 6m LLL D.Scheinert TCT 2010
PACIFIRE In.Pact Pacific vsPTA SFA De novo/ISR 6m LLL M. Werk Cirse 2011
DEB better than PTA in TLR
reduction .
Mean Lesion Length 7,2 cm.
At least 15% of procedure finished
with stent implantation
Paccocath Moxy In.Pact
In.Pact™ DEB with FreePac™ Coating Technology
Urea ‘Spacer’ Molecule
Paclitaxel Molecule
biocompatible | hydrophilic naturally-occurring
high degree of transfer efficiency
In.Pact• Medtronic-Invatec DEB balloon
line
Freepac• proprietary hydrophilic drug
coating formulation– separates Paclitaxel molecules– balances hydrophilic and
lipophilic properties– facilitates Paclitaxel elution
into the vessel wall
Acute ResultsDevice success 100%
Technical success 89.6%
PTA alone 100(87.6 %)
PTA + stenting 14 (12.3 %)
Reason for stenting
Flow limiting dissection 12 (11.7 %)
Final Result (resid.Sten.) 12.2 ±9.5 %
Survival from TLR, Occlusion, >50% Restenosis
• 6m Primary Patency = 87.8%
• 1y Primary Patency = 83.7%PSVR < 2.5
0-3 m 0-6 m 0-12 m
DeathAmputation
TLR
1 (1.1%)0%
1 (1.1%)
1 (1.1%)0%
4 (4.5%)
2 (2.2%)0%
8 (8.7%)
Clinical Evaluation of a Paclitaxel-Eluting Balloon for Treatment of Femoropopliteal Arterial
Disease. 12-Month Results From a Multicenter Italian Registry
Antonio Micari, MD, PHD et Al.,Palermo, Mercogliano, Cotignola, Lecce, Bari, and Rapallo,
Italy
J Am Coll Cardiol Intv 2012;5:331– 8
Our Strategy
Balloon PTA - DEB – Provisional Stenting
Pre-dilatation (120”) 5,0-150mm Balloon
Basal Angio
After Pre-Dilatation Spiral Dissection
Drug Eluting Balloon Dilatation (180”)
6,0 - 40mm5,0 -120mm
Urea ‘spacer’ Molecule
Paclitaxel Molecule
In.Pact• Medtronic-Invatec DEB balloon line
Freepac• proprietary hydrophilic drug coating
formulation– separates Paclitaxel molecules– balances hydrophilic and lipophilic
properties– facilitates Paclitaxel elution into the
vessel wall
After DEB - Dilatation
Persistent (after 2 more dilatations)Spiral Dissection
What should I do?Leave it? Stenting? Other?
Our Choice: to Stent.Which Stent?
-The Heliflex Ti design can be bent up to 180° and can be twisted into a double knot without kinking
HIGHER:HIGHER:•FLEXIBILITY
•CONFORMABILITY•FRACTURE RESISTANCE
HELIFLEX HELIFLEX Bio Active Coating Bio Active Coating
(Titanium (Titanium Nitride Oxide)Nitride Oxide)
HELIFLEX HELICOÏDAL STRUCTURE
SUPERIORCORROSION RESISTANCE
FEATURES & BENEFITS
The HELIFLEX Ti self-expanding stent is the
only peripheral stent to benefit from the patented
Titanium-Nitride-Oxide Bio Active Coating to
reduce RESTENOSIS, THROMBOSIS,
CORROSION and FRACTURE.
Self-Expandable HeliFlex Ti6,0-80 mm6,0-80 mm
Post-Stent Implantation Stent Post Dilatation
Balloon 6,0-120 nc
Final Angiography
Closing Remarks
SFA Angioplasty is still a challenge procedure.
There is no role for primary stenting in the SFA setting.
Drug Coated Balloon have shown improved long term
patency after SFA angioplasty.
Neverthenless, somethimes, bailout stenting is necessary
to achieve a good acute result.
New generation stent, as Heliflex Ti, seems to have a
better perfomance, lower rate of fractures and might
improve SFA-PTA long term results.
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