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)

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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.