1http://diako.de

Tuesday, Jan 22, 2019, 14:24-14:30

Current developments in drug elutingtechnologies for complex SFA treatment

S.Müller-Hülsbeck, MD, EBIR, FCIRSE, FICA, FSIR

ACADEMIC HOSPITALS Flensburg of Kiel University – Faculty of Medicine

Ev.-Luth. Diakonissenanstalt zu Flensburg

Knuthstraße 1, 24939 FLENSBURG

Dept. of Diagnostic and Interventional

Radiology / Neuroradiology

2http://diako.de

Disclosure

Speaker name:

.....Stefan Müller-Hülsbeck.........................................................

I have the following potential conflicts of interest to report:

Consulting: Terumo, Boston Scientific, Eurocor Tech

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

x

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Complex SFA treatment ?

•Objectives

Definition of complex SFA lesions

Introductional remarks

DISRUPT trial

LOCOMOTIVE trial

IMPERIAL trial – long-lesions

SPORTS trial

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Definition of complex SFA lesions

• TASC C or TASC D lesion

• Lesion length >15cm (stenoses or occlusions)

• Calcified plaque burden

• Long-distant SFA re-occlusion after implants

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Calcified plaque burden

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Calcified plaque burden

Wire-Interwoven Nitinol Stent

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Primary patency(KM)

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Heparin-Bonded Stent-Graft – TASC II C and D(lesions longer than 20cm!)

• Prospective, single arm, multicenter clinical trial

• 71 pts; mean lesion length 26.5±5.31cm

Viabahn™Heparin-Bonded

Primarypatency

@12month

67

Secondarypatency

@12month

96.9

Zeller T et al. Heparin-bonded stent-graft for the treatment of TASC II C and D femoropopliteal lesions: the Viabahn-25 cm trial. J Endovasc Ther. 2014 Dec;21(6):765-74.

In lesions ≥20 cm, the 24-month patency rates were 65.2 versus 26.7 % for

VIABAHN® versus BMSLammer J et al. Cardiovasc Intervent Radiol. 2015 Feb;38(1):25-32.

Endovascular bypass concept

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Leave nothing behind strategy

Fanelli F et al. Calcium Burden Assessment and Impact on Drug-Eluting Balloons in Peripheral Arterial Disease. Cardiovasc Intervent Radiol (2014) 37:898–907.

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Goal of Lithoplasty & DCB

•Obtain a better lumen with PTA

•Avoid stents – “leave nothing behind strategy”

•Overcome the main limitation of DCB: severe calcium

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Next Steps in Shockwave Lithoplasty Clinical Development

Lithoplasty as primary

therapy

Results:

•Low rate of vascular complications

Provisional stenting (1.1%)

•Consistent effectiveness

High acute gain (3.0 mm)

Low residuals stenosis (23.8%)

Sustained 6 month results

DISRUPT PAD I

DISRUPT PAD II

DISRUPT PAD III

Combination therapy

•Goal is to assess the optimal therapy to dilate heavily calcified lesions.

• All patients who do not receive a stent will be treated with a drug-coated balloon.

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Disrupt PAD III Study Design

Study Design: Randomized study of the Shockwave Medical Peripheral Lithoplasty System with DCB versus standard balloon angioplasty with DCB to treat moderate and severely calcified femoropopliteal arteries (Disrupt PAD III).

Objective: The objective is to assess the optimal therapy to dilate heavily calcified lesions with Lithoplasty® versus traditional angioplasty, in achieving less than 30 % stenosis without the need for a stent. In addition, all patients who do not receive a stent will be treated with a drug-coated balloon.

Treatment arm (N=167)Lithoplasty + IN.PACT DCB

Control arm (N=167)PTA +

IN.PACT DCB

334 subjects45 global sites

Randomization 1:124 months follow-up

Moderate and severely calcified femoropopliteal arteries

Rutherford 2 to 4RVD 4-7, stenosis ≥70%,

Lesion length 5–18 cm occlusive or ≤10 cm CTO

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Leave little behind strategy

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Multi-Loc-Stent

Sigl M, Beschorner U, Zeller T, Waliszewski M, Langhoff R, Tautenhahn J, Amendt K. Focal Stenting of Complex Femoropopliteal Lesions with the Multi-LOC Multiple Stent Delivery System: 12-Month Results of the Multicenter LOCOMOTIVE Study. Cardiovasc Intervent Radiol. 2018 Oct 25. doi: 10.1007/s00270-018-2095-9. [Epub ahead of print]

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LOCOMOTIVE study:

Sigl M, Beschorner U, Zeller T, Waliszewski M, Langhoff R, Tautenhahn J, Amendt K. Focal Stenting of Complex Femoropopliteal Lesions with the Multi-LOC Multiple Stent Delivery System: 12-Month Results of the Multicenter LOCOMOTIVE Study. Cardiovasc Intervent Radiol. 2018 Oct 25. doi: 10.1007/s00270-018-2095-9. [Epub ahead of print]

75 ptsMulti-Loc

Primarypatency

@12month

85.7

TLR@

12month

9.3

Multi-LOC for flOw liMiting Outcomes after POBA and/or DCB Treatment in the infrainguinal position with the objecIVE to implantmultiple stent segments

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If there is a need for a scaffold?

„...if there is a need foran implant, all implantsshould be DES. This may be the end of theBMS era for femoro-popliteal disease

treatment.“

Any evidence?

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IMPERIAL Clinical Study Overview

Primary

Investigators

Global: William A. Gray, MD

European: Stefan Müller-Hülsbeck, MD

Study Design

RCT

(Eluvia DES vs Zilver PTX)

Long Lesion

Sub-study

(Eluvia)

Pharmacokinetic

Sub-study (Eluvia)

• 2:1 randomized

• Single-blind

• Non-inferiority trial

• Single arm

• Lesion length 140 mm-

190 mm

• Single-arm

Patients

N=465

Eluvia N=309 vs

Zilver PTX N=156

N=50 N=13

Investigational

Centers65 study centers: US, Canada, New Zealand, Belgium, Germany, Austria, Japan

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IMPERIAL: Long Lesion EffectivenessPrimary Patency at 12 Months

•Kaplan-Meier estimate: 87.9% at 12 months

•Observed rate: 87.0% (40/46)

Gray WA, VIVA 2018

• 1-year mortality 0%

Months Since ProcedurePrim

ary P

ate

ncy R

ate

(%

)

0 1 2 3 4 5 6 7 8 9 10 11 12 13

0%

20%

40%

60%

80%

100%

87.9%

Primary patency defined as duplex ultrasound PSVR ≤2.4, in the absence of clinically-driven target lesion revascularization or bypass of the target lesion, as assessed by the DUS core lab.

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CTO stenting

• Inclusion criteria:

Lesions > 15cm !!!

Started 2017: more than100 pts. enrolled

SportsTrial

DES vs. BMS vs. DCB

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CTO stentingSportsTrial

DES vs. BMS vs. DCB

DES:Eluvia vs. BMS vs. DCB (bail-out stenting with Mulit-Lock)

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Conclusions

• Drug-eluting technologies are expected to play an expanding role in endovascular treatment of PAD, also for complex SFA treatment

• Attempts combining drug-eluting technologies with others following the strategy “leaving nothing behind” are very promising and need further evaluation

• Attempts combining drug-eluting technologies with others following the strategy “leaving little behind” are very promising also and need further evaluation

• DES helps to provide a permanent scaffold in case of poor lumen gain, remaining plaque burden, recoil and/or flow-limiting dissection for complex SFA treatment as shown in the IMPERIAL long-lesion trial

• Data from the SPORTS trial are still pending

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Tuesday, Jan 22, 2019, 14:24-14:30

Current developments in drug elutingtechnologies for complex SFA treatment

S.Müller-Hülsbeck, MD, EBIR, FCIRSE, FICA, FSIR

ACADEMIC HOSPITALS Flensburg of Kiel University – Faculty of Medicine

Ev.-Luth. Diakonissenanstalt zu Flensburg

Knuthstraße 1, 24939 FLENSBURG

Dept. of Diagnostic and Interventional

Radiology / Neuroradiology