How to treat in-stent-restenosisin the femoropopliteal tract?

What does the literature tells us?

Michel J. Bosiers, MD

Consultant Vascular and Endovascular Surgery

St. Franziskus-Hospital Münster

Director: Prof. G. Torsello

Disclosure

Speaker name: Michel Bosiers

I have the following potential conflicts of interest to report:

Consulting

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

Results with DCB, SES & DES in the SFA

0

10

20

30

40

50

60

70

80

90

100

0 5 10 15 20 25 30

Lesion Length (cm)

THUNDER

FEMPAC

12

-mo

nth

Pri

mar

yP

ate

ncy

(%)

FAST – FACT

RESILIENT

DURABILITY

ASTRON

VIENNA

DURABILITY-200

ZILVER PTX

ZILVER PTX long lesions

20-40%

restenosis

Morphology of ISR versus de novo lesions

Classification of ISR : TOSAKA I, II and III

1/ Drug Coated Balloons

The longer and more

complex the lesions

the worse the

• Primary Patency

• Freedom from TLR

1/ Drug Coated Balloons

• Benefit at 1- and 2- years

• Catch-up at 3- years

2/ Drug Coated Stents

81.00%

60.80%

Zeller T, Dake MD, Tepe G, Brechtel K, Noory E, Beschorner U, et al.

Treatment of femoropopliteal in-stent restenosis with paclitaxel- eluting stents. JACC Cardiovasc Interv 2013;6:274-81.

108 pt, 119 ISR lesions

30% occlusions

3/ Covered Stents

RELINE study

PTA (N=44)Mean Lesion Length 190 (30-270)*

stenosis (pre) 75.0 %

chronic occlusion 25.0 %

acute occlusion 0.0 %

Calcified lesion 25.0 %**

9 bail-out procedures after failedPTA

Viabahn (N=39)Mean Lesion length 173 (30-

330)

stenosis (pre) 76.9 %

chronic occlusion 20.5 %

acute occlusion 2.6 %

Calcified lesion 33.3%

* Missing data of 3 patients** Missing data of 1 patient

RELINE study : 12-month Primary Patency

vs.

72.50 %

26.40 %

p<0.001

Number at risk baseline 1MFU 6MFU 12MFU

PTA 53 39 31 12

Viabahn 47 44 42 30

RELINE study : 12-month freedom from TLR

vs.

81.20 %

40.60 %

p<0.001

Number at risk baseline 1MFU 6MFU 12MFU

PTA 53 39 33 17

Viabahn 47 46 43 33

RELINE study : 24-month Primary Patency

vs.

58.4 %

11.6 %

p<0.001

Number at risk baseline 1MFU 6MFU 12MFU 24MFU

PTA 44 33 26 11 4

Viabahn 39 37 35 26 16

RELINE study : 24-month freedom from TLR

vs.

66.3 %

23.0 %

p<0.001

Number at risk baseline 1MFU 6MFU 12MFU 24MFU

PTA 44 33 28 16 8

Viabahn 39 38 35 27 17

4/ Laser Atherectomy

• EXCITE ISR trial

• Prospective, multicenter , randomized study

Excimer Laser PTA

Dippel EJ, Makam P, Kovach R, George JC, Patlola R, Metzger DC, et al.

randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis:

initial results from the eXCiTe isr trial (eXCimer laser randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis).

JACC Cardiovasc Interv 2015;8(1 Pt A):92-101.

4/ Laser Atherectomy – EXCITE ISR

4/ Laser Atherectomy – EXCITE ISR

4/ Laser Atherectomy – EXCITE ISR

5/ Laser Atherectomy + DCB

Kokkinidis DG, et al. Laser Atherectomy Combined With Drug-Coated Balloon Angioplasty Is Associated With Improved 1-Year

Outcomes for Treatment of Femoropopliteal In-Stent Restenosis. J Endovasc Ther. 2018 Feb;25(1):81-88

DCB + Laser:

72.50%

POBA + Laser:

50.50%

6/ Atherectomy + DCB

Not in the IFU , risk of stent strut entrapment

Guidelines

ESVS 2017

Conclusion• DCB is an efficient treatment for short ( Tosaka I ) ISR

lesions , but may lack long term durability in more complex lesions.

• Viabahn and DES seems to be a better option in Tosaka II and III lesions.

• ELA + DCB seems to be a promising alternative : needs further investigation

• What about atherectomy

• There is absolute need for a new RCT comparing the different treatment options

How to treat in-stent-restenosisin the femoropopliteal tract?

What does the literature tells us?

Michel J. Bosiers, MD

Consultant Vascular and Endovascular Surgery

St. Franziskus-Hospital Münster

Director: Prof. G. Torsello