FMRP 2015 |

LINC 2015, Leipzig

RELINE-trial : 24 months results with the Viabahn vs PTA for in-stent restenosis

Koen Deloose, MD 1

Marc Bosiers Koen Deloose Joren Callaert

A.Z. Sint-Blasius, Dendermonde

Patrick Peeters Jürgen Verbist

OLV Hospital, Aalst

Lieven Maene Roel Beelen

R.Z. Heilig Hart, Tienen

Koen Keirse Bart Joos

Imelda Hospital, Bonheiden

FMRP 2015 |

Disclosure slide

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

2

FMRP 2015 |

The results of modern generation stents?

3

1 yr ppr 1 yr CD-TLR mean LL

85,5% 80,4%

86%

78%

6,2

22,6

9,9

6,6

Zilver PTX Complete SE Tigris Biomimics Resilient Stroll Durability II Durability I Supera Viastar Supera LL

9,0%

[1] Dake MD et al. Circ Cardiovasc Interv. 2011; [2] Scheinert D LINC 2013; [3] Laird JR et al. Circ Cardiovasc Interv. 2010; [4] Cordis SMART Control

IFU 100000000922.1; [5] Matsumura JS J Vasc Surg. 2013;; [6] Bosiers M J Endovasc Ther. 2009; [7] Lammer J et al. J Am Coll Cardiol. 2013

With the courtesy of Medtronic Academia of Medical Education

20-25% in-stent restenosis

FMRP 2015 |

The results of modern generation stents?

4

Chemical block Inhibiting smooth muscle cell migration and proliferation

DEB DES

Mechanical block Creating physical barrier &

Remove the stimulus for ISR from the equation

Covered stents

20-25% in-stent restenosis

FMRP 2015 |

• Stabile et al. : single center registry (39 patients) on the use of DCB (IN.pact Admiral Medtronic) for treatment of femoral ISR (JACC 2012;60:1739-1742)

5

Primary patency : 92.2% @ 12 months Primary patency : 70.3% @ 24 months

Chemical block

Inhibiting SMC migration & proliferation : DEB

FMRP 2015 |

• Liistro et al. : DEBATE –ISR : single center registry on the use of DCB (IN.pact

Admiral Medtronic©) for treatment of femoral ISR (JACC 2012:60:B97)

• 44 patients DCB vs historical cohort POBA (42) ; 100% diabetics

• MLL 131 mm

6

PPR @ 12 months 80.5% - Freedom from TLR : 86.4% @ 12 months ; 68% @ 24 months

Chemical block

Inhibiting SMC migration & proliferation : DEB

FMRP 2015 |

• Krankenberg et al. : FAIR trial : multi-center randomized, controled trial on the use

of DCB (IN.pact Admiral Medtronic©) and POBA for treatment of femoral ISR

• 119 patients : 62 DCB vs 57 POBA ; MLL 82 mm

7

PPR @ 12 months 70.5% Freedom from TLR : 90.8% @ 12 months

Chemical block

Inhibiting SMC migration & proliferation : DEB

Presented @ LINC 2014, Leipzig, Germany

FMRP 2015 | 8

Chemical block

Inhibiting SMC migration & proliferation : DES

Zilver PTX Single Arm Study , 787 patients, 119 ISR lesions, mll 133mm

Zeller et al. JACC 2013;6:274-81

FMRP 2015 | 9

N° of patients Average

lesion length Primary patency

Kazemi TCT 2006

17 15 cm 65% @12M

Ansel 2007

27 26 cm 52% @18M

Monahan JVS 2011

24 N/A 62% @12M

Shamerri Ann Saudi Med 2012

24

24.5 cm

85.1%@12M

-> non-randomized, single center data

Mechanical block

Creating physical barrier : Covered stents

FMRP 2015 | 10

The RELINE Trial

Physician initiated, randomized, controled,

multi-center trial comparing the new generation Viabahn endoprothesis (Gore & Associates, Flagstaff,AZ) and POBA in the treatment of

femoral in-stent restenosis

FMRP 2015 | 11

The RELINE Trial

Physician initiated, randomized, controled,

multi-center trial comparing the new generation Viabahn endoprothesis (Gore & Associates, Flagstaff,AZ) and POBA in the treatment of

femoral in-stent restenosis

1:1 randomization

83 patients*

Rutherford 2-5

* After Protocol Deviations were excluded

FMRP 2015 |

RELINE study : Endpoints

• Primary patency at 12 months

– no evidence of restenosis/occlusion within the treated lesion based on CFDU (peak systolic velocity ratio ≤2.5) & without TLR within 12 months

• Primary Patency at 24 months

– No evidence of restenosis/occlusion within the treated lesion based on CFDU (peak systolic velocity ratio ≤2.5) & without TLR within 24 months

12

FMRP 2015 |

RELINE study : Inclusion criteria • Rutherford classification 2-5

• Ankle‐brachial index ≤0.8

• Restenosis/reocclusion in a stent (implanted >30 days) in the

superficial femoral artery

• Total target lesion length between 4 - 27 cm (comprising in‐stent restenosis and adjacent stenotic disease)

13

FMRP 2015 |

RELINE study: Patient demographics

Characteristic VIABAHN ISR

N=39 PTA

N=44 p-value

General

Male (%)

Female (%)

29 (74.4%)

10 (25.6%)

32 (72.7%)

12 (27.3%) 0.853

Age (min – max; ±SD)

67.69 (49 – 86; 9.77)

68.98 (48 – 86; 9.71)

0.791

Rutherford categorization

Claudication (R 2-3) (%)

Critical Limb Ischemia (R 4-5) (%)

34 (87.2%)

5 (12.8%)

36 (81.8%)

8 (18.2%) 0.508

Rutherford 2 (%)

Rutherford 3 (%)

Rutherford 4 (%)

Rutherford 5 (%)

12 (30.8%)

22 (56.4%)

4 (10.3%)

1 (2.6%)

5 (11.4%)

30 (68.2%)

3 (6.8%)

6 (13.6%)

0.065

14

FMRP 2015 |

RELINE study: Patient demographics

Characteristic VIABAHN ISR

N=39 PTA

N=44 p-value

Medical history Nicotine abuse Never

Current

Previous

13 (33.3%)

16 (41.0%)

10 (25.6%)

12 (27.3%)

16 (36.4%)

16 (36.4%)

0.569

Hypertension No

Yes, medically treated

Yes, not medically treated

12 (30.8%)

26 (66.7%)

1 (2.6%)

16 (36.4%)

27 (61.4%)

1 (2.3%)

0.865

Diabetes Mellitus No

Yes, insulin dependent

Yes, non-insulin dependent

26 (66.7%)

6 (15.4%)

7 (17.9%)

28 (63.6%)

7 (15.9%)

9 (20.5%)

0.951

Renal insufficiency No

Yes

37 (94.9%)

2 (5.1%)

41 (93.2%)

3 (6.8%) 0.889

Hypercholesterolemia No

Yes

22 (56.4%)

17 (43.6%)

15 (34.1%)

29 (65.9%) 0.069

Obesity No

Yes

28 (71.8%)

11 (28.2%)

33 (75.0%)

11 (25.0%) 0.935

15

FMRP 2015 | 16

The RELINE Trial : lesion characteristics

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%

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 failed PTA

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

FMRP 2015 | 17

86.1 %

93.0 %

P=0.316

The RELINE Trial : 1 – 2 yr survival

95.3 %

91.9 %

P=0.383

1 year 2 year

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

PTA 44 44 43 41 36

Viabahn 39 38 37 33 25

FMRP 2015 | 18

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

The RELINE Trial : 1 – 2 yr primary patency

28.0 %

74.8 %

p<0.001

1 year 2 year

FMRP 2015 | 19

66.3 %

23.0 %

p<0.001

The RELINE Trial : 1 – 2 yr freedom TLR

42.0 %

80.0 %

p<0.001

1 year 2 year

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

PTA 44 33 28 16 8

Viabahn 39 38 35 27 17

FMRP 2015 |

Conclusion

• There is some evidence that chemical solutions are valuable in the battle against ISR.

• The RELINE results prove, even on the longer run, that a mechanical barrier (like the Viabahn stentgraft) is also a promising tool for treatment of in-stent restenosis

20

FMRP 2015 |

LINC 2015, Leipzig

RELINE-trial : 24 months results with the Viabahn vs PTA for in-stent restenosis

Koen Deloose, MD 21

Marc Bosiers Koen Deloose Joren Callaert

A.Z. Sint-Blasius, Dendermonde

Patrick Peeters Jürgen Verbist

OLV Hospital, Aalst

Lieven Maene Roel Beelen

R.Z. Heilig Hart, Tienen

Koen Keirse Bart Joos

Imelda Hospital, Bonheiden