12 Month outcomes from the Lutonix ISR randomized Trial

Koen Deloose, MD

Head of Vascular Surgery, AZ Sint Blasius

Dendermonde, Belgium

2 ID3 Medical – 2017 |

Disclosure slide

I have the following potential conflicts of interest to report:

Consulting: Medtronic, Spectranetics, Biotronik, Abbott, Bard

iVascular, Bentley, Cook, GE Healthcare

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

Speaker name: Koen Deloose, MD

3 ID3 Medical – 2017 |

The results of modern generation stents?

20-30% in-stent restenosis Chemical block

Inhibiting smooth muscle cell migration and

proliferation

DEB DES

Deblocking Removing hydrated

collagen matrix/neo-intimal hyperplasia

Atherectomy

Mechanical block Creating physical

barrier/removing ISR stimulus from the equation

Covered stents

Doesn’t seem to work that

good as a stand alone therapy

Adding more lifelong metal, probably the origin of ISR,

can’t be the optimal solution

4 ID3 Medical – 2017 |

Lutonix ISR randomized trial A Prospective, Multicenter, Single-Blind,

Randomized, Controlled Trial Comparing the Lutonix® Drug Coated Balloon vs. Standard

Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis

5 ID3 Medical – 2017 |

Levant 2 Design: DSMB, Blinded CEC and Core Lab

Randomized Blinded Study Design

Baseline Angiogram

Test Arm

Dilatation with Drug

Coated Balloon

Control Arm

Dilatation with uncoated

balloon

Defined Pre-Dilatation

(Balloon inflated to ~1mm <RVD)/

Enrollment

Randomization

2:1

Defined bailout stenting

(if necessary) with FDA approved Stent.

Standard Post-Dilatation per physician

discretion.

Recruitment

53 patients 29 patients

6 ID3 Medical – 2017 |

EVENT

Pre

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Pro

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Post

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1 M

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6 M

on

th

12

Mo

nth

24

Mo

nth

36

, 48

& 6

0

mo

nth

s

Rep

eat

An

gio

/Rev

asc

Inclusion/Exclusion Criteria √ √

Informed Consent √

Med Hx √

Pregnancy Test √

Physical Exam √ √ √ √ √ √ √

Medication Compliance √ √ √ √ √ √ √

Resting ABI √ √ √ √ √ √ √

Rutherford Classification √ √ √ √ √

WIQ & EQ5D Questionnaires √ √ √ √

Angiogram √ √

Adverse Event Monitoring √ √ √ √ √ √ √ √

Duplex Ultrasound √ √ √ √

Study Follow-up

7 ID3 Medical – 2017 |

Summary DCB Subjects

(N=53)

PTA Subjects

(N=29)

Age (Years), Mean ± SD (n) 68.9 ± 9.35 (53) 67.0 ± 8.64 (29)

BMI ≥ 30 kg/m2(n/N) 41.5 % (22/53) 42.9% (12/28)

Diabetes, % (n/N) 37.7% (20/53) 55.2% (16/29)

Baseline Target Limb Rutherford Grade, % (n/N)

2

3

4

17.0% (9/53)

77.4% (41/53)

5.7% (3/53)

13.8% (4/29)

75.9% (22/29)

10.3% (3/29)

RVD (mm), Mean ± SD (n) 4.7 ± 0.66 (53) 4.7 ± 0.52 (29)

CTO, % (n/N) 9.4% (5/53) 6.9% (2/29)

Calcification, % (n/N) 47.2% (25/53) 71.4% (20/28)

Baseline ABI of Target Limb, Mean ± SD (n) 0.77 ± 0.15 (46) 0.78 ± 0.20 (24)

Treated Length (mm), Mean ± SD (n) 152.4 ± 62.5 (50) 142.0 ± 74.7 (27)

% Bail out / Provisional Stenting – post dilation 0.0 % 0.0%

Subject Characteristics

8 ID3 Medical – 2017 |

Kaplan-Meier Primary Safety Survival Estimates

Primary Safety Non-Inferior to PTA

Primary Safety Endpoint: Freedom from all-cause perioperative (≤30 day) death and freedom at 1 year from index limb amputation (above and below the ankle) index limb re-intervention, and index-limb-related death.

9 ID3 Medical – 2017 |

Freedom From DCB Subjects

% [95% CI]

PTA Subjects

% [95% CI]

All Cause Death 100.0 [NA, NA] 96.3% [76.3%, 99.5%]

Major Amputation 100.0 [NA, NA] 100.0 [NA, NA]

Minor Amputation 100.0 [NA, NA] 96.3% [76.5%, 99.5%]

Major Vascular Complications 98.1% [89.7%, 100.0%] 92.9% [76.5%, 99.1%]

Additional Safety Profile

Similar DCB and PTA Safety Profiles

10 ID3 Medical – 2017 |

Kaplan-Meier TLR-Free Survival Estimates

Large Improvement in fTLR

28.5% Improvement with DCB

11 ID3 Medical – 2017 |

28.6% Improvement with DCB Defined as an improvement in Rutherford Category compared to

baseline and freedom from TVR

Sustained Clinical Benefit

Sustained clinical benefit: Improvement in Rutherford Class and freedom from TVR

DCB Subjects PTA Subjects

Success %

(n/N)

95% CI Success %

(n/N)

95% Cl

12 Months 61.2% (30/49) [46.2%, 74.8%] 47.6% (10/21) [25.7%, 70.2%]

12 ID3 Medical – 2017 |

• Only Randomized Blinded DCB ISR Study

Blinded CEC and Core Lab Adjudication

• No Bail-out / Provisional Stenting

• DCB Safety non-inferior to PTA

In lesions up to 315 mm

Low rate of vascular complications (1.9%)

• 28.5% Difference in Improvement over PTA for Freedom from Clinically Driven TLR

• 28.6% Difference in Improvement over PTA in Sustained Clinical Benefit

Conclusions

12 Month outcomes from the Lutonix ISR randomized Trial

Koen Deloose, MD

Head of Vascular Surgery, AZ Sint Blasius

Dendermonde, Belgium