Hiroshi Ando, MDKasukabe Chuo General Hospital

Saitama, Japan

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

Disclosure

Hiroshi Ando, MD

Kasukabe Chuo General Hospital

✓

Difficult to Avoid Restenosis

after Balloon Angioplasty

3M-Restenosis = 73%Iida O, Soga Y, et al. EJVES 2012

3M-Restenosis = 69%Schmidt A, et al. CCI 2010;76:1047–1054

J-BEAT Angio

Multicenter prospective registry

101 infrapopliteal lesions (63 CLI patients)

Courtesy of Dr. Soga

Time to Wound Healing

Courtesy of Dr. Soga

Median: 97±10 days

OLIVE registry J-BEAT Angio

Median: 117±79 daysIida O, Soga Y, et al. EJVES 2012Iida O, Nakamura M, et al.

Circ Cardiovasc Interv. 2013

Time to Wound Healing

N. Azuma et al. Eur J Vasc Endovasc Surg. 2012

Median

9M!!

To complete wound healing for dialysis pts,

we spend too much time!!

Courtesy of Dr. Soga

Time to Wound Healing is

longer than Time to Restenosis

Wound healing 3-4M > restenosis 3M

(dialysis 9M !)

Courtesy of Dr. Soga

Repeat balloon angioplasty is

often needed to achieve complete

wound healing.

6 and 12 month follow up data DES trials

P.P: primary patency

ACHILLES

SES/PTA

YUKON-BTK

SES/BMS

DESTINY

EES/BMS

DESTINY II

EES

PES BTK-70self-expanding

BVSeverolimus-eluting

Patients(n) 99 82 78 60 70 22

Rutherford(CLI)

3 to 5 2 to 5(51.2%)

4 to 5 4 to 5(96.7%)

4 to 5 3 to 6(60%)

LL(mm)MLL±SD(mm) 26.9±20.

931±9 15.9±910.

2

30-10047.4 19.7

5-5020.2

CTO(%) 81.3 15 53.3 14.3

P.P(%) 75 80.6 85.2 75.4 72.6 94.4

TLR(%) 10.0 9.2 8.7 15.1 20.9 5.6

Death(%) 10.1 22.4 18.1 10.7 10.6 4.6

Limb salvage(%) 86.2 97.4 94.8 96.6 100

DES > BMS > PTA

Atherectomy Devices to CLI Treatment

Device study Patient MeanL.L

(mm)

Procedure success(%)

Limb sulvage(%)

MAE(%)

Diamondback Calcium360

25 91 93.1 88/12M 6.7

Laser LACI 145 110 86 92/6M 18

TurboHawk DefinitiveLE

201 72 83 95/12M 9.5

Study Design

Study Design

Study Design

Study Design Prospective, Multicenter, Single Arm, Real-world Registry

Objective

To demonstrate safety and assess the clinical use and outcomes of the Lutonix DCB for treatment of stenosis or occlusion of native below-the-knee arteries in a heterogeneous patient population in real world clinical practice

Number of patients/sites

371 subjects enrolled from 26 international sites

Inclusion CriteriaRutherford Class: 3-5, ≥ 70% stenosis lesion, target vessel(s) reconstitute(s) at or above the ankle with inline flow to at least one patent (<50% residual stenosis) inframalleolar outflow vessel

Exclusion CriteriaNeurotrophic ulcer or heel pressure ulcer or ulcer potentially involving calcaneus (index limb)

Primary EndpointsSafety: Freedom from BTK MALE+POD at 30-daysEfficacy: Freedom from TLR at 6 months

Follow-up 1, 6, 12 and 24 Months

The Global Lutonix DCB BTK Registry

PI Name

Prof. Willfort-Ehringer

Dr. Loewe

Prof. Brodmann

Prof. Hausegger

Dr. Lerut

Dr. Lansink

Dr. Clemens

Dr. Zech

Dr. Giménez-Gaibar

Dr. Alves

Prof. Sapoval

Dr. Lichtenberg – Study Co-PI

Dr. Thieme

Study Centers

PI Name

Prof. Scheinert – Study Co-PI

Prof. Eckstein

Dr. Sunderdiek

Prof. Tepe

Dr. Perez Delgado

Prof. Zeller

Prof. Karnabatidis

Prof. Brountzos

Dr. Rossato

Dr. Cioppa

Dr. Tolva

Dr. Butterfield

Dr. Rana

EVENT

Pre

-Pro

ced

ure

Pro

ced

ure

Po

st-P

roce

du

re

30

Day

6 M

on

th

12

Mo

nth

24

Mo

nth

Visit Window±2

Weeks

±1

Month

±1

Month

±2

Months

Inclusion/Exclusion

Criteria√ √

Informed Consent √

Medical History √

Routine Physical Exam √ √ √¹ √ √ √¹

Current Medication √ √ √ √ √

Rutherford Classification √ √¹ √ √ √¹

Adverse Event

Monitoring√ √ √ √ √ √

Wound Healing

Assessment√ √¹ √ √ √¹

Patient Follow-up

¹Required only if clinical visit occurs

DescriptionBTK Study Registry

(N=364)

Age (Years), Mean ± SD (n) 73.6 ± 9.5 (364)

Gender, % (n/N)

Female

Male

28.0% (102/364)

72.0% (262/364)

BMI ≥30 kg/m², % (n/N) 23.7% (85/358)

Hypertension, % (n/N) 86.8% (316/364)

Dyslipidemia, % (n/N) 62.4% (227/364)

Diabetes 64.0% (233/364)

Current/Previous Smoker, % (n/N) 50.5% (184/364)

Rutherford Category

3

4

5

23.7% (86/363)

10.5% (38/363)

65.8% (239/363)

Demographics / Baseline Characteristics

RCC 5

65.8%

(239/363)

DescriptionBTK Study Registry

(N=364)

Lesion Location¹

Popliteal

Tibioperoneal Trunk

Anterior Tibial

Posterior Tibial

Peroneal

6.9% (25/364)

20.6% (75/364)

51.1% (186/364)

22.3% (81/364)

22.8% (83/364)

Total Target Length (mm), Mean ± SD (n) 121 ± 97.9 (364)

Average RVD (mm), Mean ± SD (n)

(min, max)

2.7 ± 0.52 (361)

(1.7, 4.5)

Calcification, % (n/N)

Severe Calcification, % (n/N)

64.3% (279/434)

23.9% (83/348)

TASC

A

B

C

D

Unknown

25.3% (92/363)

26.2% (95/363)

16.8% (61/363)

14.3% (52/363)

17.4% (63/363)

Lesion Characteristics

¹Subjects may be in more than one category.

TASC C/D

31.1%

(113/363)

Freedom from Primary Safety Events

Freedom at 30-Days from the composite of all-cause death, above-ankle amputation

or major re-intervention, i.e., new bypass graft, jump/interposition graft revision, or

thrombectomy/thrombolysis of the index limb involving a below-the-knee artery.

Time N1

Survival2

% [95% CI]

Month 1 (30 Days) 346 98.6% [96.6%, 99.4%]

Month 6 (183 Days) 250 94.9% [91.6%, 96.9%]

Month 12 (365 Days) 144 92.8% [88.5%, 95.6%]

¹Subjects ongoing without an event at the beginning of the visit window

²Primary safety response estimate based on Kaplan-Meier estimate

6M: 94.9%12M: 92.8%

Freedom From N¹Survival²

% [95% CI]

All Cause Death Survival 150 86.5% [81.2%, 90.4%]

Major Amputation 145 94.8% [91.0%, 97.0%]

Re-intervention for Thrombosis/Thrombolysis 141 91.5% [86.3%, 97.4%]

Re-intervention For Distal Embolization 150 100.0% [NA, NA]

TVR 117 75.0% [68.1%, 80.6%]

Unexpected Device or Drug Related Event 150 99.6% [97.2%, 99.9%]

Additional Safety Profile - 12 months

¹Subjects ongoing without a failure at the beginning of the visit window

²Survivor rate based on Kaplan-Meier Estimate

Freedom from TLR

¹Subjects ongoing without a TLR failure at the beginning of the visit window

²TLR-Free response estimate based on Kaplan-Meier estimates

Time N1

Survival2

% [95% CI]

Month 1 (30 Days) 344 98.9% [97.0%, 99.6%]

Month 6 (183 Days) 237 90.6% [86.4%, 93.5%]

Month 12 (365 Days) 117 76.0% [69.2%, 81.5%]

6M: 90.6%12M: 76.0%

Rutherford Category Shift – 12 months

DescriptionBTK Study Registry

(N=144)

Improved by 5 Levels

Improved by 4 Levels

Improved by 3 Levels

Improved by 2 Levels

Improved by 1 Levels

No Change

Worsened by 1 Levels

23.6% (34/144)

9.7% (14/144)

26.4% (38/144)

11.1% (16/144)

6.3% (9/144)

20.1% (29/144)

2.8% (4/144)

77% Improved by >1 RCC

60% Improved by >3 RCC

• Only BTK Multi-Center On-going Registry Study

• Freedom from TLR 76.0% at 12 months

• Low Amputation Rate – 5.2% at 12 months

• ~60% Improvement by >3 Rutherford Classifications at 12 months

• ZERO Re-interventions for Distal Embolization at 12 months

• Promising Treatment Effect in Below-the–Knee Arteries

• Safety Outcomes Consistent with the Strong Safety Profile of the

Lutonix DCB in PAD

12 Month Conclusions

Hiroshi Ando, MDKasukabe Chuo General Hospital

Saitama, Japan