Global Diabetic Analysis of Lutonix® DCB SFA Combined

Trials

Koen Deloose, MD

Head Dept Vascular Surgery

AZ Sint Blasius Dendermonde, Belgium

2iD3 Medical – 2019 |

Disclosure slide

I have the following potential conflicts of interest to report:

Consulting: Medtronic, Spectranetics, Biotronik, Abbott, BD/BARD,

iVascular, Bentley, Cook, GE Healthcare, Contego medical,

Boston Scientific, Cardionovum, B Braun, Terumo

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

3iD3 Medical – 2019 |

Meta-Analysis

Comparing SFA diabetic to non-diabetic subjects from the Levant 2, Levant 2 Continued Access, Global Registry and Long Lesion Studies

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4iD3 Medical – 2019 |

Study population

Total Subjects

(n=1800)

Diabetic(n=699)

Levant 2 –19.6% (137/699)Levant 2 CA – 35.2% (246/699)

Global Registry – 39.1% (273/699)Long Lesion – 6.2% (43/699)

Non-Diabetic(n=1101)

Levant 2 –16.3% (179/1101)Levant 2 CA – 39.0% (429/1101)

Global Registry – 38.0% (418/1101)Long Lesion – 6.8% (75/1101)

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5iD3 Medical – 2019 |

History of Risk Factors

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History of Risk Factors, n (%) DM No DM P-Value(N=699) (N=1101)

Smoking Status, n/N (%)

Current

Never

Previous

213/686 (31.0%)

158/686 (23.0%)

315/686 (45.9%)

441/1077 (40.9%)

226/1077 (21.0%)

410/1077 (38.1%)

<0.001

Dyslipidemia or Hypercholesteremia, n/N (%) 558/699 (79.8%) 819/1101 (74.4%) 0.008

Hypertension, n/N (%) 643/676 (95.1%) 921/1008(91.4%)

0.003

Renal Failure, n/N (%) 38/699 (5.4%) 35/1101 (3.2%)

0.020

Congestive Heart Failure, n/N (%) 45/699 (6.4%) 36/1101 (3.3%) 0.002

History of CAD, n/N (%) 270/601 (44.9%) 279/905 (30.8%) <0.001

Previous MI, n/N (%) 159/550 (28.9%) 161/743 (21.7%) 0.003

Previous PVD, n/N (%) 487/699 (69.7%) 691/1101 (62.8%) 0.003

6iD3 Medical – 2019 |

Lesion Characteristics

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DM (N=699) Non-DM (N=1101)

Total Lesion Length, n

Mean mm, (SD)

Min - Max

688

85.3 (71.28)

2.3 - 380.0

1077

84.8 (76.46)

3.0 - 500.0

Number of Treated Lesions, n/N (%)

1

2

3

4

618/690 (89.6%)

67/690 (9.7%)

5/690 (0.7%)

0/690 (0.0%)

998/1083 (92.2%)

78/1083 (7.2%)

6/1083 (0.6%)

1/1083 (0.1%)

Baseline Stenosis, n

Mean %, (SD)

Min - Max

688

84.6 (14.03)

6.0 - 100

1079

86.2 (13.13)

40 - 100

Final Stenosis, n

Mean %, (SD)

Min - Max

247

32.2 (24.70)

0.0 - 150

363

32.3 (24.42)

0.0 - 150

Calcification, n/N (%) 373/600 (62.2%) 585/956 (61.2%)

Baseline RVD Average(mm), n

Mean (SD)

Min - Max

686

4.9 (0.75)

2.0 - 7.0

1076

5.0 (0.75)

3.0 - 7.5

SFA, n/N (%) 606/699 (86.7%) 968/1101 (87.9%)

Popliteal, n/N (%) 136/699 (19.5%) 203/1101 (18.4%)

Any Dissection, n/N (%) 334/688 (48.5%) 511/1076 (47.5%)

7iD3 Medical – 2019 |

Lesion Characteristics

TASC D

TASC C

TASC B

TASC A40.5%

24.1%

24.6%

10.8%

33.5%

31.8%

26.9%

7.9%

0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 35.0% 40.0% 45.0%

DM Non-DM

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8iD3 Medical – 2019 |

Baseline Rutherford Category

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4.6%

1.5%

27.6%

59.7%

6.2%

0.4%

0.0%

4.0%

1.4%

26.7%

59.6%

7.0%

1.0%

0.1%

Class 0

Class 1

Class 2

Class 3

Class 4

Class 5

Class 6

0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0% 70.0%

DM Non-DM

9iD3 Medical – 2019 |

Freedom from Clinically Driven TLR

Count Information at Visit Day

Group Time Point Survival %1 (95% CI)

Cumulative

Subjects

with Events

Cumulative

Subjects

Censored

Subjects

Left

Difference

95% CI3 P-value3

Diabetes Day 1

Day 30

Day 180

Day 365

100.0% (NA, NA)

99.6% (98.7%, 99.9%)

97.3% (95.8%, 98.3%)

90.9% (88.5%, 92.9%)

0

3

18

60

0

13

30

61

699

683

651

578

-0.2% (-0.7, 0.4%)

-0.0% (-1.6, 1.5%)

-0.9% (-3.7, 1.8%)

0.594

0.980

0.507

No

Diabetes

Day 1

Day 30

Day 180

Day 365

100.0% (NA, NA)

99.7% (99.2%, 99.9%)

97.4% (96.2%, 98.2%)

91.8% (90.0%, 93.4%)

1

3

28

85

5

26

54

81

1095

1072

1019

935

1 95% CI based on log-log transform.2 95% CI for difference based on Greenwood error estimates.3 Null hypothesis is that rates are equal evaluated using Greenwood error estimates.

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10iD3 Medical – 2019 |

Major Amputation Rate

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*Null hypothesis is that rates are equal evaluated using normal approximation

DM Non DM P-Value

(N=699) (N=1101)

30 Days 1/687 (0.1%) 0/1079 (0.0%) 0.317

6 Months 4/672 (0.6%) 0/1056 (0.0%) 0.045

12 Months 5/653 (0.8%) 0/1025 (0.0%) 0.025

11iD3 Medical – 2019 |

Minor Amputation Rate

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*Null hypothesis is that rates are equal evaluated using normal approximation

DM Non DM P-Value

(N=699) (N=1101)

30 Days 3/687 (0.4%) 1/1079 (0.1%) 0.199

6 Months 3/670 (0.4%) 1/1056 (0.1%) 0.199

12 Months 5/649 (0.8%) 1/1025 (0.1%) 0.059

12iD3 Medical – 2019 |

Target Vessel Revascularization

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*Null hypothesis is that rates are equal evaluated using normal approximation

DM Non DM P-Value

(N=699) (N=1101)

30 Days 4/687 (0.6%) 4/1079 (0.4%) 0.539

6 Months 34/670 (5.1%) 44/1056 (4.2%) 0.386

12 Months 86/651 (13.2%) 109/1029 (10.6%) 0.110

13iD3 Medical – 2019 |

Rutherford Change

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Diabetes

(N=763)

No Diabetes

(N=1190) Rutherford Class at Baseline n

Mean (SD)

Min - Max

759

2.8 (0.62)

0.0 - 6.0

1190

2.7 (0.64)

0.0 - 5.0

Rutherford Class at 30 Days n

Mean (SD)

Min - Max

106

0.8 (1.32)

0.0 - 6.0

172

0.5 (0.92)

0.0 - 3.0

30 Days Change from Baseline n

Mean (SD)

Min - Max

106

-2.2 (1.13)

-4.0 - 2.0

172-2.3 (1.05)-4.0 - 2.0

Rutherford Class at 6 Months n

Mean (SD)

Min - Max

569

0.9 (1.15)

0.0 - 5.0

896

0.7 (1.02)

0.0 - 5.0

6 Months Change from Baseline n

Mean (SD)

Min - Max

568

-1.9 (1.21)

-4.0 - 2.0

896

-2.0 (1.12)

-4.0 - 2.0

Rutherford Class at 12 Months n

Mean (SD)

Min - Max

545

1.0 (1.24)

0.0 - 6.0

873

0.7 (1.06)

0.0 - 5.0

12 Months Change from Baseline n

Mean (SD)

Min - Max

544

-1.8 (1.32)

-5.0 - 3.0

873

-2.0 (1.15)

-5.0 - 2.0

14iD3 Medical – 2019 |

Summary

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Lutonix DCB EQUALLY EFFECTIVE indiabetics & non-diabetics

• Diabetic / Non-Diabetic lesion characteristics are well matched ; Diabetics have higher risk factors (except from smoking)

• 1 Year Outcomes

• TLR Free: 90.9% DM / 91.8% Non-DM

• Major Amputation: 0.8% DM / 0.0% Non-DM

• Minor Amputation: 0.8% DM / 0.1% Non-DM

• TVR: 13.2% DM / 10.6% Non-DM

• Rutherford Change : -1.8% DM / -2.0% Non-DM

Global Diabetic Analysis of Lutonix® DCB SFA Combined

Trials

Koen Deloose, MD

Head Dept Vascular Surgery

AZ Sint Blasius Dendermonde, Belgium