in depth look at safety events with difficult lesions 6 ... › media ›...

In Depth Look at Safety Events with

Difficult Lesions 6 Month BTK IDE

UpdateA Prospective, Multicenter, Single Blind, Randomized,

Controlled Trial Comparing the Lutonix Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Below-the-

Knee (BTK) Arteries

Jihad Mustapha, MD

Advanced Cardiac & Vascular Amputation Centers, Grand Rapids, MI

© 2019 BD. BD and the BD Logo are trademarks of Becton, Dickinson and Company.

Speaker name: Jihad Mustapha

.................................................................................

I have the following potential conflicts of interest to report:

X Consulting: BD, Boston Scientific, Cardioflow, Cardiovascular Systems, Inc, Medtronic, Philips, PQ Bypass, and 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

Disclosure


Study Co-Principle Investigators

Dr. Marianne BrodmannSuppl. Leitung der Klin. Abteilung f. AngiologieUniv. Klinik für Innere MedizinMedizinische Universtität Graz

Dr. Patrick GeraghtyWashington University School of MedicineDepartment of Surgery660 South Euclid Avenue, Campus 8109St. Louis, MO 63110

Dr. Jihad Mustapha Advanced Cardiac & Vascular Amputation Prevention Centers1525 East Beltline NE, Suite 101Grand Rapids, MI 49525


Lutonix Global BTK Study

Enrollment by Geography

US 275EU 122Japan 40Canada 5

442 Randomized Subjects(DCB - 287, PTA - 155)

Multicenter participation:

51 sites8 countriesEnrollment: Jun 2013 – Dec 2017


Study Synopsis

ObjectiveTo demonstrate the superior efficacy and non-inferior safety of the LUTONIX®

014 DCB by direct comparison to standard PTA for treatment of stenosis or occlusion of below-the-knee arteries

Study DesignProspective, Multicenter, Single Blind, Randomized, Safety and Efficacy

Test DeviceLUTONIX® 0.014” OTW Drug Coated PTA Dilatation Catheter

RandomizationSubjects will be randomized 2:1 to Lutonix DCB or standard PTA catheter.

Clinical Follow-up1, 6, 12, 24, 36 Months


Primary Endpoints


Looking at safety and efficacy, ie Death, Mj Amputation

Demographics and Risk Factors


No Difference

Demographics and Risk Factors


Baseline Rutherford Category

62.7%

51.9%

15.3%

17.4%

13.4%

17.7%

8.6%

13.1%

TASC A

TASC B

TASC C

TASC D

P Value 0.073

DCB (N=351)

PTA (N=209)


Higher TASC C&D in the DCB arm

Preliminary Baseline Angio Data


Preliminary Baseline Angio Data (Cont.)


NO Difference

Preliminary Baseline Angio Data (Cont.)


Primary Endpoints (30-Day Safety*)

*Freedom at 30 days from TVR, major index limb amputation, and device and all cause death.


Primary Endpoints (KM 30-Day Safety)

Count Information at Visit Day Survival Difference

Group Time Point

Survival

%1

Cumulative

Subjects

with Events

Cumulative

Subjects

Censored

Subjects

Left2

Difference

(95% CI)3 P-value3

DCB Day 1

Day 30

Day 180

100.0%

99.3%

97.8%

0

2

6

1

5

24

286

280

257

-0.1% (-1.7, 1.5%)

2.6% (-1.3, 6.4%)

0.526

0.096

PTA Day 1

Day 30

Day 180

100.0%

99.4%

95.3%

0

1

7

0

1

17

155

153

131

1 Kaplan-Meier estimate of proportion of subjects without a key safety event at the visit day2 Subjects ongoing without an event at the visit day3 95% CI for difference and p-value for one-sided test that DCB response is less than or equal to Standard PTA response obtained from Kaplan-Meier estimates and standard error estimates from Greenwood's

method


1 Kaplan-Meier estimate of proportion of subjects without a key safety event at the visit day2 Subjects ongoing without an event at the visit day3 95% CI for difference and p-value for one-sided test that DCB response is less than or equal to Standard PTA

response obtained from Kaplan-Meier estimates and standard error estimates from Greenwood's method

Primary Endpoints (KM 6 Month Efficacy)

Count Information at Visit Day Survival Difference

GroupTime

PointSurvival %1

Cumulative

Subjects

with Events

Cumulative

Subjects

Censored

Subjects

Left2

Difference

(95% CI)3 P-value3

DCB

Day 1

Day 30

Day 180

100.0%

97.7%

85.3%

0

7

41

24

24

51

299

292

231

2.0% (-1.4, 5.8%)

14.6% (5.6, 23.9%)

0.137

<.0014

PTA

Day 1

Day 30

Day 180

100.0%

95.6%

70.7%

0

7

42

21

24

45

163

153

97

85.3% DCB PP at 180 days

14.6% DCB ∆ vs. PTA (p = 0.001)


1 Kaplan-Meier estimate of proportion of subjects without a composite failure event at the visit day.2 Subjects ongoing without an event at the visit day3 95% CI for difference and p-value for one-sided test that DCB response is less than or equal to Standard PTA

response obtained with bootstrap approach resampling individual subjects

All Cause Death


DCB PTA P-value

40/287 (13.9%) 20/155 (12.9%) 0.761

*Deaths reported to date

Snap shot all cause mortality up to date .

RCC 5 / All DCB SubjectsDemographics and Risk Factors


Subjects

RCC 5

(N=161)

All DCB

(N=287)Age (Years):

N

Mean (SD)

161

73.1 (9.76)

287

72.9 (9.65)

Gender, % (n)

Male

Female

71.4% (115 / 161)

28.6% (46 / 161)

70.4% (202 / 287)

29.6% (85 / 287)

History of Risk Factors, % (n)

Diabetes

Dyslipidemia

Hypertension

Cigarette Smoking

Current

Former

99.4% (160 / 161)

80.1% (129 / 161)

73.3% (118 / 161)

91.9% (148 / 161)

57.1% (92 / 161)

13.0% (21 / 161)

44.1% (71 / 161)

99.3% (285 / 287)

71.1% (204 / 287)

78.4% (225 / 287)

92.0% (264 / 287)

59.2% (170 / 287)

15.0% (43 / 287)

44.3% (127 / 287)

Identical between the two group

RCC 5 / All DCB SubjectsPreliminary Baseline Angio Data


Flow Pathways

DCB RCC 5

All

DCB

Total Target Lesion Length, mm (n/N) 131.9 (177/179) 111.1 (349/352)

Mean Initial % Stenosis, % (n/N) 89.3 %(179/179) 87.7% (352/352)

Average RVD mm, (n/N) 2.4 (179/179) 2.5 (350/352)

Run-off Present through Foot, % (n/N) 94.3% (165/175) 94.5% (310/328)

Any Calcification, % (n/N) 63.7% (114/179) 59.9% (211/252)

Severe Calcification, % (n/N) 19.6% (35/179) 15.1% (53/352)

TASC Lesion Type, % (n/N) A B C D

43.3% (77/178) 19.1% (34/178) 21.9% (39/178) 15.7% (28/178)

51.9% (182/351)17.4% (61/351)17.7% (62/351)13.1% (46/351)

Safety - RCC 5 / All DCB Subjects


Count Information at Visit Day

Group Time Point

Survival

%1

Cumulative

Subjects

with Events

Cumulative

Subjects

Censored

Subjects

Left2

RCC 5

DCB

Day 1

Day 30

Day 180

100.0%

98.7%

96.0%

0

2

2

1

5

8

160

154

151

All

DCB

Day 1

Day 30

Day 180

100.0%

99.3%

97.8%

0

2

6

1

5

24

286

280

257

RCC 5

PTA

Day 1

Day 30

Day 180

100.0%

98.9%

92.8%

0

1

6

0

0

10

87

86

71

All

PTA

Day 1

Day 30

Day 180

100.0%

99.4%

95.3%

0

1

7

0

1

17

155

153

1311 Kaplan-Meier estimate of proportion of subjects without a key safety event at the visit day2 Subjects ongoing without an event at the visit day

The same safety at 6 month

Efficacy - RCC 5 / All DCB Subjects


Count Information at Visit Day

GroupTime

Point

Survival

%1

Cumulative

Subjects

with Events

Cumulative

Subjects

Censored

Subjects

Left2

RCC 5

DCBDay 1

Day 30

Day 180

100.0%962.%79.4%

06

30

202039

159153110

All

DCBDay 1

Day 30

Day 180

100.0%

97.7%

85.3%

0

7

41

24

24

51

299

292

231

RCC 5

PTADay 1

Day 30

Day 180

`100.0%

93.2%

61.6%

0

6

32

13

16

22

91

82

50

All

PTADay 1

Day 30

Day 180

100.0%

95.6%

70.7%

0

7

42

21

24

45

163

153

97

1 Kaplan-Meier estimate of proportion of subjects without a composite failure event at the visit day.2 Subjects ongoing without an event at the visit day

RCC 5All Subjects

Dotted line all pts in the study

RF 5 patients benefited the most

18% efficacy benefit in RF 5 vs 15% in all DCB

Conclusion

• Rutherford 5 more complex patients

• Longer lesions

• More calcification

• More severe calcification

• Comparable safety between all subjects and

Rutherford 5 subjects

• Comparable treatment effect between all subjects

and Rutherford 5 subjects

* Statistically significant© 2019 BD. BD and the BD Logo are trademarks of Becton, Dickinson and Company.

In Depth Look at Safety Events with

Difficult Lesions 6 Month BTK IDE

UpdateA Prospective, Multicenter, Single Blind, Randomized,

Controlled Trial Comparing the Lutonix Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Below-the-

Knee (BTK) Arteries

Jihad Mustapha, MD

Advanced Cardiac & Vascular Amputation Centers, Grand Rapids, MI


in depth look at safety events with difficult lesions 6 ... › media ›...

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