Dissecting the TOBA data above and below the knee: what it ......1Schneider, JACC: Cardiovasc Interv...

William A. Gray MD FACC FSCAI

System Chief of Cardiovascular Services,

Main Line Health

President, Lankenau Heart Institute

Wynnewood, Pennsylvania

USA

Dissecting the TOBA data

above and below the knee:

what it means in practice

1Kokkinidis, Intervent Cardiol Clin 2017Images ©Intact Vascular, Inc.

Lesions with dissections have a TLR rate 3.5 times higher than lesions without dissection1

Current tools for dissection repair (stents) have limitations

Dissection: Mechanism of Angioplasty

Tack Endovascular System®for post-PTA dissection repair

ATK Tack® Implant Six pre-loaded implants on a single delivery system

6mm deployed length

Self-sizing Nitinol fits vessel diameters 2.5 – 6.0mm

6F delivery system

BTK Tack® Implant Four pre-loaded nitinol implants

• 6mm deployed length

• Self-sizes to tapering BTK anatomy 1.5 – 4.5mm

• 4F delivery system

• 150cm working length

Tack Implants and Conventional Stents

Tack Stent

Traditional Stent

Radial force High

Inflammation MinimalChronic hyperplastic

changes

Pre-clinical study histology images1

SizingSelf-sizes from 3.5 – 6.0 mm; 1 SKU for ATK

Requires more precise sizing; multiple SKU

1Schneider, JACC: Cardiovasc Interv 20152Bosiers, J Vasc Surg 2016

Metal burden6mm length,

open cell design

>70% more metal to treat the same length dissection2

Low

Conventional Stent

ATK Tack® Implant

Addresses stent drawbacks with novel design:

Main Line Health

Lankenau Heart Institute

Lutonix® is a registered trademark of BD Interventional

IN.PACT™ and Admiral™ are trademarks of Medtronic, Inc.

1Bosiers, J Vasc Surg 20162Gray, J Am Coll Cardiol: Cardiovasc Interv 20193Brodmann, Cathet Cardiovasc Interv 2018

*12m results from standard lesion group (n =169); an additional 32 patients with long lesions (>15 - ≤25cm) were enrolled and analyzed separately

TOBA Dissection Repair Trials (N=820)

TOBA II Study Design

Prospective, multi-center, single-arm, non-blinded study in US, Europe

213 subjects, ALL with post-PTA dissection following POBA (n=90) or Lutonix® angioplasty (n=123)

Primary Safety Endpoint:

Freedom from the occurrence of any new-onset MAE(s) at 30 days:•Index limb amputation (above the ankle)•CEC adjudicated CD-TLR•All-cause death at 30 days

Primary Efficacy Endpoint:

Primary patency at 12 months:•Freedom from CEC adjudicated CD-TLR and•Freedom from core lab adjudicated DUS-derived binary restenosis (PSVR ≥ 2.5)

Key Observational Endpoints:

• Freedom from CEC adjudicated CD-TLR• Tack Performance: Dissection Resolution, Migration and Fracture• Changes in Rutherford, ABI and Quality of Life measures

Tack Optimized Balloon Angioplasty Study for Post-Dissection Repair of the Superficial Femoral and Proximal Popliteal Arteries (TOBA II)

Angiographic Core Laboratory/Clinical Events Committee: Yale Cardiovascular Research Group ● Vascular Ultrasound Core Laboratory: VasCore

TOBA II: First and Only Pivotal Trial to Enroll

100% dissected vessels*

Standard Balloon Angioplasty

TOBA IIIncluded All Dissections

LEVANT 2IN.PACT SFAILLUMENATE

Excluded

Moderate or Severe?

Presence of angiographic dissection?

No TOBA IIExcluded

Yes

Dissections are site-reported (visual estimate during index procedure); 99.5% core-lab adjudicated dissection rate

Patient

Characteristics

Mean ±SD (N)

or n/N (%)

Age (y) 68.2 ± 9.1 (213)

Male gender 151/213 (70.9%)

BMI 29.3 ± 6.1 (212)

ABI in treated leg 0.76 ± 0.21 (200)

Rutherford 2

3

4

68/213 (31.9%)

136/213 (63.8%)

9/213 (4.2%)

Diabetes mellitus 92/213 (43.2%)

Coronary disease 128/211 (60.7%)

Renal insufficiency 19/213 (8.9%)

Hypertension 191/213 (89.7%)

Hyperlipidemia 184/211 (87.2%)

Key Baseline Patient/Lesion Characteristics(Intent to Treat Population)

Lesion

Characteristics

Mean ±SD (N)

or n/N (%)

Target vessel: SFA

P1

SFA and P1

184/211 (87.2%)

12/211 (5.7%)

15/211 (7.1%)

Target lesion length (mm) 74.3 ±40.6 (210)

PTA treated length (mm) 96.7

Proximal RVD (mm)

Distal RVD (mm)

5.3 ± 0.7 (211)

5.5 ± 0.7 (211)

Total Occlusion 49/211 (23.2%)

Calcification:

Moderate

Severe

113/211 (53.6%)

12/211 (5.7%)

Patent Run-Off Vessels:

0

1

2

3

6/207 (2.9%)

72/207 (34.8%)

86/207 (41.5%)

43/207 (20.8%)

Safety1 Population Met/Not Met p-value*

30-Day Freedom from MAE:

• Index limb amputation

• CD-TLR

• All-cause death

Intent to Treat(n=212)

MET <0.0001

TOBA II Primary Endpoints Met

*Fisher’s exact test for one proportion, p-values and 95% CI are one-sided

Efficacy2 Population Met/Not Met p-value*

Primary Patency at 12 Months:

• Freedom from CEC adjudicated CD-TLR

and

• Freedom from core lab adjudicated DUS-

derived binary restenosis (PSVR ≥ 2.5)

Intent to Treat(n=183)

MET 0.0006

Per Protocol(n=176)

MET 0.0005

1Objective PG derived from VIVA PG: Rocha-Singh, Catheter Cardiovasc Interv 20072Objective PG derived from LEVANT 2: Rosenfield, N Engl J Med 2015

213 subjects with post-PTA dissection following POBA (n=90) or Lutonix® angioplasty (n=123)

12 Month Kaplan-Meier Estimates

Primary Patency 79.3%

Fre

ed

om

fro

m C

linic

all

y D

riven T

arg

et

Lesi

on R

evasc

ula

rizati

on (

CD

-TL

R)

(%)

0

10

20

30

40

50

60

70

80

90

100

Days since Index Procedure

0 30 60 90 120 150 180 210 240 270 300 330 360 390

Database Date: 17Jun2018

Freedom from CD-TLR 86.5%

Dissections are site-reported (visual estimate during index procedure); 99.5% core-lab adjudicated dissection rate

(Core lab adjudicated)

Patency results include POBA and DCB

treatment in 100% dissected vessels

100% Dissected Vessel Population60% Moderate/Severe Calcium

Patency results include POBA and DCB

treatment in 100% dissected vessels

No dissection A B C D E F

Pre-Tack: Dissection Severity

10.0%

20.1%

44.5%

24.4%

0.5%0.5%

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

% o

f Su

bje

cts

(N=2

09

)

Pre-Tack Worst Dissection Grade

Mean ±SD (N)

or n/N (%)

Total number of dissections 369

Number of dissections per subject 1.8 ± 0.9 (209)

Mean dissection length (mm) 20.7 ± 21.4 (368)

69.4% of subjects had a dissection ≥ Grade C

before using Tack


No dissection

Post-Tack: Dissections Resolved

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

% o

f D

isse

ctio

ns

(N=3

69

)

92.1%

Post-Tack Dissection Grade

69.4% of subjects had a dissection ≥ Grade C

before using Tack

Post PTAGrade C

(core lab)

Post Tack No dissection

(core lab)

2 Tacks

Images courtesy of Prof. Marianne Brodmann, MD


Mean ±SD (N)

or % (n/N)

Total number of Tack implants deployed 871

Number of dissections per subject 1.8 ± 0.9 (209)

Number of Tack implants per subject 4.1 ± 2.5 (213)

Bailout stent rate 0.5% (1/213)

Freedom from Tack fracture at 12 months 100%

Freedom from Tack migration at 12 months 99.9% (870/871*)

Tack Stability and Durability

*2.6mm per core lab at 12-month X-ray

Significant, Sustained Clinical Improvement

p<0.0001

12 M Baseline

63% improved ≥ 2 classes

Rutherford Clinical Category

0.65

0.7

0.75

0.8

0.85

0.9

0.95

ABIp<0.0001

0

10

20

30

40

50

WIQp<0.0001

0

10

20

30

40

50

60

70

PAQp<0.0001

% o

f P

atie

nts

Rutherford Clinical Category

All p-values calculated using Wilcoxon Signed Rank TestThese analyses were not included in the overall Type I error control for the study

1Rosenfield, N Engl J Med 2015

TOBA II DCB group and LEVANT 2 DCB arm1 TOBA II POBA group and LEVANT 2 POBA arm1

Observational data only ● Patient populations and study methodologies differed ● Not powered for statistical significance

TOBA II Patency ObservationsDCB-like patency in longer, more occluded

and severely dissected vesselsNotably higher patency rate with POBA

in severely dissected vessels

Main Line Health


TOBA III

Prospective, multi-center, single-arm, non-blinded study in US, Europe

201 subjects, ALL with post-PTA dissection following IN.PACT™ Admiral™ DCB angioplasty169 patients with standard lesions ≤150mm and 32 patients with long lesions >150mm -≤250mm

Primary Safety Endpoint:

Freedom from the occurrence of any new-onset MAE(s) at 30 days:•Index limb amputation (above the ankle)•CEC adjudicated CD-TLR•All-cause death at 30 days

Primary Efficacy Endpoint:

Primary patency at 12 months:•Freedom from CEC adjudicated CD-TLR and•Freedom from core lab adjudicated DUS-derived binary restenosis (PSVR ≥ 2.5)

Key Observational Endpoints:

• Freedom from CEC adjudicated CD-TLR• Tack Performance: Dissection Resolution, Migration and Fracture• Changes in Rutherford, ABI and Quality of Life measures

Tack Optimized Balloon Angioplasty Study for Post-Dissection Repair of the Superficial Femoral and Proximal Popliteal Arteries (TOBA III)

Angiographic Core Laboratory/Clinical Events Committee: Yale Cardiovascular Research Group ● Vascular Ultrasound Core Laboratory: VasCore

TOBA III Study Design

Key Inclusion Criteria

• RVD 2.5 – 6.0 mm, inclusive

• De novo or non-stented restenotic lesion in SFA and/or P1:

Standard Lesion Length (mm) Long Lesion Length (mm)

70 - 99% stenosis: ≥20 - ≤150 70 - 99% stenosis: >150 - ≤250

100% occlusion: ≤100 100% occlusion: ≤150

• Presence of ≥ 1 patent (DS% <50) infrapopliteal vessel

• Post-PTA residual DS ≤30% AND

Presence of at least one dissection Grade A to F

Key Exclusion

Criteria

• Previous bypass in target limb

• Acute/sub-acute thrombosis

and/or occlusion

• Post-PTA residual DS >30%

• Severe calcium

TOBA III Key Eligibility Criteria

Main Line Health


Mean ± SD (N), or % (n/N)

Standard

LesionLong Lesion

Target vessel

SFA

P1

SFA and P1

90.0% (153/170)

2.9% (5/170)

6.5% (11/170)

96.9% (31/32)

0.0% (0/32)

3.1% (1/32)

Target lesion length

(mm)68 ± 42 (170) 154 ± 56 (32)

PTA treated length

(mm)99 ± 43 (164) 215 ± 53 (30)

Reference vessel diameter (mm)

Proximal

Distal

5.2 ± 0.8 (170)

5.2 ± 0.8 (170)

5.3 ± 0.9 (32)

4.9 ± 0.8 (32)

Diameter stenosis (%) 82 ± 17 (170) 86 ± 18 (32)

Mean ± SD (N), or n/N (%)

Standard

LesionLong Lesion

Total

Occlusion

34.7%

(59/170)

50.0%

(16/32)

Calcification (PARC)

None / Mild

Moderate

Severe

64.1% (109/170)

15.9% (27/170)

20.0% (34/170)

68.8% (22/32)

21.9% (7/32)

9.4% (3/32)

Number of patent run-off vessels

0

1

2

3

1.2% (2/167)

21.6% (36/167)

46.1% (77/167)

31.1% (52/167)

0.0% (0/30)

26.7% (8/30)

50.0% (15/30)

23.3% (7/30)

Site reported lesion length (mm): 73 ± 38 (standard), 192 ± 34 (long lesion)

TOBA III Baseline Lesion Characteristics(Core lab adjudicated)

Main Line Health


Post-Tack Dissection Resolution

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

% D

isse

ctio

n R

eso

luti

on

(N

=30

1)

98.8% of dissections

completely resolved

% D

isse

ctio

n R

eso

luti

on

(N

=83

)

Mean ±SD (N), or % (n/N)

Standard Lesion Long Lesion

Total number of dissections 301 83

Number of dissections per patient 1.8 ± 1.1 (167) 2.6 ± 1.0 (32)

Dissection length (mm) 22 ± 18 (301) 30 ± 25 (83)

Worst dissection per patient

A : 14%

B: 40.9%

≥C: 45.1%

B: 56.3%

≥C: 43.7%

Tack implants deployed per patient 4.1 ± 2.5 (169) 7.0 ± 3.6 (31)

Bail out stent rate 0.6% (1/169) 0.0% (0/32)

Long lesionStandard lesion

97.7% of dissections

completely resolved

Pre-Tack Dissection Grade(Core lab adjudicated)

Grade D (core lab) 3 Tacks Placed: No Dissection (core lab)

Main Line Health


Safety1 Population Met/Not Met p-value*

30-Day Freedom from MAE:• Index limb amputation

• CD-TLR

• All-cause death

Intent to Treat

(n=166)MET <0.0001

*Fisher’s exact test for one proportion

Efficacy1 Population Met/Not Met p-value*

Primary Patency at 12 Months:

• Freedom from CEC adjudicated CD-TLR

AND

• Freedom from core lab adjudicated DUS-

derived binary restenosis (PSVR ≥ 2.5)

Intent to Treat

(n=183)MET <0.0001

Per Protocol

(n=176)MET <0.0001

!Objective PG derived from: Werk Circ Cardiovasc Interv 2012, Micari JACC Cardiovasc Interv 2012, IN.PACT™ Admiral™ SSED

TOBA III Primary Endpoints Met

Main Line Health


95.0%

Pri

mary

Pate

ncy (

%)

0

10

20

30

40

50

60

70

80

90

100

Time in Days

0 30 60 90 120 150 180 210 240 270 300 330 360 390

DaysStandard Lesion

Primary Patency (95% CI) At Risk

30 100.0%(100.0%,100.0%)

159

180 98.1% (96.0%,100.0%) 156

360 95.0% (91.5%,98.4%) 150

390 91.8% (87.5%,96.1%) 145

Primary Patency: freedom from CEC-adjudicated CD-TLR and freedom from core lab-adjudicated DUS-derived binary restenosis (PSVR ≥ 2.5)

95.0% 97.5%

Fre

edom

fro

m C

D-T

LR

(%

)

0

10

20

30

40

50

60

70

80

90

100

Time in Days

0 30 60 90 120 150 180 210 240 270 300 330 360 390

97.5%

DaysStandard Lesion

Freedom CD-TLR (95% CI) At Risk

30 100%100.0%, 100.0%)

165

180 98.2% (96.1%, 100.0%) 160

360 97.5% (95.2%, 99.9%) 92

390 94.4% (87.9%, 100.0%) 27

Primary Patency, Freedom from CD-TLR

Primary Patency

100% Dissected Vessels

Freedom from CD-TLR


(ITT population; standard lesion)

Main Line Health


96.8%

Fre

edom

fro

m C

D-T

LR

(%

)

0

10

20

30

40

50

60

70

80

90

100

Time in Days

0 30 60 90 120 150 180 210 240 270 300 330 360 390

89.3%

Pri

mary

Pate

ncy (

%)

0

10

20

30

40

50

60

70

80

90

100

Time in Days

0 30 60 90 120 150 180 210 240 270 300 330 360 390

91.8%96.8%

Primary Patency, Freedom from CD-TLR

Primary Patency


Freedom from CD-TLR


89.3%

DaysLong Lesion

Primary Patency (95% CI) At Risk

30 96.4% (89.6%,100.0%) 27

180 96.4% (89.6%,100.0%) 27

360 89.3% (77.8%,100.0%) 25

390 75.0% (59.0%,91.0%) 21

DaysLong Lesion

ff CD-TLR (95% CI) At Risk

30 96.8% (90.6%, 100.0%) 29

180 96.8% (90.6%, 100.0%) 29

360 96.8% (90.6%, 100.0%) 20

390 81.7% (60.5%, 100.0%) 7

(ITT population; long lesion)

Main Line Health


TOBA II BTK

Main Line Health


Prospective, single-arm pivotal IDE study

PopulationPatients with CLI and angiographic evidence of a dissection

post-PTA requiring repair in the mid/distal popliteal, tibial

and/or peroneal arteries

Enrollment 233 patients at 41 US, international sites

Primary

Endpoints・Safety: MALE + POD at 30d

・Efficacy: freedom from MALE at 6m + POD at 30d

Secondary

Endpoints・Tacked segment patency at 6 months (DUS flow/no flow)

・Target limb salvage at 6 months

Key

Observational

Endpoints

・Dissection resolution

・Freedom from CD-TLR

・Target lesion patency

・Changes from baseline:

-Rutherford

-Wound status

-Quality of life

MALE + POD: composite of all-cause death, above-ankle target limb amputation, or major re-intervention to

the target lesion(s), defined as new bypass graft, jump/interposition graft revision, or

thrombectomy/thrombolysis

BTK

POBA

Dissection?

Screen

Failure

NO

YES

Requires

repair?

YES

NO

Tack Endovascular System

introduced (enrolled / ITT)30d 6m 12m 24m 36m

TOBA II BTK Design and Endpoints

Main Line Health


TOBA II BTK Baseline Patient Characteristics

Mean ± SD (N)

or % (n/N)

Age (y) 74.4 ± 10.0 (233)

Gender

Male 67.4% (157/233)

BMI 28.8 ± 5.6 (231)

BMI ≥ 30 37.2% (86/231)

TBI target limb 0.43 ± 0.23 (117)

Rutherford Class

3 16.3% (38/233)

4 33.5% (78/233)

5 50.2% (117/233)

% (n/N)

Smoking History

Current/Former 62.2% (145/233)

Never 37.8% (88/233)

Diabetes mellitus 65.7% (153/233)

Arterial hypertension 93.6% (218/233)

Coronary artery disease 56.1% (129/230)

MI 22.0% (51/232)

PCI / CABG 43.9% (101/230)

Chronic renal insufficiency 24.1% (56/232)

History of previous

peripheral intervention50.2% (117/233)

(ITT population)

Main Line Health


TOBA II BTK Baseline Lesion Characteristics

Mean ± SD (N)

or % (n/N)

Lesion type (site reported)

De novo 93.8% (257/274)

RVD (mm)*

Proximal 3.5 ± 1.0 (248)

Distal 2.6 ± 0.7 (248)

Pre-PTA DS % 85 ± 17 (248)

CTO 47.6% (118/248)

Calcification (PARC)

None / mild 64.1% (159/248)

Moderate 18.1% (45/248)

Severe 17.7% (44/248)

Mean ± SD (N)

or % (n/N)

Lesion length (mm)

Target lesion length 80 ± 49 (248)

PTA treated length 154 ± 110 (238)

Most distal target lesion location

P2 4.0% (10/248)

P3 1.2% (3/248)

Tibioperoneal trunk 10.1% (25/248)

Anterior tibial 41.1% (102/248)

Posterior tibial 22.6% (56/248)

Peroneal 21.0% (52/248)

*Protocol specified a balloon-to-vessel ratio of 1:1 (by visual estimate)

(core lab adjudicated; ITT population)

Main Line Health


Tack Delivery42

52

177

139

90

101

121

20

17

102

38

15

% (n/N)

Device success* 96.5% (303/314)

Bail out stent rate 1.3% (3/233)

Within Tacked segment 0.4% (1/233)

*successful deployment of the Tack(s) at the intended target site(s) and

withdrawal of the delivery catheter from the introducer sheath (per device)

Tack deployment site

Anterior tibial 44%

Peroneal 18%

Posterior tibial 17%

Tibioperoneal trunk 11%

Popliteal 10% # of Tacks placed

in vessel segment#

Anterior

Tibial

Posterior

Tibial

Prox: 49.1%

Mid: 24.0%

Dist: 14.9%


Dissection Resolution

1National Heart Lung and Blood Institute, 1985

Pre-Tack

Post

A: 21%

B: 39%

C: 12%

D: 27%

E: 1%

Pre-Tack

NHLBI Dissection Grade1

Mean ± SD (N)

Dissections per patient 1.4 ± 0.6 (229)

Dissection length (mm) 24 ± 18 (341)

Tacks per patient 4.0 ± 2.8 (230)

100% of dissections were fully

resolved with Tack placement


Main Line Health


Primary Safety% (n/N)

[97.5% CI]*

Performance

GoalEndpoint p-value*

MALE + POD at 30d ITT1.3% (3/228)

12.0% MET <0.0001[ - , 3.8%]

• Above-ankle amputation 0.9% (2/229)

• All-cause death 0.4% (1/229)

• Major reintervention to the target lesion 0.0% (0/229)

†Continuity corrected z-test for one proportion. One sided lower 97.5% confidence bound.

Primary Efficacy% (n/N)

[97.5% CI]†

Performance

GoalEndpoint p-value†

Freedom from

MALE at 6m + POD at 30d

ITT95.6% (196/205)

74.0% MET <0.0001[91.8%, - ]

PP 95.8% (183/191)

[91.8%, - ]

*Exact binomial test for one proportion. Confidence interval is the one-sided exact 97.5% upper bound.

TOBA II BTK Primary Endpoints Met

MALE + POD: composite of all-cause death, above-ankle target limb amputation, or major

re-intervention to the target lesion(s), defined as new bypass graft, jump/interposition

graft revision, or thrombectomy/thrombolysis

Main Line Health


87.7%

87.3%

Pate

ncy

(%)

0

10

20

30

40

50

60

70

80

90

100

Time in Days

0 30 60 90 120 150 180 210

Day

s

Tacked Segment

Patency (95% CI)At Risk

30 99.7% (99.0%,100%) 300

180 87.7% (84.0%,91.4%) 264

210 82.1% (77.7%,86.4%)

Day

s

Target Lesion

Patency (95% CI)At Risk

30 99.5%(98.5%,100.0%

)196

180 87.3% (82.7%,92.0%) 172

210 81.2% (75.8%,86.7%)

*DUS flow or no flow at 6m; Tacked segment: Tack implant + 5mm of artery proximal and distal; Tacks w/in 1cm are considered same segment†DUS flow or no flow at 6m in PTA treated length

Tacked Segment Patency: 87.7%

Target Lesion Patency: 87.3%Tacked Segment Patency*

Target Lesion Patency†


6-Month Patency

Main Line Health


92.0%

Fre

edom

fro

m C

D-T

LR

(%

)

0

10

20

30

40

50

60

70

80

90

100

Time in Days

0 30 60 90 120 150 180 210

Day

sff CD-TLR (95% CI) At Risk

30 100% (100%,100%) 225

180 92.0% (88.3%,95.8%) 152

210 88.7% (84.1%,93.3%) 105

6m K-M Freedom from CD-TLR: 92.0%6m K-M Target Limb Salvage: 98.6%

98.6%

Fre

edom

fro

m A

mputa

tion (

%)

0

10

20

30

40

50

60

70

80

90

100

Time in Days

0 30 60 90 120 150 180 210

Day

sff Maj Amp (95% CI) At Risk

30 99.1% (97.9%,100%) 225

180 98.6% (97.1%,100%) 163

210 98.0% (96.0%,100%) 112


Limb Salvage and Freedom from CD-TLR

Main Line Health


95.7%

Fre

edom

fro

m A

mputa

tion-f

ree S

urv

ival (%

)

0

10

20

30

40

50

60

70

80

90

100

Time in Days

0 30 60 90 120 150 180 210

Day

sAFS* (95% CI) At Risk

30 98.7% (97.2%,100%) 225

180 95.7% (93.0%,98.5%) 173

210 92.5% (88.6%,96.3%) 122

6m K-M Amputation-Free Survival: 95.7%6m K-M Survival: 97.0%

97.0%

Surv

ival (%

)

0

10

20

30

40

50

60

70

80

90

100

Time in Days

0 30 60 90 120 150 180 210

Day

sSurvival (95% CI) At Risk

30 99.6% (98.7%,100%) 225

180 97.0% (94.7%, 99.4%) 173

210 94.3% (90.9%,97.8%) 122

*Zero amputations in RC3 patients

(ITT population)

All-Cause Mortality, Amputation-Free Survival

Main Line Health


0,1 2 3 4 5 6

Baseline Rutherford Class

(n=199)

% o

f P

atie

nts

60%

50%

40%

30%

20%

10%

0%

74.0% of

CLI patients

improved to

RC ≤3

45.3% of

all patients

improved

≥3 classes

16.3%

33.5%

50.2%

*Wilcoxon Signed Rank test

16.3%

33.5%

50.2%

7.0%

16.1%

55.8%

3.0%

17.1%

1.0%

6-Month Rutherford Class

(n=199)

p<0.0001*

(site-reported; ITT population)

Significant Improvement in Rutherford

Main Line Health


•Summary

– Dissection is a frequent occurrence and associated with

worse long term patency outcomes, and stents have both

biological and clinical drawbacks

– In 3 separate studies of exclusive (TOBA II, TOBA II BTK,

and TOBA III):

•The Tack resulted in successful resolution of dissection in almost all

cases

•The use of the Tack was correlated with good angiographic and

clinical outcomes, and significantly improved patency---dramatically in

the case of TOBA II BTK and TOBA III---as compared with historical

controls in all 3 trials

•The Tack preserves future treatment options

•The inventory advantages over stents (2 SKUs for all ATK and BTK

intervention) are obvious

Main Line Health


Thank you

William A. Gray MD FACC FSCAI

System Chief of Cardiovascular Services,

Main Line Health

President, Lankenau Heart Institute

Wynnewood, Pennsylvania

USA

Dissecting the TOBA data

above and below the knee:

what it means in practice

Date post:	24-Mar-2021
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Dissecting the TOBA data above and below the knee: what it ......1Schneider, JACC: Cardiovasc Interv...

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