dissecting the toba data above and below the knee: what it ......1schneider, jacc: cardiovasc interv...
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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
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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
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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
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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:
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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)
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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
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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
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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%)
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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)
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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
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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
(Core lab adjudicated)
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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
(Core lab adjudicated)
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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
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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
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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
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Main Line Health
Lankenau Heart Institute
TOBA III
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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
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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
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Main Line Health
Lankenau Heart Institute
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)
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Main Line Health
Lankenau Heart Institute
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)
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Main Line Health
Lankenau Heart Institute
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
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Main Line Health
Lankenau Heart Institute
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
100% Dissected Vessels
(ITT population; standard lesion)
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Main Line Health
Lankenau Heart Institute
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
100% Dissected Vessels
Freedom from CD-TLR
100% Dissected Vessels
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)
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Main Line Health
Lankenau Heart Institute
TOBA II BTK
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Main Line Health
Lankenau Heart Institute
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
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Main Line Health
Lankenau Heart Institute
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)
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Main Line Health
Lankenau Heart Institute
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)
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Main Line Health
Lankenau Heart Institute
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%
(core lab adjudicated; ITT population)
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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
(core lab adjudicated; ITT population)
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Main Line Health
Lankenau Heart Institute
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
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Main Line Health
Lankenau Heart Institute
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†
(core lab adjudicated; ITT population)
6-Month Patency
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Main Line Health
Lankenau Heart Institute
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
(core lab adjudicated; ITT population)
Limb Salvage and Freedom from CD-TLR
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Main Line Health
Lankenau Heart Institute
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
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Main Line Health
Lankenau Heart Institute
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
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Main Line Health
Lankenau Heart Institute
•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
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Main Line Health
Lankenau Heart Institute
Thank you
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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