1. Lawrence A. Garcia, MD DISCLOSURES Consulting Fees
ev3, Inc., Spectranetics, Pathway Medical Technologies, Inc., Boston Scientific Corporation
Ownership Interest (Stocks, Stock Options or Other Ownership Interest)
Scion Cardio-Vascular, Arsenal Medical, TissueGen, Inc.

2. Plaque excision: a critical review
Lawrence A. Garcia, MD
Chief, Section Interventional Cardiology
Co-Director, Vascular Medicine Program
Director, Interventional Cardiology Fellowship Program
St. Elizabeth’s Medical Center
Tuft’s University School of Medicine
Boston, MA

3. Infra-inguinal Intervention

4. Forces Exerted on the SFA
Unfavorable anatomy
Two bifurcations/articulations
Unique vessel forces
Diffuse disease
High incidence of occlusive disease
Extremly complex lesion morphologies
Competitive flow via PFA
Extension / Contraction 1.
Torsion 2.
Flexion 4.
Compression 3.

5. Strategies to Improve Outcomes
Subintimal angioplasty
Cutting balloon
Nitinol self-expanding stent (SES)
(PTFE)-covered stent grafts
Biodegradable stents
Cutting balloon angioplasty
Cryoplasty
Atherectomy -thrombectomy
Drug-eluting stents
Brachytherapy?

6. Strategies to Improve Outcomes
Angioplasty/subintimal angioplasty
Cutting balloon
Nitinol self-expanding stent (SES)
(PTFE)-covered stent grafts
Biodegradable stents
Cutting balloon angioplasty
Cryoplasty
Plaque modification
Directional atherectomy
Rotational systems
Drug-eluting stents
Brachytherapy?
DES alternatives

7. Nitinol Self-expanding stenting 2009 at 12 months
Fem-Pac
Idev
Thunder
Durability
Resilient
Vibrant
Absolute

8. Plaque Modification Therapies
Laser
Directional atherectomy
Rotational devices

9. Plaque Excision Debulks without balloon for apposition
Carbide cutter/speed 8000 rpm
Cutter height varies with cutter design

10. Plaque Excision Registry Data
Numerous single center data registries or reports
To date no randomized trial of current technology

11. Patients 60 Lesions 66(70) TASC Length 8.9cm+/-0.8 PE alone 80%
B /20%
C 32/44%
D 19/27%
Length cm+/-0.8
>10cm 32%
PE alone %
Adj Rx %
Stent %
SVS Grade
SVS /33%
SVS 4 22/31%
SVS /36%
Technical success 87.1%
Repeat PE %
Complications
Emboli %
Perforation %
Keeling et al JVS ; 25-31

12. Results Primary patency (duplex) Secondary patency
All 61.7%
Secondary patency
All 76%
Restenosis/occlusion %(12)
Amputation 6.7%(4)
Limb salvage 86.2%

13. Critical Limb Ischemia
30 Days
3 Months
6 Months
Death
8.7%
14.5% MI
1.4%
Amputation
11.8%
17.1%
21.1%
AKA
5.3%
6.6%
BKA
3.9%
Transmetatarsal/digital
7.9%
10.5%
Avoidance of any planned amputation or performance of lesser extent amputation
92.1%
84.2%
81.6%
Kandzari J Endo Ther 2005

14. Columbia Data 960 lesions/400 patients Patients
550 PTA/410 EA
Patients
Claudicants 35%
CLI 65%
Tissue loss 50-60%
Treated multi-level disease
Diabetes-100%
Sambol et al AVS 2008

15. SFA # CTO Pop Tibial Multi level LESION DISTRIBUTION Length (mm)
% stenosis
# CTO
SFA
PTA
(n=203)
91.3  88.3
85.1  12.6
48 (23.6)
Atherectomy
(n=120)
91.3  88.8
86.6  14.0
40 (33.3)
Pop
(n=83)
51.3  45.6
83.4  13.4
17 (20.5)
(n=73)
36.4  30.9
84.4  13.1
16 (21.9)
Tibial
(n=155)
61.7  62.9
84.1  13.5
45 (29.0)
(n=179)
45.2  46.0
91.7  12.0
97 (54.2)
Multi
level
(n=111)
216.3  116.6
88.2  12.4
44 (39.6)
(n=37)
180.2  114.9
98.3  4.4
32 (86.5)

16. Indications to treat P value PTA n (%) Atherectomy n (%) Indications
Claudication
89 (32.1)
51 (26.3)
0.13
CLI
188 (67.9)
143 (73.7)
0.18
Rest Pain
42 (15.2)
20 (10.3)
0.13
Tissue loss
146 (52.7)
123 (63.4)
0.02

17. Secondary Patency (months)
Patency in CLI
Primary Patency
(months)
Secondary Patency (months)
Limb Salvage 12 18 DM
CLI
Ath (n=254)
59.6 ± 3.6
51.5 ± 4.0
74.4 ± 3.2
68.4 ± 3.6
79.8 ± 3.0
76.9 ± 3.3
PTA (n=310)
47.2 ± 3.4
38.8 ± 3.6
62.9 ± 3.1
52.0 ± 3.9
71.6 ± 3.0
62.1 ± 4.0
p value
.001
.008
.002

18. Secondary Patency (months)
Patency by Lesion Location
Primary Patency
(months)
Secondary Patency (months)
Limb Salvage 12 18
SFA
Ath (n=100)
59.1 ± 6.0
40.5 ± 6.6
83.2 ± 4.4
70.6 ± 6.0
92.2 ± 3.1
PTA (n=178)
62.7 ± 4.4
57.3 ± 4.7
82.3 ± 3.3
80.0 ± 3.6
88.0 ± 2.9
86.8 ± 3.1
p value
.959
.364
.537
.720
.262
.207
Pop
Ath
(n=63)
65.0 ± 6.8
56.9 ± 7.4
83.2 ± 5.2
74.9 ± 6.5
86.5 ± 4.8
83.2 ± 5.7
PTA
(n=72)
61.8 ± 7.0
58.4 ± 7.4
74.4 ± 5.9
63.5 ± 7.7
83.0 ± 5.4
75.2 ± 7.2
.596
.788
.196
.179
.532
.365

19. Secondary Patency (months)
Patency by Lesion Location
Primary Patency
(months)
Secondary Patency (months)
Limb Salvage 12 18
Tib
Atherect (n=155)
63.4 ± 4.4
54.9 ± 5.2
76.8 ± 3.9
68.9 ± 4.8
81.7 ± 3.7
78.3 ± 4.2
PTA (n=128)
50.1 ± 5.0
40.8 ± 5.6
61.3 ± 4.7
52.0 ± 5.9
70.8 ± 4.5
59.9 ± 6.3
p value
.013
.011
.001
.010
.004
Multi-level
Atherect
(n=32)
47.3 ± 9.9
36.5 ±10.2
74.7 ± 8.3
67.9 ±10.0
84.0 ± 7.4
PTA
(n=93)
45.2 ± 6.0
32.1 ± 6.3
72.0 ± 5.4
62.4 ± 6.9
82.9 ± 4.4
75.0 ± 6.6
.631
.537
.773
.699
.752
.519

20. Kaplan-Meier analysis of limb salvage for Tibial lesions6 12 18 24
PTA 71 35 22 15
Atherectomy
111 57 17
# At risk:

21. Several Pro’s and Con’s for Calcium
Pathway system rotational atherectomy
Early data with small study population
Aspirates and can use distal protection
Larger sheath/slower procedure
Largest lumen 3.2mm (perhaps larger)
FoxHollow “rockhawk”
Requires distal protection (Spider filter)
US only surgical indication
Still maintains directional control and distal protection
Requires larger sheath (8 Fr)/slower procedure
Can effectively treat large vessels to 6-7 mm
CSI orbital atherectomy system
Early data with small study population (6 mos data)
No aspiration/distal protection
Smaller sheath/faster procedure
Larger lumen capable of 5-5.5mm

22. Atherectomy: Where and When
Workhorse
Niche
Short lesions (<7 cm)
Durable results
Questionable cost over POBA/DEB
Long lesions (>15 cm)
No current data to support
Current stent data surprisingly poor
Potential adjunct with DEB
DEFINITIVE LE
ISRS
Untested /off-label
Potentially useful/DEB
DEFINITIVE LE AR
Thrombotic
Potentially very useful (laser/pathway)
Occlusions
No data
Pitfalls
Calcific atheroma
Change arterial compliance
Both short and long lesions
All devices may be uniquely situated to treat this challenging lesion subset
Non-stentable locations
Common femoral
Popliteal
Tibial vessels
ISRS (off-label)
Potentially useful
Adjunctive Rx

23. Nitinol Self-expanding stenting 2009 at 12 months
Here is the unmet need!
Resilient
Durability
Fem-Pac
Idev
Thunder
Absolute
Vibrant

24. What to conclude??
PTA/stenting is the “gold” standard for endovascular therapy of the SFA with several previso’s
Current studies are at an early stage of study
Covered stents one year data surprisingly poor
Where to use is now unclear
Drug elution
Zilver PTX trial has fastest elution preliminary data good
Alternative therapies may be compelling in this difficult region
This needs the rigors of RCT’s
DEFINITIVE LE ( )
Combined therapy may afford the best primary patency without remote complications in the SFA and tibial circulations
Laser/drug or stent/covered stent
Atherectomy/drug or stent
Drug angioplasty/scoring
Focal DES
Stenting should be reserved for bailout at this time-this remains a key question
Future investigations will be key