1. Wires, balloons, drug-eluting devices, ect.
NEW TECHNOLOGIES:
Wires, balloons, drug-eluting devices, ect.
Fabrizio Fanelli
Vascular & Interventional Radiology Unit
Department of Radiological Sciences
“Sapienza” – University of Rome

2. Below The Knee Arteries
Small vessels
Long lesions
Occlusions > stenoses
More vessels
Calcifications
L. Graziani – Eur J Vasc Endovasc Surg 2007

3. CLI : Mean Length Treated lesions
5% ATG
63±61 mm
55% FEM-POP
116±113 mm
185±121 mm
96% BTK
R.Ferraresi - oral presentation CICE 2012

4. PTA F.U. PATENCY TLR DEBATE 1 12 mos 28.0% 24.0% Leipzig Registry2
31.0 %
50.0%
DEBELLUM 3
47.1%
47.0%
BMS
F.U.
PATENCY
TLR
ACHILLES4
12 mos
57.1%
16.0%
DESTINY5
54.3 %
33.6%
YUKON6
55.6%
13.0%
1) F. Liistro - oral presentation TCT 2012
4) K. Katsanos - oral presentation CIRSE 2011
2) A. Schmidt – JACC 2011
3) F. Fanelli - oral presentation CIRSE 2012
5) M. Bosiers – J Vasc Surg 2012
6) A. Rastan – European Heart Journal 2011

5. …. New Technologies ….

6. Micro-puncture set
Guidewires
Micro-guidewires
Introducers
Support catheters
Low profile balloon catheters
Atherectomy devices
Drug eluting balloons (DEB)
Bare metal stents
Drug eluting stents (DES)

7. Micro-puncture set
Guidewires
Micro-guidewires
Introducers
Support catheters
Low profile balloon catheters
Atherectomy devices
Drug eluting balloons (DEB)
Bare metal stents
Drug eluting stents (DES)

8. Drug Eluting Balloons In.Pact Amphirion – Medtronic /Invatec
Advance LP 18 PTX – Cook
Freeway II/Dior – Eurocor
Elutax – Aachen Medical

9. real world BTK complex lesions
DEB BTK Leipzig Registry
Study type
Prospective single center, single arm, investigator initiated study
Objective
Assess IN.PACT Amphirion™ efficacy for the treatment of long BTK lesions occlusions
Population
Symptomatic patients with CLI or severe claudication
Eligibility
At least one lesion BTK ≥ 80 mm
Prim. Endpoint
3 month restenosis rate
Nr of patients
104 / 109 limbs
IN.PACT™ Amphirion in
real world BTK complex lesions
A. Schmidt – JACC 2011

10. DEB BTK Leipzig Registry
vs historical PTA cohort (A.Schmidt - Cath. and Cardiovasc. Interventions 2010)
DEB BTK Leipzig Registry
DEB
(angio subgroup)
PTA
(historical group)
# patients / limbs
74 / 79
58 / 62
Male gender
51 (68.9%)
38 (65.5%)
mean age (y)
73.5 ± 9.3
70.5 ± 8.08
diabetics
54 (73%)
52 (89.7%)
Renal insuff.
34 (45.9%)
30 (51.7%)
RC 3
16 (20.3%)
0 (0%)
RC 4
14 (17.7%)
16 (25.8%)
RC 5
49 (62%)
46 (74.2%)
RC 6
avg lesion length
173 ± 87 mm
183 ± 75 mm
Tot occlusions
61.9%
64.9%
DEB
(angio subgroup)
PTA
(historical group)
3m Ang. FU
Restenosis (>50%)
27.4%
69%
Full-segment Resten.
10%
56%
Restenosis Length
64 mm
155 mm
12m Clinical FU
15m Clinical FU
Deaths
16.3%
10.5%
Limb Salvage
95.6%
100%
Clinical Improvement (1)
91.2%
76.5%
Compl. wound healing
74.2%
78.6%
TLR
17.3%
50%
(1) clinical improvement = reduction in size and/or depth of ulceration or improvement of rest-pain

11. DEB BTK Leipzig Registry
vs historical PTA cohort (A.Schmidt - Cath. and Cardiovasc. Interventions 2010)
DEB BTK Leipzig Registry
DEB
(angio subgroup)
PTA
(historical group)
# patients / limbs
74 / 79
58 / 62
Male gender
51 (68.9%)
38 (65.5%)
mean age (y)
73.5 ± 9.3
70.5 ± 8.08
diabetics
54 (73%)
52 (89.7%)
Renal insuff.
34 (45.9%)
30 (51.7%)
RC 3
16 (20.3%)
0 (0%)
RC 4
14 (17.7%)
16 (25.8%)
RC 5
49 (62%)
46 (74.2%)
RC 6
avg lesion length
173 ± 87 mm
183 ± 75 mm
Tot occlusions
61.9%
64.9%
DEB
(angio subgroup)
PTA
(historical group)
3m Ang. FU
Restenosis (>50%)
27.4%
69%
Full-segment Resten.
10%
56%
Restenosis Length
64 mm
155 mm
12m Clinical FU
15m Clinical FU
Deaths
16.3%
10.5%
Limb Salvage
95.6%
100%
Clinical Improvement (1)
91.2%
76.5%
Compl. wound healing
74.2%
78.6%
TLR
17.3%
50%
(1) clinical improvement = reduction in size and/or depth of ulceration or improvement of rest-pain

12. DEBATE BTK Investigator initiated, single center Study
Randomized (1:1) DEB vs. standard PTA
Primary Endpoint: 12-month Angiographic
Binary (>50%) Restenosis Rate
Secondary Endpoints: TLR and Reocclusion
CLI + Diabetes
150 (Tibial) Lesions
Random (1:1)
DEB
(75 lesions)
Std PTA
(75 lesions)
Key Inclusions
RC and Diabetes
Stenosis / occlusions >40 mm in at least 1 tibial vessel with distal run-off
Key Exclusions
Allergy to Paclitaxel
Contraindication for combined antiplatelet treatment
Life expectancy <1 year
Aspirin + Clopidogrel (1 month)
12-month Angiographic
and Clinical follow-up
24-month Duplex
and Clinical follow-up
F. Liistro - oral presentation TCT 2012

13. DEB
PTA p
Patients 65 67 /
Age
74±9.4
75±9.6
0.7
Smoke
13 (20%)
7 (10.4%)
0.1
Hypertension
46 (70.8%)
52 (77.6%)
0.4
Hypercholesterolemia
23 (35.4%)
16 (23.9%)
Diabetes
65 (100%)
67 (100%) 1
Obesity
23 (35.3%)
26 (38.8%)
0.5
Dialysis
7 (10.8%)
Coronary artery disease
12 (18.5%)
10 (14.9%)
0.6
Limbs 71 72
0.9
Texas wound ulcer class. I C
1 (1.4%)
3 (4.2%)
II C
5 (6.9%)
I D
7 (9.9%)
9 (12.5%)
II D
34 (47.9%)
32 (44.4%)
III D
26 (36.6%)
23 (31.9%)

15. DEBELLUM
Drug Eluting Balloon Evaluation for Lower Limb mUltilevel treatMent
Investigator initiated, single center Study
Randomized (1:1) DEB vs. standard PTA
Primary Endpoint: 6-month LLL
Secondary Endpoints: TLR, Primary Patency, Fontaine change, MAE at 6 and 12 months
Key Inclusions
Fontaine Stage IIb, III, IV
SFA, popliteal and BTK lesions either isolated or concomitant
De-novo lesions
Stenosis or occlusions cm
F. Fanelli - oral presentation CIRSE 2012

16. 12-mos TLR
analysis per lesion

17. DEBELLUM - 12 mos F.U. DEB PTA Angio 6 mos Angio 12 mos
Restenosis rate
15.3%
(2 lesions)
41.1%
(7 lesions)
23.07%
(3 lesions)
52.9%
(9 lesions)
TLR
7.69%
(1 lesion)
23.5%
(4 lesions)
47.0%
(8 lesions)
Occlusion rate
9.1%
Death
Major amputation
10%
(1 patient)
9.09%
9.09% (1 patient)
Minor amputation
18.8%
(2 patients)
18.8% (2 patients)

18. Prospective Randomized Multicenter Trial
50 pts.
RC: 4-6
>50% calcified stenosis
popliteal, tibial and peroneal aa.

19. OA + PTA
PTA p
Stenting
6.9 %
14.3 %
0.44
Dissection
6 pts
1 pts ns
Perforation / 1
Distal Embolization
Max Inflation Press
<0.001
2 - 4
59.3 %
11.8 %
5 - 6
14.8 %
8.8 %
7 - 8
7.4 %
26.5 %
9 - 10
32.4 %
>12
11.1 %
Mean
5.9 ± 4.2
9.4 ± 3.8

20. OA + PTA
PTA p
Stenting
6.9 %
14.3 %
0.44
Dissection
6 pts
1 pts ns
Perforation / 1
Distal Embolization
Max Inflation Press
<0.001
2 - 4
59.3 %
11.8 %
5 - 6
14.8 %
8.8 %
7 - 8
7.4 %
26.5 %
9 - 10
32.4 %
>12
11.1 %
Mean
5.9 ± 4.2
9.4 ± 3.8

21. Secondary Endpoints

22. DEB F.U. PATENCY TLR DEBATE 1 12 mos 71.0% 13.0% Leipzig Registry2
72.6 %
17.3%
DEBELLUM 3
76.9%
15.3%
PTA
F.U.
PATENCY
TLR
DEBATE 1
12 mos
28.0%
24.0%
Leipzig Registry2
3 mos
31.0 %
50.0%
DEBELLUM 3
47.1%
47.0%
1) F. Liistro - oral presentation TCT 2012
3) F. Fanelli - oral presentation CIRSE 2012
2) A. Schmidt – JACC 2011

23. What about Stent … ?

24. DEB F.U. PATENCY TLR DEBATE 1 12 mos 71.0% 13.0% Leipzig Registry2
72.6 %
17.3%
DEBELLUM 3
76.9%
15.3%
BMS
F.U.
PATENCY
TLR
ACHILLES4
12 mos
57.1%
16.0%
DESTINY5
54.3 %
33.6%
YUKON6
55.6%
13.0%
1) F. Liistro - oral presentation TCT 2012
4) K. Katsanos - oral presentation CIRSE 2011
2) A. Schmidt – JACC 2011
3) F. Fanelli - oral presentation CIRSE 2012
5) M. Bosiers – J Vasc Surg 2012
6) A. Rastan – European Heart Journal 2011

25. DEB F.U. PATENCY TLR DEBATE 1 12 mos 71.0% 13.0% Leipzig Registry2
72.6 %
17.3%
DEBELLUM 3
76.9%
15.3%
DES
F.U.
PATENCY
TLR
ACHILLES4
12 mos
75.0%
10.0%
DESTINY5
85.2 %
8.7%
YUKON6
80.6%
13.8%
1) F. Liistro - oral presentation TCT 2012
4) K. Katsanos - oral presentation CIRSE 2011
2) A. Schmidt – JACC 2011
3) F. Fanelli - oral presentation CIRSE 2012
5) M. Bosiers – J Vasc Surg 2012
6) A. Rastan – European Heart Journal 2011

26. Everolimus-eluting stent vs. bare metal stent
JVIR 2009; 20(9):
Everolimus-eluting stent vs. bare metal stent
103 pts CLI
Angioplasty + Bailout stenting

27. HR: 4.8, CI p<0.001
HR: 2.5, CI p=0.006
D. Siablis – JVIR 2009; 20(9):

29. Xcience-Prime
Xcience-Prime

30. Conclusions DEB patency rate similar to DES but with the advantage of
“nothing left behind”.
Efficacy of DEB in very calcified arteries still under evaluation
Combined treatment with atherectomy must be validated.

31. The Future … Bioabsorbable Stent Adaption to flexion, extension
•Overcome Stent fractures
•Positive Remodelling
•Might act as a transporter (Gen-Therapy)
•Surgeon’s friend

32. ABSORB Study
Poly-L-lactide + Everolimus
30 pts.
5-y F.U.
- No cardiac death
- No thrombosis
- MACE: 3.4 %
- LLL 0.27 mm