1. Nitinol Stents with Polymer-free Paclitaxel Coating
for
Stenosis of Failing Infrainguinal Bypass Grafts
G. Baldino
Vascular Surgery Dept.
Galliera Hospital
Genoa
Dear collegues…. esteemed chairmen….good afternoon. First of all I want to thank Professor Setacci for the kind invitation and congratulate him for the wonderful organization of this Course.
The topic of my presentation will be about nitinol stent with polymer-free Paclitaxel coating for stenosis of failing infrainguinal bypass grafts.

2. Conflict-of-interest disclosure slide
Speaker name: Giuseppe Baldino
I have the following potential conflicts of interest to report:
Consulting
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
Here are my disclosures....

3. Infrainguinal Bypass
Infrainguinal Bypass is an effective and recognized treatment in PAD
However, a significant proportion (up to 30%) of these bypass are prone to develop stenosis
Infrainguinal bypass is an effective and recognized treatment in peripheral artery disease. However, as we can see from this review of the literature, a significant proportion, up to 30%,of these grafts are prone to develop stenosis that threaten their patency.

4. Infrainguinal Bypass Grafts Revision
At least fifteen percent of infrainguinal bypass require a revision over time. Four-point-five of these bypass require more than one revision.
Nguyen LL, Conte MS, Menard MT et al. J Vasc Surg 2004; 40(5): 916–23

5. Infrainguinal Failing Graft Treatment: Open Surgery Gold Standard
Open surgery remains the gold standard in this field; it provides over time an increased freedom from further reinterventions (68%) compared with endovascular treatment (52%).
68%
52%
As you can see in this chart taken from the Prevent III Trial…open surgery remains the gold standard in this field. It provides over time an increased freedom from further reinterventions (68%) compared with endovascular treatment (52%)
Berceli et al. PREVENT III J Vasc Surg 2007

6. Reinterventions after initial graft revision:
Open Surgery vs Endovascular
But It’s interesting to underline….again from Prevent III Trial data….that while for occluded grafts a significant benefit was observed in the surgical group compared to the endovascular one…
such benefit does not appear to be present for non-occluded graft revision.
While for occluded grafts a significant benefit was observed in the surgical group compared to the endovascular one…
…such benefit does not appear to be present for non-occluded graft revisions.
Berceli et al. PREVENT III J Vasc Surg 2007

7. Endovascular Treatment Failing Infrainguinal Grafts
RESTENOSIS RATES
PTA
(62)
66%
Cutting
balloon
(57)
38%
PTA
(134)
30%
PTA
(79)
42%
PTA
(87)
46%
The main technique reported in the literature for endovascular treatment of failing infrainguinal grafts is plain balloon angioplasty…with recurrence of restenosis varying from thirty to sixty-six percent.
Other techniques, like cutting balloon angioplasty, directional atherectomy or stenting have been proposed but none of these appears clearly superior to balloon angioplasty.
Berceli et al.
PREVENT III
J Vasc Surg
2007
Spinosa et al.
J Vasc Surg
2009
Schneider et al.
J Vasc Surg
2008
Tong et al.
J Cardiovasc Surg
2002

8. Cook Zilver PTX in Failing Infrainguinal Bypass Graft
Multimedica – Milan
(n=6)
Good results of nitinol stents with paclitaxel coating in the SFA
Evaluating outcomes of Cook ZilverPTX stent implantation in patients presenting with stenosis of infrainguinal bypass grafts (Jan Apr. 2013).
Osp. Galliera – Genoa
(n=6)
The good results of nitinol stents with paclitaxel coating in the SFA led us
…as well as Dr. Losa and Dr. Airoldi from Milan Multimedica Center…
to the idea of evaluating outcomes of Cook Zilver-PTX stent implantation in patients presenting with stenosis of infrainguinal bypass grafts.

9. Cook Zilver PTX in Failing Infrainguinal Bypass Graft
We published our preliminary results this year in The Journal of Cardiovascular Surgery.

10. Patients clinical characteristics
Age, mean±SD
73±9
Gender (M/F)
8/12 (66%)
Diabetes (%)
7/12 (58%)
Hypertension
Hypercholesterolemia
9/12 (75%)
Statin therapy
10/12 (83%)
Smokers
3/12 (25%)
Indication
Critical limb ischemia
Claudication
11/12 (92%)
1/12 (8%)
Time interval from graft placement
Early <6 month
Intermediate 6-12 month
Late >12 month
2/12 (17%)
5/12 (42%)
To date we have available data on twelve patients treated....here you can see the clinical characteristics of the population.

11. Lesions characteristics
Target lesion
location
Proximal
(n=10)
Body
(n=1)
We treated eight vein and four PTFE grafts.
Almost all lesions were segmental stenosis, only in two cases the lesion was longer than 20 millimeters.
We treated fourteen lesions in twelve patients, ten localized at the proximal anastomosis, 3 at the distal anastomosis and only one involved the body of the graft.
Distal
(n=3)

12. Procedural Characteristics Previous interventions
Patients
Previous interventions
Zilver PTX stent used
Associated procedure 1
PTA (4 times)
Cutting balloon (1 time)
DEB (1 time)
7.0x40 mm 2
PTA (2 times)
PTA of BTK vessels 3
PTA (1 time)
6.0x40 mm 4
6.0x100 mm 5
PTA (1 time on both anastomotic lesions) 6
7.0x100 mm 7 8 9
Bare nitinol stent 10 11
6.0x80 mm
Mechanical Thrombolysis and UK 12
In this slide you can see the procedural characteristics.

13. No Stent fractures on Rx
6-Months Outcomes
Duplex scan outcomes 8%
Patent, no restenosis (n=11)
Occluded (n=1)
Restenosis if PSV > 2.5 m/sec or PSV ratio >3.5
92%
100% Limb Salvage
No Stent fractures on Rx 8%
We report here the six-months outcomes of the procedures.
In eleven cases (ninety-two percent) we didn’t have restenosis.
One stent occluded.
None of the patients lost his limb.
No stent fractures were seen on x-ray.
At follow-up eleven patients (ninety-two percent) were in class 1 and 1 patient was in class 2 according to the Rutherford classification.
Clinical outcomes
Rutherford class 1 (n=11)
92%
Rutherford class 2 (n=1)

14. No Stent fractures on Rx
1-Year Outcomes
10%
Duplex scan outcomes
Patent, no restenosis (n=9)
Occluded (n=1)
Restenosis if PSV > 2.5 m/sec or PSV ratio >3.5
90%
100% Limb Salvage
No Stent fractures on Rx
10%
Here you can see the one-year outcomes of the procedures.
In nine cases (ninety percent) we didn’t have restenosis.
Only one stent occluded, as you have already seen.
None of the patients lost his limb.
No stent fractures were seen on x-ray.
At follow-up nine patients were in class 1 and one patient was in class 2 according to the Rutherford classification.
Clinical outcomes
Rutherford class 1 (n=9)
90%
Rutherford class 2 (n=1)

15. Long Term Outcomes – Genoa Group patients
Mean Follow-up 20 months
17%
Primary Patency
Patent, no restenosis (n=5)
Occluded (n=1)
83%
100% Limb Salvage
1 Fem-popl btk Heparin Bonded PTFE Bypass +
Distal Vein St. Mary’s Boot - Patent after 15 months
17%
Here we can see the long term outcomes of the Genoa group patients, in which the results reported at 1-year follow-up persist overtime.
Clinical outcomes
Rutherford class 1 (n=5)
83%
Rutherford class 2 (n=1)
No Stent Fractures on Rx

16. Clinical Case 1
Below Knee Femoropopliteal Reversed Safenous Vein Bypass (2008)
We can skip the clinical cases and go straight to the conclusions.
12-month Recurrent stenosis
Proximal Anastomosis
(2009)
Prox Anastomosis
Stenting 6.0 x 30 mm
2009
6-month In-Stent Restenosis
and Stent Fracture
2009

17. Clinical Case 1
Below Knee Femoropopliteal Reversed Safenous Vein Bypass (2008)
A PTA with first generation drug eluted ballon (five point five by thirty-nine millimeters) was carried out.
But again after 6 months we found an in-stent restenosis at the same site.
We treated the restenosis with drug eluting self-expandable nitinol stenting (Cook Zilver-PTX six point zero by forty millimeters).
At 36-month follow-up (five years from the first intervention) Angio-CT scan shows stent patency without restenosis.
PTA with DEB
5.5x39 mm
2009
6-months Recurrent Stenosis
2010
Restenting with DES
Cook Zilver-PTX 6x40 mm
2010
36-month angioCT
Follow-up Zilver PTX
2013

18. Below Knee Femoropopliteal Reversed Safenous Vein Bypass (2008)
Clinical Case 1
Below Knee Femoropopliteal Reversed Safenous Vein Bypass (2008)
STENT
Again we can see again the 36-month follow-up CT scan and the in stent normal Doppler flow
36-months angioCT
Follow-up Zilver PTX
2013
36-months DUS Follow-up
Rutherford Class 1
2013

19. Clinical Case 2
Below Knee Femoropopliteal Heparin Bonded Bypass (2012)
Here you can see another more recent case of below-the-knee femoropopliteal PTFE heparin bonded graft trombosis.
8 months later we found acute thrombosis of the bypass.
We performed first mechanical thrombectomy and then pulse-spray thrombolysis with urokinase, with the AngioJet Thrombectomy System.
8-months Bypass
Thrombosis
2013
Mechanical thrombectomy – pulse-spray thrombolysis with UK – AngioJet
2013

20. Clinical Case 2
Below Knee Femoropopliteal Heparin Bonded Bypass (2012)
After endovascular thrombectomy and thrombolysis, stenosis at the proximal and distal anastomosis have been demonstrated.
We treated both lesions with drug eluting self-expandable nitinol stents.
Prox and Dist anastomotic
Recurrent Stenosis
2013
Prox Stenting DES
Zilver PTX 6x80 mm
2013
Dist Stenting DES
Zilver PTX 6x40 mm
2013

21. Clinical Case 2
Below Knee Femoropopliteal Heparin Bonded Bypass (2012)
PROXIMAL STENT
DISTAL STENT
Here you can see the normal 6-month follow-up of these stents.
6-month Follow-up Normal Duplex Scan
Rutherford Class 1
2013

22. Conclusions
The optimal treatment for hemodynamically significant infrainguinal bypass graft stenosis is not known and there is concern about stenting in an area of high mechanical stress
The mechanism of restenosis is multifactiorial and includes:
So, in conclusion, the optimal treatment for hemodynamically significant infrainguinal bypass graft stenosis is not known and there is concern about stenting in an area of high mechanical stress.
The mechanism of restenosis is multifactiorial and includes: neointimal proliferation, acute recoil and late recoil.

23. The clinical benefits of the Zilver-PTX nitinol stents in the SFA
Conclusions
Our preliminary experience with Cook Zilver-PTX Stents for Stenosis of Failing Infrainguinal Bypass Grafts
shows promising clinical and duplex scan results with target vessel patency of 90% and no stent fractures on x-ray at 12 months
The clinical benefits of the Zilver-PTX nitinol stents in the SFA
can also be extended to complex lesions like those observed in patients with infrainguinal failing grafts
Our preliminary experience with Cook Zilver-PTX Stents for Stenosis of Failing Infrainguinal Bypass Grafts
shows promising clinical and duplex scan results with target vessel patency of ninety percent and no stent fractures on x-ray at 12 months.
Based on our results, we are confident that:
the clinical benefits of the Zilver PTX-nitinol stents in the SFA can also be extended to complex lesions like those observed in patients with infrainguinal failing grafts.

24. Thanks for your attention.