1. Is Zilver PTX DES the De Facto Stent to Deploy?
Krishna Rocha-Singh, MD, FACC, FAHA Chief Scientific Officer Prairie Heart Institution of Illinois St. John’s Hospital
Springfield, IL

2. Krishna Rocha-Singh, MD
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship
Company
Grant/Research Support
Consulting Fees/Honoraria
Major Stock Shareholder/Equity
Royalty Income
Ownership/Founder
Intellectual Property Rights
Other Financial Benefit
None
Medtronic, Alucent, BSC, Zimmer-BioMet, ROX, CSI, SPNC, SymicBio
PQ Bypass, Vatrix, Aneurysm Diagnostics, Inc.
Convergence Consulting, LLC
Yes
VIVA Board Member

3. Is Zilver PTX DES the De Facto Stent to Deploy?
Lecture Goals:
Acknowledge the pitfalls of comparing clinical trial/registry using different nitinol stent platforms with varying assessment metrics/timeframes and patient cohorts.
Consider the importance of long-term clinical data to assess clinical utility.
Appreciate evolving role of DES vs. DCB ± BMS in treating complex SFA lesions in the evolving DCB era

4. How Good are Bare Metal Nitinol Stents
How Good are Bare Metal Nitinol Stents? 999 Patient Level Data Sets in RC 2-4 Claudicants with Atherosclerotic FP Occlusive Disease
Alphabetical listing of studies included:
COMPLETE SE
DURABILITY II
RESILIENT
STROLL
VIBRANT
ZILVER PTX BMS Arm
Speak to why selected; they were selected b/c

5. VIVA SFA Nitinol Stent Meta-Analysis: Limitations/Caveats
Exploratory analyses of published data
full pre-specification not possible since trials well-known and published
Variation in definitions
Adds variability but may enhance generalizability of lesion length and ABI findings
Large sample size helps to offset variability concern
Sample size constrained by available data

6. VIVA SFA Nitinol Stent Meta-Analysis: Limitations/Caveats
Selection bias since only studied approved FDA PMS bare metal stents
Approvable stents are the target of inference so unsuccessful stents not relevant
Selection of cutoffs for lesion length and ABI post-hoc
Sensitivity analyses for tertiles/quartiles help assess robustness

7. VIVA SFA Nitinol Stent Patient Level Meta-Analysis in 999 Patients: Methods
Trial specific definitions utilized:
Primary patency
2.0 PSVR cutoff for 5 studies, 2.5 for one study
Intervention = patency failure for 5 of 6 studies
Target Lesion Revascularization (TLR)
Defined as clinically-driven in 5 studies; uncertain in 1 study

8. Summary of Patient/Lesion Characteristics and Endpoints
Overall Summary of Baseline Data and Primary Patency

9. Lesion Length Association with Patency and CD-TLR at 12-mos
Good slide relating patency, lesion length and TLR…was this CD-TLR?
UPDATED DATA
Patency and TLR Results by Lesion Tertile

10. DUR II Baseline Lesion Characteristics: Impact of Time on Durability
Lesion length (mm) (Normal-to-Normal method)*
109.6 ± 45.0
Lesion length (mm) (20-to-20 method)§
89.1 ± 44.8
Pre-procedure diameter stenosis (%)
85.8 ± 16.2
Total Occlusion (%)
Mean occlusion lesion length (mm)§
48.1
102.7
Calcification (%)
None/Mild
30.0
Moderate
26.8
Severe
43.2

11. Freedom from Loss of Primary Patency (PSVR < 2.0) at 3 Years
66.1%
77.9%
60.0%
287 Subjects
Freedom from loss of primary patency at 3 years was 60.0%

12. Zilver PTX Drug-Eluting Peripheral Stent
Mechanical scaffold: Zilver Flex® Stent Platform
Drug therapy: Paclitaxel only
3 µg/mm2 dose density
No polymer or binder
PTX Coated
Uncoated

13. Zilver PTX Global Clinical Program
Zilver PTX RCT
Zilver PTX SAS
Zilver PTX Japan PMS
Key Study
Criteria
No significant untreated inflow tract stenosis
ALL patients treated with Zilver PTX enrolled (up to enrollment limit), NO exclusion criteria
At least one patent runoff vessel
Maximum 2 Zilver PTX stents per lesion
Maximum 4 Zilver PTX stents per patient
Lesion length ≤ 14 cm
No exclusions
One lesion per limb
No prior stent in SFA
ISR included
Excluded if serum creatinine > 2.0, renal failure, or dialysis
Antiplatelets
Clopidogrel or ticlopidine recommended for 60 days, aspirin indefinitely
Follow-up
5 years
2 years
Patency
DUS core laboratory analysis
DUS site analysis
Stent Integrity
X-ray core laboratory analysis
Increasingly complex patients and lesions

14. Patient Demographics and Comorbidities
RCT
SAS
Japan PMS
Patients
236
787
905
Age (years)
68 ± 10
67 ± 10
74 ± 9
Diabetes
50%
36%
59%
High cholesterol
76%
58%
61%
Hypertension
89%
80%
85%
Renal disease1
10%
11%
44%
Lesion length (cm)
6.6 ± 3.9
10.0 ± 8.2
14.7 ± 9.7
Total occlusions
33%
38%
42%
In-stent restenosis (ISR) 0%
15%
19%
Rutherford 4-6 (CLI) 9%
20%
1 Of patients with renal disease in the Japan PMS, 82% were in renal failure (eGFR < 60 and/or dialysis)
Increasingly complex patients and lesions

15. Zilver PTX Primary Patency by DUS
Months
Primary Patency (n = lesions)
RCT
(n = 318)
SAS
(n = 842)
Japan PMS
(n = 702) 12
84.4%
82.8%
86.4% 24
76.3%
N/A
72.3%
Primary patency rate is consistent across studies

16. 4-Year Primary Patency (PSVR < 2.0) Zilver PTX in Diabetic Patients
69.3%
Non-Diabetics
p = 0.50
log-rank
65.9%
Diabetics

17. SUPERB Study Overview Design: Key inclusion criteria Limitations
Prospective, single-arm, multicenter
Primary safety and effectiveness endpoints compared to VIVA OPG
Angiographic core lab: -BIDMC
Sonographic core lab: Vascor, Massachusetts General Hospital
264 subjects (ITT); 34 sites; 36 month follow-up
Key inclusion criteria
Lifestyle limiting claudication or rest pain (Rutherford-Becker 2-4)
Resting ABI ≤0.9
Single SFA/proximal popliteal lesion (>60% stenosis or total occlusion); lesion ≥3cm above knee joint
Lesion length mm
Limitations
Single-arm study
Routine duplex imaging only obtained through 12 months

18. SUPERB: Freedom From TLR Through 3 Years
12 Months
89%
24 Months
84%
Freedom From TLR 0%
20%
40%
60%
80%
100%
180
360
540
720
900
1080
36 Months
82%
Δ 3 years 7%
Time Post Index Procedure (Days)

19. SUPERB: Outcomes in Severe Calcification
Freedom From TLR (K-M)
Superb Severe Calcification Subset
Severe calcification
45%
Patency (VIVA 1 year)
89%
Severe Ca++ defined as 1cm both sides vessel

20. SUPERB: Deployment Technique Impact on Freedom from TLR
(±10%)
(11-20%)
(21-40%)
(>40%)

21. Is Zilver PTX the De Facto DES to Deploy?
5-year follow-up from the Zilver PTX RTC provides important insights regarding long-term outcomes v. BMS
Zilver PTX data in more complex anatomies (TASC C & D lesions) and high-risk patient cohorts (DM, CRF, ISR, etc.):
Promising >1 year outcomes (TLR, patency)
These benefits increase with time – results with Zilver PTX continue to diverge from standard care over 5 years with no late catch-up
Questions of cost-effectiveness, particularly in complex anatomies and patient cohorts, of Zilver PTX v. Supera v. DCB ± atherectomy devices awaits further analysis