Transcript Current State of SFA Interventions

Zilver PTX Trial
Bhagat K. Reddy, MD, FACC
Director of Vascular Medicine & Endovascular Interventions
Piedmont Heart Institute
Atlanta, GA
®
Zilver
PTX™ Clinical Trials
• Global Sponsor: Cook Incorporated
• Physician Steering Committees:
– Michael Dake, M.D. (Global Principal Investigator)
Randomized Study
–
–
–
–
–
–
Gary Ansel, M.D. (co-PI)
Michael Jaff, D.O.
Lindsay Machan, M.D.
Takao Ohki, M.D., Ph.D.
Richard Saxon, M.D.
H. Bob Smouse, M.D.
Registry Study
–
–
–
–
Gunnar Tepe, M.D.
Fabrizio Fanelli, M.D.
Dierk Scheinert, M.D.
Jöerg Tessarak, M.D.
Registry Study Site
Herz-Zentrum (Bad Krozingen, Germany)
Heart Center Leipzig, Angiology
(Leipzig, Germany)
Gemeinschaftspraxis (Leipzig, Germany)
St. Blasius Hospital, Dendermonde
(Dendermonde, Belgium)
Imelda Hospital, Bonheiden
(Bonheiden, Belgium)
Endosurgery and Lithotripsy Center
(Moscow, Russian Federation)
Universitat Klinik Tubingen
(Tubingen, Germany)
St. Franziskus Hospital Münster
(Münster, Germany)
University Hospital Ostrava-Poruba
(Ostrava-Poruba, Czech Republic)
Center for Cardiology & Vascular Intervention
Praxis (Hamburg, Germany)
Careggi Hospital (Florence, Italy)
University of Roma “La Sapienza”
(Rome, Italy)
Amphia Hospital
(Breda, The Netherlands)
Centre Hospitalier Universitaire de Sherbrooke
(Sherbrooke, Canada)
Asan Medical Center (Seoul, Korea)
Enrolled
Registry Study Site
Enrolled
69
Seoul National University Hospital
(Seoul, Korea)
Hospital Universitario La Fe
(Valencia, Spain)
Samodzielny Publicczny (Lublin, Poland)
50
St. Francois (Quebec, Canada)
10
47
Samsung Medical Center (Seoul, Korea)
10
45
Hospital Europeen Georges Pompidou
(Paris, France)
10
42
Centrum Medyczne (Katowice, Poland)
10
153
110
34
27
24
20
15
15
13
13
Malmo Univeritetssjukhus
(Malmo, Sweden)
University Hospital Antwerp
(Edegem, Belgium)
Zurich University Hospital
(Zurich, Switzerland)
Catharina Hospital
(Eindhoven, The Netherlands)
Policlinico G. B. Rossi (Verona, Italy)
Hospital Clinic of Barcelona
(Barcelona, Spain)
Hospital Jean Minjoz
(Besancon Cedex, France)
Hospital Clinico Universitario
(Valencia, Spain)
Total Enrollment = 792 patients at 30 investigative sites
12
12
11
9
7
5
5
4
4
3
3
Zilver® PTX™
• Paclitaxel only
– No polymer or binder
– 3 µg/mm2 dose density
• Zilver®, self-expanding nitinol stent
– Flexible, durable platform
Uncoated
PTX™ Coated
PTX™
Indication
®
Zilver
• Treatment of symptomatic
disease of the
above-the-knee
femoropopliteal artery
– Proximal: 1 cm below
bifurcation
– Distal: medial femoral
epicondyle
• Reference vessel diameter
of 4 - 9 mm
Clinical Trial Status
• Randomized Study (480 patients)
– United States, Japan and Germany
– Enrollment complete
• Registry Study (792 patients)
– Europe, Russia, Canada and Korea
– Patients treated with Zilver® PTX™ stents
– Enrollment complete
Registry Study
• Patients assigned to Zilver® PTX™ only
• Includes complex SFA lesions (nearly “all comers”)
–
–
–
–
–
Rutherford category 2 or greater
No lesion length limitation
Up to 4 DES per patient - longest stent 8 cm
Multiple lesions per leg
Stenosis (≥ 50% DS), occlusion, re-stenosis, in-stent
restenosis
• Follow-up through 2 years
• Currently available data
– 12-month follow-up for 592 patients (673 lesions)
– 24-month follow-up for 177 patients (221 lesions)
Demographics
12 Months
24 Months
592
177
67 ± 9
66 ± 9
73%
76%
Height (cm)
170 ± 9
170 ± 8
Weight (kg)
79 ± 15
77 ± 15
Diabetes
35%
36%
High Cholesterol
59%
63%
Hypertension
82%
83%
Past/Current Smoker
80%
83%
Overall Patients (n)
Age (years)
% Male
Baseline Angiographic Data
12 Months
24 Months
Overall Lesions (n)
673
221
Lesion Length (cm)
9.4 ± 7.8
9.3 ± 8.0
Proximal RVD (mm)
5.4 ± 0.8
5.4 ± 0.8
Distal RVD (mm)
5.3 ± 0.8
5.3 ± 0.8
MLD in Lesion (mm)
% Diameter Stenosis
0.84 ± 0.88 0.76 ± 0.73
84 ± 17
86 ± 14
Lesion Characteristics
Lesion
Characteristics
* TASC 2000
12 Months
24 Months
Patients
592
177
Lesions
673
221
TASC class *: A
28%
22%
B
30%
36%
C
25%
27%
D
13%
13%
> 7 cm
46%
46%
Total Occlusion
36%
33%
Restenosis (all)
25%
37%
In-stent Restenosis
16%
24%
Results
• Stent Integrity
• Safety
• Effectiveness
Stent Integrity
Time Period †
Potential Fractures *
6 Months
1.4% (21/1486)
12 Months
1.8% (21/1198)
* Pending core lab confirmation (rates may decrease)
† Zilver® PTX™ Registry did not include stent X-rays at 24-month follow-up
Integrity data for the Zilver® stent platform are also available for 96
stents implanted in the femoropopliteal arteries (above, behind and
below the knee) of 34 patients, with a mean follow-up of 2.4 years,
showing a 1% fracture rate (1/96, stents).
Ferriera, et al., Eur J Vasc Endovasc Surg 34, 707-708, 2007
Safety: Event-free Survival
Event-free survival defined as freedom from:
– Death, amputation (toe, foot, or leg)
– Revascularization
• Clinically driven re-intervention for > 50% DS within treated
segment (including ± 5 mm)
• Surgical bypass of target vessel
– Worsening of Rutherford Classification
(by two classes or to a Class 5 or 6)
12 Months
24 Months
Patients
596
181
Event-free Survival
87%
78%
Effectiveness:
Freedom from TLR
TLR defined as:
– Clinically driven re-intervention for > 50% DS within treated
segment (including ± 5 mm)
12 Months
24 Months
Patients
593
177
Lesions
675
221
Freedom from TLR
89%
82%
Freedom from TLR Probability
Freedom from TLR
Days after Procedure
Clinical Outcomes
Clinical
Measure
Preprocedure
12 Months
24 Months
ABI
0.65 ± 0.26
(n = 686)
0.90 ± 0.24 *
(n = 582)
0.88 ± 0.21
*
(n = 161)
Most
Common
Rutherford
Score
3
(n = 433/763)
0*
(n = 290/563)
0*
(n = 77/171)
Walking
Distance
Score
31 ± 26
(n = 659)
71 ± 32 *
(n = 565)
68 ± 33 *
(n = 158)
Walking
Speed
Score
35 ± 28
(n = 643)
66 ± 31 *
(n = 553)
67 ± 31 *
(n = 156)
* p < 0.01 compared to pre-procedure
Freedom from TLR
Subgroup
12 Months
24 Months
Overall
89% (n = 674)
82% (n = 221)
TASC C and D*
86% (n = 225)
75% (n = 87)
De novo
92% (n = 501)
88% (n = 139)
Restenosis (all)
81% (n = 170)
72% (n = 81)
Restenosis (not ISR)
86% (n = 64)
69% (n = 29)
In-stent Restenosis (ISR)
76% (n = 106)
73% (n = 52)
< 7cm Lesions
94% (n = 355)
91% (n = 116)
> 7 to 14 cm Lesions
89% (n = 158)
72% (n = 53)
> 14 cm Lesions
77% (n = 154)
73% (n = 49)
Occlusions
86% (n = 429)
78% (n = 72)
Stenosis
90% (n = 243)
85% (n = 149)
*TASC 2000
Literature Comparisons:
TLR at 12 Months
Literature
Study
Inclusion Criteria
• No in-stent restenosis
Resilient:
• Lesion length < 15 cm
(Katzen ISET 2008) • Rutherford 1-3
FAST:
(Krankenberg 2007)
• De novo lesions
• Length 1 - 10 cm
– Multiple lesions < 10
cm total
• ≥ 70% DS
• No in-stent restenosis
Durability:
• Lesion length ≤ 14
(Scheinert TCT 2008) • Rutherford 2-4
Matching Registry Subset
TLR
12 Months
LifeStent
13%
(n = 153)
Luminexx Stent
15%
(n = 127)
Protégé
EverFlex Stent
21%
(n = 134)
TLR
12 Months
Zilver® PTX™
5%
(n = 402)
Excluded: ISR, lesions > 15 cm
and Rutherford > 3
Zilver® PTX™
5%
(n = 237)
Excluded: RS lesions and
lesions < 1 cm or > 10 cm
Zilver® PTX™
6%
(n = 133)
Excluded: ISR, lesions >14, < 7 cm
and Rutherford < 2 or > 4
Literature Comparisons:
TLR at 24 Months
Literature
Study
Inclusion Criteria
• No in-stent restenosis
Resilient:
• Lesion length < 15 cm
(Katzen VEITH 2008) • Rutherford 1-3
Matching Registry Subset
TLR
24 Months
LifeStent
20%
(n = 153)
TLR
24 Months
Zilver® PTX™
8%
(n = 115)
Excluded: ISR, lesions > 15 cm
and Rutherford > 3
Conclusions
• The Zilver® stent platform appears to have
excellent durability (i.e., fracture resistance)
in the SFA
• Results through 2 years with the Zilver®
PTX™ stent show
– No safety concerns apparent
– Favorable effectiveness (TLR rates, clinical
outcomes, comparison to literature)