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Looking Forward: 2nd Generation DES: Looking Forward: 2nd Generation DES: Exciting potential, challenging evaluations! Exciting potential, challenging evaluations!
DES platforms: Combination product DES platforms: Combination product A priori rule ofwhich delivers aTechnologies: Device which delivers a drug Device Breakthrough drug Components: TheComponents: is the worst generation. first generation Stent platform Stent platform Polymer coating Near Polymer coating Horizon Second Generation DES: Drug Drug ENDEAVOR/RESOLUTE (MEDTRONIC)
COSTAR (CONOR/J&J) Implantation technique Implantation technique XIENCE (ABBOT)
Drug adjunct: dual antiplatelet therapy Drug adjunct: dual antiplatelet therapy BIOSENSORS/TERUMO etc. Patient substrate(s) Patient substrate(s)
Driver Endeavor
ENDEAVOR II ENDEAVOR II
TLR Probability
50 45 40 35
Endeavor
Driver
1.00 0.90 0.80 0.70 0.60 0.50 0.40 0.30 0.20 0.10 0.00
TLR Probability
Frequency
30 25 20 15 10 5 0 -0.40 -0.20 0.00 0.20 0.40 0.60 0.80 1.00 1.20 1.40 1.60 1.80 2.00 2.20 2.40 2.60 2.80
3.00
ENDEAVOR III: Angiographic and IVUS Results at 8 Months ENDEAVOR III: Angiographic and IVUS Results at 8 Months
Endeavor n=282
Angiographic f/u % (N) RVD (mm) MLD (mm) In-Stent In-Segment DS (%) BAR (%) In-Stent In-Segment In-Stent In-Segment 87.3 (323) 2.74 2.08 1.92 24.3 29.9 9.2 11.7 0.60 0.34
Cypher n=94
83.2 (113) 2.84 2.52 2.16 11.0 23.9 2.1 4.3 0.15 0.13
pvalue
0.27 0.07 <0.001 <0.001 <0.001 <0.001 0.02 0.04 <0.001 <0.001
Distal
0 Proximal
18 mm ZES
Distal
ENDEAVOR II: Stent Thrombosis & Timing ENDEAVOR II: Stent Thrombosis & Timing
No Stent Thrombosis After 14 Days
Driver
1.2% (7)
1 2 3
12 13 14
30
100
150
200
270
300
325
360 Days
Endeavor
0.5% (3)
ENDEAVOR III
Endeavor
Cypher
1.4
1.8
2.2
2.6
% of patients 0 mm In-Segment LL
9.6% Endeavor
46.8% Cypher
Hydrophilic
Hydrophilic polymer: Polyvinyl pyrrolidinone (PVP) for initial drug burst and enhanced biocompatibility Hydrophobic polymer: based upon hydrophobic butyl methacrylate (C10) for combining with zotarolimus and uniform drug dispersion Combination polymer: hydrophobic hexyl methacrylate, hydrophilic vinyl pyrrolidinone and vinyl acetate (C19) to support delayed drug elution and biocompatibility
In-stent
In-segment
2.900.38 15.16+5.38 0.83+0.34 2.430.45 1.610.59 2.380.40 0.050.20 0.01+0.18 17.747.57 0
CoStar Paclitaxel-Eluting Coronary Stent System CoStar Paclitaxel-Eluting Coronary Stent System
A Stent Specifically Designed for Controlled Drug Delivery from a Bioresorbable Polymer
Single
Adjacent
Conor Clinical Trials Dose Formulations Conor Clinical Trials Dose Formulations
Formulations
D1 D2
10g / 10D
D3
10g / 10D
D4
30g / 10D
D5
10g / 30D
D6
30g / 30D
D11
3g / 30D
Stent Platform
Stainless Steel with Paclitaxel Cobalt Chromium with Paclitaxel Cobalt Chromium with Paclitaxel Cobalt Chromium with Paclitaxel
Trial
10g / 5D
Bi-Direct*
Bi-Direct*
Mural
Bi-Direct*
Mural
Mural
Mural
Group 1
Group 2
Group 3
Arm 1
Arm 2
CoStar +
* Bi-Directional = direction of paclitaxel elution is both mural and luminal Bi+ CoStar Stent randomized against TAXUS Stent in a 3:2 ratio.
Caution: CoStar is an investigational device in the U.S. and not available for sale. sale. Limited by law to investigational use in the U.S.
Conor Medsystems and CoStar are trademarks of Conor Medsystems. Conor Medsystems, Inc. 2005
0.80 0.80
P = 0.008 P = 0.19
0.60 0.60 0.40 0.40 0.26 0.26 0.20 0.20 0.06 0.06 0.00 0.00 In-Stent In-Stent -0.20 -0.20 Prox Edge Prox Edge Distal Edge Distal Edge In-Segment In-Segment -0.04 -0.04 0.08 0.08 0.07 0.07 0.39 0.39 0.44 0.44 0.22 0.22
CoStar Arm
10 m / 30 days / Mural
Post-Procedure ECG
William Wijns M.D. 8 Month Clinical F/U* Dean Kereiakes M.D. QCA and IVUS* with
TAXUS Arm
N = 600 patients
5 Year Clinical F/U - Conducted Yearly
* Primary Endpoint - 8-Month MACE
98% 96% 94% 92% 90% 88% 86% 84% 0 30 60 90 120 150 180 HR (95% CI)=0.622 (0.423-0.915) HR (95% CI)=0.612 (0.433-0.865)
91.2% 92.0%
CoStar (n = 972)
Taxus (n = 670)
210 240
87.5%
270
P-value=0.645
P-value=0.645
99.0% 98.9%
CoStar (n = 972)
86% 84% 0 30 60 90
Taxus (n = 670)
210 240 270
P-value=0.002
98% 96% 94% 92% 90% 88% 86% 84% 0 30 HR (95% CI)=0.468 (0.286-0.766) 92.2% 96.3%
CoStar (n = 972)
60 90 120
Taxus (n = 670)
150 180 210 240 270
OR (95% CI)
XIENCE V Everolimus Eluting CSS Components XIENCE V Everolimus Eluting CSS Components
MULTI-LINK VISION Stent MULTI-LINK VISION Stent Delivery System
Everolimus
Fluoropolymer
Acute Long-Term
CYPHER
TAXUS
ENDEAVOR
XIENCE V
Strut Thickness:
Strut Thickness:
Strut Thickness:
Strut Thickness:
140 um
Polymer Thickness:
132 um
Polymer Thickness:
91 um
Polymer Thickness:
81 um
Polymer Thickness:
12.6 um
Total:
16 um
Total:
5.3 um
Total:
7.6 um
Total:
152.6 um
148 um
96.3 um
88.6 um
Everolimus Everolimus
Developed by Novartis Developed by Novartis Immunosuppressant drug Immunosuppressant drug
M
G1 1
G2 2
Cell cycl e
S
G0 0
Targets primary causes of chronic rejection in Targets primary causes of chronic rejection in heart, renal, and lung transplant patients heart, renal, and lung transplant patients
14-Day Rabbit Iliac Re-endothelialization Study: 14-Day Rabbit Iliac Re-endothelialization Study:
Representative Photomicrographs of Competitive Stents Representative Photomicrographs of Competitive Stents
XIENCE V CYPHER TAXUS ENDEAVOR
Photos on file at Abbott Vascular, Shown with permission from Dr. Renu Virmani
SPIRIT II .11
.07 1.3%
Late Loss in stent (mm) Late Loss in segment (mm) Binary Restenosis stent Binary Restenosis segment MACE Platform in
.12
.16 0%
in
<5% 7.7%
ML VISION
3.4% 2.7%*
ML VISION
<5% 7.4%
S Stent
<5% 4.7%
S Stent
Source: Eberhard Grube, MD., TCT 2004; Patrick Serruys, MD., TCT 2004; MACE defined as cardiac death, MI, all TLR and TVR-CABG *SPIRIT II MACE Definition: cardiac death, MI and ischemia driven TLR
Study Algorithm
1002 pts enrolled at 65 U.S sites
RVD 2.5 mm - 3.75 mm; Lesion length 28 mm Max. 2 lesions each in a different epicardial vessel
Pre-rand: ASA 300 mg, clopidogrel 300 mg load unless on chronic Rx
Everolimus-eluting
Paclitaxel-eluting
XIENCE V
TAXUS
Clinical f/u: 1, 6, 9 months and yearly for 1-5 years Angio f/u (N=564) @ 8 mos; IVUS f/u (N=240) @ 8 mos
% of Lesions
1.5
2.5
Days
NC=0.5 NC=0.3
Stent thrombosis
Death
MI
Death or MI
*F/U window 14 days. E = early (30d); L = late (>30d-9mo); C = cardiac; NC = non cardiac; Q = Q-wave; NQ = non Q-wave
S-Stent Proprietary biodegradable PLA Biolimus A9 Tiger Rx balloon catheter 6-cell: 2.5-3.25mm / 8-28mm 9-cell: 3.5-4.0mm / 8-28mm
Not available for sale in the United Sates.
Biolimus A9
12 10
CH3 3 O
S S
H3C 3
16
OH N H O
1
OCH3 O 3
Cell cycle
G2 G2
O
35
H3C 3
22
OH
32 28
34
OCH3 3 O
X M M
Paclitaxel
CH3 3 O
CH3 OCH3 3 3
CH3 CH3 3 3
Rapamycin Derivative C55H87NO14 (MW=986Da) More lipophilic than Sirolimus / Everolimus Immunosuppressant
PLA
Molecular weight Mass loss Lactic acid Mass transport of lactic acid
Krebs cycle
CO2+H2O
Not available for sale in the United Sates.
- abluminal surface only (contacts vessel wall) - 10 microns coating thickness - degrades in 9 months releasing CO2+ water
BioFlex I stent
Stent Platform:
- stainless steel (112 microns) - corrugated ring, quadrature-link design - radius link enhances axial fatigue resistance
40 35 30 25 20 15 10 5 0
32.818.3 31.44.6
S-Stent
BioMatrix BioMatrix
th on 6-m
th on 2-m
th on 6-m
th on 2-m
Russia
United States
Latvia U.K. Denmark Lithuania Netherlands Poland Ireland Germany Belgium Czech Rep. Austria Slovenia Ukraine Switz. France Hungary Romania Bulgaria Georgia Spain Italy Portugal GreeceTurkey
China
Japan
Redundancy
Venezuela Columbia Brazil
Panama
Added Cost
Paraguay Chile Uruguay Argentina South Africa Australia
New Zealand
October 2002
Second Generation DES: Are New DES Really Better? Encore Seoul 2007 Mitchell W. Krucoff MD, FACC
Professor of Medicine // Cardiology Professor of Medicine Cardiology Duke University Medical Center Duke University Medical Center Director, Cardiovascular Devices Unit Director, Cardiovascular Devices Unit Duke Clinical Research Institute Duke Clinical Research Institute