Transcript Symposia Speaker Binder - Clinical Trial Results

The TAXUS™ Paclitaxel-Eluting Stent
Program
The safety and effectiveness of the TAXUS™ Express2™ Stent
has not been established in patients with coronary artery
reference vessel diameters less than 2.5 mm or in lesions longer
than 28 mm or in patients with diabetes
Table of Contents
• Drug-eluting stent overview
• Drug-eluting stent benefits
In your opinion … Part 1
– Consistently low revascularization rates
In your opinion … Part 2
– Excellent safety with desirable healing
In your opinion … Part 3
– Ability to treat various patients and lesions
Drug-Eluting Stent Overview
From Bare Metal to Drug-Eluting Stents
Key Bare Metal Stent Characteristics
• Binary restenosis
Restenosis
Reduction
• Large lumens
Healing
• Deliverability
Deliverability and
Conformability
Key Drug-Eluting Stent Characteristics
• Dramatic TLR/TVR reduction
• Consistent performance throughout the target
lesion
• Predictable results across all patient subsets
• Desirable late loss
• Complete endothelialization
• Wide margin of safety
• Various lesion access
• Excellent conformability
• Minimize incomplete apposition
Drug-Eluting Stent Benefits
• Reduced angiographic restenosis
• Reduced clinical restenosis
• Comparable safety compared to bare-metal stents
• Improved patient outcomes
• Positive trends in various lesion subsets
• Positive trends in various patient populations
In your opinion ...
• Which patients should receive drug-eluting stents?
• What factors are critical to consider when trying to minimize repeat
revascularizations?
• What are the most important components of a drug-eluting stent and
why?
TAXUS IV Clinical Trial
TLR Overall at 9 Months
Control* (n=652)
20
TAXUS™ Stent** (n=662)
RR=0.39 [0.26-0.59]
P<0.0001
RR=0.27 [0.16-0.43]
P<0.0001
15
12.0
11.3
10
P=0.48
5
3.0
1.1
4.7
1.7
0
TLR
*= Express® Control Stent. **= TAXUS™ Express® Stent
TVR - non TLR
TVR
TAXUS IV Clinical Trial
TLR Overall at 12 Months
20
TAXUS™ Stent** (n=662)
Control* (n=652)
25
RR=0.29 [0.19-0.43]
P<0.0001
RR=0.41 [0.29-0.57]
P<0.0001
P=0.74
16.7
15
14.7
10
6.8
5
4.2
3.1
2.7
0
TLR
*= Express® Control Stent. **= TAXUS™ Express® Stent
TVR - non TLR
TVR
TAXUS IV Clinical Trial
TLR/TVR Overall at 9 Months
TAXUS™ Stent** (n=662)
Control* (n=652)
15
P<0.0001
P<0.0001
P=0.0008
P<0.0001
P=0.0001
P=0.005
12.0
11.3
10
9.0
8.7
4.7
5
3.0
2.4
3.6
3.1
3.4
1.1
0.6
0
TLR
TLR PCI
*= Express® Control Stent. **= TAXUS™ Express® Stent
TLRCABG
TVR
TVR PCI
TVRCABG
TAXUS IV Clinical Trial
TLR/TVR Overall at 12 Months
Control* (n=652)
25
P<0.0001
P<0.0001
P=0.0003
TAXUS™ Stent** (n=662)
P<0.0001
P<0.0001
P=0.0120
20
16.7
15
14.7
13.5
11.8
10
6.8
5
4.2
5.3
3.5
3.7
4.0
1.7
0.8
0
TLR
TLR PCI
*= Express® Control Stent. **= TAXUS™ Express® Stent
TLRCABG
TVR
TVR PCI
TVRCABG
Impact of Diabetes Mellitus
TAXUS IV Clinical Trial TLR at 9 Months
25
Control* (n=652)
TAXUS™ Stent** (n=662)
P=0.004
TLR (%)
20
P=0.32
17.4
P<0.0001
15
10
13.0
9.8
5
0
5.9
4.8
2.4
N=489
N=507
No diabetes
*= Express® Control Stent. **= TAXUS™ Express® Stent
N=109
N=104
Diabetes oral meds
N=54
N=51
Diabetes insulin requiring
Impact of Diabetes Mellitus
TAXUS IV Clinical Trial TLR at 12 Months
TAXUS™ Stent** (n=662)
Control* (n=652)
30
P<0.0001
P=0.12
P=0.0063
TLR (%)
21.1
20
16.7
13.1
10
7.7
5.9
3.4
0
N=489
N=507
No Diabetes
*= Express® Control Stent. **= TAXUS™ Express® Stent
N=109
N=104
Diabetes- oral meds
N=54
N=51
Diabetes - insulin
requiring
Impact of Vessel Diameter (QCA)
TAXUS IV Clinical Trial TLR at 9 Months
25
TLR (%)
20
15
Control* (n=652)
TAXUS™ Stent** (n=662)
P<0.0001
15.4
P=0.0004
11.2
P=0.057
10
6.7
5
0
3.4
N=214
N=206
≤2.5 mm
*= Express® Control Stent. **= TAXUS™ Express® Stent
3.1
N=241
N=257
>2.5 - 3.0 mm
RVD (mm)
2.5
N=195
N=197
>3.0 mm
Impact of RVD (visual assessment)
TAXUS IV Clinical Trial TLR at 9 Months
Control* (n=652)
TAXUS™ Stent** (n=662)
25
TLR (%)
20
P=0.0001
17.5
P<0.0001
15
9.4
10
5
0
3.3
N=154
N=150
<3.0 mm
*= Express® Control Stent. **= TAXUS™ Express® Stent
2.7
N=498
N=511
≥3.0 mm
Impact of Stent Diameter
TAXUS IV Clinical Trial TLR at 9 Months
TAXUS™ Stent** (n=662)
Control* (n=652)
25
P=0.0001
20
18.0
TLR (%)
P=0.0002
15
11.5
P=0.002
10
7.3
5
3.7
3.1
1.0
0
N=133
N=131
2.5 mm
*= Express® Control Stent. **= TAXUS™ Express® Stent
N=304
N=323
3.0 mm
Stent diameter (mm)
N=206
N=197
3.5 mm
Impact of Lesion Length (QCA)
TAXUS IV Clinical Trial TLR at 9 Months
TAXUS™ Stent** (n=662)
Control* (n=652)
25
P=0.0009
20
18.6
TLR (%)
P=0.0001
15
10
P=0.01
5
0
10.5
9.9
3.3
N=226
N=214
<10 mm
N=325
N=351
10 - 20 mm
Lesion length (mm)
*= Express® Control Stent. **= TAXUS™ Express® Stent
3.3
2.8
N=97
N=91
>20 mm
Impact of Total Stent Length
TAXUS IV Clinical Trial TLR at 9 Months
Control* (n=652)
25
TAXUS™ Stent** (n=662)
P<0.0001
20
17.9
TLR (%)
P=0.0004
15
10
P=0.002
9.2
5
0
11.8
3.5
N=382
N=372
16 mm
2.6
N=127
0.8
N=126
24 mm
Stent length (mm)
*= Express® Control Stent. **= TAXUS™ Express® Stent
N=134
N=153
≥32 mm
Lesion Length Response (tertile analysis)
TAXUS IV Clinical Trial TLR at 9 Months
29.8
TLR (%)
30
TAXUS™
Stent
Control
12.4 11.4
20
11.4 12.3
2.7
6.7
10
6.8
7.7
0
0
5
5
<1 10-1 >1
7.7
2.6
3.4
2.5
2.4
0
5
5
<1 10-1 >1
Lesion Length (mm)
2.7
4.2
> 3.0
4
3.4
2.5-3.0
< 2.5
TAXUS IV Clinical Trial
Restenosis at 9 Months
Control* (n=267)
TAXUS™ Stent** (n=292)
40
RR=0.30 [0.19, 0.46]
P<0.0001
RR=0.23 [0.13, 0.38]
P<0.0001
Restenosis (%)
30
26.6
24.4
20
10
5.5
7.9
0
In-stent
*= Express® Control Stent. **= TAXUS™ Express® Stent
Analysis segment
TAXUS IV Clinical Trial Restenosis
Impact of Vessel Diameter (QCA)
In-Segment Restenosis (%)
TAXUS™ Stent** (n=291)
Control* (n=267)
50
P<0.0001
40
38.5
P=0.0001
27.8
30
P=0.10
20
15.2
10.2
10
0
N=78
N=98
≤2.5 mm
N=97
N=105
>2.5 - 3.0 mm
RVD (mm)
*= Express® Control Stent. **= TAXUS™ Express® Stent
6.8
6.7
N=92
N=88
>3.0 mm
TAXUS IV Clinical Trial Restenosis
Impact of Stent Diameter
Control* (n=267)
50
TAXUS™ Stent** (n=291)
In-Segment Restenosis (%)
P=0.0002
40
40.8
P<0.0001
31.2
30
P=0.13
20
12.9
0
9.1
8.8
10
N=49
N=57
2.5 mm
*= Express® Control Stent. **= TAXUS™ Express® Stent
N=125
N=143
3.0 mm
Stent diameter (mm)
5.5
N=93
N=91
3.5 mm
Reduced In-Stent Binary Restenosis
No Edge Effect in TAXUS IV Clinical Trial
35%
% of patients
30%
P<0.001
P<0.001
26.6
Control*
24.4
25%
TAXUS™
Stent**
20%
15%
10%
7.9
5%
P=0.81
3.4 2.7
P=0.27
5.5
1.9 0.7
0%
Analysis
segment
*= Express® Control Stent. **= TAXUS™ Express® Stent
Proximal
edge
Stented
segment
Distal edge
Intent-to-treat, angiographic subset (n=732)
9-Month % Diameter Stenosis
Improved In-Stent and at Both Edges in TAXUS IV Clinical
Trial
% Diameter Stenosis
60%
Control*
P<0.0001
P<0.0001
50%
40%
30%
39.8
TAXUS™
Stent**
37.2
26.3
20%
P=0.0167
16.1
13.2
P=0.0001
17.4
11.8
10%
7.6
0%
Analysis
segment
*= Express® Control Stent. **= TAXUS™ Express® Stent
Proximal
edge
Stented
segment
Distal edge
Intent-to-treat, angiographic subset (n=732)
TAXUS II Clinical Trial
Uniform Suppression of Neointima at 6 Months
IVUS analysis of TAXUS II clinical trial patients showed uniform
neointimal suppression throughout the entire stent
3.0
Control*
TAXUS™ Stent**
P=ns
2.0
Neointimal
hyperplasia area
[mm2]
P=ns
1.0
0.0
proximal
*= Express® Control Stent. **= TAXUS™ Express® Stent
distal
proximal
distal
TAXUS IV Clinical Trial
Uniform Suppression of Neointima at 9 Months
IVUS analysis of TAXUS IV clinical trial patients showed uniform
neointimal suppression throughout the entire stent
4
Control*
3
Neointimal
area (mm2)
P=ns
TAXUS™ Stent**
2
P=ns
1
0
proximal
*= Express® Control Stent. **= TAXUS™ Express® Stent
distal
proximal
distal
Restenosis Reduction
Formula for Fighting Restenosis
Several drug-eluting stent characteristics may contribute to
restenosis reduction.

The multifunctional effects of a drug may contribute to
reducing restenosis

Polymeric coatings may provide uniform drug delivery
across the stent

High degrees of lipophilicity may increase vascular
absorption in the tissue surrounding the stent

Minimal overhang may potentially reduce trauma at the
edges
Multifunctional Effects
Uniform Drug Delivery
Rapid Drug
Absorption
Balloon Overhang
Restenosis Reduction
Multifunctional Activity
The TAXUSTM Stent elutes paclitaxel, a multifunctional
microtubular inhibitor.
• Paclitaxel is believed to have multifunctional effects which reduce:
– Inflammation
– Proliferation and migration of smooth muscle cells
– Extra-cellular matrix secretion
Microtubule Network:
Paclitaxel promotes the
formation of stable
microtubules, thereby inhibiting
multiple cellular functions
Note: Image Courtesy of Dr. Vladimir Rodionov
Restenosis Reduction
Paclitaxel and Taxol are Different
Paclitaxel
Composition
Delivery
*
Taxol
100% Paclitaxel
Paclitaxel +
Cremophor EL +
Dehydrated alcohol
Elution from stent
Intravenous
Dose
1. 5 µg/kg*
Indication
Restenosis
3,280 µg/kg ovarian CA
- 4,250 µg/kg in breast CA
Cancer
Based on Implantation of a Single 3.5mm X 16mm TAXUS™ Express2™ Stent with Total Loaded Dose of 108 g. Dose in g/kg Calculated Using Average Body
Surface Area of 1.7m2 and 70kg Body Weight. Note: Taxol is a registered trademark of Bristol Meyers Squibb.
Paclitaxel
Wide Safety Window
Paclitaxel’s broad safety window inhibits smooth muscle cell proliferation &
migration while allowing the vessel to heal.
Healing
Paclitaxel
Endothelial cells are less sensitive than smooth muscle cells
to the effects of paclitaxel.
Restenosis
• Paclitaxel is a multi-functional drug
which appears to:
– Inhibit proliferation
Prevents
– Inhibit migration
– Inhibit inflammation
Endothelialization
– Inhibit secretion
• The TAXUS™ paclitaxel-eluting stent
appears not to delay endothelialization
Promotes
Complete endothelialization of a paclitaxel-eluting stent in a porcine
coronary artery.
Restenosis Reduction
Uniform Drug Distribution
The TransluteTM Polymer provides protection and controlled
release of paclitaxel.
Translute Polymer is intended to protect the drug
during crimping, packaging, distribution, preparation,
sterilization, delivery to the lesion, and stent
expansion
Translute Polymer is intended to control the
release of the drug during the critical period of
the restenotic cascade
Restenosis Reduction
Lipophilicity
Paclitaxel is highly lipophilic which may increase vascular
absorption in tissue surrounding the stent.
Outside the cell
Paclitaxel (green)
Lipid
Bi-Layer
Inside the cell
In controlled clinical studies, use of
the TAXUS™ Stent resulted in
consistently low revascularization
rates across a broad range of patient
and lesion types
In your opinion ...
• How do you define “safety” as it relates to drug-eluting stents?
• Do you believe that late loss is an indication of efficacy, safety or both?
• How important is late loss?
• What affects vascular healing after stent implantation?
TAXUS IV Clinical Trial
9-Month MACE and TVF
TAXUS™ Stent** (n=662)
Control* (n=652)
20
P=0.80
P=0.88
P<0.0001
P<0.0001
P=0.0002
15.0
15
14.4
12.0
11.3
10
8.5
5
3.7 3.5
P=0.0001
7.6
4.7
3.0
1.1 1.4
0
Cardiac
death
MI
*= Express® Control Stent. **= TAXUS™ Express® Stent
TLR
TVR
MACE
TVF
TAXUS IV Clinical Trial
12-Month MACE and TVF
Control* (n=652)
TAXUS™ Stent** (n=662)
25
P=1.00
P=0.33
P<0.0001
P<0.0001
P<0.0001
19.8
20
P<0.0001
19.2
16.7
14.7
15
10.6
10
9.7
6.8
4.6
5
3.5
4.2
1.2 1.4
0
Cardiac
Death
MI
*= Express® Control Stent. **= TAXUS™ Express® Stent
TLR
TVR
MACE
TVF
TAXUS IV Clinical Trial
Stent Thrombosis at 12 Months
In-hospital
31 days - 6 months
TAXUS™
Stent**
0.3
Discharge - 30 days
12 months
0.6%
(n=4)
0.3
P=0.75
(n=662)
Control*
0.3
(n=652)
0
0.2
0.3
0.4
0.8%
(n=5)
0.2
0.6
0.8
1
Stent thrombosis, %
Note: There were no additional stent thrombosis between 6 and 9 months in
either the TAXUS Stent or Control.
*= Express® Control Stent. **= TAXUS™ Express® Stent
Healing
Late Loss
Late loss provides evidence of healing
• A drug-eluting stent should not
completely eliminate the body’s
healing response
• Neointima indicates healing after
drug-eluting stent implantation
• Consistently low but positive late
loss values across studies may
indicate healing
Image Courtesy of Dr. Robert Schwartz
Healing
Late Loss in Bare Metal Stents
• Late loss in bare metal stents is typically 1.0mm
• Late loss is thought to be largely comprised of neointima
• Late loss is nearly always a positive number, indicating the lumen
decreases in size
0.50mm
MLD post-procedure
MLD follow-up
+
0.50mm
Illustrations by Boston Scientific. Images not to scale.
Late Loss
1.0mm
Healing
Late Loss in Bare Metal Stents
• The Express2™ Stent strut thickness is 0.0052”, which converts to 0.13mm
• This is well within the amount of late loss of a bare metal stent, suggesting
complete stent strut coverage
Lumen
Neointima
0.50mm
MLD follow up
0.0052”= 0.13mm
Illustrations by Boston Scientific. Images not to scale.
0.13mm
Healing
TAXUS IV Clinical Trial Late Loss to Strut Thickness
Relationship
• The Express2™ Stent strut thickness is 0.0052”, which converts to 0.13mm
• Based on the TAXUS IV trial late loss values, neointima would be sufficient to
completely cover the stent struts.
Lumen
MLD follow up
Neointima
0.0052”= 0.13mm
Illustrations by Boston Scientific. Images not to scale.
0.130mm
0.195mm
Healing
Paclitaxel Selective Impact
Paclitaxel allows healing to occur within the vessel, as
evidenced by low but positive late loss.
Endothelial cells are less sensitive than
smooth muscle cells to the effects of
Paclitaxel.
Low but positive late loss provides
evidence that vessel healing has
occurred.
4.9
5.0
Late loss =~0.30mm
0.30 mm
0.15 mm
0.15 mm
Paclitaxel IC50 (nM)
•
4.0
3.0
3.0
2.0
1.0
0.0
SMC
Note: Image courtesy of Dr. Robert Schwartz; In vitro cell culture study performed by Dr. Luszher
EC
TAXUS IV Clinical Trial
Late loss as a Predictor of TLR
Logistic regression combining all patients
100
50
0
0.00
Late loss <0.6
mm
weak
predictor of
TLR
0.50
1.00
1.50
Late Loss (mm)
Late loss >0.6mm
increasing
probability of TLR
2.00
2.50
TAXUS IV Clinical Trial
Late loss as a Predictor of Restenosis
Logistic regression combining all patients
Probability for
Restenosis (%)
100
Late loss >0.6
increasing
probability of
restenosis
50
0
0.00
0.50
1.00
Late Loss (mm)
1.50
2.00
2.50
In animal and controlled human
clinical studies, the TAXUS™ stent
consistently demonstrated excellent
safety with desirable healing
In your opinion ...
• What role does the stent platform play in terms of drug-eluting stent
safety and efficacy?
• Why is conformability important with drug-eluting stents?
• What tradeoffs are you willing to make as it relates to stent designs?
Deliverability and Conformability
Excellent deliverability and conformability will continue to be
important features with drug-eluting technology…
Bare Metal Stents
Drug-Eluting Stents
(Desired Features)
 Deliverability:
- access lesions
 Conformability
(Desired Features)


Deliverability:
- access more lesions with longer
stents when necessary
Conformability:
- provide strut apposition to the
vessel for uniform coverage and
drug absorption
Stent apposition contributes to efficacy and
safety
•The Express2 Stent platform was designed for excellent deployment
with excellent stent to vessel conformability.
•A conformable stent provides uniform strut
apposition to the vessel wall.
•A broad working range and high RBP
combine to provide excellent sizing flexibility.
3.0 mm System
Nominal
Express2™ Stent
9 atm
Quarter Size
14 atm
Rated Burst
Pressure
18 atm
1.1:1
15 atm
Working Range*
9 atm
Importance of Stent Apposition
Achieving proper stent strut apposition may be a key contributor to both efficacy and
safety of drug eluting stents, specifically SATs.
Efficacy
(Restenosis
Reduction)
Safety
(Healing)
Contact between the vessel wall and the stent strut may be
essential for drug absorption.
Uniform stent apposition allows for uniform drug absorption
and uniform restenosis reduction.
Incomplete stent apposition / under-deployment may increase
the risk of thrombus formation & SAT’s.
Healing
Incomplete Apposition Nomenclature
Safety
Sub Acute Thrombosis (SAT)
Under - deployment and incomplete apposition increase the risk of
SAT
Incomplete Apposition
– A recent study noted that “78% of SAT
occurs in arteries with stent under deployment1,” highlighting the importance
of stent deployment and apposition
1Cheneau,
et al. Circulation 2003;108;43-47
TAXUS IV Clinical Trial
Incomplete Apposition at 9 Months
Control*
TAXUS™ Stent**
P-value
6.4%
11.6%
0.24
(7/109)
(13/112)
3.0%
4.0%
(3/100)
(4/99)
5.4%
6.4%
(5/93)
(6/94)
Persistent
1.1%
3.2%
(1/93)
(3/94)
Late acquired
2.2%
1.1%
(2/93)
(1/94)
Post-procedure
9 month
0.72
Paired data
Resolved
*= Express® Control Stent. **= TAXUS™ Express® Stent
1.00
0.62
0.62
TAXUS IV Clinical Trial
Correlation of Incomplete Apposition and Safety
Resolved IA
(n=11)
Persistent IA
(n=4)
Acquired IA
(n=3)
0%
0%
0%
Cardiac death
0%
0%
0%
Q-wave MI
0%
0%
0%
Non-Q-wave MI
0%
0%
0%
TVR overall
0%
0%
0%
TLR
0%
0%
0%
0%
0%
0%
MACE overall
Stent thrombosis
The TAXUS™ Stent showed no safety events at 9
months in patients with resolved, persistent or late
acquired IA
Excellent deliverability and
conformability of the Express® stent
platform makes it easy to treat various
patient and lesion types
Drug-Eluting Stent Benefits
Summary of Ideal Characteristics

Sustained TLR and
restenosis
reduction, within the
stent and at the
edges

Consistent results
across patients and
lesions
TLR and
Restenosis
Reduction
Stent
Drug
DES

Access to various
lesions

Strut apposition
Deliverability and
Conformability
Polymer
Healing

Low rates of major
adverse events

Consistently low
and desirable late
loss
TAXUSTM Express2TM Paclitaxel-Eluting Coronary
Stent System
INDICATIONS
The TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System is indicated for improving luminal
diameter for the treatment of de novo lesions <28 mm in length in native coronary arteries >2.5 to <3.75
mm in diameter.
CONTRAINDICATIONS
Use of the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System is contraindicated in patients with:
• Known hypersensitivity to paclitaxel or structurally related compounds.
• Known hypersensitivity to the polymer or its individual components.
Coronary Artery Stenting is contraindicated for use in:
• Patients in whom antiplatelet and/or anticoagulant therapy is contraindicated.
• Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon
or proper placement of the stent or delivery device.
TAXUSTM Express2TM Paclitaxel-Eluting Coronary
Stent System
WARNINGS
• To maintain sterility, the inner package should not be opened or damaged prior to use.
• The use of this product carries the risks associated with coronary artery stenting, including
subacute thrombosis, vascular complications, and/or bleeding events.
• Patients with known hypersensitivity to 316L stainless steel may suffer an allergic reaction
to this implant.
Potential adverse events (in alphabetical order) which may be associated with the use of a coronary
stent in native coronary arteries include but are not limited to:
Aneurysm, Arrhythmias, Bleeding complications, Death, Distal Emboli, Emergent CABG, Myocardial
Infarction, Myocardial Ischemia, Occlusion, Stent Delivery Failures, Target Lesion Revascularization,
Thrombosis, Vascular complications, Vessel Dissection.
Potential adverse events not captured above that may be unique to the paclitaxel drug coating:
Alopecia, Allergic reaction to the drug or the polymer, Anemia, Blood product transfusion, Gastrointestinal
symptoms, Hematologic dyscrasia, Hepatic enzyme changes, Histologic changes in vessel wall, including
inflammation, cellular damage or necrosis, Myalgia/Arthralgia, Peripheral neuropathy.
TAXUSTM Express2TM Paclitaxel-Eluting Coronary
Stent System
The safety and effectiveness of the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System have
not been established in the following patient populations:
• Women who are pregnant or lactating.
• Men intending to father children.
• Pediatric patients.
• Patients with unresolved vessel thrombus at the lesion site.
• Patients with coronary artery reference vessel diameters <2.5 mm or >3.75 mm.
• Patients with lesions located in the saphenous vein grafts, in the unprotected left main
coronary artery, ostial lesions, or lesions located at a bifurcation.
• Patients with diffuse disease or poor flow distal to the identified lesions.
• Patients with tortuous vessels (>60 degrees) in the region of the obstruction or proximal to
the lesion.
• Patients with a recent acute myocardial infarction where there is evidence of thrombus or
poor flow.
• Patients with multiple overlapping stents.
• Patients with longer than 12 month follow-up.
TAXUSTM Express2TM Paclitaxel-Eluting Coronary
Stent System
Prior to use, please see the complete “Directions for Use” at www.taxus-stent.com for more information on
Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.
CAUTION
Federal law restricts this product to sale by or on the order of a physician.
TRADEMARKS
TAXUS and Express2 are trademarks and Express is a registered trademark of Boston Scientific
Corporation or its affiliates.