TAXUS IV 2-Year Clinical Results The safety and effectiveness of the TAXUS TM Express 2TM...

TAXUS IV 2-Year Clinical Results

The safety and effectiveness of the TAXUSTM Express2TM Paclitaxel-Eluting Coronary Stent System have been established

up to 12 months in the treatment of de novo lesions ≤ 28mm in length in native coronary arteries

≥ 2.5 to ≤ 3.75mm in diameter. Please refer to the directions for use for the clinical experience observed in

three clinical studies TAXUS IV, II and I.

TAXUS and Express are trademarks of Boston Scientific Corporation or its affiliates. Copyright © 2004 by Boston Scientific Corporation or its affiliates. All rights reserved.

ControlControl(n=652)(n=652)

Study populationStudy population(n=1,314)(n=1,314)

12-month follow-up12-month follow-up(n=1,272; 97%)(n=1,272; 97%)


2-year follow-up2-year follow-up(n=1,238; 94%)(n=1,238; 94%)


TAXUS IV Clinical Trial:TAXUS IV Clinical Trial: Patient FlowPatient Flow

TAXUS StentTAXUS Stent(n=662)(n=662)

TAXUS IV Clinical Trial- TAXUS™ Express® Stent / Control- Express® Stent



TAXUS IV Clinical Trial:TAXUS IV Clinical Trial: Baseline Clinical FeaturesBaseline Clinical Features

Control(n=652)

TAXUS Stent(n=662)

P-Value

Age (yrs) 62.1 ± 10.9 62.8 ± 11.2 0.21

Male gender 72.4% 71.8% 0.81

Diabetes mellitus* 25.0% 23.4% 0.52

- insulin requiring 8.3% 7.7% 0.76

Hypertension 69.0% 70.5% 0.55

Hyperlipidemia 65.6% 65.0% 0.82

Current smoker 20.1% 23.4% 0.16

Prior MI 29.9% 30.5% 0.86

Unstable angina 32.7% 35.8% 0.25


The safety and effectiveness of the TAXUS™ Express® Stent have not been established in patients with diabetes.

4.7

17.6

21.1

3.9

14.3

17.4

2.2

8.610.6

0.8

4.85.6

0

5

10

15

20

25

30

TLR TLR - PCI

TLR-CABG

TVR TVR - PCI

TVR-CABG

Even

t (%

)

Control TAXUS Stent

TAXUS IV Clinical Trial:TAXUS IV Clinical Trial: 2-Year Revascularization2-Year Revascularization

P<0.0001 P<0.0001P<0.0001 P=0.0002 P=0.01P<0.0001


ΔΔ 11.8% 11.8%ΔΔ 10.6% 10.6%

ΔΔ 8.3% 8.3%

94.4%94.4%

82.6%82.6%

85.1%85.1%

95.7%95.7%

88.6%88.6%

96.9%96.9% 1.3%1.3%

2.5%2.5%

100100

9090

7070

7575

8080

9595

8585

TL

R-f

ree

(%)

TL

R-f

ree

(%)

TL

R-f

ree

(%)

TL

R-f

ree

(%)

00 100100 200200 300300 400400 500500 600600 700700 7507505050 150150 250250 350350 450450 550550 650650

DaysDays

TAXUS TAXUS

ControlControlP<0.0001P<0.0001

24 mos.24 mos.12 mos.12 mos.9 mos.9 mos.

TAXUS IV Clinical Trial: TAXUS IV Clinical Trial: Freedom From TLR to 2 YearsFreedom From TLR to 2 Years


100100

9090

7070

7575

8080

9595

8585

TV

R-f

ree

(%)

TV

R-f

ree

(%)

TV

R-f

ree

(%)

TV

R-f

ree

(%)

00 100100 200200 300300 400400 500500 600600 700700 7507505050 150150 250250 350350 450450 550550 650650

DaysDays

TAXUSTAXUS

ControlControlP<0.0001P<0.0001

89.4%89.4%

78.9%78.9%

24 mos.24 mos.12 mos.12 mos.

83.1%83.1%

93.1%93.1%

ΔΔ 10.5% 10.5%

ΔΔ 10.0% 10.0%

ΔΔ 7.4% 7.4%

9 mos.9 mos.

87.9%87.9%

95.3%95.3%

TAXUS IV Clinical Trial: TAXUS IV Clinical Trial: Freedom From TVR to 2 YearsFreedom From TVR to 2 Years

3.7%3.7%

4.2%4.2%


100100

9090

7070

7575

8080

9595

8585

MA

CE

-fre

e (%

)M

AC

E-f

ree

(%)

MA

CE

-fre

e (%

)M

AC

E-f

ree

(%)

00 100100 200200 300300 400400 500500 600600 700700 7507505050 150150 250250 350350 450450 550550 650650

DaysDays

TAXUSTAXUS

ControlControl

P<0.0001P<0.0001

85.3%85.3%

75.1%75.1%

24 mos.24 mos.12 mos.12 mos.

79.8%79.8%

89.4%89.4%

ΔΔ 10.2% 10.2%

ΔΔ 9.6% 9.6%

ΔΔ 6.6% 6.6%

9 mos.9 mos.

84.9%84.9%

91.5%91.5%

TAXUS IV Clinical Trial: TAXUS IV Clinical Trial: Freedom From MACE to 2 YearsFreedom From MACE to 2 Years

4.1%4.1%

4.7%4.7%


0.3 0.3

0.3

0.2

0.3 0.5

0.3 0.3

0.3

0.2

0.3 0.5

TAXUS IV Clinical Trial: TAXUS IV Clinical Trial: Stent ThrombosisStent Thrombosis

P=0.77P=0.77

1.1%(n=7)

0.8%(n=5)

* All within 1-6 months

Stent Thrombosis, %

TAXUSStent

CONTROL

In-Hospital

31 days – 1 Year*

Discharge – 30 Days

1 – 2 Years


TAXUS Stent N=3TAXUS Stent N=3

Patient 1Patient 1ST day 519

59 yr old M; 3.5x32 mm stent mid-RCA; 59 yr old M; 3.5x32 mm stent mid-RCA;

fell off ladder; tibiofemoral surgery and lumbar fell off ladder; tibiofemoral surgery and lumbar laminectomy; stent thrombosis 10d laterlaminectomy; stent thrombosis 10d later

Plavix d/c before surg, ASA uncertain


55 yr old M; 55 yr old M;

2.5x16 mm stent proximal LAD 2.5x16 mm stent proximal LAD No Plavix, ASA

occasional


46 yr old M; 46 yr old M;

3.5x16 mm stent distal RCA 3.5x16 mm stent distal RCA Uncertain compliance

CircumstancesASA/Plavix®

status

TAXUS IV Clinical Trial:TAXUS IV Clinical Trial:Stent Thromboses Between 1 and 2 YearsStent Thromboses Between 1 and 2 Years

Plavix is a trademark of Sanofi-Synthelabo Corp.

2.25.4

17.4

21.124.0 24.9

1.84.6 5.6

10.6

14.0 14.7

0

5

10

15

20

25

30

35

CardiacDeath

MI TLR TVR TVF MACE

Even

t (%

)

Control TAXUS Stent

TAXUS IV Clinical Trial: TAXUS IV Clinical Trial: 2-Year Adverse Cardiac Events2-Year Adverse Cardiac Events

P=0.67 P<0.0001P=0.50 P<0.0001 P<0.0001P<0.0001


11.914.6

25.4

5.75.26.1

0

10

20

30

<2.5 ≥2.5 - <3.0 ≥3.0RVD

TL

R (

%)

Control TAXUS Stent

P<0.0001

P=0.026

N=212 N=203 N=243 N=256 N=195 N=201

P=0.0004

TAXUS IV Clinical Trial: TAXUS IV Clinical Trial: Subset DataSubset Data – – 2 Year TLR2 Year TLR

The safety and effectiveness of the TAXUS™ Express® Stent have not been established in patients with coronary artery reference vessel diameter less than 2.5mm.


22.5

16.815.8

8.95.7

4.3

0

10

20

30

<10 mm ≥10 - <20 ≥20 mmLesion Length

TL

R (

%)

Control TAXUS Stent

P<0.0001 P=0.009

N=226 N=214 N=323 N=351 N=99 N=91

P<0.0001

The safety and effectiveness of the TAXUS™ Express® Stent have not been established in patients with coronary artery in lesions longer than 28mm.


TAXUS IV Clinical Trial: Subset DataTAXUS IV Clinical Trial: Subset Data – – 2 Year TLR2 Year TLR

0

10

20

30

40

<9.9 9.9-14.6 >14.6 <9.9 9.9-14.6 >14.6

TL

R (

%)

TL

R (

%)

Lesion Length (mm)Lesion Length (mm)

ControlControl TAXUS StentTAXUS Stent

>> 3.0 3.02.5-3.02.5-3.0

< 2.5< 2.5

RVD (mm

)

RVD (mm

)

Tertile analysisTertile analysis

The safety and effectiveness of the TAXUS™ Express® Stent have not been established in patients with coronary artery reference vessel diameter less than 2.5mm or in lesions longer than 28mm.



17.7

22.0

15.9

6.28.0

4.9

0

10

20

30

No Diabetes Diabetes - All Diabetes- Insulin

TL

R (

%)

Control TAXUS Stent

P<0.0001 P=0.08

N=489 N=507 N=163 N=155 N=54 N=51

P=0.0005

The safety and effectiveness of the TAXUS™ Express® Stent have not been established in patients with diabetes.



15.7

19.6

5.06.6

0

5

10

15

20

25

LAD Non LAD

Target Vessel

TL

R (

%)

Control TAXUS Stent

P<0.0001 P<0.0001

N=269 N=264 N=381 N=396



12 mo9 mo

24 mo

Control11.3n=652

P<0.0001

14.7p<0.0001

17.4*P<0.0001*

N=652

22.0*N=163

P=0.0005* 17.7*N=54

P=0.0786*

25.4*P<0.0001*

N=212

22.5*P=0.0092*

n=99

19.6P=0.0016

16.0N=163

P=0.00213.0n=54

P=0.32

16.7P=0.12 15.4

n=214P<0.0001

20.1p<0.0001

18.6N=97

P<0.0001

21.6P=0.0014

Diabetics Insulin TreatedDiabetics

9 mo12 mo

24 mo4.2

7.15.3 5.5

8.0*N=155

6.2*N=51 6.1*

N=203

8.9*N=91

Small Vessel<2.5mm

Long Lesion>20mm

All Patients

TLR TLR TLR TLR TLR

5.95.6*N=662

The safety and effectiveness of the TAXUS™ Express® Stent have not been established in patients with coronary artery reference vessel diameter less than 2.5mm, in lesions longer than 28mm or in

patients with diabetes.

TAXUS IV Clinical Trial: TAXUS IV Clinical Trial: Subset Data % TLR to 24-monthSubset Data % TLR to 24-month

* Kaplan-Meier estimate (log-rank) 2 year9-Month and 12-Month TAXUS IV Clinical Trial TLR calculated as Fischer ITT analysis

5.2n=155

3.0n=662

5.9n=51 3.3

n=913.4

n=206

Paclitaxel-ElutingStent***


At 2-year follow-up, the incremental benefits of having

received the TAXUS stent rather than a bare metal stent

continue to increase, with no apparent evidence of late

catch-up.

TAXUS-IV Clinical Trial: 2-Year ConclusionTAXUS-IV Clinical Trial: 2-Year Conclusion

INDICATIONSThe 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 <3.75mm in diameter.

CONTRAINDICATIONSUse 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.

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.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.

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.

CAUTIONFederal law restricts this product to sale by or on the order of a physician.

TRADEMARKSTAXUS, Express2 and Express are trademarks of Boston Scientific Corporation or its affiliatesNIR is a trademark of Medinol, Ltd., Jerusalem, Israel.

TAXUS IV 2-Year Clinical Results The safety and effectiveness of the TAXUS TM Express 2TM...

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