DES in the Real World DES in the Real World Association Franco- - - PowerPoint PPT Presentation

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DES in the Real World DES in the Real World Association Franco- - - PowerPoint PPT Presentation

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DES in the Real World DES in the Real World Association Franco- -Libanaise Libanaise 2005 2005 Association Franco Dr. Joseph Elias Dr. Joseph Elias The Changing Face of Interventional Cardiology Emphasize evolution from BENESTENT to DES

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SLIDE 1

DES in the Real World DES in the Real World

Association Franco Association Franco-

  • Libanaise

Libanaise 2005 2005

  • Dr. Joseph Elias
  • Dr. Joseph Elias
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SLIDE 2

Emphasize evolution from BENESTENT to DES Landmark trials Emphasize high relevance of clinical efficacy and safety evidence in complex lesions/patients at high risk for restenosis Highlight DES as the broadest and most consistent evidence in treating TODAYS challenging PCI population

The Changing Face of Interventional Cardiology

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SLIDE 3

The early days of stenting – Stress/Benestent (1994)

The Changing Face of Interventional Cardiology

Diabetes Diabetes 16% 16% Lesion length (mm) Lesion length (mm) 7 7-

  • 10

10

  • No. of lesions treated
  • No. of lesions treated

1 1 Only de novo lesions Only de novo lesions No No

Acute MI CTO SVG Multivessel Left main Bifurcation ISR Ostial

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SLIDE 4

Complexity - Risk Relationship From Concept to Clinical Evidence

  • The more complex the lesion / higher the risk for

restenosis, the more relevant ARE the differences in performance of different stents –

  • BMS vs. DES and CYPHER vs. TAXUS !!
  • Differences include
  • Late loss
  • Restenosis
  • MACE
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SLIDE 5

DES Players DES Players

Major Players Major Players

  • Cypher

Cypher (FDA) (FDA)

( (Rapamycin Rapamycin) )

  • Taxus

Taxus (FDA) (FDA)

( (Paclitaxel Paclitaxel) ) Minor Players

Drug

Product

Company

Paclitaxel Pico Elite AMG Paclitaxel Artax Aachen Resonance Paclitaxel Taxcor EuroCor Biolimus A9 Biomatrix DES Biosensors Paclitaxel Constar Conor Rapamycin or Paclitaxel Yukon Yukon Paclitaxel Infinnium Sahajanand Paclitaxel Euca Tax Eucatech ABT -578 Zomaxx Abbott Dexamethaso ne Dexamet Abbott Tacrolimus Janus DES Sorin ABT -578 Endeavor Medtronic

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SLIDE 6

European and US Pivotal Trials: J&J European and US Pivotal Trials: J&J

MACE, Overall Stent Thrombosis

10%

(2 yrs.)

0%

(2 yrs.)

Late Loss

  • 0.01mm In-stent

(6 mos.)

RAVEL Trial n=238 TLR

2.5%

(2 yrs.)

Binary Restenosis

0.0% In-stent

(6 mos.)

SIRIUS Trial n=1058

7.1%

(9 mos.)

0.4%

(9 mos.)

0.17mm In-stent 0.24 mm In-lesion (8 mos.) 4.1%

(9mos.)

3.2% In-stent 8.9% In-segment (8 mos)

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SLIDE 7

European and US Pivotal Trials: BSC European and US Pivotal Trials: BSC

MACE, Overall Stent Thrombosis

10.9%

(12 mos.)

1.5%

(12 mos.)

Late Loss

0.31 mm In-stent 0.43 mm Analysis Segment (6 mos.)

TLR

4.7%

(12 mos.)

Binary Restenosis

2.3% In-stent 5.5% Analysis Segment (6 mos.)

TAXUS II-SR Trial n=267

3.0%

(9 mos.)

8.5%

(9 mos.)

0.6%

(9 mos.)

5.5% In-stent 7.9% Analysis Segment (9 mos) 0.39 mm In-stent 0.23 mm Analysis Segment (9 mos.)

TAXUS IV Trial n=1326

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SLIDE 8

Head To Head Trials Head To Head Trials

98.6* 98.6* 99.0 99.0 96.6* 96.6* 95.3 95.3

Device Delivery Device Delivery Success (%) Success (%)

1.6* 1.6* 2.0 2.0 1.8 1.8 0.4 0.4

Stent Stent Thrombosis Thrombosis (%) (%)

11.6 11.6 7.0 7.0 11.5 11.5 10.4 10.4

TVF (%) TVF (%)

10.8 10.8 6.2 6.2 10.6* 10.6* 9.2 9.2

MACE (%) MACE (%)

8.3 8.3 4.8 4.8 5.4* 5.4* 5.0 5.0

TLR (%) TLR (%)

11.9 11.9 6.7 6.7 11.1* 11.1* 9.6 9.6

Binary Restenosis Binary Restenosis In Segment In Segment (%) (%)

7.6 7.6 3.2 3.2 8.3* 8.3* 7.0 7.0

Binary Restenosis Binary Restenosis In In Stent Stent (%) (%)

0.32 0.32 0.19 0.19 0.16 0.16 0.04 0.04

Late Loss (mm) Late Loss (mm) In Segment In Segment

0.49 0.49 0.37 0.37 0.31 0.31 0.09 0.09

Late Loss (mm) Late Loss (mm) In In Stent Stent

SIRTAX (9m) SIRTAX (9m)2

2

CYPHER TAXUS CYPHER TAXUS REALITY (8m) REALITY (8m)1

1

CYPHER TAXUS CYPHER TAXUS

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SLIDE 9

MACE Rates in ‘Real World’ Patients

MACE at 6 months

10,0 6,0 8,0 2,0 Diabetics

4.6

MACE Rates

4,0

4149 n=

IDDMs

6.9

1378

Small Vessel <2.5mm

4.0

1333

Long Lesions >30mm

3.6

950

Multi- vessel

4.2

1525

Women

4.4

3234

AMI

4.9

1016

CTO

3.3

415

ISR

3.9

1766

BIF

4.9

1684

0,0

All Patients 3.1% MACE

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SLIDE 10

DES in the Real DES in the Real World World DES in the DES in the Real World Real World

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SLIDE 11

DES Launch DES Launch

  • Cypher

Cypher Launch Launch

– – Worldwide: April 15, 2002 Worldwide: April 15, 2002 in Milan By Dr. Antonio in Milan By Dr. Antonio Colombo Colombo – – Middle East: Middle East: May 15, 2002 in the May 15, 2002 in the American University American University Hospital Beirut. Hospital Beirut. Dr.

  • Dr. Alam

Alam

  • Taxus

Taxus Launch Launch

– – Worldwide: Worldwide: – – Middle East: Middle East: March 2003,Al March 2003,Al Khalidy Khalidy Hospital, Jordan, Hospital, Jordan, Dr.

  • Dr. Goussous

Goussous

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SLIDE 12

DES Penetration Rate % in ME DES Penetration Rate % in ME

Q205 Q205 Q105 Q105 Q404 Q404 Q304 Q304 Q204 Q204 Q104 Q104 Country Country

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DES Penetration Rate % in ME DES Penetration Rate % in ME

70 70 55 55 60 60 55 55 50 50 40 40 Saudi Arabia Saudi Arabia Q205 Q205 Q105 Q105 Q404 Q404 Q304 Q304 Q204 Q204 Q104 Q104 Country Country

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SLIDE 14

DES Penetration Rate % in ME DES Penetration Rate % in ME

60 60 60 60 55 55 50 50 45 45 40 40 United Arab Emirates United Arab Emirates 70 70 55 55 60 60 55 55 50 50 40 40 Saudi Arabia Saudi Arabia Q205 Q205 Q105 Q105 Q404 Q404 Q304 Q304 Q204 Q204 Q104 Q104 Country Country

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SLIDE 15

DES Penetration Rate % in ME DES Penetration Rate % in ME

45 45 40 40 40 40 35 35 35 35 30 30 Pakistan Pakistan 60 60 60 60 55 55 50 50 45 45 40 40 United Arab Emirates United Arab Emirates 70 70 55 55 60 60 55 55 50 50 40 40 Saudi Arabia Saudi Arabia Q205 Q205 Q105 Q105 Q404 Q404 Q304 Q304 Q204 Q204 Q104 Q104 Country Country

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SLIDE 16

DES Penetration Rate % in ME DES Penetration Rate % in ME

25 25 22 22 20 20 16 16 14 14 10 10 Jordan Jordan 45 45 40 40 40 40 35 35 35 35 30 30 Pakistan Pakistan 60 60 60 60 55 55 50 50 45 45 40 40 United Arab Emirates United Arab Emirates 70 70 55 55 60 60 55 55 50 50 40 40 Saudi Arabia Saudi Arabia Q205 Q205 Q105 Q105 Q404 Q404 Q304 Q304 Q204 Q204 Q104 Q104 Country Country

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SLIDE 17

DES Penetration Rate % in ME DES Penetration Rate % in ME

24 24 22 22 22 22 20 20 18 18 16 16 Iran Iran 25 25 22 22 20 20 16 16 14 14 10 10 Jordan Jordan 45 45 40 40 40 40 35 35 35 35 30 30 Pakistan Pakistan 60 60 60 60 55 55 50 50 45 45 40 40 United Arab Emirates United Arab Emirates 70 70 55 55 60 60 55 55 50 50 40 40 Saudi Arabia Saudi Arabia Q205 Q205 Q105 Q105 Q404 Q404 Q304 Q304 Q204 Q204 Q104 Q104 Country Country

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SLIDE 18

DES Penetration Rate % in ME DES Penetration Rate % in ME

20 20 18 18 15 15 13 13 11 11 10 10 Lebanon Lebanon 24 24 22 22 22 22 20 20 18 18 16 16 Iran Iran 25 25 22 22 20 20 16 16 14 14 10 10 Jordan Jordan 45 45 40 40 40 40 35 35 35 35 30 30 Pakistan Pakistan 60 60 60 60 55 55 50 50 45 45 40 40 United Arab Emirates United Arab Emirates 70 70 55 55 60 60 55 55 50 50 40 40 Saudi Arabia Saudi Arabia Q205 Q205 Q105 Q105 Q404 Q404 Q304 Q304 Q204 Q204 Q104 Q104 Country Country

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SLIDE 19

DES Penetration Rate % in ME DES Penetration Rate % in ME

17 17 15 15 14 14 13 13 11 11 10 10 Egypt Egypt 20 20 18 18 15 15 13 13 11 11 10 10 Lebanon Lebanon 24 24 22 22 22 22 20 20 18 18 16 16 Iran Iran 25 25 22 22 20 20 16 16 14 14 10 10 Jordan Jordan 45 45 40 40 40 40 35 35 35 35 30 30 Pakistan Pakistan 60 60 60 60 55 55 50 50 45 45 40 40 United Arab Emirates United Arab Emirates 70 70 55 55 60 60 55 55 50 50 40 40 Saudi Arabia Saudi Arabia Q205 Q205 Q105 Q105 Q404 Q404 Q304 Q304 Q204 Q204 Q104 Q104 Country Country

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SLIDE 20

DES Penetration Rate % in ME DES Penetration Rate % in ME

10 10 10 10 8 8 8 8 6 6 6 6 North Africa North Africa 17 17 15 15 14 14 13 13 11 11 10 10 Egypt Egypt 20 20 18 18 15 15 13 13 11 11 10 10 Lebanon Lebanon 24 24 22 22 22 22 20 20 18 18 16 16 Iran Iran 25 25 22 22 20 20 16 16 14 14 10 10 Jordan Jordan 45 45 40 40 40 40 35 35 35 35 30 30 Pakistan Pakistan 60 60 60 60 55 55 50 50 45 45 40 40 United Arab Emirates United Arab Emirates 70 70 55 55 60 60 55 55 50 50 40 40 Saudi Arabia Saudi Arabia Q205 Q205 Q105 Q105 Q404 Q404 Q304 Q304 Q204 Q204 Q104 Q104 Country Country

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SLIDE 21

DES Penetration Rate

10 20 30 40 50 60 70 80 Q1 04 Q2 04 Q3 34 Q4 04 Q1 05 Q2 05 % Lebanon Jordan Egypt KSA UAE Iran North Africa Pakistan

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SLIDE 22

10 20 30 40 50 60 70 % Q1 04 Q2 04 Q3 34 Q4 04 Q1 05 Q2 05

DES Penetration Rate - Upper Gulf

Lebanon Jordan KSA Pakistan

%

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SLIDE 23

10 20 30 40 50 60 70 % Q1 04 Q2 04 Q3 34 Q4 04 Q1 05 Q2 05

DES Penetration Rate- Lower Gulf

UAE

%

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SLIDE 24

5 10 15 20 25 % Q1 04 Q2 04 Q3 34 Q4 04 Q1 05 Q2 05

DES Penetration Rate - North Africa

Egypt Iran North Africa

%

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SLIDE 25

EUROPE Units MS % Units MS % Units MS % Units % DES Q2 CY04 28,098 40% 42,897 60% 70,995 30% Q3 CY04 30,820 42% 43,117 58% 73,937 33% Q4 CY04 36,825 36% 63,838 63% 1,291 1% 101,954 40% Q1 CY05 42,514 40% 61,458 58% 1,591 2% 105,563 42% Other Total Market Cordis Boston Scientific

DES Penetration in Europe DES Penetration in Europe

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SLIDE 26

Switzerland Units MS % Units MS % Units MS % Units % DES Q2 CY04 1,669 46% 1,986 54% 3,655 67% Q3 CY04 1,480 44% 1,876 56% 3,356 69% Q4 CY04 2,052 44% 2,411 52% 168 4% 4,631 77% Q1 CY05 2,419 54% 1,896 42% 181 4% 4,496 80% Other Total Market Cordis Boston Scientific

SWITZERLAND SWITZERLAND

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SLIDE 27

Portugal Units MS % Units MS % Units MS % Units % DES Q2 CY04 1,409 59% 982 41% 2,391 64% Q3 CY04 1,283 63% 747 37% 2,030 61% Q4 CY04 1,362 50% 1,279 47% 76 3% 2,717 65% Q1 CY05 1,463 53% 1,216 44% 73 3% 2,752 79% Other Total Market Cordis Boston Scientific

PORTUGAL PORTUGAL

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SLIDE 28

Austria Units MS % Units MS % Units MS % Units % DES Q2 CY04 844 45% 1,017 55% 1,861 42% Q3 CY04 748 41% 1,060 59% 1,808 45% Q4 CY04 881 35% 1,576 63% 45 2% 2,502 56% Q1 CY05 997 39% 1,531 60% 43 2% 2,572 59% Other Total Market Cordis Boston Scientific

AUSTRIA AUSTRIA

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SLIDE 29

Uk&Ireland Units MS % Units MS % Units MS % Units % DES Q2 CY04 2,751 21% 10,441 79% 13,192 45% Q3 CY04 4,376 28% 11,188 72% 15,564 50% Q4 CY04 4,582 22% 16,430 78% 97 21,109 60% Q1 CY05 5,048 30% 11,492 69% 92 1% 16,632 55% Other Total Market Cordis Boston Scientific

UK & IRELAND UK & IRELAND

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SLIDE 30

Nordic Units MS % Units MS % Units MS % Units % DES Q2 CY04 1,774 33% 3,534 67% 5,308 39% Q3 CY04 1,899 32% 3,993 68% 5,892 43% Q4 CY04 2,782 35% 5,097 65% 7,879 51% Q1 CY05 3,745 46% 4,388 54% 17 8,151 54% Other Total Market Cordis Boston Scientific

NORDIC NORDIC

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SLIDE 31

Spain Units MS % Units MS % Units MS % Units % DES Q2 CY04 1,097 21% 4,012 79% 5,109 37% Q3 CY04 1,993 38% 3,268 62% 5,261 40% Q4 CY04 1,915 27% 4,779 68% 338 5% 7,032 48% Q1 CY05 2,386 30% 5,245 66% 334 4% 7,965 52% Other Total Market Cordis Boston Scientific

SPAIN SPAIN

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SLIDE 32

France Units MS % Units MS % Units MS % Units % DES Q2 CY04 6,641 47% 7,423 53% 14,064 35% Q3 CY04 6,835 51% 6,655 49% 13,490 39% Q4 CY04 7,617 40% 11,258 59% 165 1% 19,040 45% Q1 CY05 9,114 42% 12,231 57% 234 1% 21,580 50% Other Total Market Cordis Boston Scientific

FRANCE FRANCE

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SLIDE 33

Italy Units MS % Units MS % Units MS % Units % DES Q2 CY04 7,029 54% 6,046 46% 13,075 34% Q3 CY04 6,462 54% 5,417 46% 11,879 36% Q4 CY04 8,005 48% 8,303 50% 256 2% 16,564 43% Q1 CY05 9,558 47% 10,327 51% 429 2% 20,314 48% Other Total Market Cordis Boston Scientific

ITALY ITALY

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SLIDE 34

Netherlands Units MS % Units MS % Units MS % Units % DES Q2 CY04 1,201 45% 1,440 55% 2,641 31% Q3 CY04 1,153 38% 1,844 62% 2,997 35% Q4 CY04 1,785 41% 2,566 59% 3 4,354 42% Q1 CY05 1,767 43% 2,328 57% 2 4,097 42% Other Total Market Cordis Boston Scientific

NETHERLANDS NETHERLANDS

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SLIDE 35

Belgium Units MS % Units MS % Units MS % Units % DES Q2 CY04 883 41% 1,281 59% 2,164 26% Q3 CY04 914 46% 1,083 54% 1,997 27% Q4 CY04 1,042 43% 1,327 55% 55 2% 2,424 30% Q1 CY05 1,074 47% 1,162 51% 63 3% 2,298 29% Other Total Market Cordis Boston Scientific

BELGIUM BELGIUM

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SLIDE 36

Germany Units MS % Units MS % Units MS % Units % DES Q2 CY04 2,800 37% 4,735 63% 7,535 11% Q3 CY04 3,677 38% 5,986 62% 9,663 14% Q4 CY04 4,802 35% 8,812 64% 88 1% 13,702 18% Q1 CY05 4,941 34% 9,641 66% 123 1% 14,705 20% Other Total Market Cordis Boston Scientific

GERMANY GERMANY

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SLIDE 37

USA Units MS % Units MS % Units % DES Q2 CY04 19,863 68% 9,553 32% 29,416 79% Q3 CY04 17,834 60% 11,778 40% 29,612 84% Q4 CY04 18,932 63% 11,197 37% 30,129 85% Q1 CY05 18,403 60% 12,205 40% 30,608 86% Total Market Cordis Boston Scientific

DES Penetration in USA DES Penetration in USA

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SLIDE 38

10 20 30 40 50 60 70 80 90 % Q4 04 Q2 05

DES Penetration Rate Including USA & Europe

USA KSA UAE Europe Jordan Iran Lebanon Egypt North Africa

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SLIDE 39

Conclusion Conclusion

  • Interventional Cardiologists are increasingly treating

Interventional Cardiologists are increasingly treating more complex patients more complex patients

  • Efficacy and safety of The DES has been confirmed in

Efficacy and safety of The DES has been confirmed in most complex lesions and patient sub sets, including most complex lesions and patient sub sets, including Diabetes, small vessels, Diabetes, small vessels, instent instent restenosis,long lesions restenosis,long lesions and chronic total occlusions and chronic total occlusions

  • DES can be cost effective by:

DES can be cost effective by:

  • Reducing

Reducing direct costs direct costs of PCI or CABG for repeat revascularization

  • f PCI or CABG for repeat revascularization
  • Reducing

Reducing indirect costs indirect costs including lost productivity, costs of additional including lost productivity, costs of additional cath cath lab capacity, and cost of delayed treatment lab capacity, and cost of delayed treatment

  • Providing an effective, safe PCI procedure with minimal risk of

Providing an effective, safe PCI procedure with minimal risk of restenosis restenosis

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SLIDE 40

Unfortunately Unfortunately the economic condition remains the economic condition remains the key player in expanding the the key player in expanding the use of DES use of DES

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SLIDE 41

THE Real World THE Real World (DES 10%) (DES 10%) THE Real World THE Real World (DES 90%) (DES 90%)