DES in the Real WorldDES in the Real WorldAssociation FrancoAssociation Franco--L ib anaiseL ib anaise 2 0 0 52 0 0 5

D r. J ose p h E l iasD r. J ose p h E l ias

� 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

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

The Changing Face of Interventional Cardiology

DiabetesDiabetes 16%16%L esio n l en g th ( m m )L esio n l en g th ( m m ) 77--1010N o . o f l esio n s tr eatedN o . o f l esio n s tr eated 11O n l y d e n o v o l esio n sO n l y d e n o v o l esio n sN oN o � Acute MI

� CTO

� SVG

� Multivessel

� Left main

� Bifurcation

� ISR

� Ostial

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

DES PlayersDES PlayersMajor PlayersMajor Players

��CypherCypher (FDA)(FDA)

((RapamycinRapamycin))

��TaxusTaxus (FDA)(FDA)

((PaclitaxelPaclitaxel))

Mi n or PlayersDrugProductCompany

PaclitaxelPico EliteAMG

PaclitaxelArtaxAachenResonance

PaclitaxelTaxcorEuroCor

Biolimus A9BiomatrixDESBiosensors

PaclitaxelConstarConor

Rapamycin or PaclitaxelYukonYukon

PaclitaxelInfinniumSahajanand

PaclitaxelEuca TaxEucatech

ABT -578ZomaxxAbbott

DexamethasoneDexametAbbott

TacrolimusJanusDESSorin

ABT -578EndeavorMedtronic

European and US Pivotal Trials: J&JEuropean 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 Trialn=238

TLR 2.5%(2 yrs.)

Binary Restenosis0.0% In-stent

(6 mos.)

SIRIUS Trialn=1058

7.1%(9 mos.)

0.4%(9 mos.)

0.17mm In-stent0.24 mm In-lesion

(8 mos.)

4.1%(9mos.)

3.2% In-stent8.9% In-segment

(8 mos)

European and US Pivotal Trials: B SCEuropean and US Pivotal Trials: B SC

MACE, Overall

Stent Thrombosis

10.9%(12 mos.)

1.5%(12 mos.)

Late Loss0.31 mm In-stent

0.43 mm Analysis Segment(6 mos.)

TLR 4.7%(12 mos.)

Binary Restenosis2.3% In-stent

5.5% Analysis Segment(6 mos.)

TAXUS II-SR Trialn=267

3.0%(9 mos.)

8.5%(9 mos.)

0.6%(9 mos.)

5.5% In-stent7.9% Analysis Segment

(9 mos)

0.39 mm In-stent0.23 mm Analysis Segment

(9 mos.)

TAXUS IV Trialn=1326

Head To Head TrialsHead To Head Trials

98.6*98.6*99.0 99.0 96.6*96.6*95 .395 .3Device Delivery Device Delivery S u cces s ( % )S u cces s ( % )

1 .6*1 .6*2 .0 2 .0 1 .8 1 .8 0 .4 0 .4 S t en tS t en t T h ro m b o s is T h ro m b o s is ( % )( % )

1 1 .6 1 1 .6 7 .0 7 .0 1 1 .5 1 1 .5 1 0 .4 1 0 .4 T V F ( % )T V F ( % )1 0 .81 0 .86.2 6.2 1 0 .6*1 0 .6*9.2 9.2 M A C E ( % )M A C E ( % )8.3 8.3 4 .8 4 .8 5 .4 *5 .4 *5 .0 5 .0 T L R ( % )T L R ( % )

1 1 .9 1 1 .9 6.7 6.7 1 1 .1 *1 1 .1 *9.6 9.6 Binary Restenosis Binary Restenosis In SegmentIn Segment ( % )( % )

7 .6 7 .6 3 .2 3 .2 8.3 *8.3 *7 .0 7 .0 Binary RestenosisBinary RestenosisIn In StentStent ( % )( % )

0 .3 2 0 .3 2 0 .1 90 .1 90 .1 60 .1 60 .0 40 .0 4L a t e L o s s ( m m )L a t e L o s s ( m m )In SegmentIn Segment

0 .4 90 .4 90 .3 70 .3 70 .3 10 .3 10 .0 90 .0 9L a t e L o s s ( m m )L a t e L o s s ( m m )In In StentStent

SIRTAX (9m)SIRTAX (9m)22C Y P H E R T A X U SC Y P H E R T A X U S

RE AL ITY (8 m)RE AL ITY (8 m)11C Y P H E R T A X U SC Y P H E R T A X U S

MACE Rates in ‘Real World’ Patients

MACE at 6 months

10,0

6,0

8,0

2,0

Diabetics

4.6

MA

CE

Rat

es

4,0

4149n=

IDDMs

6.9

1378

SmallVessel

<2.5mm

4.0

1333

LongLesions>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

DES in the Real DES in the Real W o r ldW o r ld

DES in the DES in the Real W o r ldReal W o r ld

DES L au nc hDES L au nc h•• CypherCypher L a u n c hL a u n c h

–– W o r l d w i d e : A p r i l 1 5 , 2 0 0 2 W o r l d w i d e : A p r i l 1 5 , 2 0 0 2 i n M i l a n B y D r . A n t o n i o i n M i l a n B y D r . A n t o n i o C o l o m b oC o l o m b o

–– M i d d l e E a s t : M i d d l e E a s t : M a y 1 5 , 2 0 0 2 i n t h e M a y 1 5 , 2 0 0 2 i n t h e A m e r i c a n U n i v e r s i t y A m e r i c a n U n i v e r s i t y H o s p i t a l B e i r u t . H o s p i t a l B e i r u t . D r . D r . A l a mA l a m

•• T a x u sT a x u s L a u n c hL a u n c h

–– W o r l d w i d e :W o r l d w i d e :

–– M i d d l e E a s t :M i d d l e E a s t :M a r c h 2 0 0 3 , A l M a r c h 2 0 0 3 , A l K h a l i d yK h a l i d yH o s p i t a l , J o r d a n ,H o s p i t a l , J o r d a n ,D r . D r . G o u s s o u sG o u s s o u s

DES P enetr atio n Rate % in M EDES P enetr atio n Rate % in M EQ 2 0 5Q 2 0 5Q 1 0 5Q 1 0 5Q 4 0 4Q 4 0 4Q 3 0 4Q 3 0 4Q 2 0 4Q 2 0 4Q 1 0 4Q 1 0 4C o u n t r yC o u n t r y

DES P enetr atio n Rate % in M EDES P enetr atio n Rate % in M E7 07 05 55 560605 55 55 05 04 04 0S a u d i A r a b i aS a u d i A r a b i aQ 2 0 5Q 2 0 5Q 1 0 5Q 1 0 5Q 4 0 4Q 4 0 4Q 3 0 4Q 3 0 4Q 2 0 4Q 2 0 4Q 1 0 4Q 1 0 4C o u n t r yC o u n t r y

DES P enetr atio n Rate % in M EDES P enetr atio n Rate % in M E

606060605 55 55 05 04 54 54 04 0U n i t e d A r a b E m i r a t e sU n i t e d A r a b E m i r a t e s7 07 05 55 560605 55 55 05 04 04 0S a u d i A r a b i aS a u d i A r a b i aQ 2 0 5Q 2 0 5Q 1 0 5Q 1 0 5Q 4 0 4Q 4 0 4Q 3 0 4Q 3 0 4Q 2 0 4Q 2 0 4Q 1 0 4Q 1 0 4C o u n t r yC o u n t r y

DES P enetr atio n Rate % in M EDES P enetr atio n Rate % in M E

4 54 54 04 04 04 03 53 53 53 53 03 0P a k i s t a nP a k i s t a n606060605 55 55 05 04 54 54 04 0U n i t e d A r a b E m i r a t e sU n i t e d A r a b E m i r a t e s7 07 05 55 560605 55 55 05 04 04 0S a u d i A r a b i aS a u d i A r a b i aQ 2 0 5Q 2 0 5Q 1 0 5Q 1 0 5Q 4 0 4Q 4 0 4Q 3 0 4Q 3 0 4Q 2 0 4Q 2 0 4Q 1 0 4Q 1 0 4C o u n t r yC o u n t r y

DES P enetr atio n Rate % in M EDES P enetr atio n Rate % in M E

2 52 52 22 22 02 01 61 61 41 41 01 0J o r d a nJ o r d a n4 54 54 04 04 04 03 53 53 53 53 03 0P a k i s t a nP a k i s t a n606060605 55 55 05 04 54 54 04 0U n i t e d A r a b E m i r a t e sU n i t e d A r a b E m i r a t e s7 07 05 55 560605 55 55 05 04 04 0S a u d i A r a b i aS a u d i A r a b i aQ 2 0 5Q 2 0 5Q 1 0 5Q 1 0 5Q 4 0 4Q 4 0 4Q 3 0 4Q 3 0 4Q 2 0 4Q 2 0 4Q 1 0 4Q 1 0 4C o u n t r yC o u n t r y

DES P enetr atio n Rate % in M EDES P enetr atio n Rate % in M E

2 42 42 22 22 22 22 02 01 81 81 61 6I r a nI r a n2 52 52 22 22 02 01 61 61 41 41 01 0J o r d a nJ o r d a n4 54 54 04 04 04 03 53 53 53 53 03 0P a k i s t a nP a k i s t a n606060605 55 55 05 04 54 54 04 0U n i t e d A r a b E m i r a t e sU n i t e d A r a b E m i r a t e s7 07 05 55 560605 55 55 05 04 04 0S a u d i A r a b i aS a u d i A r a b i aQ 2 0 5Q 2 0 5Q 1 0 5Q 1 0 5Q 4 0 4Q 4 0 4Q 3 0 4Q 3 0 4Q 2 0 4Q 2 0 4Q 1 0 4Q 1 0 4C o u n t r yC o u n t r y

DES P enetr atio n Rate % in M EDES P enetr atio n Rate % in M E

2 02 01 81 81 51 51 31 31 11 11 01 0L e b a n o nL e b a n o n2 42 42 22 22 22 22 02 01 81 81 61 6I r a nI r a n2 52 52 22 22 02 01 61 61 41 41 01 0J o r d a nJ o r d a n4 54 54 04 04 04 03 53 53 53 53 03 0P a k i s t a nP a k i s t a n606060605 55 55 05 04 54 54 04 0U n i t e d A r a b E m i r a t e sU n i t e d A r a b E m i r a t e s7 07 05 55 560605 55 55 05 04 04 0S a u d i A r a b i aS a u d i A r a b i aQ 2 0 5Q 2 0 5Q 1 0 5Q 1 0 5Q 4 0 4Q 4 0 4Q 3 0 4Q 3 0 4Q 2 0 4Q 2 0 4Q 1 0 4Q 1 0 4C o u n t r yC o u n t r y

DES P enetr atio n Rate % in M EDES P enetr atio n Rate % in M E

1 71 71 51 51 41 41 31 31 11 11 01 0E g y p tE g y p t2 02 01 81 81 51 51 31 31 11 11 01 0L e b a n o nL e b a n o n2 42 42 22 22 22 22 02 01 81 81 61 6I r a nI r a n2 52 52 22 22 02 01 61 61 41 41 01 0J o r d a nJ o r d a n4 54 54 04 04 04 03 53 53 53 53 03 0P a k i s t a nP a k i s t a n606060605 55 55 05 04 54 54 04 0U n i t e d A r a b E m i r a t e sU n i t e d A r a b E m i r a t e s7 07 05 55 560605 55 55 05 04 04 0S a u d i A r a b i aS a u d i A r a b i aQ 2 0 5Q 2 0 5Q 1 0 5Q 1 0 5Q 4 0 4Q 4 0 4Q 3 0 4Q 3 0 4Q 2 0 4Q 2 0 4Q 1 0 4Q 1 0 4C o u n t r yC o u n t r y

DES P enetr atio n Rate % in M EDES P enetr atio n Rate % in M E

1 01 01 01 088886666N o r t h A f r i c aN o r t h A f r i c a1 71 71 51 51 41 41 31 31 11 11 01 0E g y p tE g y p t2 02 01 81 81 51 51 31 31 11 11 01 0L e b a n o nL e b a n o n2 42 42 22 22 22 22 02 01 81 81 61 6I r a nI r a n2 52 52 22 22 02 01 61 61 41 41 01 0J o r d a nJ o r d a n4 54 54 04 04 04 03 53 53 53 53 03 0P a k i s t a nP a k i s t a n606060605 55 55 05 04 54 54 04 0U n i t e d A r a b E m i r a t e sU n i t e d A r a b E m i r a t e s7 07 05 55 560605 55 55 05 04 04 0S a u d i A r a b i aS a u d i A r a b i aQ 2 0 5Q 2 0 5Q 1 0 5Q 1 0 5Q 4 0 4Q 4 0 4Q 3 0 4Q 3 0 4Q 2 0 4Q 2 0 4Q 1 0 4Q 1 0 4C o u n t r yC o u n t r y

DES Penetration Rate

01020304050607080

Q1 04 Q2 04 Q3 34 Q4 04 Q1 05 Q2 05

%

Lebanon

Jordan

Egypt

KSA

UAE

Iran

North Africa

Pakistan

0

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

%

0

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%

0

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%

EUROPEUnits 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 MarketCordis Boston Scientific

DES P enetr atio n in Eu r o p eDES P enetr atio n in Eu r o p e

SwitzerlandUnits 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 MarketCordis Boston Scientific

SWITZERLANDSWITZERLAND

PortugalUnits 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 MarketCordis Boston Scientific

P O RTU G ALP O RTU G AL

AustriaUnits 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 MarketCordis Boston Scientific

AU STRIAAU STRIA

Uk&IrelandUnits 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 MarketCordis Boston Scientific

U K & IRELANDU K & IRELAND

NordicUnits 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 MarketCordis Boston Scientific

NO RDICNO RDIC

SpainUnits 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 MarketCordis Boston Scientific

SP AINSP AIN

FranceUnits 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 MarketCordis Boston Scientific

FRANCEFRANCE

ItalyUnits 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 MarketCordis Boston Scientific

ITALYITALY

NetherlandsUnits 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 MarketCordis Boston Scientific

NETH ERLANDSNETH ERLANDS

BelgiumUnits 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 MarketCordis Boston Scientific

B EL G I U MB EL G I U M

GermanyUnits 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 MarketCordis Boston Scientific

G ERM ANYG ERM ANY

USAUnits 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 MarketCordisBoston Scientific

DES P enetr atio n in U SADES P enetr atio n in U SA

0102030405060708090

%

Q4 04 Q2 05

DES Penetration Rate Including USA & Europe

USA

KSA

UAE

Europe

Jordan

Iran

Lebanon

Egypt

North Africa

C o nc lu s io nC o nc lu s io n�� Interventional Cardiologists are increasingly treating Interventional Cardiologists are increasingly treating

m ore com p lex p atientsm ore com p lex p atients�� E f f icacy and saf ety of T h e D E S h as b een conf irm ed in E f f icacy and saf ety of T h e D E S h as b een conf irm ed in

m ost com p lex lesions and p atient su b sets, inclu ding m ost com p lex lesions and p atient su b sets, inclu ding D iab etes, sm all vessels, D iab etes, sm all vessels, instentinstent restenosis, long lesions restenosis, long lesions and ch ronic total occlu sionsand ch ronic total occlu sions

�� D E S can b e cost ef f ective b y:D E S can b e cost ef f ective b y:�� Reducing Reducing direct costsdirect costs o f P C I o r C A B G f o r r ep ea t r ev a s cul a r iz a t io no f P C I o r C A B G f o r r ep ea t r ev a s cul a r iz a t io n�� Reducing Reducing in direct costsin direct costs incl uding l o s t p r o duct iv it y , co s t s o f a ddit io na l incl uding l o s t p r o duct iv it y , co s t s o f a ddit io na l

ca t hca t h l a b ca p a cit y , a nd co s t o f del a y ed t r ea t m entl a b ca p a cit y , a nd co s t o f del a y ed t r ea t m ent�� P r o v iding a n ef f ect iv e, s a f e P C I p r o cedur e w it h m inim a l r is k o f P r o v iding a n ef f ect iv e, s a f e P C I p r o cedur e w it h m inim a l r is k o f r es t eno s isr es t eno s is

UnfortunatelyUnfortunatelyth e ec onom i c c ond i ti on rem ai ns th e ec onom i c c ond i ti on rem ai ns th e k ey p layer i n ex p and i ng th e th e k ey p layer i n ex p and i ng th e

us e of D E Sus e of D E S

THE Real WorldTHE Real World( D ES 1 0 % )( D ES 1 0 % )

THE Real WorldTHE Real World( D ES 9 0 % )( D ES 9 0 % )