The Changing Face of Interventional Cardiology
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1 DES in the Real World Association Franco-L L ib anaise DD r. JJ ose pp h h EE ll ias
2 The Changing Face of Interventional Cardiology 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
3 The Changing Face of Interventional Cardiology The early days of stenting Stress/Benestent (1994) Diabetes 16% LL esio n n ll en gg th (( mm m m )) 7-10 NN o o.. oo f f ll esio nn s tr eated 1 OO nn ll y y dd e nn oo vv o o ll esio nn s NN oo Acute MI CTO SVG Multivessel Left main Bifurcation ISR Ostial
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
5 DES Players Major Players Cypher (FDA) (Rapamycin) Taxus (FDA) (Paclitaxel) Mi n or Players Company Medtronic Sorin Abbott Abbott Eucatech Sahajanand Yukon Conor Biosensors EuroCor Aachen Resonance AMG Product Endeavor Janus DES Dexamet Zomaxx Euca Tax Infinnium Yukon Constar Biomatrix DES Taxcor Artax Pico Elite Drug ABT -578 Tacrolimus Dexamethaso ne ABT -578 Paclitaxel Paclitaxel Rapamycin or Paclitaxel Paclitaxel Biolimus A9 Paclitaxel Paclitaxel Paclitaxel
6 European and US Pivotal Trials: J&J TLR RAVEL Trial n= % (2 yrs.) SIRIUS Trial n= % (9mos.) MACE, Overall 10% (2 yrs.) 7.1% (9 mos.) Stent Thrombosis 0% (2 yrs.) 0.4% (9 mos.) Late Loss Binary Restenosis -0.01mm In-stent (6 mos.) 0.0% In-stent (6 mos.) 0.17mm In-stent 0.24 mm In-lesion (8 mos.) 3.2% In-stent 8.9% In-segment (8 mos)
7 European and US Pivotal Trials: BB SC TAXUS II-SR Trial n=267 TAXUS IV Trial n=1326 TLR 4.7% (12 mos.) 3.0% (9 mos.) MACE, Overall 10.9% (12 mos.) 8.5% (9 mos.) Stent Thrombosis 1.5% (12 mos.) 0.6% (9 mos.) Late Loss Binary Restenosis 0.31 mm In-stent 0.43 mm Analysis Segment (6 mos.) 2.3% In-stent 5.5% Analysis Segment (6 mos.) 0.39 mm In-stent 0.23 mm Analysis Segment (9 mos.) 5.5% In-stent 7.9% Analysis Segment (9 mos)
8 Head To Head Trials LL aa tt e LL oo ss s s (( mm m m )) In Stent RE AL ITY (8 m) 1 CC YY PP HH EE R R TT AA XX UU SS SIRTAX (9m) 2 CC YY PP HH EE R R TT AA XX UU SS LL aa tt e LL oo ss s s (( mm m m )) In Segment Binary Restenosis In Stent (( %% )) * Binary Restenosis In Segment (( %% )) * TT LL R R (( %% )) * MM AA CC E E (( %% )) * TT VV F F (( %% )) SS tt en tt TT hh ro mm (( %% )) bb oo ss is * Device Delivery SS uu cces s s (( %% )) * *
9 MACE Rates in Real World Patients 10,0 8,0 6.9 All Patients 3.1% MACE MACE Rates 6,0 4, ,0 0,0 Diabetics IDDMs Small Vessel <2.5mm Long Lesions >30mm Multivessel Women AMI CTO ISR BIF n= MACE at 6 months
10 WW DES in the Real oo rr ld DES in the Real WW oo rr ld
11 MM MM DES LL au nc h Cypher LL aa uu nn cc h TT aa xx uu ss LL aa uu nn cc h WW oo rr ll dd ww ii dd e e :: AA pp rr ii l l 11 55,, ii n n MM ii ll aa n n BB y y DD r r.. AA nn tt oo nn ii o o CC oo ll oo mm bb oo WW oo rr ll dd ww ii dd e e :: MM ii dd dd ll e e EE aa ss t t :: aa y y 11 55,, ii n n tt hh e e AA mm ee rr ii cc aa n n UU nn ii vv ee rr ss ii tt y y HH oo ss pp ii tt aa l l BB ee ii rr uu t t.. DD r r.. AA ll aa mm MM ii dd dd ll e e EE aa ss t t :: aa rr cc h h ,, AA l l KK hh aa ll ii dd yy HH oo ss pp ii tt aa l l,, JJ oo rr dd aa n n,, DD r r.. GG oo uu ss ss oo uu ss
12 DES PP enetr atio n Rate %% in MM E CC oo uu nn tt rr yy QQ QQ QQ QQ 44 QQ QQ
13 DES PP enetr atio n Rate %% in MM E CC oo uu nn tt rr yy QQ QQ QQ QQ 44 QQ QQ SS aa uu dd i i AA rr aa bb ii aa
14 DES PP enetr atio n Rate %% in MM E CC oo uu nn tt rr yy QQ QQ QQ QQ 44 QQ QQ SS aa uu dd i i AA rr aa bb ii aa UU nn ii tt ee d d AA rr aa b b EE mm ii rr aa tt ee ss
15 DES PP enetr atio n Rate %% in MM E CC oo uu nn tt rr yy QQ QQ QQ QQ 44 QQ QQ SS aa uu dd i i AA rr aa bb ii aa UU nn ii tt ee d d AA rr aa b b EE mm ii rr aa tt ee ss PP aa kk ii ss tt aa nn
16 DES PP enetr atio n Rate %% in MM E CC oo uu nn tt rr yy QQ QQ QQ QQ 44 QQ QQ SS aa uu dd i i AA rr aa bb ii aa UU nn ii tt ee d d AA rr aa b b EE mm ii rr aa tt ee ss PP aa kk ii ss tt aa nn JJ oo rr dd aa nn
17 DES PP enetr atio n Rate %% in MM E CC oo uu nn tt rr yy QQ QQ QQ QQ 44 QQ QQ SS aa uu dd i i AA rr aa bb ii aa UU nn ii tt ee d d AA rr aa b b EE mm ii rr aa tt ee ss PP aa kk ii ss tt aa nn JJ oo rr dd aa nn II rr aa nn
18 DES PP enetr atio n Rate %% in MM E CC oo uu nn tt rr yy QQ QQ QQ QQ 44 QQ QQ SS aa uu dd i i AA rr aa bb ii aa UU nn ii tt ee d d AA rr aa b b EE mm ii rr aa tt ee ss PP aa kk ii ss tt aa nn JJ oo rr dd aa nn II rr aa nn LL ee bb aa nn oo nn
19 DES PP enetr atio n Rate %% in MM E CC oo uu nn tt rr yy QQ QQ QQ QQ 44 QQ QQ SS aa uu dd i i AA rr aa bb ii aa UU nn ii tt ee d d AA rr aa b b EE mm ii rr aa tt ee ss PP aa kk ii ss tt aa nn JJ oo rr dd aa nn II rr aa nn LL ee bb aa nn oo nn EE gg yy pp tt
20 DES PP enetr atio n Rate %% in MM E CC oo uu nn tt rr yy QQ QQ QQ QQ 44 QQ QQ SS aa uu dd i i AA rr aa bb ii aa UU nn ii tt ee d d AA rr aa b b EE mm ii rr aa tt ee ss PP aa kk ii ss tt aa nn JJ oo rr dd aa nn II rr aa nn LL ee bb aa nn oo nn EE gg yy pp tt NN oo rr tt h h AA ff rr ii cc aa
21 DES Penetration Rate % Q1 04 Q2 04 Q3 34 Q4 04 Q1 05 Q2 05 Lebanon Jordan Egypt KSA UAE Iran North Africa Pakistan
22 DES Penetration Rate - Upper Gulf % % Q1 04 Q2 04 Q3 34 Q4 04 Q1 05 Q2 05 Lebanon Jordan KSA Pakistan
23 DES Penetration Rate- Lower Gulf % % Q1 04 Q2 04 Q3 34 Q4 04 Q1 05 Q2 05 UAE
24 DES Penetration Rate - North Africa % 10 5 Egypt Iran North Africa 0 Q1 04 Q2 04 Q3 34 Q4 04 Q1 05 Q2 05
25 DES PP enetr atio n in Eu rr oo pp e EUROPE Cordis Boston Scientific Other Total Market Units MS % Units MS % Units MS % Units % DES Q2 CY04 28,098 40% 42,897 % 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%
26 SWITZERLAND Switzerland Cordis Boston Scientific Other Total Market 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%
27 PP OO RTU GG AL Portugal Cordis Boston Scientific Other Total Market Units MS % Units MS % Units MS % Units % DES Q2 CY04 1,409 59% % 2,391 64% Q3 CY04 1,283 63% % 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%
28 AU STRIA Austria Cordis Boston Scientific Other Total Market Units MS % Units MS % Units MS % Units % DES Q2 CY % 1,017 55% 1,861 42% Q3 CY % 1,0 59% 1,808 45% Q4 CY % 1,576 63% 45 2% 2,502 56% Q1 CY % 1,531 % 43 2% 2,572 59%
29 UU K K && IRELAND Uk&Ireland Cordis Boston Scientific Other Total Market 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 % Q1 CY05 5,048 30% 11,492 69% 92 1% 16,632 55%
30 NO RDIC Nordic Cordis Boston Scientific Other Total Market 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%
31 SP AIN Spain Cordis Boston Scientific Other Total Market 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%
32 FRANCE France Cordis Boston Scientific Other Total Market 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%
33 ITALY Italy Cordis Boston Scientific Other Total Market 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%
34 NETH ERLANDS Netherlands Cordis Boston Scientific Other Total Market 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%
35 BB EL GG II UU MM Belgium Cordis Boston Scientific Other Total Market Units MS % Units MS % Units MS % Units % DES Q2 CY % 1,281 59% 2,164 26% Q3 CY % 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%
36 GG ERM ANY Germany Cordis Boston Scientific Other Total Market 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%
37 DES PP enetr atio n in UU SA USA Boston Scientific Cordis Total Market Units MS % Units MS % Units % DES Q2 CY04 19,863 68% 9,553 32% 29,416 79% Q3 CY04 17,834 % 11,778 40% 29,612 84% Q4 CY04 18,932 63% 11,197 37% 30,129 85% Q1 CY05 18,403 % 12,205 40% 30,8 86%
38 DES Penetration Rate Including USA & Europe % Q4 04 Q2 05 USA KSA UAE Europe Jordan Iran Lebanon Egypt North Africa
39 CC oo nc lu ss io n mm pp pp EE ff ff TT hh DD EE S S hh bb mm pp pp b b DD DD EE S S bb ff bb oo f f PP CC I I oo r r CC AA BB G G ff oo r r rr t t rr aa ss aa rr aa tt ll oo ss t t pp rr oo y y,, ss tt s s oo f f aa l l tt hh ll aa b b pp aa y y,, aa ss t t oo f f aa yy tt rr tt mm PP rr oo vv aa ff ss aa ff PP CC I I pp rr oo ww h h mm aa l l rr k k oo f f rr tt ss Interventional Cardiologists are increasingly treating ore com lex atients icacy and saf ety of e as een conf irm ed in ost com lex lesions and atient su sets, inclu ding iab etes, sm all vessels, instent restenosis, long lesions and ch ronic total occlu sions can e cost ef ective y: Reducing direct costs ep ea ev cul iz io n Reducing in direct costs incl uding duct iv it co ddit io na ca ca cit nd co del ed ea ent iding n ef ect iv e, e cedur e it inim is es eno is
40 Unfortunately th e ec onom ii c c cc ond ii ti on rem ai ns th e kk ey pp layer ii n ex pp and ii ng th e us e of DD EE SS
41 THE Real World (( DD ES %% )) THE Real World (( DD ES %% ))
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