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

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 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) Diabetes 16% Diabetes 16% Lesion length (mm) 7- -10 10 Lesion length (mm) 7 No. of lesions treated 1 No. of lesions treated 1 Only de novo lesions Only de novo lesions � Acute MI � Multivessel � ISR No No � CTO � Left main � Ostial � SVG � Bifurcation

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 Players DES Players Major Players Minor Players Major Players Company Drug Product Medtronic Endeavor ABT -578 Cypher (FDA) (FDA) � Cypher � Janus Sorin DES Tacrolimus Dexamethaso (Rapamycin Rapamycin) ) ( Abbott Dexamet ne Abbott Zomaxx ABT -578 Eucatech Euca Tax Paclitaxel Taxus (FDA) (FDA) � Taxus Sahajanand Infinnium Paclitaxel � Rapamycin or Yukon Yukon Paclitaxel Conor Constar Paclitaxel (Paclitaxel Paclitaxel) ) ( Biomatrix Biosensors DES Biolimus A9 EuroCor Taxcor Paclitaxel Aachen Resonance Artax Paclitaxel AMG Pico Elite Paclitaxel

European and US Pivotal Trials: J&J European and US Pivotal Trials: J&J RAVEL Trial SIRIUS Trial n=238 n=1058 2.5% 4.1% TLR (2 yrs.) (9mos.) MACE, Overall 10% 7.1% (2 yrs.) (9 mos.) 0.4% Stent Thrombosis 0% (9 mos.) (2 yrs.) 0.17mm In-stent -0.01mm In-stent Late Loss 0.24 mm In-lesion (6 mos.) (8 mos.) 3.2% In-stent 0.0% In-stent Binary Restenosis 8.9% In-segment (6 mos.) (8 mos)

European and US Pivotal Trials: BSC European and US Pivotal Trials: BSC TAXUS IV Trial TAXUS II-SR Trial n=1326 n=267 4.7% 3.0% TLR (12 mos.) (9 mos.) MACE, Overall 10.9% 8.5% (12 mos.) (9 mos.) 1.5% 0.6% Stent Thrombosis (12 mos.) (9 mos.) 0.31 mm In-stent 0.39 mm In-stent Late Loss 0.43 mm Analysis Segment 0.23 mm Analysis Segment (6 mos.) (9 mos.) 2.3% In-stent 5.5% In-stent 5.5% Analysis Segment Binary Restenosis 7.9% Analysis Segment (6 mos.) (9 mos)

Head To Head Trials Head To Head Trials REALITY (8m) 1 1 SIRTAX (9m) 2 2 REALITY (8m) SIRTAX (9m) CYPHER TAXUS CYPHER TAXUS CYPHER TAXUS CYPHER TAXUS Late Loss (mm) Late Loss (mm) 0.09 0.31 0.37 0.49 0.09 0.31 0.37 0.49 In In Stent Stent Late Loss (mm) Late Loss (mm) 0.04 0.16 0.19 0.32 0.04 0.16 0.19 0.32 In Segment In Segment Binary Restenosis Binary Restenosis 7.0 8.3* 3.2 7.6 7.0 8.3* 3.2 7.6 In Stent In Stent (%) (%) Binary Restenosis Binary Restenosis 9.6 11.1* 6.7 11.9 9.6 11.1* 6.7 11.9 In Segment In Segment (%) (%) TLR (%) TLR (%) 5.0 5.0 5.4* 5.4* 4.8 4.8 8.3 8.3 MACE (%) MACE (%) 9.2 10.6* 6.2 10.8 9.2 10.6* 6.2 10.8 TVF (%) TVF (%) 10.4 11.5 7.0 11.6 10.4 11.5 7.0 11.6 Stent Thrombosis Stent Thrombosis 0.4 0.4 1.8 1.8 2.0 2.0 1.6* 1.6* (%) (%) Device Delivery Device Delivery 95.3 96.6* 99.0 98.6* 95.3 96.6* 99.0 98.6* Success (%) Success (%)

MACE Rates in ‘Real World’ Patients 10,0 All Patients 3.1% MACE 8,0 6.9 MACE Rates 6,0 4.9 4.9 4.6 4.4 4.2 4.0 3.9 3.6 4,0 3.3 2,0 0,0 Diabetics IDDMs Small Long Multi- Women AMI CTO ISR BIF Vessel Lesions vessel <2.5mm >30mm n= 4149 1378 1333 950 1525 3234 1016 415 1766 1684 MACE at 6 months

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

DES Launch DES Launch • Cypher Cypher Launch Launch • Taxus Taxus Launch Launch • • – Worldwide: April 15, 2002 Worldwide: April 15, 2002 – Worldwide: Worldwide: – – in Milan By Dr. Antonio in Milan By Dr. Antonio Colombo Colombo – Middle East: Middle East: – – Middle East: Middle East: – May 15, 2002 in the May 15, 2002 in the March 2003,Al Khalidy March 2003,Al Khalidy American University American University Hospital, Jordan, Hospital, Jordan, Hospital Beirut. Hospital Beirut. Dr. Goussous Dr. Goussous Dr. Alam Alam Dr.

DES Penetration Rate % in ME DES Penetration Rate % in ME Country Q104 Q204 Q304 Q404 Q105 Q205 Country Q104 Q204 Q304 Q404 Q105 Q205

DES Penetration Rate % in ME DES Penetration Rate % in ME Country Q104 Q204 Q304 Q404 Q105 Q205 Country Q104 Q204 Q304 Q404 Q105 Q205 Saudi Arabia 40 50 55 60 55 70 Saudi Arabia 40 50 55 60 55 70

DES Penetration Rate % in ME DES Penetration Rate % in ME Country Q104 Q204 Q304 Q404 Q105 Q205 Country Q104 Q204 Q304 Q404 Q105 Q205 Saudi Arabia 40 50 55 60 55 70 Saudi Arabia 40 50 55 60 55 70 United Arab Emirates 40 45 50 55 60 60 United Arab Emirates 40 45 50 55 60 60

DES Penetration Rate % in ME DES Penetration Rate % in ME Country Q104 Q204 Q304 Q404 Q105 Q205 Country Q104 Q204 Q304 Q404 Q105 Q205 Saudi Arabia 40 50 55 60 55 70 Saudi Arabia 40 50 55 60 55 70 United Arab Emirates 40 45 50 55 60 60 United Arab Emirates 40 45 50 55 60 60 Pakistan 30 35 35 40 40 45 Pakistan 30 35 35 40 40 45

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

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

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

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

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

DES Penetration Rate 80 Lebanon 70 Jordan 60 Egypt 50 % KSA 40 30 UAE 20 Iran 10 North Africa 0 Pakistan Q1 04 Q2 04 Q3 34 Q4 04 Q1 05 Q2 05

DES Penetration Rate - Upper Gulf 70 60 50 Lebanon 40 Jordan % 30 % KSA 20 Pakistan 10 0 Q1 04 Q2 04 Q3 34 Q4 04 Q1 05 Q2 05

DES Penetration Rate- Lower Gulf 70 60 50 40 % UAE % 30 20 10 0 Q1 04 Q2 04 Q3 34 Q4 04 Q1 05 Q2 05

DES Penetration Rate - North Africa 25 20 15 Egypt % Iran % 10 North Africa 5 0 Q1 04 Q2 04 Q3 34 Q4 04 Q1 05 Q2 05