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TCT ‘06 Key Highlights. Boston Scientific Corporation. Glossary at end of presentation. TCT ’06 Key Highlights. The TAXUS ™ Stent significantly reduces the need for repeat procedures by >50% and is proven to be as safe -- or safer -- than a BMS *
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TCT ‘06 Key Highlights Boston Scientific Corporation Glossary at end of presentation
TCT ’06 Key Highlights • The TAXUS™ Stent significantly reduces the need for repeat procedures by >50% and is proven to be as safe -- or safer -- than a BMS* • TAXUS Stent is superior in diabetic patients** • Endeavor™ Stent has Late Stent Thrombosis (LST)† *TAXUS 4 –year meta-analysis, presented by Dr. Gregg Stone, TCT 2006. TAXUS Stent meta-analysis: TAXUS II1 (4 yr) , IV2 (4 yr), V3 (2yr), VI4 (3 yr) (N=3445). 1. Colombo et al. Circulation. 2003;108:788; 2. Stone et al. N Engl Med. 2004;350:221; 3. Stone et al. JAMA. 2005;294:1215; 4. Dawkins et al. Circulation. 2005;112:3306. **TC WYRE registry data presented by Dr. Kandzari and Dr. O’Neill at TCT 2006. Kaiser Permanente registry data presented by Dr. Brar at TCT 2006. Centro Cuore Columbus (Milan II) data presented by Dr Cosgrave at TCT 2006. Prairie Heart Institute registry data presented by Dr. Mishkel et al. TCT 2006. †Cutlip, Stent Thrombosis new standard definitions, TCT 2006. Endeavor is a trademark of Medtronic Corp. PSST 3813
The TAXUS™ Stent significantly reduces the need for repeat procedures by >50% and is proven to be as safe --or safer --than a BMS* • New data confirms excellent long-term outcomes with the TAXUS stent in ~3500 patients out to 4 years* *TAXUS 4 –year meta-analysis, presented by Dr. Stone, TCT 2006. TAXUS Stent meta-analysis: TAXUS II1 (4 yr) , IV2 (4 yr), V3 (2yr), VI4 (3 yr) (N=3445). 1. Colombo et al. Circulation. 2003;108:788; 2. Stone et al. N Engl Med. 2004;350:221; 3. Stone et al. JAMA. 2005;294:1215; 4. Dawkins et al. Circulation. 2005;112:3306. PSST 3813
TAXUS™ Stent: Significantly lower TLRand as safe -- or safer-- than a BMS TAXUS Stent 4 yr meta-analysis TAXUS II1 (4 yr) , IV2 (4 yr), V3 (2yr), VI4 (3 yr) studies (N=3445) p=0.55 p=0.53 p=0.40 p=0.80 p=0.29 p<0.0001 20.4% Events (%) Δ – 0.5% 10.5% 8.1% 7.6% 7.0% 6.4% 3.1% 2.6% 1.5% 1.2% 0.9% 1.3% TLR Death or QWMI QWMI CardiacDeath All Death Stent Thrombosis TAXUS Stent (N=1718) Bare Metal Stent (N=1727) *TAXUS 4 –year meta-analysis, presented by Dr. Stone, TCT 2006. TAXUS Stent meta-analysis: TAXUS II1 (4 yr) , IV2 (4 yr), V3 (2yr), VI4 (3 yr) (N=3445). 1. Colombo et al. Circulation. 2003;108:788; 2. Stone et al. N Engl Med. 2004;350:221; 3. Stone et al. JAMA. 2005;294:1215; 4. Dawkins et al. Circulation. 2005;112:3306. PSST 3813
TAXUS™Stent: Death or QWMI As safe --or safer-- than a BMS TAXUS Stent meta-analysis TAXUS II1 (4 yr) , IV2 (4 yr), V3 (2yr), VI4 (3 yr) studies (N=3445) p=0.72 p=0.79 p=0.80 p=0.97 p=0.82 Δ – 0.5% Death or QWMI (%) TAXUS Stent (N=1718) Bare Metal Stent (N=1727) *TAXUS 4 –year meta-analysis, presented by Dr. Stone, TCT 2006. TAXUS Stent meta-analysis: TAXUS II1 (4 yr) , IV2 (4 yr), V3 (2yr), VI4 (3 yr) (N=3445). 1. Colombo et al. Circulation. 2003;108:788; 2. Stone et al. N Engl Med. 2004;350:221; 3. Stone et al. JAMA. 2005;294:1215; 4. Dawkins et al. Circulation. 2005;112:3306. PSST 3813
TAXUS™Stent is superior in diabetic patients* • Four independent studies show the TAXUS Stent is superior in diabetics* • Paclitaxel appears to have a more effective mechanism of action than sirolimus ± *TC WYRE registry data presented by Dr. Kandzari and Dr. O’Neill at TCT 2006. Kaiser Permanente registry data presented by Dr. Brar at TCT 2006. Centro Cuore Columbus (Milan II) data presented by Dr Cosgrave at TCT 2006. Prairie Heart Institute registry data presented by Dr. Mishkel et al. TCT 2006. ±Mechanism of paclitaxel in diabetics described by Dawkins et al in EuroInterv.2006;2:61-68; and described by Patterson et al in Arterioscler Thromb Vasc Biol. 2006;26:1-8. PSST 3813
TAXUS™ Stent and CYPHER™ Stent: Assessment Guide Favors Cypher Stent TAXUS Stent TLR (%) Favors TAXUSStent CYPHERStent TLR (%) PSST 3813 CypherTM is a registered trademark of Cordis Corporation
The TAXUS™ Stent is Superior to the Cypher™ Stent in Diabetics± Size of circle adjusted for number of patients n=250 ** n=1129 ** n=745 ** TAXUS Stent TLR (%) n=498 n=389 n=189 n = 250 ** n=293 n=160 ** n=536 n=4,187 n=248 CYPHERStent TLR (%) *CYPHER INTEGRATED ANALYSIS AND TAXUS META-ANALYSIS (IDDM). Pooling of data performed by Boston Scientific. Data points represent similar lesion types from the two referenced trials, but are not head to head trials. ** STENT IDDM, SOLACI, TC-WYRE, PRAIRIE HEART, RESEARCH /T-Search are TVR Cypher is a registered trademark of J&J/ Cordis Corp. Milan Registry presented by Dr. Colombo at ACC 2005: STENT Registry presented by Dr. Simonton at ACC 2006; ISAR Diabetes study published Dibra. NEJM 2005;353:663-70; SOLACI Registry presented by Dr. Sousa at TCT 2005; T-SEARCH RESEARCH Registry published Ong at, et al. J Am Col Cardiol 2005;45:1135-41 Diabetes I, II presented by Dr. Sabate at PCR 2005. *Cypher Stent integrated analysis presented by Dr. Stone at TCT 2006. TAXUS meta-analysis presented by Dr. Stone at TCT 2006 . ±TC-WYRE Registry presented by Dr. Kandzari at TCT 2006. Prairie Heart Registry e-poster presented by Dr. Mishkel at TCT 2006. MILAN II Registry presented by Dr. Cosgrove at TCT 2006. PSST 3813
New studies from TCT confirm that the TAXUS™ Stent is Superior in Diabetics TC WYRE Registry Kaiser Permanente Registry MILAN II Registry Prairie Heart Institute Registry 12-Month TVR 12-Month Death, MI,TVR 12-Month TVR 9-Month TLR p=0.4 p=n.s. p=0.02* 31% p=0.004 67% 56% 26.3% 11.1% 9.0% 8.5% 8.5% 4.0% 2.8% N=171 N=171 N=247 N=289 N=272 N=227 N=928 N=201 TAXUS Stent: Clinically Superior TAXUS Stent: Clinically Superior Trend favors TAXUS Stent Trend favors TAXUS Stent TAXUSStent Cypher™Stent TC WYRE registry data presented by Dr. Kandzari and Dr. O’Neill at TCT 2006. Kaiser Permanente registry data presented by Dr. Brar at TCT 2006. Centro Cuore Columbus (Milan II) data presented by Dr Cosgrave at TCT 2006. Prairie Heart Institute registry data presented by Dr. Mishkel et al. TCT 2006. Cypher is a registered trademark of J&J/ Cordis Corp. * Log-Rank p-value. PSST 3813
TAXUS™ Stent: Significantly lower TLRand as safe -- or safer -- than a BMS in diabetics TAXUS Stent 4 yr meta-analysis: All Diabetics TAXUS II1 (4 yr) , IV2 (4 yr), V3 (2yr), VI4 (3 yr) studies (N=814) p=0.58 p=0.75 p=0.18 p=0.31 p<0.0001 p=0.80 25.5% Events (%) Δ – 3.0% 13.1% 12.6% 11.0% 9.6% 9.1% 4.6% 3.8% 1.7% 1.2% 1.4% 0.5% TLR CardiacDeath Death or QWMI All Death Stent Thrombosis QWMI TAXUS Stent (N=399) Bare Metal Stent (N=415) TAXUS 4 year meta-analysis, presented by Dr. Baim, TCT 2006. 1. Colombo et al. Circulation. 2003;108:788; 2. Stone et al. N Engl Med. 2004;350:221; 3. Stone et al. JAMA. 2005;294:1215; 4. Dawkins et al. Circulation. 2005;112:3306. the TAXUS IV and VI studies and Express2 Stent in the TAXUS V study. Paclitaxel-Eluting NIR Stent and TAXUS Express Stent are investigational devices only. PSST 3813
TAXUS™ Stent: Mortality benefit in Diabetic patients*~ New TCT 2006 data ~ S.T.E.N.T. RegistryInsulin-Treated Diabetics 9-months Prairie Heart Institute Registry All Diabetics 9-months MILAN II RegistryAll Diabetics 12-months p=0.005 p=0.07 p=0.32 58% Mortality Rate (%) N=263 N=235 N=147 N=113 N=928 N=201 Trend favors TAXUS Stent Trend favors TAXUS Stent TAXUS Stent: Clinically Superior TAXUSStent Cypher™Stent S.T.E.N.T. Registry presented at ACC 2006 by Dr. Simonton.*Prairie Heart Institute study presented by Dr. Mishkel et al. TCT 2006. Centro Cuore Columbus (Milan II) data presented by Dr Cosgrave at TCT 2006.Cypher is a registered trademark of J&J/ Cordis Corp. PSST 3813
Endeavor™ Stent has shown Late Stent Thrombosis (LST)† • The Endeavor Stent has shown Late and Very Late Stent Thrombosis (VLST)† • Zotarolimus-eluting stents failed to meet their primary endpoint in head to head clinical studies against current leading drug-eluting stents** • The Endeavor Stent may be less effective in high risk patients± †Endeavor LST data presented by Dr. Don Cutlip, TCT 2006. **Endeavor III, presented by Dr. Kandzari, TCT 2005. ZoMaxx I, presented by Dr. Chevalier, TCT 2006. ± Journal of Interventional Cardiology 2005, 19: 405-413, Dr. Leon. Endeavor is a trademark of Medtronic Corporation. Zotarolimus is ABT578, the same drug on ZoMaxx™ and Endeavor™ Stents. ZoMaxx is a trademark of Abbott Corp. PSST 3813
The Endeavor™ Stent has shown Late Stent Thrombosis ENDEAVOR Trials (ENDEAVOR I, II, IICA, III n=1317) No Long Term 4 year data available Three fold increase in ST rates with new ARC “Dublin” definition*^ Data available only out to 2 years ? Endeavor Stent Thrombosis rates utilizing new ARC “Dublin” Definition*^ 0.2% 0.2% Endeavor Stent Thrombosis rate as previously reported* 0.5% 0.5% 0.3% 0.3% 0.3% 4 Year Total: % 2 Year Total: 1.0% <30 Day Total: 0.3% ? Early (<30 days) Late (30 days-1year) Very Late (>1year) *Endeavor Pooled analysis, presented by Dr. Fajadet at TCT 2006. *^ Stent Thrombosis new standard definitions, presented by Dr. Cutlip at TCT 2006. Reference ARC definition in glossary. Endeavor is a registered trademark of Medtronic Corp. Endeavor IICA (Controlled Access) is the registry arm of the Endeavor II trial. PSST 3813
Zotarolimus-eluting stents failed primary endpoint in head to head clinical studies¥ Zomaxx I Study 9-month In segment Late Loss (mm) Endeavor III Study 8-months In segment Late Loss (mm) p<0.001 p=0.003 N=199 N=197 N=328 N=113 Cypher™ Stent TAXUS™ Stent Endeavor™Stent ZoMaxx™Stent ZoMaxx Stent is no longer being commercialized* ¥Zomaxx I Study, presented by Dr. Chevalier at TCT 2006, Endeavor III Study presented by Dr. Kandzari, TCT 2005. *Abbott press release October 3, 2006. Cypher is a registered trademark of J&J/ Cordis Corp.ENDEAVOR is a registered trademark of Medtronic Corp.ZoMaxx is a registered trademark of Abbott Corp. PSST 3813
The Endeavor™ stent may be less effective in high risk patients± Endeavor II study: 9 months TAXUS IV study: 9 months TLR (%) TLR (%) <2.5mm >16mm >20mm <2.5mm TAXUS Stent N=662 Endeavor™ Stent N=598 TAXUS IV presented by Dr. Stone at TCT 2003. TAXUS stent is not approved for vessels < 2.25. ENDEAVOR II presented by Dr. Wijns, ACC 2005. ± Journal of Interventional Cardiology 2005, 19: 405-413, Dr. Leon. ENDEAVOR is a trademark of Medtronic, Corp. PSST 3813
Glossary: Recently Proposed Stent Thrombosis Definition (ARC “Dublin” Definition) • NEED FOR A COMMON ST DEFINITION • BSC TAXUS trials protocols • originally Definite ST AND Probable ST (almost identical to “Dublin” Definition) • J&J clinical trial protocols • originally Definite ST • then added Probable ST • Medtronic clinical trial protocols • originally Definite ST ARC: Academic Research Consortium. Presented at TCT 2006 PSST 3813
Glossary • Clinical Trials and Registries • Cypher Integrated Analysis is a trial sponsored by J&J Cordis Corp. • Endeavor I, II and III are trials sponsored by Medtronic, Corp. • Zomaxx I is a trial sponsored by Abbott Corp. • S.T.E.N.T IDDM is an independent registry • MILAN and MILAN II are independent registries • TC WYRE is an independent registry • Prairie Heart is an independent registry • Kaiser Permanente is an independent registry • SOLACI is an independent registry • Research/T-Search is an independent registry • Diabetes I and II are independent registries • ISAR Diabetes is an independent registry • TAXUS Stent meta-analysis: TAXUS II (4 yr) , IV (4 yr), V (2yr), VI (3 yr) studies: TAXUS™ Stents include the Paclitaxel-Eluting NIR™ Stent (NIR is a trademark of Medinol, Ltd, Jerusalem) in the TAXUS II study, the TAXUS™ Express™ Stent in the TAXUS IV and VI studies and the TAXUS™ Express2™ Stent in the TAXUS V study. BMS Control includes the NIR in the TAXUS II study, Express™ Stent in the TAXUS IV and VI studies and Express2 Stent in the TAXUS V study. Paclitaxel-Eluting NIR Stent and TAXUS Express Stent are investigational devices only. PSST 3813