1 / 16

The TAXUS™ Stent: Superiority in Diabetics*

The TAXUS™ Stent: Superiority in Diabetics*. Glossary at end of presentation.

chick
Télécharger la présentation

The TAXUS™ Stent: Superiority in Diabetics*

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. The TAXUS™ Stent: Superiority in Diabetics* Glossary at end of presentation *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. PSST# 3827A

  2. TAXUS™Stent is superior in diabetic patients* • Independent studies show the TAXUS Stent is superior in diabetics* • Paclitaxel appears to have a more effective mechanism of action than sirolimus in diabetic patients ± • The benefits are seen in efficacy AND SAFETY with the TAXUS 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. Prairie Heart Institute registry data presented by Dr. Mishkel et al. TCT 2006. ^ TAXUS 4 –year meta-analysis (All Diabetics) presented by Dr. Stone, TCT 2006. TAXUS Stent meta-analysis (all diabetics): 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.±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# 3827A

  3. TAXUS™Stent is superior in diabetic patients* • Independent studies show the TAXUS Stent is superior in diabetics* • Paclitaxel appears to have a more effective mechanism of action than sirolimus in diabetic patients± • The benefits are seen in efficacy AND SAFETY with the TAXUS 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. Prairie Heart Institute registry data presented by Dr. Mishkel et al. TCT 2006. ^ TAXUS 4 –year meta-analysis (All Diabetics) presented by Dr. Stone, TCT 2006. TAXUS Stent meta-analysis (all diabetics): 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.±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# 3827A

  4. TAXUS™ Stent: Statistically Significant TLR reduction in Complex Insulin-treated patients** ** * EndeavorTMStent ENDEAVOR II Study TAXUS Stent Meta-Analysis CypherTMStent Integrated Analysis 9-Month TLR 9-Month TLR 9-Month TLR 19.4% p=0.46 p=0.0063 p=1.00 16.9% 13.6% 11.5% 10.1% 5.8% N per arm not available N=70 total N=136 N=120 N=62 N=69 No Significant Difference No Significant Difference TAXUS Stent: Clinically Superior TAXUSStent EndeavorStent CypherStent BMS Control Cypher™is a trademark of Cordis Corp.Endeavor™ is a trademark of Medtronic Corp. ENDEAVOR II study data published in Circulation. 2006;114:798:806. *Trials included in CypherTM Integrated Analysis: RAVEL, SIRIUS, E SIRUS and C SIRIUS all studies sponsored by J&J-Cordis: Results published on TCTMD.com. **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.. Paclitaxel-Eluting NIR Stent and TAXUS Express Stent are investigational devices only. PSST# 3827A

  5. Head-to-head efficacy data favors TAXUS™ Stent over Cypher™ Stent in Diabetic Patients RE-SEARCH / T-SEARCH registry SOLACI registry MILAN registry REALITY study 12-Month TLR 12-Month TVR 9-Month TLR 8-Month In lesion restenosis p=n.s. p=n.s. p=n.s. p=n.s. 18.4% Odds ratio 95 % CI 15.9% 8.6% 5.8% 5.7% 4.1% CypherTM stent better TAXUSTM stent better N=145 N=148 N=420 N=325 N=228 N=151 Trend favors TAXUS Stent Trend favors TAXUS Stent Trend favors TAXUS Stent Trend favors TAXUS Stent TAXUS Stent CypherStent RESEARCH / T SEARCH data published by Dr. Ong in Am J Cardiol 2005;96:358; RESEARCH / T SEARCH is an independent registry. SOLACI data presented by Dr. Sousa, TCT 2005, SOLACI is an independent registry. MILAN Experience data published by Dr. Cosgrave in Am J Cardiol 2005;96:1663. MILAN Experience is an independent registry. REALITY published by Dr. Morice in JAMA. 2006;295:895. REALITY is a study sponsored by J&J/ Cordis Corp. CypherTM Stent is a registered trademark of J&J/ Cordis Corp. PSST# 3827A

  6. 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 CypherStent 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# 3827A

  7. The TAXUS™ Stent is Superior to the Cypher™ Stent in Diabetics± From these data in >4,400 diabetic patients, for every 100 TLR with the Cypher™ Stent, there are 73 TLR with the TAXUS™ Stent 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

  8. Diabetic EvidenceIncluding TCT ‘06 From these data in >4,400 diabetic patients, for every 100 TLR with the Cypher™ Stent, there are 73 TLR with the TAXUS™ Stent n=250 TAXUS™ Stent TLR (%) n=1129 n=745 n=498 n = 250 n=389 n=189 ^ n=293 n=4,187 n=160 CYPHER™ Stent TLR (%) n=536 n=248 ^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, T-Search / RESEARCH are TVR Cypher is a 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 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# 3827A

  9. Real World Registries reinforces TAXUS™ Stent performance in Diabetic Populations 12-Month TLR 6-Month TLR 6-Month TLR 6-Month TLR 3.6% 3.1% 2.0% 1.9% Diabetics N=260 Diabetics N=765 Diabetics N=1.236 Diabetics N=1.251 TAXUSStent* WISDOM Milestone II ARRIVE I ARRIVE II OLYMPIA I Phase I 6-Month TLR 1.1% Diabetics N=261 TAXUS™ Express2™ Stent was used in WISDOM, MILESTONEII, ARRIVE I+II registries, TAXUS™ Liberté™ Stent was used in the OLYMPIA registry, WISDOM registry presented by Dr. Russell, TCT 2004; sponsored by Boston Scientific Corp., MILESTONE II registry presented by Dr. Niemela, PCR 2005, sponsored by Boston Scientific Corp.; ARRIVE I registry presented by Dr. Lasala, TCT 2005; sponsored by Boston Scientific Corp., ARRIVE II registry presented by Dr. Lasala, ACC 2006; sponsored by Boston Scientific Corp., OLYMPIA I registry presented by Dr. Calderon, SOLACI 2006; sponsored by Boston Scientific Corp. PSST# 3827A

  10. TAXUS™Stent is superior in diabetic patients* • Independent studies show the TAXUS Stent is superior in diabetics* • Paclitaxel appears to have a more effective mechanism of action than sirolimus in diabetic patients± • The benefits are seen in efficacy AND SAFETY with the TAXUS 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. Prairie Heart Institute registry data presented by Dr. Mishkel et al. TCT 2006. ^ TAXUS 4 –year meta-analysis (All Diabetics) presented by Dr. Stone, TCT 2006. TAXUS Stent meta-analysis (all diabetics): 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.±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# 3827A

  11. 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. Paclitaxel-Eluting NIR Stent and TAXUS Express Stent are investigational devices only. PSST# 3827A

  12. TAXUS™ Stent: Mortality rates better 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# 3827A

  13. Cypher™ Stent all-cause mortality to 4 years in Diabetic sub-group vs total population Total population N=1748 Diabetic patients N=428 100% 100% 96.0% 94.8% 95% 95% P*=0.194 P*=0.002 93.3% Δ 8.2% 90% 90% 87.8% 85% 85% 80% 80% 0 360 720 1080 1440 0 360 720 1080 1440 Cypher Stent BMS control Adapted from Serruys TCT 2006. Serruys independent patient level analysis of the Cypher Stent presented at TCT 2006 Trials included in Cypher Integrated Analysis: RAVEL, SIRIUS, E SIRUS and C SIRIUS all studies sponsored by J&J-Cordis. Cypher is a trademark of J&J/ Cordis Corp. * Log rank p-value PSST# 3827A

  14. TAXUS™ Stent 4-Year Meta-AnalysisDiabetic Sub-Group TAXUS All-Cause Mortality to 4 Years by Diabetic Sub-Group Total Population n=3441 All Diabetics n=814 No Statistical Difference p=n.s. p=n.s. TAXUS 4 –year meta-analysis (All Diabetics) presented by Dr. Stone, TCT 2006. TAXUS Stent meta-analysis (all diabetics): 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. 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# 3827A

  15. TAXUS™Stent is superior in diabetic patients* • Independent studies show the TAXUS Stent is superior in diabetics* • Paclitaxel appears to have a more effective mechanism of action than sirolimus in diabetic patients± • The benefits are seen in efficacy AND SAFETY with the TAXUS 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. Prairie Heart Institute registry data presented by Dr. Mishkel et al. TCT 2006. ^ TAXUS 4 –year meta-analysis (All Diabetics) presented by Dr. Stone, TCT 2006. TAXUS Stent meta-analysis (all diabetics): 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.±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# 3827A

  16. Glossary • Clinical Trials and Registries • Cypher Integrated Analysis includes SIRIUS, E-SIRIUS, C-SIRIUS and RAVEL (studies sponsored by J&J Cordis Corp.) • Endeavor I, II and III are studies sponsored by Medtronic, Corp. • Zomaxx I is a trial sponsored by Abbott Corp. • S.T.E.N.T is an independent registry • MILAN and MILAN II are independent registries • TC WYRE is a registry sponsored by Boston Scientific • 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# 3827A

More Related