DEScover OneYear Clinical Results Presented at Transcatheter Cardiovascular

DEScover: One-Year Clinical Results Presented at Transcatheter Cardiovascular Therapeutics 2006 Presented by Dr. David O. Williams and Dr. J. Dawn Abbott

DEScover One-Year Clinical Results: Study Design • Prospective/observational study • 140 clinical sites in the US • Each site to enroll at least 60 consecutive patients undergoing PCI: – Target -7, 500 patients – Enrollment period: December 2004 –June 2005 • Exclusion criteria: refusal or inability to provide written informed consent and/or HIPAA authorization www. Clinical trial results. org Presented at TCT 2006

DEScover One-Year Clinical Results: Definitions • Death – All cause mortality • Myocardial infarction – Evolutionary ST-segment elevation, or – New Q-waves or LBBB, or – CK>2 ULN and elevated CK-MB or troponin • Stent thrombosis – Acute (0 -24 hours), sub-acute (>24 hours – 30 days), or late (>30 days) – Classified as definite or probable (composite presented) – Adjudicated by an independent events committee • Angiographic characteristics were evaluated at the clinical sites www. Clinical trial results. org Presented at TCT 2006

DEScover One-Year Clinical Results: Study Population Enrolled patients n = 7752 > 1 stent attempted n = 7420 (96%) Balloon angioplasty n = 325 (4%) Bare-metal stent (BMS) Drug-eluting stent (DES) n = 397 (5%) n = 7023 (95%) SES only Combinations PES only n = 3873 (55%) n = 514 (7%) n = 2636 (38%) www. Clinical trial results. org Presented at TCT 2006

DEScover One-Year Clinical Results: Baseline Characteristics Mean Age, SD (years) Prior coronary bypass (%) Prior angioplasty (%) Mean ejection fraction, SD Ejection fraction <40% (%) BMS Group (n=397) SES Group (n=3873) PES Group (n=2636) 66. 0 + 11. 9 63. 6 + 12. 0 64. 7 + 11. 6 p-value BMS vs. DES 0. 001 26. 6 18. 3 20. 0002 29. 5 36. 9 38. 1 0. 0017 49. 5 + 13. 9 52. 7 + 12. 5 52. 8 + 13. 0 <0. 0001 20. 0 13. 2 13. 5 0. 001 www. Clinical trial results. org • Patients in the BMS group were older (p=0. 001), had a higher percentage of prior coronary bypass (p=0. 0002), a lower percentage of prior angioplasty (p=0. 0017), a lower ejection fraction (p<0. 0001), and a greater percentage EF <40% (p=0. 001) than patients in the DES group. Presented at TCT 2006

DEScover One-Year Clinical Results: Baseline Characteristics BMS SES PES Group (n=397) (n=3873) (n=2636) Vessel Disease: Single Double Triple Indication for procedure (%) Acute MI Unstable Angina Stable Angina Objective Evidence of Ischemia Other/Undetermined www. Clinical trial results. org 59. 2 21. 5 19. 3 57. 6 26. 6 15. 9 p-value BMS vs. DES 0. 03 57. 5 27. 4 15. 1 <0. 0001 31. 8 26. 3 9. 6 23. 7 21. 0 31. 6 14. 4 25. 0 20. 8 34. 2 14. 5 23. 3 8. 6 8. 0 7. 1 • Patients in the BMS group had greater multivessel disease (p=0. 03) as well as a higher incidence of acute MI and unstable angina (p<0. 0001) than patients in the DES group. Presented at TCT 2006

DEScover One-Year Clinical Results: Procedural Characteristics BMS Group SES Group PES Group (n=397) (n=3873) (n=2636) Mean attempted lesions, SD 1. 3 + 0. 5 1. 5 + 0. 7 1. 4 + 0. 7 Multi-lesion intervention (%) 25. 5 34. 7 32. 3 1. 2 + 0. 5 1. 4 + 0. 7 1. 3 + 0. 6 13. 2 17. 5 15. 1 Mean stents used, SD Stent overlap (%) Lesion type (%) total occlusion de novo lesion 19. 1 96. 5 www. Clinical trial results. org 11. 2 93. 7 9. 9 94. 1 • Patients in the BMS group had fewer attempted lesions p-value BMS (p<0. 0001), a lower vs. DES frequency of multi<0. 0001 lesion intervention (p=0. 0005), fewer 0. 0005 stents used (p<0. 0001), less stent overlap <0. 0001 (p=0. 06) than DES patients 0. 06 <0. 0001 0. 01 • BMS patients had a higher incidence of total occlusions (p<0. 0001) and de novo lesion intervention (p=0. 01) Presented at TCT 2006

DEScover One-Year Clinical Results: Procedural Characteristics Mean max. diam. of stent used, SD Mean max. length of stent used, SD Persistent flow reduction (%) Procedural Success Complete Partial Failure • Patients in the BMS group had a BMS Group SES Group PES Group p-value BMS significantly larger maximum diameter (n=397) (n=3873) (n= 2636) vs. DES of stent used 3. 3 + 0. 9 3. 0 + 0. 4 2. 9 + 0. 4 <0. 0001 (p<0. 0001), but a shorter stent length 18. 3 + 6. 8 20. 2 + 7. 2 18. 6 + 7. 0 0. 0002 (p=0. 0002) than patients in the DES 2. 3 0. 7 <0. 0001 group 0. 005 96. 7 2. 8 0. 5 www. Clinical trial results. org 98. 7 1. 3 0. 1 98. 3 1. 5 0. 2 • BMS patients had a significantly higher incidence of persistent flow reduction (p<0. 0001) and a lower procedural success rate (p=0. 005) than DES patients Presented at TCT 2006

DEScover One-Year Clinical Results: BMS vs. DES Adverse Events (%) at one-year post-PCI for BMS (n=397) vs. DES (n=6509) patients p=0. 007 p=0. 62 p=0. 005 p=0. 19 p=0. 0007 p=0. 67 www. Clinical trial results. org p=0. 002 • Death (p = 0. 005), CABG (p = 0. 0007), TVR (p = 0. 007) and the composite of Death/MI (p = 0. 002) were significantly lower in DES group versus BMS group at oneyear post-PCI on univariate analysis Presented at TCT 2006

DEScover In Hospital Results: SES vs. PES Adverse Events (%) in-hospital post-PCI for SES (n=3873) vs. DES (n=2636) patients p=0. 18 p=0. 40 p=0. 67 p=0. 49 p=0. 22 p=0. 31 www. Clinical trial results. org p=0. 41 • There was no statistically significant difference in adverse events between SES and PES patients inhospital post. PCI. Presented at TCT 2006

DEScover One-Year Clinical Results: SES vs. PES Adverse Events (%) at one-year post-PCI for SES (n=3873) vs. DES (n=2636) patients p=0. 37 p=0. 20 p=0. 64 p=0. 45 p=0. 20 p=0. 53 p=0. 06 www. Clinical trial results. org • There was no statistically significant difference in adverse events between SES and PES patients at one-year post-PCI. Presented at TCT 2006

DEScover One-Year Clinical Results: BMS vs. DES • Patient selection – BMS placed more often in AMI, CABG – DES preferred for prior stent procedures • Clinical outcomes – Unadjusted data for death favored DES (3. 1% vs. 5. 9%, p=0. 005) and Death/MI (5. 2% vs. 9. 0%, 0. 002) but no difference following adjustment (HR 0. 74, 95% CI 0. 52 -1. 07) – Unadjusted data favored DES for TVR (6. 0% vs. 9. 5%, 0. 007) as well as adjusted results (HR 0. 58, 95% CI 0. 40 -0. 83). www. Clinical trial results. org Presented at TCT 2006

DEScover One-Year Clinical Results: SES vs. PES • Patient selection – Baseline clinical and angiographic features nearly identical • Clinical outcomes – Early, intermediate, and one-year clinical outcomes similar (p=ns) with rates of major adverse events low • Death • MI • Death/MI • Stent thrombosis 3. 3%, 2. 8% 2. 2%, 2. 6% 5. 2%, 5. 3% 0. 5%, 0. 8% – No significant differences in rates of any repeat PCI, CABG, or TVR (6. 3%, 5. 5%) www. Clinical trial results. org Presented at TCT 2006

DEScover One-Year Clinical Results: Limitations • Number of BMS patients relatively small in comparison to DES group • Selection bias between BMS and DES patients (BMS put in STEMI pts, CABG pts etc) • Adjustment may not compensate for baseline differences • No information regarding antiplatelet therapy usage during follow-up • Follow-up beyond one-year desirable www. Clinical trial results. org Presented at TCT 2006