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 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 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) n = 397 (5%) Drug-eluting stent (DES) n = 7023 (95%) SES only n = 3873 (55%) Combinations n = 514 (7%) PES only n = 2636 (38%) Presented at TCT 2006

DEScover One-Year Clinical Results: Baseline Characteristics BMS Group (n=397) SES Group (n=3873) PES Group (n=2636) p-value BMS vs. DES Mean Age, SD (years) 66.0 + 11.9 63.6 + 12.0 64.7 + 11.6 0.001 Prior coronary bypass (%) 26.6 18.3 20.0 0.0002 Prior angioplasty (%) 29.5 36.9 38.1 0.0017 Mean ejection fraction, SD 49.5 + 13.9 52.7 + 12.5 52.8 + 13.0 <0.0001 Ejection fraction <40% (%) 13.2 13.5 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 Group (n=397) SES Group (n=3873) PES Group (n=2636) p-value BMS vs. DES Vessel Disease: Single Double Triple 59.2 21.5 19.3 57.6 26.6 15.9 57.5 27.4 15.1 0.03 Indication for procedure (%) Acute MI Unstable Angina Stable Angina Objective Evidence of Ischemia Other/Undetermined 31.8 26.3 9.6 23.7 8.6 21.0 31.6 14.4 25.0 8.0 20.8 34.2 14.5 23.3 7.1 <0.0001 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 Patients in the BMS group had fewer attempted lesions (p<0.0001), a lower frequency of multi-lesion intervention (p=0.0005), fewer stents used (p<0.0001), less stent overlap (p=0.06) than DES patients BMS patients had a higher incidence of total occlusions (p<0.0001) and de novo lesion intervention (p=0.01) BMS Group (n=397) SES Group (n=3873) PES Group (n=2636) p-value BMS vs. DES Mean attempted lesions, SD 1.3 + 0.5 1.5 + 0.7 1.4 + 0.7 <0.0001 Multi-lesion intervention (%) 25.5 34.7 32.3 0.0005 Mean stents used, SD 1.2 + 0.5 1.3 + 0.6 Stent overlap (%) 13.2 17.5 15.1 0.06 Lesion type (%) total occlusion de novo lesion 19.1 96.5 11.2 93.7 9.9 94.1 0.01 Presented at TCT 2006

DEScover One-Year Clinical Results: Procedural Characteristics Patients in the BMS group had a significantly larger maximum diameter of stent used (p<0.0001), but a shorter stent length (p=0.0002) than patients in the DES group 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 BMS Group (n=397) SES Group (n=3873) PES Group (n= 2636) p-value BMS vs. DES Mean max. diam. of stent used, SD 3.3 + 0.9 3.0 + 0.4 2.9 + 0.4 <0.0001 Mean max. length of stent used, SD 18.3 + 6.8 20.2 + 7.2 18.6 + 7.0 0.0002 Persistent flow reduction (%) 2.3 0.3 0.7 Procedural Success Complete Partial Failure 96.7 2.8 0.5 98.7 1.3 0.1 98.3 1.5 0.2 0.005 Presented at TCT 2006

DEScover One-Year Clinical Results: BMS vs. DES Adverse Events Adverse Events (%) at one-year post-PCI for BMS (n=397) vs. DES (n=6509) patients p=0.007 p=0.62 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 one-year post-PCI on univariate analysis p=0.005 p=0.19 p=0.0007 p=0.67 Presented at TCT 2006

DEScover In Hospital Results: SES vs. PES Adverse Events Adverse Events (%) in-hospital post-PCI for SES (n=3873) vs. DES (n=2636) patients p=0.18 There was no statistically significant difference in adverse events between SES and PES patients in-hospital post-PCI. p=0.40 p=0.67 p=0.49 p=0.22 p=0.31 p=0.41 Presented at TCT 2006

DEScover One-Year Clinical Results: SES vs. PES Adverse Events Adverse Events (%) at one-year post-PCI for SES (n=3873) vs. DES (n=2636) patients p=0.37 There was no statistically significant difference in adverse events between SES and PES patients at one-year post-PCI. p=0.20 p=0.64 p=0.45 p=0.20 p=0.53 p=0.06 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). 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 3.3%, 2.8% MI 2.2%, 2.6% Death/MI 5.2%, 5.3% Stent thrombosis 0.5%, 0.8% No significant differences in rates of any repeat PCI, CABG, or TVR (6.3%, 5.5%) 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 Presented at TCT 2006