Updated 3-Year Meta-Analysis of the TAXUS Clinical Trials Safety and Efficacy Demonstrated in 3,445 Randomized Patients Time allocation for this talk is 15 minutes. Approximately 25 – 30 slides. Gregg W. Stone, MD Columbia University Medical Center The Cardiovascular Research Foundation

Conflict of Interest Disclosure The following relationships exist related to this presentation: Consultant/Advisory Board (Boston Scientific)

TAXUS II, IV, V, VI: N=3,445 10.5 13.4 17.2 20.6 2.75 2.69 2.79

TAXUS II, IV, V, VI: N=3,445 N/A

Analysis of All Pts, TAXUS II, IV, V, VI Control (n=1727) TAXUS (n=1718) All Patients (n=3445)

Baseline Characteristics Overall Population, TAXUS II, IV, V, VI Control (n=1727) TAXUS (n=1718) P Value Diabetes 24.0% 23.2% 0.60 RVD (mm) 2.73±0.51 2.74±0.51 0.84 Lesion length (mm) 15.1±8.0 15.2±7.9 0.85 Type B2/C lesions 68.3% 67.0% 0.72 Multiple stents 19.5% 20.3% 0.58 QCA RVD <2.5mm 34.1% 33.7% 0.83 Visual length >26mm 14.6% 15.4% 0.54

TAXUS Trials Meta-Analysis: FU Duration 1 yr 2 yr 3 yr ACC’05 TCT’05

TAXUS Meta-Analysis Low Frequency Long-Term Safety Events Efficacy 3445 intent-to-treat patients overall 1727 bare metal Express vs. 1718 TAXUS Express 2289 with 2-year follow-up 1843 with 3-year follow-up 2627 pts with angiographic follow-up 1040 pts with IVUS follow-up Low Frequency Safety Events Long-Term Efficacy Overall Subgroups

Freedom from Stent Thrombosis Days Since Index Procedure Stent Thrombosis out to 3-Years Overall Population, TAXUS II, IV, V, VI 9m 6m 12m 2 yr 3 yr 100% 90% 80% Freedom from Stent Thrombosis TAXUS N = 1718 Control N = 1727 100 200 300 400 500 600 700 800 900 1000 1095 Days Since Index Procedure

Freedom from Stent Thrombosis Days Since Index Procedure Stent Thrombosis out to 3-Years Overall Population, TAXUS II, IV, V, VI 9m 6m 12m 2 yr 3 yr 100% 90% 80% 98.7% (T) 99.2% (C) p = 0.36 Stent Thrombosis Between 6 Mo and 2 Yrs N=0 Control N=8 TAXUS Stent Thrombosis Between 2 and 3 Years N=1 Control N=0 TAXUS Freedom from Stent Thrombosis TAXUS N = 1718 Control N = 1727 100 200 300 400 500 600 700 800 900 1000 1095 Days Since Index Procedure

Freedom from Cardiac Death Days Since Index Procedure 3-Year Freedom from Cardiac Death Overall Population, TAXUS II, IV, V, VI 9m 6m 12m 2 yr 3 yr 100% 90% 80% 70% 98.0% (C) 97.9% (T) P=0.81 Freedom from Cardiac Death TAXUS N = 1718 Control N = 1727 100 200 300 400 500 600 700 800 900 1000 1095 Days Since Index Procedure

3-Year Freedom from Any Death Overall Population, TAXUS II, IV, V, VI 2 yr 3 yr 100% 90% 80% 70% 60% 95.7% (C) 95.4% (T) p=0.89 Freedom from Any Death TAXUS N = 1718 Control N = 1727 100 200 300 400 500 600 700 800 900 1000 1095 Days Since Index Procedure

3-Year Freedom from MI Overall Population, TAXUS II, IV, V, VI 2 yr 3 yr 100% 90% 80% 70% 60% 93.6% (C) 93.4% (T) p=0.96 Freedom from MI TAXUS N = 1718 Control N = 1727 1095 500 600 700 800 900 1000 100 200 300 400 Days Since Index Procedure

3-Year Freedom from TLR Overall Population, TAXUS II, IV, V, VI 2 yr 3 yr 100% 90% 80% 70% 60% 90.6% (T) Δ9.1% Δ10.5% Freedom from TLR 80.1% (C) TAXUS N = 1718 Control N = 1727 p<0.0001 1095 500 600 700 800 900 1000 100 200 300 400 Days Since Index Procedure

% Binary Restenosis at 6-9 Months All Patients, TAXUS II, IV, V, VI (N=3,445) Control (n=1727) TAXUS (n=1718) p<0.0001 p<0.0001 69% 59% Patients (%) 338/1227 105/1247 368/1229 154/1249 In-Stent Analysis Segment

Effect of Vessel Size on 3-Year TLR TAXUS II, IV, V, VI MetaAnalysis 2 yr 3 yr 100% 90% 80% 70% 60% >3.0 2.5-3.0 ≤2.5 >3.0 2.5-3.0 Freedom from TLR Control TAXUS RVD >3.0 RVD2.5≤3.0 RVD≤2.5 P=0.0001 P<0.0001 ≤2.5 1095 500 600 700 800 900 1000 100 200 300 400 Days Since Index Procedure

Effect of Lesion Length on 3-Year TLR TAXUS II, IV, V, VI MetaAnalysis 2 yr 3 yr 100% 90% 80% 70% 60% <18 18-26 >26 18-26 Freedom from TLR <18 Control TAXUS >26mm 18-26mm <18mm P=0.002 P=0.0006 P<0.0001 >26 1095 500 600 700 800 900 1000 100 200 300 400 Days Since Index Procedure

Effect of Vessel Size and Lesion Length on 3-Year TLR Control TAXUS RVD in terciles (mm) 3-Year TLR (%) ≤2.5 >2.5<3.0 ≥3.0 <11 ≥17 <11 ≥17 ≥11≤17 ≥11≤17 Lesion Length in terciles (mm)

Days Since Index Procedure Effect of Diabetic Status on 3-year TLR TAXUS II, IV, V, VI MetaAnalysis 9m 12m 2 yr 3 yr 100% 90% 80% 70% 60% NonD Diab NonD Freedom from TLR Diab Control TAXUS Non-Diabetic P<0.0001 Diabetic P<0.0001 1095 500 600 700 800 900 1000 100 200 300 400 Days Since Index Procedure

Effect of Diabetic Status on 3-year TLR TAXUS II, IV, V, VI MetaAnalysis Control TAXUS p<0.0001 p<0.0001 p=0.005 52% 53% 61% 3-Year TLR (%) N= 1312 1319 279 279 136 120 Diabetic (Oral Agents) Diabetic (Insulin-Requiring) Non-Diabetic

Single vs. Multiple Stents TAXUS II, IV, V, VI Meta-Analysis Single Stents (n=2740) Control (n=1378) TAXUS (n=1362) All Patients Multiple Stents (n=684) Control (n=336) TAXUS (n=348)

Baseline Characteristics Multiple Stent Patients, TAXUS II, IV, V, VI Control n=336 TAXUS n=348 P value Type C lesions 70.3 68.7 0.67 RVD (mm) 2.72±0.55 2.71±0.52 0.73 Diabetes (%) 28.6 28.2 0.93 Lesion length (mm) 23.7±10.4 23.6±9.7 0.95 Stent length (mm) 41.6±11.4 41.7±10.7 0.83 Stent:lesion Ratio 2.07±1.14 2.07±1.11 0.92 Overlap stents (%) 85.3 81.7 0.30

MACE, Cumulative to 30 Days Multiple Stent Patients, TAXUS II, IV, V, VI Control (n=336) TAXUS (n=348) p=1.00 p=1.00 p=0.015 p=0.027 p=1.00 p=1.00 Adverse events (%) Cardiac Death Q-Wave MI Non-Q Wave MI MACE All Death ST

MACE, Cumulative to 3 Years Multiple Stent Patients, TAXUS II, IV, V, VI Control (n=336) TAXUS (n=348) p=0.67 p=0.49 p=0.21 p=0.0002 p=0.03 p=0.51 Adverse events (%) Cardiac Death Q-Wave MI Non-Q Wave MI MACE All Death ST

Freedom from cardiac death Days Since Index Procedure 3-Year Freedom from Cardiac Death Multiple Stent Patients, TAXUS II, IV, V, VI 9m 12m 2 yr 3 yr 100% 90% 80% 70% 60% 99.1% (T) 98.4% (C) Freedom from cardiac death p=0.67 TAXUS N = 348 Control N = 336 1095 500 600 700 800 900 1000 100 200 300 400 Days Since Index Procedure

3-Year Freedom from MI Multiple Stent Patients, TAXUS II, IV, V, VI 2 yr 3 yr 100% 90% 80% 70% 60% 90.0% (T) Freedom from MI 88.3% (C) p=0.40 TAXUS N = 348 Control N = 336 1095 500 600 700 800 900 1000 100 200 300 400 Days Since Index Procedure

3-Year Freedom from TLR Multiple Stent Patients, TAXUS II, IV, V, VI 2 yr 3 yr 100% 90% 80% 70% 60% 88.5% (T) Δ16.6% Δ19.9% Freedom from TLR p<0.0001 TAXUS N = 348 Control N = 336 68.6% (C) 1095 500 600 700 800 900 1000 100 200 300 400 Days Since Index Procedure

TLR up to 3-Years: Subgroup Summary All Pts, TAXUS II, IV, V, VI Meta-analysis HR [95% CI] HR TAXUS Control P Value All 0.42 9.3% 19.8% <0.0001 RVD ≤2.5 0.40 12.3% 27.4% RVD 2.5 - ≤3.0 0.47 9.1% 17.7% RVD >3.0 0.43 6.4% 13.2% 0.0002 Lsn Length <18 8.5% 19.0% Lsn Length 18-26 0.46 11.3% 18.5% 0.0008 Lsn Length >26 0.44 13.0% 28.2% 0.003 Non-Diabetic 8.8% Diabetic-Oral 0.39 11.8% 24.5% Diabetic-Insulin 0.37 9.2% 23.4% 0.007 Single Stent 0.45 17.2% Multiple Stents 0.33 11.5% 31.1% Univariate analysis for TLR through 3 Year, done using the Cox regression model with the Hazard Ratio (HR) and pvalue should be the one testing the HR =1 to match the previous presentation. 0.5 1.0 1.5

Summary TAXUS II, IV, V, VI Meta-Analysis to 3-Years Overall safety with the TAXUS stent to 3-years has been demonstrated No increased risk of early stent thrombosis Stent thrombosis rates at 3 years are comparable with control Increased late ST between 6 mos and 2 yrs seen (8 TAXUS vs. 0 control) – but 0 stent thrombosis with TAXUS between 2 and 3 years (vs. 1 case with control) Comparable rates of all cause death, cardiac death, and MI with TAXUS and control Marked reduction in TLR with TAXUS compared to control for 3 years with no late catch-up apparent

Summary TAXUS II, IV, V, VI Meta-Analysis to 3-Years Subgroups Significant benefit in all patient groups stratified by vessel size, lesion length and diabetic status; increased absolute benefit in higher risk cohorts Multiple stent group Increase peri-procedural non-Q MI in TAXUS pts 3-year results demonstrate similar rates of cardiac death and MI, and a marked reduction in TLR and binary restenosis