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Presented at TCT 2002

TAXUS II: Moderate Release Formula An International, Randomized, Multicenter, Blinded Trial of TAXUS TM NIRx TM MR Stent. Presented at TCT 2002. TAXUS II: Study Overview. Randomized 1:1 Triple-blind 536 Patients TAXUS TM NIRx TM SR (n=267) TAXUS TM NIRx TM MR (n=269)

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Presented at TCT 2002

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  1. TAXUS II: Moderate Release FormulaAn International, Randomized, Multicenter, Blinded Trial of TAXUSTM NIRxTM MR Stent Presented at TCT 2002

  2. TAXUS II: Study Overview • Randomized 1:1 • Triple-blind • 536 Patients • TAXUSTM NIRxTM SR (n=267) • TAXUSTM NIRxTM MR (n=269) • 30 day, 6 month, 1-5 year F/U • Primary endpoint: % in-stent net volume obstruction (IVUS) at 6 months • Inclusion Criteria • Standard risk de novo lesions • Length <12 mm • RVD >3.0 mm & <3.5 mm • Antiplatelet Regimen • ASA >75 mg (loading dose and maintained indefinitely) • Clopidogrel (loading dose 300mg and 75 mg q.d. for 6 months) TCT 2002

  3. TAXUS II: Two Consecutive Cohorts, Slow and Moderate Release Moderate Release (MR) Slow Release (SR) Cohort I SR = 267 Cohort II MR = 269 DMC TAXUS n = 131 Control n = 136 TAXUS n = 135 Control n = 134 30 Day Follow-up MR Follow-up Clinical: >96% Angiographic: >95% IVUS: >87% SR Follow-up Clinical: >99% Angiographic: >98% IVUS: >90% 6 Month Follow-up Annually 1-5 Years TCT 2002

  4. TAXUS II: Patient Demographics TAXUS MR (%)Control (%) p-value (n=135) (n=134) Male 76.0 77.0 1.000 Mean Age (years) 59.3+10.1 59.3+10.0 0.977 Prior MI 39.0 42.0 0.620 Prior Intervention 17.0 13.0 0.392 Diabetes 17.0 14.0 0.615 Unstable Angina 30.0 40.0 0.123 Hypertension 60.0 56.0 0.538 Smoker 24.0 29.0 0.411 TCT 2002

  5. TAXUS II: Baseline Lesion Characteristics TAXUS MR Control p-value (n=135) (n=134) RVD (mm) 2.72 + 0.5 2.73 + 0.5 0.769 MLD (mm) 0.95 + 0.3 0.91 + 0.4 0.380 Diameter Stenosis (%) 64.9 + 10.3 66.6 + 11.8 0.205 Lesion Length (mm) 10.16 + 4.8 10.71 + 4.1 0.309 TCT 2002

  6. TAXUS II: Primary Endpoint, In-stent Net Volume Obstruction at 6 Month IVUS 62% reduction p < 0.0001 % In-stent Net Volume Obstruction n=119 n=118 TAXUS MR Stent Control Stent TCT 2002

  7. TAXUS II: Clinical Events Through 6 Months Target Lesion Revascularization MACE* *Defined as cardiac death, MI, TVR p=0.006 p=0.002 TAXUS MR Stent Control Stent TAXUS MR Stent Control Stent TCT 2002

  8. TAXUS II: 6 Month Angiographic Restenosis Stented Segment p<0.0001 Distal Edge (5 mm) p=1.000 Proximal Edge (5 mm) p=0.3339 Restenosis (%) n=129 n=128 Control Stent Control Stent TAXUS MR Stent Control Stent TAXUS MR Stent TAXUS MR Stent TCT 2002

  9. TAXUS II: 6 Month Angiographic MLD Stented Segment p<0.0001 Distal Edge p=0.013 Proximal Edge p=0.005 (mm) n=134 n=135 Control Stent Control Stent TAXUS MR Stent Control Stent TAXUS MR Stent TAXUS MR Stent TCT 2002

  10. TAXUS II: Late Loss and Loss Index in Stented Segment Late Loss Loss Index p<0.0001 p<0.0001 (mm) n=130 n=127 n=130 n=127 TAXUS MR Stent Control Stent TAXUS MR Stent Control Stent TCT 2002

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