REALITY: 8 month results Randomized Multi-Center Head-to-Head Comparison of the Sirolimus-Eluting Stent (Cypher) and the Paclitaxel-Eluting Stent (Taxus) Presented at American College of Cardiology Scientific Sessions 2005 Presented by Dr. Marie-Claude Morice Orlando, Florida

REALITY: 8 month results 1353 patients randomized to stent implantation with either the sirolimus-eluting stent or the paclitaxel-eluting stent 27% female, 28% diabetic, mean age 63 years Sirolimus-eluting stent (Cypher) n=684 With 970 lesions Paclitaxel-eluting stent (Taxus) n=669 With 941 lesions Primary Endpoint: In-lesion binary restenosis at 8 month angiographic follow-up Secondary Endpoint: Major adverse cardiac events (MACE) at 1, 8, 12, 18, and 24 months Presented at ACC 2005

REALITY: 8 month results Primary Angiographic Endpoint at 8 Months Binary Restenosis The primary endpoint of binary in-lesion restenosis did not differ between the treatment groups (9.6% for Cypher stent group vs. 11.1% for Taxus stent group) P=NS P=NS Presented at ACC 2005

REALITY: 8 month results Angiographic Endpoints at 8 Months (late loss and minimum lumen diameter) P<0.001 P<0.001 The Cypher stent group had significantly less late lumen loss (0.09 mm vs. 0.31 mm) and had larger in-stent minimum lumen diameters (2.00 mm vs. 1.85 mm) at follow-up P<0.001 P<0.001 Presented at ACC 2005

REALITY: 8 Month Results Angiographic Endpoint at 8 Months Percent Diameter Stenosis P<0.001 The Cypher stent group had a statistically signficantly reduced percent diameter stenosis (23.1% vs. 26.7%) Presented at ACC 2005

REALITY: 8 month results Secondary Clinical Endpoint at 8 Months Major Adverse Cardiac Events (MACE) At 8 month clinical follow up, there was no difference in MACE (9.2% for Cypher stent group vs. 10.6% for Taxus stent group). No difference was seen in any component of MACE (death, MI, target lesion revascularization) Presented at ACC 2005

REALITY: 8 month results Acute and Subacute Stent Thromboses (SAT) Within first 30 days of trial By day 30, stent thrombosis was higher in the Taxus than in the Cypher stent group: (1.6% vs. 0.6%)(p=0.0723 by intent to treat) and in the as treated analysis (1.8% vs 0.4%, p=0.0196) One patient randomized to Cypher actually received a Taxus stent which thrombosed and this accounts for the difference in the intent to treat arm vs as treated analysis In a safety evaluation, the as treated analysis is preferred As Treated Analysis p=0.0196 Presented at ACC 2005

REALITY: Summary Among patients with de novo coronary lesions, treatment with the sirolimus-eluting stent (Cypher) was not associated with a difference in binary restenosis at 8 month angiographic follow-up compared to treatment with the paclitaxel-eluting stent (Taxus). Although the absolute number of stent thromboses was small, there was an increase in stent thromboses through 30 days in the Taxus stent group in the “as treated analysis”. The Cypher stent was associated with a third to a quarter of the late lumen loss observed in Taxus stents (p<0.001) and with larger lumens at follow-up (p<0.001).