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Randomized Multi-Center Head-to-Head Comparison of the Sirolimus-Eluting Stent (Cypher) and the Paclitaxel-Eluting Stent

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.

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Randomized Multi-Center Head-to-Head Comparison of the Sirolimus-Eluting Stent (Cypher) and the Paclitaxel-Eluting Stent

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  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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).

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