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 mm) and had larger in-stent minimum lumen diameters (2.00 mm vs 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= 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).