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)
Paclitaxel-eluting stent
(Taxus)
 n=684
With 970 lesions
 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
www. Clinical trial results.org
Presented at ACC 2005
REALITY: 8 month results
Primary Angiographic Endpoint at 8 Months
Binary Restenosis
25
20
P=NS
P=NS
%
15
10
9.6
11.1
7.0
8.3
•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)
5
0
In-lesion
Cypher
In-stent
Taxus
www. Clinical trial results.org
Presented at ACC 2005
REALITY: 8 month results
Angiographic Endpoints at 8 Months (late loss and minimum lumen diameter)
P<0.001
2.00
2
mm
P<0.001
1.79
1
1.85
1.71
•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
0.31
0.16
0.04
0.09
0
Late Loss,
in-lesion
Late loss,
in-stent
Cypher
www. Clinical trial results.org
MLD, inlesion
MLD, instent
Taxus
Presented at ACC 2005
REALITY: 8 Month Results
Angiographic Endpoint at 8 Months
Percent Diameter Stenosis
P<0.001
% Diameter Stenosis
30
25
26.7
23.1
• The Cypher stent
group had a
statistically signficantly
reduced percent
diameter stenosis
(23.1% vs. 26.7%)
20
15
10
5
0
Cypher
www. Clinical trial results.org
Taxus
Presented at ACC 2005
REALITY: 8 month results
Secondary Clinical Endpoint at 8 Months
Major Adverse Cardiac Events (MACE)
12
MACE %
10
10.6
9.2
8
6
4
2
0
• 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)
MACE
Cypher
www. Clinical trial results.org
Taxus
Presented at ACC 2005
REALITY: 8 month results
Acute and Subacute Stent Thromboses (SAT)
Within first 30 days of trial
Stent Thrombosis %
2.0
1.5
1.8
As Treated Analysis
p=0.0196
1.0
0.5
0.4
0.0
Cypher
www. Clinical trial results.org
Taxus
• 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
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).
www. Clinical trial results.org