1. Xience V Everolimus-eluting Stent SPIRIT First 3-year Results SPIRIT II+III Meta-analysis
Gregg W. Stone, MD
Columbia University Medical Center
The Cardiovascular Research Foundation

2. The Xience V SPIRIT Program (Results reported)
SPIRIT First
RCT vs. Vision
SPIRIT II
RCT vs. Taxus
SPIRIT III
RCT vs. Taxus
Safety and performance
N = 60
Europe
PI: PW Serruys
3 year F/U completed
First time report
Clinical support for CE launch
N = 300
EU, India, NZ
PI: PW Serruys
1 year F/U completed
Pivotal RCT with parallel registries
N = 1,002 rand
USA
PI: GW Stone
9 month F/U completed
9 month pooled pt level meta-analysis
First time report

3. SPIRIT First: Study Design
XIENCE™ V Everolimus Eluting Coronary Stent (n=28)
Single de novo Lesions
2.8 – 3.2 mm, 12 mm length
n = 60 1 :
ML VISION® Control (n=32)
Prospective, randomized, single-blind trial
Stent Size: 3.0 x 18 mm
Clinical follow-up: 1, 6, 9, 12 months,
2, 3, 4, 5 years
Angio and IVUS follow-up: 6 and 12 months
Clopidogrel: 3 months
Bailout only with BMS
Only animal data on single stent available at the onset of the study
Angiographic and IVUS core lab: Cardialysis
Enrollment Complete: April 1, 2004
PI: Patrick Serruys

4. SPIRIT First: 3-year Follow-up
Patient Population
XIENCE™ V
N=60
Control
N=28
N=32
2: Bailout
1: Major Protocol Deviation*
1: Bailout
Per-protocol
Baseline
N=27
N=29
1: Withdrew consent > 30d
1: Withdrew consent > 30d
Per-protocol
Three Year
N=26
N=28
* Pt with heart failure waiting for a heart transplant

5. SPIRIT First: 3-year Results (non hierarchical event rates)%
P=0.04
No MACE after 1-year in the XIENCE V group
No stent thromboses in either group by protocol or ARC definitions
MACE = Cardiac death, MI, or ischemic TLR

6. (1,302 randomized patients)
SPIRIT II + III Pooled Meta-analysis Xience V vs. Taxus: Trial Descriptors
(1,302 randomized patients)
SPIRIT II
SPIRIT III
N rand pts, sites
300 pts at 31 sites
1002 pts at 65 sites
Xience V : Taxus
3:1 (223:77)
2:1 (669:333)
Geography
Europe, Asia
USA
Ref ves dia (mm)
2.5 – 4.0
2.5 – 3.75
Lesion length (mm)
≤ 28
N lesions, vessels
1-2 lesions, 1/vessel
Clinical FU w/i 1st yr
1, 6, 9, 12 mos
Angio FU, completed
275/300 at 6 mos
436/564 at 8 mos
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7. SPIRIT II + III Pooled Meta-analysis Baseline Features
(1,302 randomized patients)
Xience V
(n=892 pts)
Taxus
(n=410 pts)
Age (years)
62.9 ± 10.5
62.6 ± 10.1
Male
70.3%
68.2%
Diabetes
27.9%
27.1%
- treated with insulin
7.1%
5.7%
Hypertension
74.0%
72.3%
Hypercholesterolemia
72.8%
72.1%
Current smoker
25.3%
23.8%
Prior MI
23.7%
19.3%
Unstable angina
20.8%
26.5%
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There were no significant between group differences

8. SPIRIT II + III Pooled Meta-analysis Angiographic Characteristics
(1,501 lesions in 1,302 randomized patients)
Xience V
(n=1028 lsns)
Taxus
(n=473 lsns)
LAD
41.1%
43.8%
LCX
28.0%
26.4%
RCA
30.7%
29.6%
LMCA
0.1%
0.2%
RVD (mm)
2.75 ± 0.47
2.77 ± 0.48
MLD (mm)
0.88 ± 0.43
0.89 ± 0.41
% DS
67.7 ±13.6
67.5 ±13.6
Lsn length (mm)
14.3 ± 5.7
14.5 ± 5.9
Lesion
location
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QCA
There were no significant between group differences

9. SPIRIT II + III Pooled Meta-analysis Late Lossmm
Diff [95%CI]
-0.19 [-0.25,-0.13]
P<0.0001
Diff [95%CI]
-0.11 [-0.17,-0.06]
P=0.0004
±0.48
±0.36
±0.44
±0.37
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10. SPIRIT II + III Pooled Meta-analysis Binary Restenosis%
HR [95%CI]
0.53 [0.30,0.95]
P=0.039
HR [95%CI]
0.39 [0.17,0.86]
P=0.02
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11. SPIRIT II + III Pooled Meta-analysis Ischemic TLR (9 months)6
XIENCE V
TAXUS
5.1% 5 4
Ischemic TLR (%) 3
2.4% 2
HR [95% CI]
0.47 [0.26,0.87]
p=0.01 1 3 6 9
Time in months
Number at risk
XIENCE
TAXUS

12. SPIRIT II + III Pooled Meta-analysis Stent Thrombosis (9 months)4
XIENCE V
TAXUS 3
Stent thrombosis (%) 2
HR [95% CI]
1.82 [0.20,16.31]
p=0.59 1
0.45%
0.25% 3 6 9
Time in months
Number at risk
XIENCE
TAXUS
Protocol definition = ACS + angiographic ST or unexplained death or AMI (STE or Q) in TL distribution w/i 30d

13. SPIRIT II + III Pooled Meta-analysis Cardiac Death (9 months)4
XIENCE V
TAXUS 3
HR [95% CI]
0.45 [0.09,2.24]
p=0.32
Cardiac Death (%) 2 1
0.76%
0.35% 3 6 9
Time in months
Number at risk
XIENCE
TAXUS

14. SPIRIT II + III Pooled Meta-analysis Myocardial Infarction (9 months)4
HR [95% CI]
0.62 [0.28,1.35]
p=0.22
XIENCE V
TAXUS 3
2.7%
MI (%) 2
1.7% 1 3 6 9
Time in months
Number at risk
XIENCE
TAXUS

15. SPIRIT II + III Pooled Meta-analysis Cardiac Death or MI (9 months)4
XIENCE V
TAXUS
3.2% 3
p=0.19
2.1%
Cardiac Death or MI (%) 2 1 3 6 9
Time in months
Number at risk
XIENCE
TAXUS

16. SPIRIT II + III Pooled Meta-analysis MACE (9 months)10
XIENCE V
TAXUS
8.0% 8
HR [95% CI]
0.50 [0.31,0.81]
p=0.004 6
Ischemic MACE (%)
4.1% 4 2 3 6 9
Time in months
Number at risk
XIENCE
TAXUS
MACE = Cardiac death, MI, or ischemic TLR

17. SPIRIT II + III Pooled Meta-analysis Conclusions
Compared to the Taxus paclitaxel- eluting stent, the Xience V everolimus- eluting stent results in:
Reduced late loss and binary restenosis
Reduced target lesion revascularization
Similar rates of death, MI and stent thrombosis
Fewer major adverse cardiac events