1. SPIRIT IV 2 Year Results and The SPIRIT Women Clinical Trial
One Year Clinical Follow-up
Alexandra Lansky, MD
Associate Professor of Medicine
Yale University School of Medicine
On Behalf of the SPIRIT Women Investigators

2. Alexandra J. Lansky, MD
I have no real or apparent conflicts of interest to report.

3. Fluorinated Copolymer
XIENCE V: Design Components
MULTI-LINK VISION
Cobalt Chromium
Stent
MULTI-LINK VISION
Stent Delivery System
Drug
Everolimus
Drug Matrix
Fluorinated Copolymer

4. Safety and Performance Post CE Mark Approval International
XIENCE V Clinical Trials
2 year F/U Registry
Enrollment Complete
Enrollment Complete
Enrollment Complete
5 year F/U
3 year F/U
3 year F/U
1 year F/U
SPIRIT II
SPIRIT III
SPIRIT IV
SPIRIT V
XIENCE V
USA
XIENCE V
India
SPIRIT
FIRST
SPIRIT
WOMEN
Safety and Performance
Europe
N=60
Clinical Support for
CE Launch
International
N=300
U.S. and
Japan Approval
U.S.:
65 sites
Japan:
12 sites
N=1380 (1,292/88)
U.S. Continued
Access
Expanded
Enrollment:
N=3,690
Post CE Mark Approval International
N=3,000
100 sites
Registry
N=2,700
Diabetic study
N=325
Post CE Mark Approval
International
N=2,000
100 sites
Single Arm Study
N=1600
Randomized
Sub Study
N=454
U.S. Post Approval
N=8000
India Post Approval
N=1000
Anticipated Total # Patients = 18,000

5. Enrolled (N = 3,690) at 66 US sites
SPIRIT IV
TAXUS
(N = 1,229)
XIENCE V
(N = 2,458)
RVD: 2.5 – 3.75 mm
LL: ≤ 28 mm
Enrolled (N = 3,690) at 66 US sites
Up to three de novo lesions, maximum of two lesions per epicardial vessel
Randomized
(N = 3,687)*
Qced by Guoping Su, 2/8/10
Prospective, single-blind, active-controlled, randomized trial in 3,687 pts
Clinical follow-up up to 5 years in all patients
Primary endpoint: Target lesion failure (TLF) at 1 year
Major secondary endpoints: Ischemia-driven target lesion revascularization (TLR) at 1 year; composite of cardiac death or target vessel myocardial infarction at 1 year
All endpoints powered for sequential noninferiority and superiority testing

6. SPIRIT IV − Gender Subgroup
Randomized
(N=3,687)
XIENCE V
(N=2,458)
TAXUS
(N=1,229)
Qced by Guoping Su, 2/8/10
Women
(N=1,188) 32%
Men
(N=2,499) 68%
XIENCE V
(N=792)
TAXUS
(N=396)
XIENCE V
(N=1,666)
TAXUS
(N=833)

7. SPIRIT IV − Gender Subgroup: Baseline Demographics
Women (N=1,188)
Men (N=2,499)
XIENCE V
N=792
TAXUS
N=396
P value
N=1,666
N=833
Age (in years)
65 ± 11
66 ± 10
0.10
62 ± 10
0.40
Body Mass Index (kg/m2)
31 ± 7
0.91
30 ± 5
31 ± 6
0.11
Hypertension (%)
80.7
81.1
0.94
75.8
73.8
0.28
Diabetes Mellitus (%)
35.4
38.2
0.34
30.4
29.8
0.75
Current Smoker (%)
22.3
20.7
0.60
21.7
23.2
0.38
Prior MI (%)
16.5
12.9
0.12
23.3
1.00
Unstable Angina (%)
32.1
28.2
0.18
25.6
29.2
0.06
Qced by Guoping Su, 2/8/10
N = Number of patients

8. SPIRIT IV − Gender Subgroup: Baseline Lesion Characteristics
Women (NL=1,456)
Men (NL=3,271)
XIENCE V
NL=972
TAXUS
NL=484
P value
NL=2,170
NL=1,101
Lesion Location
LAD (%) 42 41
0.74 40 39
0.82
LCX (%) 21 22
0.68 26 27
0.40
RCA (%) 37
0.95 35 34
0.61
LMCA (%) NA
QCA
RVD (mm)
2.67 ± 0.45
2.67 ± 0.44
0.96
2.78 ± 0.49
2.79 ± 0.47
0.52
MLD (mm)
0.76 ± 0.37
0.77 ± 0.38
0.57
0.74 ± 0.38
0.75 ± 0.39
0.46
% DS
71 ± 12
71 ± 13
0.42
73 ± 13
0.67
Lesion Length (mm)
14 ± 6
14 ± 7
0.54
15 ± 7
0.34
Qced by Guoping Su, 2/8/10
NL = Number of lesions

9. SPIRIT IV − Gender Subgroup: Clinical Outcomes at 2 Years
Women (N=1,188)
Men (N=2,499)
XIENCE V N=792
TAXUS N=396 P
value
XIENCE V N=1,666
TAXUS N=833
TLF (%)*
6.9
10.8
0.03
7.3
9.6
0.048
Cardiac Death (%)**
0.9
1.8
0.25
1.0
0.83
Target Vessel MI (%)**
2.4
3.9
0.14
2.3
3.3
0.18
Ischemia-driven TLR (%)**
4.1
0.02
4.9
6.7
0.09
MACE (%)*
7.1
11.3
7.5
0.08
Stent thrombosis
(ARC def/prob) (%)
0.26
1.57
0.49
1.12
0.12
Bleeding complications (%)
6.1
0.37
3.7
3.0
0.48
Qced by Guoping Su, 2/8/10
TLF = cardiac death, target vessel MI, and ischemia-driven TLR;
MACE = cardiac death, MI, ischemia-driven TLR;
*Hierarchical subject count; **Non-hierarchical subject count.

10. Pinteraction (Women vs. Men) = 0.24
SPIRIT IV − Women Subgroup:
Stent Thrombosis (ARC Definition)* at 2 Years
Acute (0 – 24 hours)
Subacute (>24 hours – 30 days)
Late (>30 days – 2 years)**
XIENCE V
N=792
0.26%
p=0.02
Qced by Guoping Su, 2/8/10, table 19.2
TAXUS
N=396
1.57%
Stent Thrombosis (%)
Pinteraction (Women vs. Men) = 0.24
*Definite or Probable per ARC definition;
**Categorical data, 730 ± 28 days

11. Pinteraction (Women vs. Men) = 0.24
SPIRIT IV − Men Subgroup:
Stent Thrombosis (ARC Definition)* at 2 Years
Acute (0 – 24 hours)
Subacute (>24 hours – 30 days)
Late (>30 days – 2 years)**
XIENCE V
N=1,665
0.49%
p=0.12
Qced by Guoping Su, 2/8/10, table 19.3
TAXUS
N=833
1.12%
Stent Thrombosis (%)
Pinteraction (Women vs. Men) = 0.24
*Definite or Probable per ARC definition;
**Categorical data, 730 ± 28 days

12. PURPOSE and METHODS
The SPIRIT Women Study provides an evaluation of the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent (EES) in the female population undergoing stent implantation*.
SPIRIT Women is a prospective, open-label, single arm, all-comer multi-center study conducted at 73 sites outside of the United States female patients were enrolled between July 2007 and March 2009.
Maximum of 4 planned XIENCE V EESCC,
Target lesions must be de novo
Reference diameter between 2.5 mm and 4.0 mm
Lesion length ≤ 28 mm.
SPIRIT Women is the first major interventional trial with drug eluting stents to focus on women and specific aspects of their health in relation to CAD

13. SPIRIT WOMEN Global Site Distribution
Hungary (2)
Israel (1)
Italy (12)
Latvia (1)
Netherlands (5)
Norway (2)
Poland (2)
Austria (3)
Belgium (3)
Denmark (1)
France (8)
Germany (15)
Portugal (4)
South Africa (2)
Spain (5)
Switzerland (3)
UK (4)
Australia (2)
Hong Kong (4)
India (6)
Malaysia (1)
China (6)
Argentina (2)
Brazil (4)
Venezuela (1)

14. STUDY DESIGN
SPIRIT WOMEN RCT
N  450 2 : 1
XIENCE V
N = 300
Prospective, double arm, multi-centre study performed in parallel with a prospective, single arm study
CYPHER Select Plus™*
N = 150
SPIRIT WOMEN
SAS
N  1600
Primary endpoint:
In-stent late loss at 270 days
Primary endpoint: Composite endpoint at 1 year
(All death, MI, TVR)
PI: Marie-Claude Morice, MD, Massy, France
Co-PI: Dr Stephan Windecker, MD, Bern, Switzerland
Steering Committee: MG Modena, Modena, Italy, G Mikhail, London, UK, F Mauri, Barcelona, Spain,
R Strasser, Dresden, Germany, L Grinfeld, Buenos Aires, Argentina
Angiographic Core Lab: BioClinica, Leiden, The Netherlands
All Events adjudicated by an independent CEC to Academic Research Consortium (ARC) Definitions
CEC: K Koch, A Hoye, C Hanet, D McClean, E McFadden, V Umans, P Agostoni
DSMB: J Tijssen, W Wijns, P Urban, K Fox
Sponsor: Abbott Vascular
SAS Enrollment Complete: 27 March 2009
* Cypher Select Plus Coronary Stent System is a registered trademark of Cordis or its affiliates.

15. CLINICAL STUDY POPULATION
Intent to Treat Baseline and 30 Days
5: Informed Consent Withdrawn
6: Lost to Follow-up
1: Missed Visit
N = 1560
240 Days
A high 98% of patients returned for 1 year follow-up
3: Informed Consent Withdrawn
4: Lost to Follow-up
3: Missed Visit
N = 1550
1-Year
Clinical Follow-up 99% at 1 Year

16. BASELINE DEMOGRAPHICS
Age 67 Years
Prior MI 26%
Unstable Angina 37%
Multi Vessel Disease 36%
Prior Cardiac Intervention 17%
Braunwald Class lll 16%
‘Real World’
N=1572
Diabetes 34%
Current Smoker 14%
Hypertension 78%
IDDM 11%
Hypercholesterolemia 64%
Family History CAD 36%
Prior Oophorectomy 9%
Prior Hysterectomy 20%
General Obesity 27%
Central Obesity* 71%
Post Menopausal 94%
*Waist circumference >88 cm

17. BASELINE LESION CHARACTERISTICS*
Left Main 1%
Mean Lesion Length 15mm
RVD ≤2.75mm 47%
Lesion length ≥20mm 29%
Mean % DS 83%
Mean RVD 2.9mm
‘Real World’
NL=2250 Lesions
Thrombus 6%
All lesion characteristics were visually assessed by the investigator. 47% of patients had a RVD <= % of patients had type B2 or C lesions and moderate to severe calcium was present in 30% of lesions. The mean lesion length was 15mm and 29% of lesions were >=20mm.
Eccentric 44%
Moderate or Severe Calcium 30%
Lesion Angulation >45º 23%
>1 Target Lesion 32%
Target Lesions Treated/Patient 1.4
ACC Lesion B2 or C 72%
*Visually assessed by Investigator

18. PRIMARY ENDPOINT RESULTS*
1 YEAR ARC DEFINED
PRIMARY ENDPOINT RESULTS*
All Death, MI and TVR % 6 9 12 15 3
XIENCE V 37
393
Days Post Index Procedure
7,8%
12%
The 12% composite endpoint rate was mainly driven by the high MI rate of 9%. Out of 139 MI events, 110 were peri-procedural MI events.
*Previous MI rates in SPIRIT III and SPIRIT IV were adjudicated using historical WHO definition. Events in SPIRIT Women were adjudicated according to Academic Research Consortium (ARC) Definitions (Peri-procedural MI=Troponin >3 times ULN)

19. 1 YEAR ARC DEFINED CLINICAL RESULTS Non-Hierarchical N=1550
All Death (%)
Cardiac Death
1.6
0.8
All ARC Defined MI* (%)
ARC Defined Peri-procedural MI
ARC Defined TV MI**
9.2
7.1#
8.7
ARC Defined Q-Wave TV MI
0.1
ARC Defined Non Q-Wave TV MI
8.6
TLR (%)
2.4
by PCI
2.1
by CABG
0.3
TVR including TLR (%)
3.0
2.7
Low rates of TLR and TVR for this complex patient and lesion population.
#111 out of 1572 patients (7.1%) had an ARC Defined Peri-procedural MI
All revascularizations are considered clinically indicated

20. 1 YEAR ARC DEFINED STENT THROMBOSIS
*90% of patients on Clopidogrel and 96% on Aspirin at 1 year follow-up
No subacute definite stent thromboses occurred

21. CONCLUSIONS
Results of the SPIRIT IV trial at 2 years demonstrated that women treated with XIENCE V EES had sustained superior safety and effectiveness with an 83% RRR in stent thrombosis compared to the Taxus stent
SPIRIT Women is the first prospective post-market study in an exclusively female “all comers” population evaluating high risk women
XIENCE V® has proven safe and effective with low rates of Target Lesion Revascularization (2.4%) and Stent Thrombosis (0.59%) despite the complexity of the population