1. The SPIRIT II Study - A Clinical Evaluation of the XIENCE™ V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions Clinical, Angiographic and IVUS 2 year results
Patrick W. Serruys, MD, PhD
Thoraxcenter, Erasmus Medical Center, Rotterdam,
the Netherlands
SCAI-ACCi2 Late-Breaking Clinical Trials III: DES
Monday March 31st, am
Professor Serruys has no conflict of interest related to this presentation
CAUTION: XIENCE™ V is an Investigational device. Limited by Federal (U.S.) law to investigational use only.
TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.
SE REV A
© 2003 Guidant

2. SPIRIT II Clinical, Angiographic and IVUS 2 Year Results Patrick W
SPIRIT II Clinical, Angiographic and IVUS 2 Year Results Patrick W. Serruys on behalf of
Germany: J. Neuzner J. Schofer M. Wiemer G. Richardt M. Desaga The Netherlands: J. Piek H. Suryapranata M. Suttorp J.A.M. te Riele France: D. Carrie J. Berland C. Spaulding Denmark: L. Thuesen H. Kelbaek K. Rasmussen
New Zealand: P. Ruygrok India: A. Seth Switzerland: E. Camenzind Spain: C. Macaya E. Garcia Belgium: F. Van den Branden V. Legrand J. Boland Poland: W. Ruzyllo Italy: A. Manari Austria: K. Huber
CAUTION: XIENCE™ V is an Investigational device. Limited by Federal (U.S.) law to investigational use only.
TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.
SE REV A
© 2003 Guidant

3. Maximum two de novo lesions
Study Design
XIENCE™ V
n = 223
Maximum two de novo lesions
300 patients 3 : 1
2.5 – 4.0 mm
n = 300
TAXUS®
n = 77
Sponsor: Abbott Vascular
PI: PW Serruys MD, PhD
SC: E Garcia MD, J Ormiston MD, M Wiemer MD
DSMB: J Tijssen PhD, T Lefèvre MD, P Urban MD
CEC: C Hanet MD, D McClean MD, V Umans MD
Angiographic and IVUS Corelab: Cardialysis (Rotterdam, NL)
Prospective, randomized (3:1), single-blind, non-inferiority to TAXUS®
Primary endpoint: Angiographic in-stent late loss at 180 days (powered for sequential non-inferiority and superiority)
Secondary endpoint: Angiographic in-segment late loss at 180 days (powered for non-inferiority)
Clinical follow-up: 30, 180, 270 days, 1, 2, 3, 4 and 5 years. Angiographic and IVUS follow-up: baseline, 180 days & 2 years (only for 152 patients)
CAUTION: XIENCE™ V is an Investigational device. Limited by Federal (U.S.) law to investigational use only.
TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.
SE REV A
© 2003 Guidant

4. XIENCE™ V TAXUS® Clinical Study Population n = 300 n = 223 n = 77
7 non-cardiac deaths
1 withdrawn at 30 days
3 withdrawn at 1 year
1 lost to FU
4 non-cardiac deaths
2 Year
Clinical
n = 211
n = 73
n = 85
nL = 100
2 Year
QCA
n = 32
nL = 35
Angiographic and IVUS
Subgroup*
n = 72
nL = 78
2 Year
IVUS
n = 31
nL =32
nL: number of lesions
*Total angiographic and IVUS subgroup: 152 patients (113 XIENCETM V, 39 TAXUS®)
Angiographic follow-up at 2-year follow-up: XIENCE™ V: 75%; TAXUS®: 82% IVUS follow-up at 2-year follow-up: XIENCE™ V: 64%; TAXUS®: 79%
CAUTION: XIENCE™ V is an Investigational device. Limited by Federal (U.S.) law to investigational use only.
TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.
SE REV A
© 2003 Guidant

5. XIENCE™ V TAXUS® Clinical Study Population n = 300 n = 223 n = 77
2 Year
Clinical
n = 211
n = 73
-3 deaths
19 refused angio/IVUS
1 withdrawn at 30 days
-3 withdrawn at 1 year
-2 medical decisions
-4 deaths
-1 angio not required (did not receive study stent)
- 2 refused angio/IVUS
Need to add 3rd animation with details on missing IVUS
n = 85
nL = 100
2 Year
QCA
n = 32
nL = 35
n = 72
nL = 78
2 Year
IVUS
n = 31
nL =32
nL: number of lesions
*Total angiographic and IVUS subgroup: 152 patients (113 XIENCETM V, 39 TAXUS®)
Angiographic follow-up at 2-year follow-up: XIENCE™ V: 75%; TAXUS®: 82% IVUS follow-up at 2-year follow-up: XIENCE™ V: 64%; TAXUS®: 79%
CAUTION: XIENCE™ V is an Investigational device. Limited by Federal (U.S.) law to investigational use only.
TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.
SE REV A
© 2003 Guidant

6. XIENCE™ V TAXUS® Clinical Study Population n = 300 n = 223 n = 77
2 Year
Clinical
n = 211
n = 73
-3 deaths
19 refused angio/IVUS
1 withdrawn at 30 days
-3 withdrawn at 1 year
-5 IVUS catheter did not cross
-4 pullback issues
-2 medical decision
-1 patient in another hospital
-2 technical problem
-1 TLR but no IVUS done
Need to add 3rd animation with details on missing IVUS
n = 85
nL = 100
2 Year
QCA
n = 32
nL = 35
-4 deaths
-1 angio not required (did not receive study stent)
2 refused angio/IVUS
1 IVUS catheter did not cross
n = 72
nL = 78
2 Year
IVUS
n = 31
nL =32
*Total angiographic and IVUS subgroup: 152 patients (113 XIENCETM V, 39 TAXUS®)
nL: number of lesions
Angiographic follow-up at 2-year follow-up: XIENCE™ V: 75%; TAXUS®: 82% IVUS follow-up at 2-year follow-up: XIENCE™ V: 64%; TAXUS®: 79%
CAUTION: XIENCE™ V is an Investigational device. Limited by Federal (U.S.) law to investigational use only.
TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.
SE REV A
© 2003 Guidant

7. Baseline Demographics
ITT
Patients with 6 month
& 2 year Angio/IVUS FU
XIENCE™ V 223 pts
TAXUS® pts
XIENCE™ V 113 pts
TAXUS® pts
Male (%) 71 79 73 82
Mean age (years) 62
Previous MI (%) 35 25
42*
18*
Prior inter. at target vessel (%) 4 5 3
Diabetes mellitus (%) 23 24 22
Insulin-dependent diabetes (%) 7 8
Hyperlipidemia req. med. (%) 69 75 77
Hypertension req. med.(%) 67 65 61 51
Current smoker (%) 32 30
*p=0.007
CAUTION: XIENCE™ V is an Investigational device. Limited by Federal (U.S.) law to investigational use only.
TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.
SE REV A
© 2003 Guidant 7

8. Baseline Angiography ITT Patients with 6 month & 2 year Angio/IVUS FU
XIENCE™ V lesions
TAXUS® lesions
XIENCE™ V lesions
TAXUS® lesions
Dual Lesions Treated (%) 17 18 15
Type B2/C Lesions 78 80 76 77
Lesion Location
LAD 41 47 43 58
LCX
29*
19*
27**
13**
RCA 30 34 29
QCA
RVD (mm)
2.70*
2.82*
2.67**
2.86**
MLD (mm)
1.06*
1.14*
0.98**
1.13**
% DS
Lesion Length (mm)
Acute Gain (mm) 61
13.0
1.43 59
13.2
1.48 63
13.3
1.52 60
13.8
1.53
*LCX p=0.072, RVD p = 0.099, MLD p=0.033.
**LCX p=0.1, RVD p = 0.061, MLD p=0.013.
CAUTION: XIENCE™ V is an Investigational device. Limited by Federal (U.S.) law to investigational use only.
TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.
SE REV A
© 2003 Guidant 8

9. In-stent Late Loss in Patients with Serial 6 Month and 2 Year Angio FU
6 Months
2 Years
XIENCETM V
TAXUS® *
XIENCETM V
TAXUS® +
XIENCE V
XIENCETM V: 0.17 ± 0.32 (nL=97)
TAXUS®: 0.33 ± 0.32 (nL=35)
P=0.0037
XIENCETM V: 0.33 ± 0.37 (nL=97)
TAXUS®: 0.34 ± 0.34 (nL=35)
P=0.6026
In this serial analysis, for patients having TLR, values of loss and neo-intimal hyperplasia observed prior to 6 month or 2 year FU were imputed at 6 months and 2 years respectively
CAUTION: XIENCE™ V is an Investigational device. Limited by Federal (U.S.) law to investigational use only.
TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.
SE REV A

10. In-segment % Diameter Stenosis
In-Stent % Diameter Stenosis in Patients with Serial 6 Month and 2 Year Angio FU
6 Months
2 Years
XIENCETM V
TAXUS® + 0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
In-segment % Diameter Stenosis
XIENCETM V
TAXUS® *
XIENCETM V: 16.0% ± 11.4% (nL=97)
TAXUS® : 18.3% ± 10.6% (nL=35)
XIENCETM V: 19.2% ± 13.9% (nL=97)
TAXUS® : 18.8% ± 11.4% (nL=35)
P values from Wilcoxon test.
TAXUS
P =
P =
In this serial analysis, for patients having TLR, values of loss and neo-intimal hyperplasia observed prior to 6 month or 2 year FU were imputed at 6 months and 2 years respectively
CAUTION: XIENCE™ V is an Investigational device. Limited by Federal (U.S.) law to investigational use only.
TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.
SE REV A
© 2003 Guidant

11. Angiographic Binary Restenosis in Patients with Serial 6 Month and 2 Year Angio FU
6 Months
2 Years
P =
XIENCETM V (nL = 97)
TAXUS® (nL = 35)
P =
P =
P =
In this serial analysis, for patients having TLR, values of loss and neo-intimal hyperplasia observed prior to 6 month or 2 year FU were imputed at 6 months and 2 years respectively
CAUTION: XIENCE™ V is an Investigational device. Limited by Federal (U.S.) law to investigational use only.
TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.
SE REV A
© 2003 Guidant

12. IVUS in Patients with Serial 6 Month and 2 Year IVUS FU
6 Months
2 Years
mm3
mm3
2.8
6.5 1 2 3 4 5 6 7
% VO
P=0.0009
P=0.0007
P =
P = 7
5.8
5.2 6 5 4 3 2 1
P values from Wilcoxon Test
% VO
In this serial analysis, for patients having TLR, values of loss and neo-intimal hyperplasia
observed prior to 6 month or 2 year FU were imputed at 6 months and 2 years respectively
XIENCETM V (nL = 69)
TAXUS® (nL = 32)
CAUTION: XIENCE™ V is an Investigational device. Limited by Federal (U.S.) law to investigational use only.
TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.
SE REV A
© 2003 Guidant

13. ARC Stent Thrombosis Definite and Probable XIENCE™ V 223 patients
TAXUS ®
77 patients
Acute stent thrombosis (%)
0.0
Sub-acute stent thrombosis (%)
1.3
220 patients
Late stent thrombosis (%)
211 patients
73 patients
Very late stent thrombosis (%)
0.9
Total stent thrombosis (%)
1.4
Acute: 0 to 24 hours after stent implantation Subacute: >24 hours to 30 days after stent implantation
Late: >30 days to 1 year after stent implantation Very late: >1 year after stent implantation
p=NS
CAUTION: XIENCE™ V is an Investigational device. Limited by Federal (U.S.) law to investigational use only.
TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.
SE REV A
© 2003 Guidant

14. 2 Year Clinical Results Hierarchical XIENCE™ V 211 patients TAXUS ®
Cardiac death %
0.5
1.4
Myocardial infarction %
Q-wave MI
Non Q-wave MI
2.8
4.1
Ischemia driven TLR %
CABG
PCI
3.3
5.5
MACE %
6.6
11.0
Non-hierarchical
XIENCE™ V
218 patients
TAXUS ®
77 patients
Ischemia driven TLR %
3.8
6.8
Non-ischemia driven TLR %
1.4
3.9
Total TLR %
4.6
9.1
MACE: cardiac death, MI, ID-TLR by CABG or PCI
CAUTION: XIENCE™ V is an Investigational device. Limited by Federal (U.S.) law to investigational use only.
TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.
SE REV A
© 2003 Guidant

15. 6 Months (6M) and 2 Year (2Y) Clinical Results
%reduction: 6M TLR: 54%; 2Y TLR: 44%; 6M MACE: 58%; 2Y MACE: 40% 1
CAUTION: XIENCE™ V is an Investigational device. Limited by Federal (U.S.) law to investigational use only.
TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.
SE REV A
© 2003 Guidant

16. Conclusions
SPIRIT II 2 year data shows a consistent reduction in clinical events for XIENCE™ V vs TAXUS® (MACE 6.6% vs 11.0%)
Low stent thrombosis rate for XIENCE ™ V at 2 years (0.9 % XIENCE ™ V vs 1.4% TAXUS® )
XIENCE™ V remains numerically lower than TAXUS® in MACE and all it's components at 2 year follow-up, despite a modest increase in late loss and neo-intima in the XIENCE ™ V arm over time.
CAUTION: XIENCE™ V is an Investigational device. Limited by Federal (U.S.) law to investigational use only.
TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.
SE REV A
© 2003 Guidant 16

17. Backup
© 2003 Guidant