Transcript Slide 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, 2008 8.45 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.
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SPIRIT II Clinical, Angiographic and IVUS
2 Year Results
Patrick W. Serruys on behalf of
Germany:
The Netherlands:
France:
Denmark:
J. Neuzner
J. Schofer
M. Wiemer
G. Richardt
M. Desaga
J. Piek
H. Suryapranata
M. Suttorp
J.A.M. te Riele
D. Carrie
J. Berland
C. Spaulding
L. Thuesen
H. Kelbaek
K. Rasmussen
New Zealand:
India:
Switzerland:
Spain:
Belgium:
Poland:
Italy:
Austria:
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.
P. Ruygrok
A. Seth
E. Camenzind
C. Macaya
E. Garcia
F. Van den Branden
V. Legrand
J. Boland
W. Ruzyllo
A. Manari
K. Huber
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Study Design
Maximum two
de novo
lesions
300 patients
2.5 – 4.0 mm
n = 300
 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)
3
:
1
XIENCE™ V
n = 223
TAXUS®
n = 77
 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 insegment 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.
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Clinical Study Population
XIENCE™ V
n = 223
n = 211
Angiographic and IVUS
Subgroup*
TAXUS®
n = 300
n = 77
2 Year
Clinical
n = 73
n = 85
2 Year
n = 32
nL = 100
QCA
nL = 35
n = 72
nL = 78
2 Year
n = 31
nL =32
IVUS
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.
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TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.
Baseline Demographics
Patients with 6 month
& 2 year Angio/IVUS FU
ITT
XIENCE™ V
223 pts
TAXUS®
77 pts
XIENCE™ V
113 pts
TAXUS®
39 pts
Male (%)
71
79
73
82
Mean age (years)
62
62
62
62
Previous MI (%)
35
25
42*
18*
4
4
5
3
Diabetes mellitus (%)
23
24
22
24
Insulin-dependent diabetes (%)
5
7
4
8
Hyperlipidemia req. med. (%)
69
75
75
77
Hypertension req. med.(%)
67
65
61
51
Current smoker (%)
32
30
32
32
Prior inter. at target vessel (%)
*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.
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Baseline Angiography
Patients with 6 month &
2 year Angio/IVUS FU
ITT
XIENCE™ V
260 lesions
TAXUS®
91 lesions
XIENCE™ V
132 lesions
TAXUS®
45 lesions
Dual Lesions Treated (%)
17
18
17
15
Type B2/C Lesions
78
80
76
77
LAD
41
47
43
58
LCX
29*
19*
27**
13**
RCA
30
34
30
29
RVD (mm)
2.70*
2.82*
2.67**
2.86**
MLD (mm)
1.06*
1.14*
0.98**
1.13**
61
59
13.2
1.48
63
60
13.8
1.53
Lesion Location
QCA
% DS
Lesion Length (mm)
13.0
Acute Gain (mm)
1.43
*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.
13.3
1.52
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In-stent Late Loss in Patients
with Serial 6 Month and 2 Year Angio FU
2 Years
6 Months
100%
100%
90%
90%
XIENCETM
% of Lesions
80%
70%
60%
*
V
80%
XIENCETM V
+
60%
TAXUS®
70%
TAXUS®
XIENCE
V
50%
50%
40%
40%
30%
30%
20%
20%
10%
10%
0%
-0.75 -0.5 -0.25
0
0.25
0.5
0.75
1
1.25
1.5
1.75
2
0%
-0.75 -0.5 -0.25
0
0.25
0.5
0.75
1
1.25
1.5
1.75
2
In-stent Late Loss (mm)
In-stent Late Loss (mm)
XIENCETM V: 0.17 ± 0.32 (nL=97)
XIENCETM V: 0.33 ± 0.37 (nL=97)
TAXUS®: 0.33 ± 0.32 (nL=35)
TAXUS®: 0.34 ± 0.34 (nL=35)
P=0.0037
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.
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2 Year Clinical Results
XIENCE™ V
211 patients
TAXUS ®
73 patients
0.5
1.4
0
0
2.8
4.1
0
0
3.3
5.5
6.6
11.0
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
Hierarchical
Cardiac death %
Myocardial infarction %
Q-wave MI
Non Q-wave MI
Ischemia driven TLR %
CABG
PCI
MACE %
Non-hierarchical
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.
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6 Months (6M) and 2 Year (2Y)
Clinical Results
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.
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ARC Stent Thrombosis
XIENCE™ V
TAXUS ®
223 patients
77 patients
Acute stent thrombosis (%)
0.0
0.0
Sub-acute stent thrombosis (%)
0.0
1.3
220 patients
77 patients
0.0
1.3
211 patients
73 patients
Very late stent thrombosis (%)
0.9
0.0
Total stent thrombosis (%)
0.9
1.4
Definite and Probable
Late stent thrombosis (%)
Acute: 0 to 24 hours after stent implantation
Late: >30 days to 1 year after stent implantation
Subacute: >24 hours to 30 days 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.
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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, 1.4% TAXUS®)
• XIENCE™ V remains numerically lower than TAXUS® in
MACE and all its 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.
SE2926406 REV A