The SPIRIT II Study - A Clinical Evaluation of the XIENCE

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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 LesionsClinical,
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 IVUS2 Year
ResultsPatrick 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.
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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

• Prospective, randomized (31), 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)

• 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)

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
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Clinical Study Population
TAXUS
n 300
XIENCE V
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 73
n 211
2 Year QCA
n 85 nL 100
n 32 nL 35
Angiographic and IVUS Subgroup
2 Year IVUS
n 72 nL 78
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.
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Clinical Study Population
TAXUS
n 300
XIENCE V
n 223
n 77
2 Year Clinical
n 73
n 211

• -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
2 Year QCA
n 85 nL 100
n 32 nL 35
2 Year IVUS
n 72 nL 78
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.
SE2926406 REV A
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Clinical Study Population
TAXUS
n 300
XIENCE V
n 223
n 77
2 Year Clinical
n 73
n 211

• -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

2 Year QCA
n 85 nL 100
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

2 Year IVUS
n 72 nL 78
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.
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Baseline Demographics
ITT ITT Patients with 6 month 2 year Angio/IVUS FU Patients with 6 month 2 year Angio/IVUS FU
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
Prior inter. at target vessel () 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
p0.007
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
ITT ITT Patients with 6 month 2 year Angio/IVUS FU Patients with 6 month 2 year Angio/IVUS FU
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
Lesion Location
LAD 41 47 43 58
LCX 29 19 27 13
RCA 30 34 30 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 p0.072, RVD p 0.099, MLD p0.033.
LCX p0.1, RVD p 0.061, MLD p0.013.
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.
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In-stent Late Loss in Patientswith Serial 6
Month and 2 Year Angio FU
2 Years
6 Months
XIENCE V
XIENCETM V 0.17 0.32 (nL97) TAXUS 0.33
0.32 (nL35) P0.0037
XIENCETM V 0.33 0.37 (nL97) TAXUS 0.34
0.34 (nL35) P0.6026
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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In-Stent Diameter Stenosis in Patientswith
Serial 6 Month and 2 Year Angio FU
6 Months
XIENCETM V 16.0 11.4 (nL97) TAXUS 18.3
10.6 (nL35)
XIENCETM V 19.2 13.9 (nL97) TAXUS
18.8 11.4 (nL35)
TAXUS
P 0.0620
P 0.9589
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.
SE2926406 REV A
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Angiographic Binary Restenosis in Patientswith
Serial 6 Month and 2 Year Angio FU
6 Months
2 Years
P 0.4400
XIENCETM V (nL 97) TAXUS (nL 35)
P 0.6079
P 0.4615
P 1.0000
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.
SE2926406 REV A
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IVUS in Patients with Serial 6 Monthand 2 Year
IVUS FU
6 Months
2 Years
mm3
mm3
P0.0009
P0.0007
P 0.2527
P 0.4026
7
5.8
5.2
6
5
4
3
2
1
0
VO
In this serial analysis, for patients having TLR,
values of loss and neo-intimal hyperplasia observe
d 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.
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ARC Stent Thrombosis
Definite and Probable XIENCE V 223 patients TAXUS 77 patients
Acute stent thrombosis () 0.0 0.0
Sub-acute stent thrombosis () 0.0 1.3
220 patients 77 patients
Late stent thrombosis () 0.0 1.3
211 patients 73 patients
Very late stent thrombosis () 0.9 0.0
Total stent thrombosis () 0.9 1.4
Acute 0 to 24 hours after stent implantation
Subacute gt24 hours to 30
days after stent implantation Late gt30 days to 1
year after stent implantation
Very late gt1 year after stent implantation
pNS
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
Hierarchical XIENCE V 211 patients TAXUS 73 patients
Cardiac death 0.5 1.4
Myocardial infarction Q-wave MI Non Q-wave MI 0 2.8 0 4.1
Ischemia driven TLR CABG PCI 0 3.3 0 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.
SE2926406 REV A
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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.
SE2926406 REV A
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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 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.
SE2926406 REV A
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