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Table 10.1-4: SPIRIT Family of Clinical Trials
Principal Clinical Outcomes from Latest Follow-up (Pre-market)
SPIRIT IV
3 Years
SPIRIT III RCT
5 Years
SPIRIT Small
Vessel
2 Years
SPIRIT PRIME
Clinical Trial
1 Year
XIENCE V
(N = 2458)
TAXUS
(N = 1229)
XIENCE V
(N = 669)
TAXUS
(N = 333)
2.25 mm XIENCE V
(N = 144)
Core Size
Registry
(N = 401)
Long Lesion
Registry
(N = 104)
TLF
9.5%
(223/2348)
11.9%
(138/1158)
13.4%
(81/605)
20.6%
(59/286)
8.3%
(11/133)
4.5%
(18/399)
7.7%
(8/104)
TVF
13.3%
(312/2348)
14.5%
(168/1158)
20.3%
(123/605)
26.6%
(76/286)
12.0%
(16/133)
N/A
N/A
MACE
9.8%
(231/2348)
12.3%
(142/1158)
14.4%
(87/605)
22.0%
(63/286)
8.3%
(11/133)
4.5%
(18/399)
7.7%
(8/104)
All Death
3.4%
(81/2348)
5.2%
(60/1158)
6.0%
(37/621)
10.3%
(31/300)
1.5%
(2/133)
0.8%
(3/399)
1.0%
(1/104)
Cardiac Death
1.4%
(34/2348)
1.9%
(22/1158)
2.7%
(17/621)
4.3%
(13/300)
1.5%
(2/133)
0.3%
(1/399)
0.0%
(0/104)
MI
3.1%
(73/2348)
4.7%
(55/1158)
4.6%
(28/605)
7.0%
(20/286)
1.5%
(2/133)
1.8%
(7/399)
4.8%
(5/104)
Cardiac Death or MI
4.5%
(105/2348)
6.0%
(70/1158)
7.1%
(43/605)
11.2%
(32/286)
3.0%
(4/133)
2.0%
(8/399)
4.8%
(5/104)
Ischemia-Driven TLR
6.3%
(148/2348)
7.9%
(92/1158)
8.9%
(54/605)
12.9%
(37/286)
5.3%
(7/133)
2.5%
(10/399)
2.9%
(3/104)
Ischemia-Driven TVR, Non TL
5.6%
(132/2348)
5.4%
(63/1158)
8.8%
(53/605)
11.9%
(34/286)
6.8%
(9/133)
2.8%
(11/399)
2.9%
(3/104)
Stent Thrombosis
ARC (Definite / Probable)
0.62%
(14/2263)
1.73%
(19/1098)
1.5%
(9/582)
1.9%
(5/268)
1.5%
(2/132)
0.5%
(2/399)
0.0%
(0/104)
ARC (Definite)
0.49%
(11/2263)
1.28%
(14/1098)
1.2%
(7/582)
0.7%
(2/268)
0.8%
(1/132)
0.5%
(2/399)
0.0%
(0/104)
Notes:
– All counts presented in this table are subject counts. Subjects are counted only once for each event for each time period.
– Data includes the follow-up window of + 28 days for all trials.
– TLF includes cardiac death, MI attributed to target vessel and ischemia-driven TLR. SPIRIT SV and PRIME used clinically indicated TLR definition rather than ischemia-
driven TLR.
– TVF includes cardiac death, MI, ischemia-driven TLR and TVR, non-target lesion.
– MACE includes cardiac death, MI, and ischemia-driven TLR.
10.2 Post-Market Clinical Trials
The XIENCE V USA study is a prospective, multi-center, FDA-mandated post-market study to evaluate the continued safety and effectiveness of the XIENCE V EECSS
in real-world settings after it was commercialized in the U.S., and also to support the FDA DAPT initiative. The objective of the SPIRIT V Single Arm Study (SAS) was
to continue the assessment of the performance of XIENCE V EECSS in the treatment of patients with
de novo
coronary artery lesions. XIENCE V India is a prospective,
open-label, multi-center, observational, single-arm registry to evaluate XIENCE V EECSS’s continued safety and effectiveness during commercial use in real-world
settings in India. Tables 10.2-1 through 10.2-2 present clinical trial designs, principal clinical outcomes at 1 year and from latest follow-up, respectively.
The results from these post-marketing clinical trials demonstrate safety and effectiveness of XIENCE V in real-world settings. In addition, XIENCE V improved
patient-reported outcomes (including better quality of life, reduced angina frequency, improved angina stability, and reduced physical limitation) at 6 months and the
improvements were sustained for 1 year in coronary artery disease patients
Table 10.2-1: SPIRIT and XIENCE V Family Clinical Trial Designs (Post-market)
XIENCE V USA Phase
I Cohort
XIENCE V USA Long-
Term Follow-up Cohort
XIENCE V USA AV-DAPT
Cohort
SPIRIT V
(SAS)
XIENCE V
India
Study Type / Design
•
Multi-center
•
Prospective
•
Single-arm
•
Multi-center
•
Prospective
•
Single-arm
•
Multi-center
•
Randomized
•
Double-blinded
•
Placebo control
•
Multi-center
•
Prospective
•
Single-arm
•
Multi-center
•
Prospective
•
Single-arm
Number of Subjects
Enrolled
8040
4663
868
2663
977
Treatment
Per site standard care
Per site standard care
Patients were randomized to
receive either thienopyridine
or placebo treatment for
additional 18 months along
with aspirin
Maximum of one
de novo
,
native target lesion per
major epicardial vessel
or side branch (no prior
stent implant, no prior
brachytherapy), maximum
of 4 planned EES
Per site standard care
Lesion Size
No angiographic restrictions
RVD = ≥ 2.25 ≤ 4.0 mm
Length ≤ 28 mm by visual
estimation
No angiographic
restrictions
Primary Endpoint
ARC definite and
probable stent
thrombosis up to
1 year
ARC definite and
probable stent
thrombosis from year
1 to 5
MACE (composite of all
death, MI, and stroke)
12 – 33 months
Composite rate of all death,
MI, TVR at 30-day
ARC ST (Definite /
probable) 1 year and
yearly after through
3 years
Co-Primary Endpoint
Cardiac death or any
MI at 1 year
Cardiac death or any MI
from year 1 to 5
ARC definite and probable
ST 12 – 33 months
None
Cardiac death and any MI
at 1 year
Clinical Follow-up
14, 30, 180 days, and
1 year
2, 3 and 4 years
15, 24, 30, and 33 months
30 days and 1 and 2 years 14, 30, 180 days and 1,
2, and 3 years
Angiographic
Follow-up
None
None
None
None
None
EL2115538 (2017-1
1-03
)
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Printed on : 2017-11-03