Table 10.2-2: SPIRIT and XIENCE V Family of Trials
Principal Clinical Outcomes (Post-market)
XIENCE V USA
Phase I
1 Year
SPIRIT V (SAS)
XIENCE V India
1 Year
2 Years
1 Year
2 Years
XIENCE V
(N = 8040)
XIENCE V
(N = 2663)
XIENCE V
(N = 2663)
XIENCE V
(N = 990)
XIENCE V
(N = 990)
TLF (ARC)
9.4%
(707/7522)
5.25%
(138/2627)
7.49%
(192/2562)
2.4%
(24/986)
3.4%
(32/942)
TLF
6.8%
(513/7505)
N/A
N/A
N/A
N/A
All Death, MI (ARC) and TVR
N/A
7.04%
(185/2627)
10.34%
(265/2562)
N/A
N/A
Cardiac Death or MI (ARC)
7.2%
(545/7522)
4.23%
(111/2627)
5.74%
(147/2562)
1.9%
(19/986)
2.8%
(26/942)
Cardiac Death or MI
3.3%
(249/7505)
N/A
N/A
N/A
N/A
TLR
4.6%
(349/7522)
1.90%
(50/2627)
3.04%
(78/2562)
1.2%
(12/986)
1.5%
(14/942)
TVR, non TLR
2.3%
(176/7522)
1.45%
(38/2627)
2.26%
(58/2562)
0.1%
(1/986)
0.1%
(1/942)
All Death
2.6%
(194/7522)
1.71%
(45/2627)
2.97%
(76/2562)
0.9%
(9/986)
1.7%
(16/942)
Cardiac Death
1.4%
(108/7522)
1.10%
(29/2627)
1.87%
(48/2562)
0.9%
(9/986)
1.7%
(16/942)
All MI (ARC)
6.3%
(475/7522)
3.54%
(93/2627)
4.45%
(114/2562)
1.3%
(13/986)
1.6%
(15/942)
All MI
2.2%
(162/7505)
N/A
N/A
N/A
N/A
Stent Thrombosis
ARC (Definite / Probable)
0.81%
(60/7380)
0.65%
(17/2607)
0.79%
(20/2523)
0.51%
(5/986)
0.53%
(5/939)
ARC (Definite)
0.54%
(40/7380)
N/A
N/A
0.41%
(4/986)
0.43%
(4/939)
Notes:
– All counts presented in this table are subject counts. Subjects are counted only once for each event for each time period.
– XIENCE V USA 1-year data include 42-day window or through randomization date if occurred earlier than 407 days for the second
enrollment phase. XIENCE V India 1-year data include 47-day window. SPIRIT V 1-year data include 28-day window.
– SPIRIT V 2-year data include 28-day window. XIENCE V India 2-year data include 47-day window.
– TLF (ARC) includes cardiac death, MI attributed to target vessel (per ARC definition), clinically indicated TLR. TLF includes cardiac
death, MI attributed to target vessel (per protocol definition), clinically indicated TLR.
10.3 Pooled Clinical Trials Analysis for Stent Thrombosis Subsequent to DAPT Interruption / Discontinuation
The XIENCE family of stents have demonstrated safety and effectiveness in multiple trials in standard / low-risk and extended-risk real-
world patients and demonstrated low stent thrombosis (ST) rates.
This includes patients who discontinued or interrupted dual antiplatelet therapy (DAPT) after 1 month post coronary stent implantation.
Clinical trials described below and / or in the published literature have been analyzed for stent thrombosis correlated with DAPT.
The data (Table 10.3-1) are from a pooled patient level analysis of the following pre- and post-market trials:
Pre-market: SPIRIT II, SPIRIT III, SPIRIT IV
Post-market: SPIRIT V, SPIRIT Women, XIENCE V USA, XIENCE V India
Table 10.3-1: Stent Thrombosis (ARC Definite / Probable) Subsequent to DAPT Interruption / Discontinuation through 730 days
Versus No Interruption; Pooled Data from 7 Pre- and Post-market Trials
Pooled 7 Trials (2 year results)
N = 11,219
DAPT Interrupted ≤30 days
DAPT Interrupted > 30 – 730 days
No Interruption of DAPT
Subsequent ST
(Def / Prob)
2.51%
(12/478)
0.38%
(13/3445)
0.66%
(44/6648)
11.0 HOW SUPPLIED
Sterile –
This device is sterilized with ethylene oxide gas. Non-pyrogenic. Do not use if the package is open or damaged.
This single-use device cannot be reused on another patient, as it is not designed to perform as intended after the first usage. Changes
in mechanical, physical, and / or chemical characteristics introduced under conditions of repeated use, cleaning, and / or resterilization
may compromise the integrity of the design and / or materials, leading to contamination due to narrow gaps and / or spaces and
diminished safety and / or performance of the device. Absence of original labeling may lead to misuse and eliminate traceability.
Absence of original packaging may lead to device damage, loss of sterility, and risk of injury to the patient and / or user.
Contents –
One (1) XIENCE Sierra Everolimus Eluting Coronary Stent System.
Storage –
Store in a dry, dark, cool place. Protect from light. Do not remove from carton until ready for use. Store at 25°C (77°F);
excursions permitted to 15 – 30°C (59 – 86°F).
12.0 PATENTS AND TRADEMARKS
This product and / or its use may be covered by one or more of the following United States Patents: 6,179,810; 6,384,046;
6,440,990; 6,629,994; 6,656,220; 6,746,423; 6,887,219; 6,887,510; 6,890,318; 6,929,657; 6,939,373; 6,957,152; 7,549,975;
7,662,130; 7,828,766; 7,833,193; 7,906,066; 7,947,207; 8,043,553; 8,052,638; 8,075,583; 8,173,062; 8,221,112; 8,221,444;
8,308,711; 8,382,738; 8,388,575; 8,388,602; 8,394,055; 8,444,608; 8,444,802; 8,535,596; 8,540,927; 8,613,722. Other U.S.
patents pending. Other patents issued and pending outside of the U.S.
CERTICAN, AFINITOR, VOTUBIA and ZORTRESS are trademarks of the NOVARTIS group of companies.
AMERICAN COLLEGE OF CARDIOLOGY is a trademark of the American College of Cardiology Foundation.
AMERICAN HEART ASSOCIATION is a trademark of the American Heart Association, Inc.
TAXUS and TAXUS LIBERTÉ are trademarks of the Boston Scientific group of companies.
XIENCE, XIENCE SIERRA, XIENCE ALPINE, XIENCE PRIME, XIENCE V, and XIENCE XPEDITION are trademarks of the Abbott group of
companies.
EL2115538 (2017-1
1-03
)
Page 9 of 206
Printed on : 2017-11-03
