Abbott XIENCE Sierra Скачать руководство пользователя страница 8

Страница: 8 / 206

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

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)

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