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Partner Durable Polymer and NANO
Polymer-Free Sirolimus-Eluting Stents:
Update on Clinical Data
Prof. Ben He MD PhD FACC
Renji Hospital, Shanghai Jiaotong Univ
Components of First Generation DES
Drug
Polymer
Stent
•
•
•
SMC inhibition
Pro-endothelial growing
Inflamation inhibition
•Carrier of Drug,
•Control release
• Plaque compression
• Vessel scaffolding
•
Delievery
System
helper for stent
delievery
®
Polymer-durable
Sirolimus-Eluting Stents
Partner

多聚物载体雷帕霉素药物洗脱支架

PBMA/PEVA聚合物,双涂层

能有效、安全地预防再狭窄
®
Partner DES
Polymer-durable
——Retrospective
Clinical Data
Organizer &
Administrator
Purpose:To evaluate the efficacy and safety of
Partner®DES in Chinese patients。
Prof. Yong Huo
Clinical results in 12 month
n=1352
5.0
3.62
4.0
2.14
%3.0
1.63
2.0
1.0
0.52
0.96
0.22
0.0
Cardiac NonDeath cardiac
Death
MI
TLR
TVR
MACE*
*MACE: cardiac death、MI、TVR
Clinical results in 24 month
n=1352
10.0
6.58
8.0
%
3.70
6.0
2.96
4.0
2.0
2.07
0.81
0.37
0.0
Cardiac NonDeath cardiac
Death
MI
TLR
TVR
MACE*
*MACE: cardiac death、MI、TVR
Compare with other data
Partner
Retrospective
n=1352
SIRIUS1
n=533
TAXUS IV2
n=662
DES
Partner
Cypher
Taxus
Lesion lenth, mm
21.99±10.57
14.4±5.7
13.4±6.3
DM, %
23.30
24.6
23.4
1yr MACEs rate, %
3.62
8.3
10.6
1yr cardiac death rate, %
0.52
1.3
1.4
1yr MI rate, %
0.96
3.0
3.5
1yr TLR rate, %
1.63
4.9
4.2
2yrs MACEs rate,%
6.58
10.9
14.7
2yrs TLR rate,%
2.96
6.3
5.6
1. David R. Holmes et al., Circulation 2004;109;634-640
2. Gregg W. Stone et al., Circulation (2004;109:1942-1947).
Conclusions from Respective
data on 1st Generation of Partner

Partner® Stent Retrospective study reflect the
real world daily practice in China

Partner®Stent is an effective and safety stent

Partner®Stent is comparable to the current daily
practice imported stents
1st Generation of DES, Success but far
from Perfect
Mechanisms for Late stent
Thrombosis
NanoTM Polymer-Free Sirolimus-Eluting
Stents

无多聚物载体的雷帕霉素洗脱支架

支架表面纳米级微孔作为药物载体


由于没有多聚物载体,更少免疫反应、从而更
少血栓、更安全
与裸金属支架相同的安全性,与药物支架相同
的有效性
Smooth in stent surface
载药纳米微孔
载药后药物均匀分布
NanoTM无载体支架载药量: 2.2μg/mm2
Late lumen loss decreased significantly
BMS
Polymer SES
Polymer-free SES
1个月组织学和造影
动物试验结果表明:
无载体SES的管腔丢失较
裸支架显著降低
与多聚物载体SES相似
QCA
Neointimal area decreased significantly
1个月IVUS动物试验显示:新生内膜面积与BMS相比显著降低
与多聚物载体SES相比无明显差异
Total endotheliazation after 1 month
B
A
A length 0.34mm
B length 0.11mm
OCT观察动物血管内皮愈合情况显示,植入后一个月,内皮已完全愈合
Less stent related inflamation

..\..\临床研究资料\Paper1\fig5\FIG8.jpg
BMS
Polymer SES
Polymer-free SES
6个月组织学动物试验结果表明:
无载体支架的免疫反应较
多聚物载体支架显著降低
与裸支架相似
Pre-Clinical results : Summary
0.163
0.5
1.833
0.833
Low inflamation
Total endothelialization
Similar late loss to DES
Similar thrombogenecity to
BMS
BMS-like safety DES
®
Partner Polymer-Free SirolimusEluting Stents: N-FIM
Purpose
To evaluate the safety and efficacy
of NanoTMin Clinical
组织和管理

主要研究单位:北京大学第一医院

主要研究者:霍勇

核心实验室:徐波,介入导管室,阜外心血管病
医院

数据管理及统计处理:北京大学第一医院统计室
参与中心及主要研究者
北京大学第一医院 霍勇
辽宁省人民医院 李占全
北京安贞医院 陈方
第四军医大学西京医院 王海昌
广东省人民医院 陈纪言
北京大学人民医院 王伟民
复旦大学附属中山医院 葛均波
北京医院 何青
北京朝阳医院 王乐丰
吉林大学第二医院 李淑梅
中国医科大学附属第一医院 齐国先
江苏省人民医院 杨志健
上海仁济医院 何奔
北京宣武医院 李康
北京同仁医院 李田昌
华中科技大学附属同济医院 曾和松
北京世纪坛医院 彭建军
武警医学院附属医院 姜铁民
华中科技大学附属协和医院 曾秋棠
浙江大学医学院附属第一医院 朱建华
浙江大学医学院附属邵逸夫医院 傅国胜
Population
Including criteria

Target vessel ref dia.2.5-4.0mm

Target lesion stenosis≥70%

Lesion length coverable for 1 stent lenth≤40mm

Patient agreement for Clin& Angio f/u

Inform consent
Excluding creteria

AMI< 1wk
Study Design
Prospective ,Multicenters, Controlled Trial
V diameter 2.5-4.0mm
Lesion stenosis≥70%
Lesion length coverabled
by 1 stent with≤40mm
length
N=200
Poly free NanoTMSES
1:1
Partner PolymerTMSES
Clinical F/U:1,3,6,12 month
CAG F/U:6个月
Clopidegrel for 6m,ASP Lifelong
Study Endpoints

Primary endpoints
- In stent & In segment late lumen loss at 6
month

Secondary endpoints


6 month MACE: death,MI,TVR,
12 month MACE: death,MI,TVR,
Inclusion & Follow-up
Stent
Pt number
6M Clin f/u
6-8M CAG f/u
12M
Clin f/u
NanoTM
143
143 (100%)
95 (66.4%)
143 (100%)
Partner
147
147(100%)
94 (63.9%)
147(100%)
TM
Baseline Demographic
NanoTM
患者
age (岁)
n=143
56.92±10.42
PartnerTM
P
n=147
59.47 ±9.82
0.56
male
76.04%
79.22%
0.62
Previous MI
34.38%
23.38%
0.11
DM
15.63%
18.18%
0.65
Hypertension
58.33%
50.65%
0.31
Hyperlipidemia
27.08%
35.06%
0.26
CAD family
history
4.17%
2.60%
0.58
Current smoker
55.21%
49.35%
0.44
ACC/AHA Lesion types
TM
Nano
试验组
A
B1
B2
C
TM
Partner
对照组
A
B1
B2
C
Pre-intervention Angiographic
results
Nano
Partner
179
189
Baseline, n
Mean
SD
Mean
SD
P
Pre-procedure reference vessel
diameter (mm)
2.79
0.47
2.81
0.52
0.59
Pre-procedure diameter stenosis (%)
73.21
14.69
69.04
14.39
0.006
Pre-procedure minimal lumen
diameter (mm)
0.76
0.46
0.88
0.45
0.01
Pre-procedure lesion length (mm)
19.58
12.44
20.57
12.04
0.44
Results post intervention
NanoTM
PartnerTM
P
Post-procedure reference vessel diameter (mm)
3.12
0.50
3.17
0.52
0.30
Post-procedure in-stent minimal lumen diameter (mm)
2.67
0.48
2.71
0.49
0.38
Post-procedure prox-edge minimal lumen diameter
(mm)
3.02
0.63
3.09
0.64
0.28
Post-procedure dist-edge minimal lumen diameter
(mm)
2.49
0.64
2.51
0.65
0.70
Post-procedure in-segment minimal lumen diameter
(mm)
2.40
0.56
2.44
0.57
0.647
Acute gain in-stent (mm)
1.91
0.51
1.83
0.52
0.17
Acute gain in-segment (mm)
1.63
0.56
1.56
0.56
0.20
CAG follou/up results at 6-8m
Follow-up, n
NanoTM
PartnerTM
112
123
Mean
SD
Mean
SD
P
3.04
0.49
3.07
0.50
0.69
2.33
0.60
2.43
0.58
0.17
2.77
0.68
2.76
0.68
0.91
2.36
0.64
2.27
0.61
0.28
Follow-up in-segment minimal lumen diameter
(mm)
2.11
0.66
2.13
0.58
0.81
Late loss in-stent (mm)
0.37
0.40
0.26
0.40
0.03
Late loss prox-edge (mm)
0.28
0.45
0.31
0.55
0.58
Late loss dist-edge (mm)
0.20
0.26
0.22
0.44
0.61
Late loss in-segment (mm)
0.34
0.42
0.30
0.48
0.54
Follow-up reference vessel diameter (mm)
Follow-up in-stent minimal lumen diameter (mm)
Follow-up prox-edge minimal lumen diameter
(mm)
Follow-up dist-edge minimal lumen diameter (mm)
MLD in 6-8 months f/u
Late loss in 6-8 months f/u—
In stent
Late loss in 6-8 months f/u—
In Lesion
Late loss in 6-8 months f/u—
In Lesion
0.45
P=0.54
0.34
0.30
0.3
0.15
In-lesion
Late loss (mm)
1
2
NanoTM
PartnerTM
Distribution of late loss in 68months CAG f/u
0.4
P=0.03
P=0.58
0.37
0.31
0.3
0.26
0.28
P=0.61
0.20
0.2
0.22
0.1
0
Late loss in-stent (mm)
NanoTM
PartnerTM
Late loss prox-edge (mm)
Late loss dist-edge (mm)
In stent restenosis in 6-8
months CAG f/u
P=0.63
6.00%
4.46%
4.00%
3.25%
2.00%
0.00%
1
2
In-stent Binary Restenosis Rate
NanoTM
PartnerTM
Main clinical results in 6-8
months
5.00%
4.00%
3.00%
2.00%
1.00%
0.00%
4.20%
4.20%
3.40%
3.40%
NanoTM
PartnerTM
TVR(%)
MACE (%)
NanoTM
(n=143)
PartnerTM
(n=147)
Death
0
0
MI
1
0
TLR
6
3
TVR
6
5
Main clinical results in 12
months
P=0.69
P=0.69
6.00%
5.00%
4.00%
3.00%
2.00%
1.00%
0.00%
4.90%
4.90%
4.08%
4.08%
NanoTM
PartnerTM
TVR(%)
MACE (%)
NanoTM
(n=143)
PartnerTM
(n=147)
Death
0
0
MI
1
0
TLR
7
4
TVR
7
6
无晚期血栓形成
N-FIM Compare with others
SIURIUS
TAXUS IV
ENDEAVOR II
SPIRIT III
N-FIM
药物支架,n
Cypher
Taxus
Endeavor
Xience V
Nano
病例数,n
533
662
598
223
121
参考管腔直径,
mm
2.79
2.75
2.74
2.70
2.78
病变长度,mm
14.4
13.4
14.05
13.0
19.58
糖尿病,%
25
23.4
18
23
16.5
6-9个月LL,mm
0.17
0.39
0.61
0.11
0.34
6-9个月再狭窄率,
%
8.9
7.9
13.2
3.4
4.46
1年TLR,%
4.9
4.2
4.5
3.4
4.9
1年MACE,%
8.3
10.6
7.6
6.0
4.9
N-FIM Conclusion

FIM 1yr clinical f/u completed

6-8 month NanoTM SES effectively prevented
restenosis,the LL & Binary restenosis is comparable
to PartnerTM

12month clinical f/u showed MACE,death、MI、TVR are
similar in this 2 stent types。

Need more data to evaluate NanoTM SES in the
prevention of Late stent thrombus
Thank you for your attention
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