1. 所有患者 Co-PIs: Profs. Serruys, Silber, Windecker
PCR 2010
1年结果
首次二代DES头对头真实世界对照试验
所有患者 Co-PIs: Profs. Serruys, Silber, Windecker
N = 2,300 名患者
17 个中心 (100% monitored) 西欧
Resolute Stent
n  1,150
Control Xience V Stent
n  1,150
Clinical
Endpoints
临床/TLF
30d
6mo
12mo
13mo
2yr
3yr
4yr
5yr
造影/OCT
460 (20%) QCA subset
50 (2%) OCT Subset
= 主要终点观测点
= 次要终点观测点
The purpose of R-AC is to directly compare the Resolute stent platform with the Xience V stent platform in a prospective, multi-center, randomized, two-arm, controlled, open-label, international, noninferiority trial in patients undergoing PCI in everyday clinical practice. The all comers design of the trial with a primary “clinical” composite endpoint will allow a comparison of the angiographic parameters of both devices, together with a valid assessment of the long-term safety of both devices.
A total of 2300 patients with symptomatic CAD including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for PCI, will participate in this study. These will be enrolled in 17 centers. Of note, inclusion criteria will be kept comprehensive to reflect routine clinical practice (“real world, all-comers” patients). 20% of the patients were randomly assigned to undergo repeat angiography at 13 months and 50 patients at selected sites underwent both an OCT and angiographic assessment. All patients will be followed for 5 years.
Primary Endpoint is a device-oriented clinical composite endpoint (i.e. TLF) and includes the following components:
• Cardiac death
• Myocardial Infarction (not clearly attributable to a non-target vessel)
• Clinically indicated/clinically driven target lesion revascularization
Major secondary endpoint is a patient-oriented clinical composite endpoint and includes the following components:
• All cause mortality
• Any Myocardial Infarction (including non-target vessel territory)
• Any Repeat Revascularization (including all target and non-target vessel)
Should NOT be referred to as MACE due to the ambiguity of this acronym
Secondary Endpoint also includes: angiographic and OCT (optical coherence tomography) at 13 months.
主要终点: TLF (复合终点包括：Cardiac Death, Target Vessel MI, Clinically driven 12mo)
次要终点: 30d, 6mo, 2 – 5 yr; angiographic & optical coherence tomography (OCT) 13 mo.
双重抗血小板治疗: ASA and clopidogrel/ticlid >6 months (per guidelines)

2. 试验入组充分反映临床实际
For distribution only in markets where Resolute DES has been approved. Not for distribution in the USA or Japan.
© 2010 Medtronic, Inc. All rights reserved. UC EE 5/10

3. Resolute达到主要终点12个月TLF
For distribution only in markets where Resolute DES has been approved. Not for distribution in the USA or Japan. © 2010 Medtronic, Inc. All rights reserved. UC EE 5/10

4. Resolute：MACE和TVF发生率
For distribution only in markets where Resolute DES has been approved. Not for distribution in the USA or Japan.
© 2010 Medtronic, Inc. All rights reserved. UC EE 5/10

5. Resolute：各个临床终点的出色表现
For distribution only in markets where Resolute DES has been approved. Not for distribution in the USA or Japan.
© 2010 Medtronic, Inc. All rights reserved. UC EE 5/10
靶血管心梗

6. Resolute和Xience V：血栓无统计学差异
早期的血栓对12个月的CD/TVMI无影响
p-values are based on Fisher's Exact Test.
p-values for outcome differences are unadjusted for multiple comparisons.
Per protocol, a statistical difference was declared if the two-sided p-value was less than 0.05
RESOLUTE All Comers was not specifically designed or powered to individually compare endpoints shown above.

7. Resolute：早期的血栓对12个月的CD/TVMI无影响
早期CD/TVMI血栓Xience V较高
Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula
p-values for outcome differences are unadjusted for multiple comparisons.
RESOLUTE All Comers was not specifically designed or powered to individually compare endpoints shown above

8. Resolute和Xience V: 13个月DS%和LL无差异
For distribution only in markets where Resolute DES has been approved. Not for distribution in the USA or Japan.
© 2010 Medtronic, Inc. All rights reserved. UC EE 5/10

9. Resolute All Comers：70%的复杂病患
For distribution only in markets where Resolute DES has been approved. Not for distribution in the USA or Japan.
© 2010 Medtronic, Inc. All rights reserved. UC EE 5/10

10. Resolute：在复杂病变中事件率
For distribution only in markets where Resolute DES has been approved. Not for distribution in the USA or Japan.
© 2010 Medtronic, Inc. All rights reserved. UC EE 5/10

11. RESOLUTE All Comers 和 LEADERS 相同的试验设计
RESOLUTE All Comers Co-PIs: Profs. Serruys, Silber, Windecker
LEADERS PI: Prof. Windecker
Real World
All Comers with symptomatic coronary artery disease
Stable and ACS Patients undergoing PCI
N = 2,300 patients
17 sites (100% monitored)
Western Europe
N = 1,700 patients
10 sites (100% monitored)
Western Europe
Resolute Stent
n  1,150
Xience V Stent
n  1,150
BioMatrix Flex
n  850
Cypher Select
n  850
Clinical/TLF
Clinical
30d
6mo
12mo
13mo
2yr
3yr
4yr
5yr
30d
6mo
9mo
12mo
2yr
3yr
4yr
5yr
Angio/OCT
Angio/OCT
420 (25%) QCA subset
46 (3%) OCT subset
460 (20%) QCA subset
50 (2%) OCT subset
1º Endpoint: TLF – Cardiac Death, TV-MI, clinically driven 12-mo
2º Endpoints: 30d, 6mo, 2 – 5 yr; angiographic & optical coherence tomography (OCT) 13 mo
Drug Therapy: ASA and clopidogrel/ticlid >6 months (per guidelines)
1º Endpoint: Cardiac Death, MI, clinically-driven 9-mo
2º Endpoints: Death, Cardiac Death, MI, TLR, TVR, ARC ST
Drug Therapy: ASA and clopidogrel/ticlid recommended ³ 12 months

12. RESOLUTE All Comers 和 LEADERS 试验
Resolute DES
N = 1140
Xience V DES
N = 1152
LEADERS
BioMatrix Flex DES
N = 857
Cypher Select DES
N = 850
Age (yr)
64.4 ±10.9
64.2 ±10.8
65  11
Men (%)
76.7
77.2 75
Diabetes mellitus (%)
23.5
23.4 26 23
ACS (%)
48.3
47.7
55%
56%
Unstable Angina (%)
19.4
18.9
22%
20%
Lesions treated per patient
1.46 ±0.73
1.48 ±0.77
1.5  0.7
1.4  0.7
Prior myocardial infarction
28.9%
30.4%
32%
33%
Prior PCI
31.8%
32.1%
36%
37%
Small vessel (RVD ≤2.75 mm)
67.8
67.4
68%
69%

13. 12个月真实世界所有患者的对比：第一代 Vs.第二代
Data come from different trials and could differ in a head-to-head comparison.