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Title: The Detrimental Impact of Chronic Renal Insufficiency


1
WELCOME
Hilton Harrisburg, September 2007
2
DES in Complex Coronary PCIState of the Art
C3 Harrisburg ,PA Sept 10-13 , 2007
  • Jeffrey W. Moses, MD
  • Professor of Medicine
  • Director, Center for Interventional
  • Vascular Therapy
  • Columbia University Medical Center

3
DES Science
2006 Present/Future
SAFETY
COST-VALUE DURABILITY DELIVERABILITY EFFICACY
4
9 Prospective, Double-Blind, Randomized
TrialsFreedom From (Protocol) Stent Thrombosis
TAXUS I, II, IV, V, VI (n3,513)
RAVEL, SIRIUS, E-SIRIUS, and C-SIRIUS (n1,748)
Time after Initial Procedure (years)
Time after Initial Procedure (years)
Stone GW et al. NEJM 2007356998-1008
5
9 Prospective, Double-Blind, Randomized
TrialsFreedom From All Cause Death
TAXUS I, II, IV, V, VI (n3,513)
RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS (n1,748)
94.7 (45)
93.9 (86)
P0.23
P0.68
93.3 (57)
93.4 (92)
Time after Initial Procedure (years)
Time after Initial Procedure (years)
Independent CRF patient-level meta-analysis
6
9 Prospective, Double-Blind, Randomized
TrialsFreedom From Myocardial Infarction
TAXUS I, II, IV, V, VI (n3,513)
RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS (n1,748)
93.8 (53)
93.7 (105)
P0.86
P0.66
93.6 (55)
93.0 (115)
Time after Initial Procedure (years)
Time after Initial Procedure (years)
Independent CRF patient-level meta-analysis
7
CYPHER 4-Study RCT Meta-Analysis (N1,748)Stent
Thrombosis 0 4 Years
RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS
Primary Thrombotic episodes before
TLR Secondary Thrombotic episodes after TLR
8
9 Prospective, Double-Blind, Randomized
TrialsFreedom From Ischemic TLR
TAXUS I, II, IV, V, VI (n3,513)
RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS (n1,748)
92.2 (66)
89.9 (166)
Plt0.0001
Plt0.0001
76.4 (202)
80.0 (338)
Time after Initial Procedure (years)
Time after Initial Procedure (years)
Stone GW et al. NEJM 2007356998-1008
9
DES Off-label use
  • More complex and unapproved indications
  • Very small vessels and very long lesions
  • Chronic total occlusions
  • Bifurcations
  • Left main disease
  • In-stent restenosis
  • Multivessel disease
  • Saphenous vein grafts
  • Acute myocardial infarction

10
The Bern-Rotterdam Experience
0.6 per year
8146 pts. treated with SES (n3823) or PES
(n4323) at 2 academic centers.
Daemon J, et al, Lancet 2007 369667-78
11
Analysis of 14 Randomized TrialsComparing SES
with BMS
Freedom from Death
100 90 80 70 60 50
Bare-metal stent
Sirolimus stent
Probability of Survival ()
0
0 1 2 3 4 5
Years after Randomization
No. at Risk Sirolimus stent 2,486 2,056 1,218 1,02
8 765 548 BMS 2,472 2,063 1,207 1,044 842 530
Kastrati et al. NEJM 2007 356 1030-9
12
Analysis of 14 Randomized TrialsComparing SES
with BMS
Freedom from MI
100 90 80 70 60 50
Bare-metal stent
Sirolimus stent
Probability of Survival ()
0
0 1 2 3 4 5
Years after Randomization
No. at Risk Sirolimus stent 2,486 1,985 1,168 983
728 516 BMS 2,472 1,983 1,148 992 798 505
Kastrati et al. NEJM 2007 356 1030-9
13
Thoraxcenter Real World Experience
5
0
0
2
c
e
D
3
0
0
2
b
e
F
0
0
0
2
n
a
J
Apr 2002
Sirolimus-eluting
Paclitaxel-eluting
Bare metal
stents
stents
stents
N2444
N979
N3019
6442 patients 13,150 stents
Serruys PW et al. FDA 12/06
14
All-cause Mortality at 3 Years
10
0
9
5
92.1
89.1
9
0
89.1
8
5
SES
vs.
B
M
S
HR
0.71
95
CI
0.54

0
.92
p0.008
2
PES
vs.
B
M
S
HR
1.02
95
C
I
0
.
93

1
.
12

p

0
.
6
9
PES
v
s. SES
HR
1
.
47

95
CI
1.13

1
.92
p0.003
7
Logrank Test
8
0
0
1
8
0
36
0
5
4
0
72
0
9
0
0
109
5
Group
0
3
0
9
0
18
0
36
0
72
0
109
5
BMS
228
7
221
1
219
5
217
0
212
6
199
0
186
2
S
E
S
97
6
95
5
95
1
94
6
93
6
88
8
83
3
P
E
S
277
6
262
0
253
7
249
9
241
4
143
2
49
1
Serruys PW et al. FDA 12/06
15
Real World Registries DES vs. BMS
All Cause Mortality Rates ()
DES
BMS
p 0.03
p 0.005
p lt0.001
N1,164
N397
N1,377
N1,285
N6,509
N5,631
(1-year)
(9-month)
(9-Month)
Adjusted HR 0.56 (95 CI 0.4,0.8), p0.0013
16
Strategic Transcatheter Evaluation of New
Therapies
Patient-Year Weighted Regression for DES vs BMS
Mortality
DES Death 0.77 BMS Death R2 0.91
n2797
n1017
n 18,650
n619
n958
n2449
DES Death ()
n6906
n826
n1748
n 32,284
n7008
n320
n4237
n928
n500
n200
n160
n322
n712
BMS Death ()
n320
n257
n18650
Size of circle adjusted for number of patients.
17
SCAAR Landmark Analysis of ALL Pts(Propensity
Score Adjusted Cumulative Event Rates)
0.10 0.08 0.06 0.04 0.02 0.00
Death
Drug-eluting stent
Cumulative Risk of Death
RR 1.03 (0.841.26)
Bare-metal stent
RR 1.32 (1.111.57)
0.0 0.5 1.0 1.5 2.0 2.5 3.0
Years
No. at Risk BMS 12,880 12,473 12,354 12,228 9,298
5,966 3,199 DES 5,770 5,605 5,541 5,471 3,434 1,77
7 626
Lagerqvist B. et al., NEJM 2007 3561009-19
18
Inclusion
19
Characteristics
Total cohort,
BMS
DES
N
N21,477
N13,785
Age of patients
35,259
66 yrs
65 yrs
Female gender
35,262
27
29
35,262
Diabetes

16
23
Hypertension

44
47
35,262
Previous
PCI
34,726
10
14
Previous CABG
34,567
11
9
Previous MI
33,678
28
29
Previous heart failure
35,262
6.9
7.9
Previous renal failure
35,262
1.0
1.3
Previous dialysis
35,262
0.4
0.6
COPD
35,262
4.7
4.5
35,262
Dementia

0.1

0.1
Cancer lt 3 years
35,262
2.6
2.6
Aspirin
before
35,206
86
91
Clopidogrel before
35,133
56
67
GP IIb/IIIa during
35,075
39
30
20
Adjusted Death /MI
Total Cohort N35,262
One Stent Cohort N18,937
21
RestenosisOne Stent Cohort
Unadjusted
Adjusted
22
Multivessel Disease
23
ARTS II Study Design
  • Multicenter, non-randomized trial
  • 607 patients in 45 centers from 19 countries
  • The main goal of the ARTS II trial is to
    demonstrate non-inferiority in clinical
    effectiveness and cost-effectiveness with the
    CYPHER stent compared to the previous results of
    the ARTS I trial

ARTS II
ARTS I
CABG N 605
CROWN CrossFlex LC N600
CYPHER Stent N607
24
ARTS II Baseline Demographics
ARTS I (PCI) N600
ARTS I (CABG) N605
ARTS II N607
77
76
77
Male ()
61
61
63
Age (years)
27
27
28
Body mass index (kg/m2)
44
42
34
Previous MI ()
19 (4)
16 (3)
26 (5)
Diabetes (IDDM) ()
45
45
67
Hypertension ()
58
58
74
Hypercholesterolemia ()
39
42
36
Family history ()
28
26
Current smokers ()
19
61
60
60
Ejection fraction (mean )
Unstable angina ()
37
38
36
Figures in Italics indicate statistical
difference (95 CI) between ARTS II and ARTS I
groups
25
ARTS II Lesion Characteristics
ARTS I (PCI) N600 pts N1606 les.
ARTS I (CABG) N605 pts N1638 les.
ARTS II N607 pts N2160 les.
of patients
69
66
46
2-VD
3-VD
27
30
54
of lesions
39
41
42
LAD location
29
29
29
LCx location
31
30
29
RCA location
66
68
61
Discrete (lt10mm)
27
25
27
Tubular (10-20mm)
Diffuse (gt20mm)
7
7
12
Type C lesion
8
8
14
Side branch involvement
35
32
34
Figures in Italics indicate statistical
difference (95 CI) between ARTS II and ARTS I
groups
26
ARTS II Procedural Characteristics
ARTS I (PCI) N600 pts N1606 les.
ARTS I (CABG) N605 pts N1638 les.
ARTS II N607 pts N2160 les.
Lesions,
2.8
2.8
3.6
Stented les. / anast. seg.,
2.5
2.8
3.2
Stents,
2.8
-
3.7
Max. inflation pressure, atm
14.6
-
16.4
Total stent length, mm
48
-
72
8-165
-
12-253
(range)
GP IIb/IIIa inhibitor use,
-
-
32
Use of arterial conduit,
-
93
-
Duration of procedure, mins
99
193
85
85
Hospital stay, days since procedure
3.9
9.6
3.4
Figures in Italics indicate statistical
difference (95 CI) between ARTS II and ARTS I
groups
27
ARTS II Deaths up to 3 Years
97.0
96.0
95.6
P (log rank) 0.20 between ARTS II and ARTS I-CABG
P (log rank) 0.33 between ARTS II and ARTS I-PCI
0
6
12
18
24
30
36
Time (Months)
28
ARTS II Death/CVA/MIs up to 3 Years
92.0
89.1
87.2
P (log rank) 0.07 between ARTS II and ARTS I-CABG
P (log rank) 0.004 between ARTS II and ARTS I-PCI
0
6
12
18
24
30
36
Time (Months)
29
ARTS II Stent Thrombosis up to 3 Years
10


Definite (angiography pathological confirmation)
9

8

7

6

of Patients
5

4

3.3
3

2

1

0









0
180
360
540
720
900
1080
30



30
ARTS II - Re-Intervention up to 3 Years
P (log rank) lt0.001 between ARTS II and ARTS
I-CABG
93.4
85.5
73.3
P (log rank) lt0.001 between ARTS II and ARTS I-PCI
0
6
12
18
24
30
36
Time (Months)
31
ARTS II MACCE up to 3 Years
P (log rank) 0.22 between ARTS II and ARTS
I-CABG
P (log rank) lt0.001 between ARTS II and ARTS I-PCI
83.8
80.6
66.0
0
6
12
18
24
30
36
Time (Months)
32
Off Label Use
33
On-Label Use of Cypher Stent
  • The CYPHER Sirolimus-eluting Coronary Stent is
    indicated in patients with symptomatic ischemic
    disease due to discrete de novo lesions of length
    lt 30 mm in native coronary arteries with a
    reference vessel diameter of gt 2.5 to lt 3.5 mm
    (http//www.fda.gov/cdrh/PDF2/p020026c.pdf).
  • On-label definition in MATRIX De novo lesion 1
    lesion 1 vessel Lesion length lt 30mm RVD
    2.5-3.5mm Also excluding
  • Diffuse disease
  • Multivessel PCI PCI with 3 of more SES
  • Use of rotablator, atherectomy or laser
  • Use of thrombectomy or intracoronary thrombus
  • Acute ST elevation MI within 72 hours before the
    procedure
  • ACS with positive CKMB prePCI
  • Ostial lesions
  • Bifurcation lesions
  • Chronic occlusions, baseline TIMI flow 0 or 1
  • Vein grafts, LIMA/RIMA, radial or GEA grafts
  • Angioplasty restenosis or in-stent restenosis
  • Severe calcification Severe tortuosity

14 Of Patients in MATRIX w/o any of above
MATRIX Registry
34
Baseline Clinical Characteristics
MATRIX Registry
35
Procedural Characteristics
MATRIX Registry
36
K-M Estimates of 2-Year Outcomes
P0.010
P0.040
P0.013
P0.036
P0.519
P0.048
P0.630
MATRIX Registry
37
Stent Thrombosis (K-M analysis)

P0.649
P0.826
P0.826
P0.829
74
01
53
01
01
01
23
53
Stent thrombosis included the definite and
probable thromboses by ARC
MATRIX Registry
38
Antiplatelet Adherence
Patients ()
MATRIX Registry
39
Stent Thrombosis
MATRIX Registry
40
Bifurcation Disease
41
Medina Classifications
Classific 111
Classific 110
Classific 100
Prox MB
Dist MB
Prox MB
Dist MB
Prox MB
Dist MB
SB
SB
SB
Legend
Classific 011
Classific 101
1 Yes Stenosis 0 No Stenosis
Prox MB
Dist MB
Prox MB
Dist MB
First Proximal MB Second Distal
MB Third Side Branch
SB
SB
Bordeaux Sept 2005
42
3 Randomized Trials 1 vs. 2 StentsMACE, TVR and
TLR
19.0
MACE
TVR
13.6
TLR
11.4
11.1
10.6
9.5
9.0
9.0
of Patients
6.3
4.5
4.5
3.4
1.9
2.9
2.1
1.9
1.9
1.0
2 Stents
1 Stent
2 Stents
1 Stent
2 Stents
1 Stent
43
Angiographic Restenosis
Bifurcation
Main Branch
28.0
Side Branch
22.5
21.8
20.0
19.2
18.7
16.0
15.0
of Bifurcations
14.2
11.5
7.0
5.7
5.1
4.8
5.0
5.0
4.6
2.0
2 Stents
1Stent
2 Stents
2 Stents
1Stent
1Stent
Colombo et al
Pan et al
Nordic
(Circ 2004)
(AHJ 2004)
(Circ 2006)
n91
n413
n85
month
6
month
6
month
6
44
NORDIC Bifurcation Study
Individual End Points after 6 months
1 Stent 2 Stents P Patients 207 206 Cardiac
death 2 (1.0) 2 (1.0) 1.00 Myocardial
infarction 0 (0.0) 1 (0.5) 0.31 Stent
thrombosis 1 (0.5) 0 (0.0) 0.31
Steigen et al Circulation 2006
45
NORDIC Bifurcation Study
2 Stents Techniques Implemented
50
29

21
Crush Culotte Other
Steigen et al Circulation 2006
46
Restenosis TLR Rates in Bifurcations Treated
with 2 Stents and Final Kissing Inflation
of Bifurcations
Time
In bifurcations treated with 2 stents ALL
undergoing FKI, the restenosis TLR rates are
continuing to decline. Why??
47
Other Technical Factors Possibly Responsible for
Decrease in Restenosis TLR
  • 2-step crush Pre-FKI side branch dilatation
  • Use of non-compliant balloons
  • High pressure side branch inflation
  • Increasing experience

Taken together we think that these factors
represent our learning curve in the treatment
of bifurcations with 2 stents
48
Approach to Bifurcational Lesions Including LM
The bifurcation is a True Bifurcation
(significant stenosis on the main and side
branches)
No
Yes
The side branch is suitable for stenting
provisional side branch stenting
Yes
No
Stent on main branch, PTCA on the side branch
The disease on the side branch extends for more
than 3 mm from the ostium of the side branch
No
Yes
Elective implantation of two stents (main and
side branch
Provisional side branch stenting
49
An approach for bifurcational lesions when using
2 stents as intention to treat
Bifurcational lesion with main branch disease
extending proximal to the bifurcation and side
branch which has origin with about 90 angle
Bifurcational lesion with main branch disease
extending proximal to the bifurcation and side
branch which ha origin with about 60 angle
Bifurcational lesion with no disease proximal to
the bifurcation or very short left main
V-Stent
T-Stent
Short-Mini Crush
Pre
Pre
Post
Pre
Post
Post
Cross Section
50
CACTUS A Prospective Randomized Study
  • n 350 patients

6-month Angio. F/U
12-, 18-, 24-month Clinical Follow-Up
1-month Clinical F/U
Crushing CYPHER SELECT n 175
de novo TRUE bifurcation lesions of the native
coronary arteries
R
Pre-dilatation
Provisional T CYPHER SELECT n 175
51
Left Main Disease
52
MAIN-COMPARE Registry Stenting (BMS vs. DES) vs.
CABG
January, 2000 March, 2003 June, 2006
Phase I (Era of Bare-Metal Stents)
LMCA disease (N775)
BMS (N336)
CABG (N439)
Phase II (Era of Drug-Eluting Stents)
LMCA disease (N1536)
DES (N805)
CABG (N731)
PCI (N1141)
CABG (N1170)
Total (N2311)
53
Primary Reason for PCIPCI Patients (N1141)
54
Baseline Risks
55
Disease Extent
56
LM Involved Site
57
Distal Bifurcation Treatment (N549 patients)
Bifurcation Stenting Techniques
Stenting Cross-Over
Bifurcation Stenting
58
Unadjusted Death
15
Log-rank P 0.807
10
Cumulative Incidence ()
CABG
7.1
6.6
5
PCI
0
1.5
1.0
0.0
0.5
2.5
3.0
2.0
Years after treatment
59
Adjusted Death
15
HR 1.27 (0.86-1.86) P0.226
10
PCI
Cumulative Incidence ()
5
CABG
0
1.5
1.0
0.0
0.5
2.5
3.0
2.0
Years after treatment
60
Adjusted Death
Cardiovascular Cause
Non-Cardiovascular Cause
15
15
HR 1.34 (0.87-2.07) P0.189
HR 0.98 (0.44-2.17) P0.954
10
10
Cumulative Incidence ()
Cumulative Incidence ()
PCI
5
5
CABG
CABG
PCI
0
0
1.0
0.0
2.0
3.0
1.0
0.0
2.0
3.0
Years after treatment
Years after treatment
61
Adjusted Death
Phase I
Phase II
HR 2.17 (1.12-4.18) P0.022
HR 0.85 (0.52-1.39) P0.527
BMS
CABG
DES
CABG
62
Adjusted Composite EventDeath or Q-wave MI
Phase I
Phase II
15
15
HR 2.58 (1.35-4.94) P0.004
HR 0.90 (0.56-1.45) P0.664
BMS
10
10
CABG
Cumulative Incidence ()
Cumulative Incidence ()
5
5
DES
CABG
0
0
1.0
0.0
2.0
3.0
1.0
0.0
2.0
3.0
Years after treatment
Years after treatment
63
New Revascularization
Phase I
Phase II
30
30
HR 5.57 (3.13-9.88) Plt0.001
HR 5.05 (2.87-8.67) Plt0.001
BMS
20
20
DES
Cumulative Incidence ()
Cumulative Incidence ()
10
10
CABG
CABG
0
0
1.0
0.0
2.0
3.0
1.0
0.0
2.0
3.0
Years after treatment
Years after treatment
64
Independent Predictors of MortalityOverall LM
Patients
65
Body or Ostial ULMNo Involvement of Bifurcation
  • 144 pts in 5 centers
  • 39 PES
  • 105 SES
  • 19.4diabetics
  • 50 IVUS guidance
  • 99 procedural success

41 pts
75 pts
28 pts
2 Milan, 1 Turin, 1 Rotterdam, 1 Korea Chieffo et
al. submitted 2007
66
Body or Ostial ULMNo Involvement of Bifurcation
  • 1 year Follow-Up
  • Angio F-U100 pts (70)
  • Death 1 pt
  • PCI 1 pt
  • CABG 1 pt

75 pts
41 pts
28 pts
Chieffo et al. submitted 2007
67
What Are the Problems with ULM Stenting with DES
  • High risk during index procedure NO
  • High risk of MI and death during FU NO
  • Up to 1 yr and most of pts in double antiplatelet
    therapy
  • Even with CABG late deaths do occur
  • High restenosis only focal and a potential issue
    only for distal bifurcations

(14/106)
(9/106)
(5/106)
68
PRECOMBATCurrent Enrollment
  • From December 2004 to March 2007

874 patients with unprotected LMCA stenosis
328 (37.5) registry patients who have any
exclusion criteria
546 (62.5) eligible patients who meet inclusion
and exclusion criteria
Medication
PCI
CABG
65 237 26
380 pts
166 pts
PCI
CABG
PCI
CABG
196 184
137 29
A total of 380 patients has been randomized
from the 546 eligible (63) patients.
69
Pre-COMBAT Random Group (ITT)Procedural
Characteristics
70
Pre-COMBAT Random Group (ITT)1-Year Outcomes
(preliminary analysis)
71
AXXENT Left Main Stent
Material Nitinol Vessel Range 3.75-4.75
mm Length 12 10 mm
8, 10 12 mm flare diameter
72
Therapeutic Approach
Pre
Final
73
What is in the Near Future?
74
Thrombosis rates according to selected patient
characteristics

ULM
Antiplatelet Therapy disc
Bifurcations
UA
Prior Brachy
Renal failure
Diabetes
Premature discontinuation
75
Aalen-Nelson estimate of the cumulative hazard
function
Patients without thienopyridine
0.16
7 patients
8 patients
0.14
0.12
0.10
Cumulative incidence of ST 58/3021 pts (1.9)
0.08
ST within 6 month 42 pts (1.4)
ST after 6 month 16 pts (0.5)
Event Rate
0.06
0.04
Patients with thienopyridine
9 patients
34 patients
0.02
0.00
Days
180
300
0
60
120
360
420
480
540
240
No. of Patients Discontinued thienopyridine On
thienopyridine
262 2759
439 2582
583 2438
1160 1861
1215 1806
1728 1293
2100 921
2207 814
2321 700
76
Clopidogrel Responsiveness at the Time of PCI and
Stent Thrombosis After Cypher w/i 30 Days N280
75th percentile
Association with Stent Thrombosis Clop NR
p0.046 High post-Rx reactivity p0.06 Clop NR
high post-Rx reactivity p0.02
Inhibition by Clopidogrel ()
25th percentile
lt10 inhibition
Reactivity Post-Clopidogrel Treatment (PRUs)
Price MJ et al, TCT 2006
77
PIs Gregg W. Stone and Chuck Simonton Sponsors
CRF and the Dickson Institute Principal study
group STENT Registry investigators
Funded by grants from Boston Scientific (lead
supporter), Accumetrics, Abbott, Cordis,
Biosensors and Medtronic
78
DES Strut and Polymer Thickness3.0 mm Diameter,
500x Magnification
79
Endeavor Safety AnalysisStent Thrombosis
According to Prospective HCRI CEC Definition
1317 pts with 2-year Follow-Up
ENDEAVOR I-III Plavix Rx for 3 months
80
In Vivo EPC Capture 1 Hour Explant
Dextran Ab coated
Dextran coated
81
Bioresorbable Stent
Igaki-Tamai
PLA
BVS
PLA
PLA
Sahajanand
Tyrosine-polycarbonate
REVA
PAE salicylate
BIT
Magnesium
Biotronik
82
HORIZONS AMI Trial
- 3400 randomized patients undergoing primary PCI
-
Hypothesis Bivalirudin compared to UFH routine
IIb/IIIa will reduce the composite rate of death,
reinfarction, TVR, stroke and major bleeding at
30-days
Hypothesis Use of the polymer-based slow-release
paclitaxel-eluting TAXUS stent will safely
reduce the 1-year rate of
ischemia-driven TLR
Sponsor The Cardiovascular Research Foundation
(PI Gregg W. Stone), with unrestricted grant
support from Boston Scientific The Medicines
Co.
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SYNTAX Randomized Trial
De novo disease acceptable for revascularization
Left main disease (minimum 710)
3-vessel disease
and /or
Primary NI endpoint 1 year MACCE All cause
death, MI, cerebrovascular events, repeat
revascularization
PIs Patrick Serruys and Frederick Mohr
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FREEDOM Trial (NHLBI)
FUTURE REVASCULARIZATION EVALUATION IN PATIENTS
WITH DIABETES MELLITUS OPTIMAL MANAGEMENT OF
MULTIVESSEL DISEASE
Eligibility DM patients with MV-CAD eligible for
stent or surgery Exclude Patients with acute
STEMI, cardiogenic shock
N2400 at 100 centers from NA, SA, EU, Rand. 11
PRIMARY Endpoint 3-year death, MI,
stroke SECONDARY Endpoints 12-month MACCE,
3-year Quality of Life
PI Valentin Fuster
85
WELCOME
Hilton Harrisburg, September 2007
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