promus element experience in amcsummitmd.com/pdf/pdf/8_jung-min ahn.pdfmyocardial infarction •...
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PROMUS Element Experience
In AMC
Jung-Min Ahn, MD.
University of Ulsan College of Medicine, Heart Institute,
Asan Medical Center, Seoul, Korea
Promus Element Luncheon Symposium:
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PROMUS Element Clinical ProgramsIn Asan Medical Center
PROMUS™ Element™
Everolimus-Eluting Stent
Historical Comparison
of
Promary Endpoint
Composite of
Death
MI
Stroke
Ischemic –driven TVR
At 12-months
Left Main Disease
Nobori™
Biolimus-Eluting Stent
PROMUS™ Element™
Everolimus-Eluting Stent
RCT
of
Compared to
Promary Endpoint
9 Months In-segment LL
Long Lesion (≥28mm)
PROMUS™ Element™
Everolimus-Eluting Stent
Registry
of
Composite of
Death
MI
TVR
at 12-months
Promary Endpoint
Real World Registry
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Comparison of Platinum Chromium Versus
Cobalt Chromium Everolimus-Eluting Stent in
Real World Practice: Outcomes from the
Multicenter Prospective IRIS-DES Registry
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Consecutive PCI patients receiving New DES
without a mixture of other DES
Clinical follow-up at 1-, 6-, and 12-months,
and annually up to 5 years
Comparison of PtCr-EES and CoCr-EES
from IRIS-DES Registry
BIOMATRIX
(N=1,000)
Prospective Enrollment since 2007 in Korean multicenters
PROMUS
ELEMENT
(N=3,000)
IRIS-PRIME
Registry
GENOUS
STEMI
(N=1,000)
CYPHER
(N=3,600)
NOBORI
(N=2,000)
XIENCE
(N=3,000)
K-XIENCE Registry
IRIS-NOBORI Registry
IRIS-BIOMATRIXRegistry
IRIS-ELEMENT Registry
IRIS-GENOUS Registry
XIENCE-PRIME
(N=2,000)
DESSIAN Registry
IRIS-RESOLUTE
Registry
RESOLUTE
INTEGRITY
(N=1,000)
IRIS-CILOTAX Registry
CILOTAX
(N=1,000)
2010.1-2011.122008.4-2010.5
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Study Population
• All consecutive patients who have ≥1 coronary
lesion with a visual estimated DS of >50%.
• Revascularization was clinically indicated
• Cardiogenic shock
• A contraindication to the placement of DESs
• life expectancy <12 months.
• PCI with a mixture of different types of DES
Inclusion Criteria
Exclusion Criteria
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Study Endpoints
Primary Endpoint
• Death
• Myocardial Infarction
• Target vessel revascularization
Secondary End Point
• Cardiac and non-cardiac deaths.
• Periprocedural MI (Q wave MI or CK-MB>3UNL)
• Spontaneous MI (cardiac enzyme elevation).
• Repeat revascularization: TVR, TLR, & NLR
• Stent thrombosis: ARC definite or probable ST
• Stent length and number implanted
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Baseline CharacteristicsPtCr-EES
(N=2990)
CoCr-EES
(N=3081)
P value
Age 63.8±10.9 63.5±10.8 0.21
Sex, Male 2113 (70.7%) 2079 (67.5%) 0.007
DM 1013 (33.9%) 1026 (33.3%) 0.63
Hypertension 1827 (61.1%) 1922 (62.4%) 0.31
Hyperlipidemia 1088 (36.4%) 1155 (37.5%) 0.38
Smoking 872 (29.2%) 891 (28.9%) 0.83
Previous PCI 319 (10.7%) 454 (14.7%) <0.001
Previous CABG 36 (1.2%) 62 (2.0%) 0.012
Previous MI 150 (5.0%) 159 (5.2%) 0.80
Previous CHF 81 (2.7%) 67 (2.2%) 0.18
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Baseline CharacteristicsPtCr-EES
(N=2990)
CoCr-EES
(N=3081)
P value
Family History 200 (6.7%) 111 (3.6%) <0.001
Chronic renal failure 95 (3.2%) 105 (3.4%) 0.62
Previous stroke 215 (7.2%) 252 (8.2%) 0.15
Peripheral vascular disease 62 (2.1%) 36 (1.2%) 0.005
Chronic lung disease 61 (2.0%) 92 (3.0%) 0.019
Ejection fraction, % 59.1±10.1 59.5±10.9 0.19
Presentation <0.001
Stable angina 1143 (38.2%) 1277 (41.4%)
Unstable angina 1008 (33.7%) 1057 (34.3%)
NSTEMI 480 (16.1%) 339 (11.0%)
STEMI 359 (12.0%) 408 (13.2%)
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Lesion and Procedure CharacteristicsPtCr-EES
(N=2990)
CoCr-EES
(N=3081)
P value
Multivessel disease 1470 (49.2%) 1636 (53.1%) 0.002
LMCA disease 213 (7.1%) 323 (10.5%) <0.001
LAD disease 2189 (73.2%) 2336 (75.8%) 0.02
Bifurcation lesion 903 (30.3%) 819 (34.0%) 0.004
Total obstruction 648 (21.7%) 359 (14.7%) <0.001
Restenotic lesion 115 (3.8%) 179 (5.8%) <0.001
Long lesion 1693 (56.7%) 1882 (61.1%) <0.001
Multivessel stenting 772 (35.4) 563 (25.8) <0.001
Total treated lesion number 1.33±0.61 1.37±0.64 0.004
Total stent number 1.620.90 1.82±1.16 <0.001
Total stent length 36.9±23.2 41.7±30.0 <0.001
Average stent diameter, mm 3.17±0.44 3.22±0.44 <0.001
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0 120 240 360 480 600 720
DMITVR_du
0.0
0.1
0.2
0.3
0.4
1 -
누적
생존
함수
Group
2
3
2-중도절단됨
3-중도절단됨
1 - 생존함수
15%
15%
Unadjusted Kaplan-Meier Curve
CoCr-EES
PtCr -EES
0 120 240 360 480 600 720
0
10
20
30
No. at Risk
PtCr-EES
CoCr-EES
2578
2720
900
2503
450
2251
2990
3081
Days Since Procedure
Cu
mu
lati
ve In
cid
en
ce,
%
Primary End Point(Death, MI, or Target Vessel Revascularization)
Log-Rank P=0.12
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0 120 240 360 480 600 720
DMITVR_du
0.0
0.1
0.2
0.3
0.4
0.5
1 -
누적
생존
함수
Group
2
3Adjusted Kaplan-Meier Curve
CoCr-EES
PtCr -EES
0 120 240 360 480 600 720
0
10
20
30
No. at Risk
PtCr-EES
CoCr-EES
Days Since Procedure
Cu
mu
lati
ve In
cid
en
ce,
%
HR (95%CI) 1.01 (0.87-1.18), P=0.89
Primary End Point(Death, MI, or Target Vessel Revascularization)
2578
2720
900
2503
450
2251
2990
3081
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DeathCoCr-EES
PtCr -EES
Adjusted Kaplan-Meier Curve
0 120 240 360 480 600 720
fu_du
0.0
0.1
0.2
0.3
0.4
0.5
1 -
누적
생존
함수
Group
2
3
1 - 생존함수
0 120 240 360 480 600 720
0
10
20
30
2745
2986
996
2827
499
2567
Days Since Procedure
Cu
mu
lati
ve In
cid
en
ce,
%
No. at Risk
PtCr-EES
CoCr-EES
HR (95%CI) 1.27 (0.91-1.772), p=0.16
1
1.51.5 1.5
0
1
2
3
4
5
Cardiac Death Non-CD
P=0.33 P=0.8
2-Year Event Rate
2990
3081
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0 120 240 360 480 600 720
0
10
20
30
2600
2761
940
2603
458
2362
Days Since Procedure
Cu
mu
lati
ve In
cid
en
ce,
%
Adjusted Kaplan-Meier Curve
Myocardial Infarction
No. at Risk
PtCr-EES
CoCr-EES
CoCr-EES
PtCr -EES
0 120 240 360 480 600 720
anyMI_du
0.0
0.1
0.2
0.3
0.4
0.5
1 -
누적
생존
함수
Group
2
3
1 - 생존함수
HR (95%CI) 0.89 (0.71-1.11), P=0.277.4
1.2
5
1.3
0
2
4
6
8
10
12
14
Peri-MI Spon-MI
P<0.001 P=0.35
2-Year Event Rate
2990
3081
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0 120 240 360 480 600 720
0
10
20
30
2578
2720
900
2525
449
2229
Days Since Procedure
Cu
mu
lati
ve In
cid
en
ce,
%
Adjusted Kaplan-Meier Curve
Death or MI
No. at Risk
PtCr-EES
CoCr-EES
CoCr-EES
PtCr -EES
0 120 240 360 480 600 720
DMI_du
0.0
0.1
0.2
0.3
0.4
1 -
누적
생존
함수
Group
2
3
1 - 생존함수
HR (95%CI) 0.95 (0.79-1.13), P=0.54
2990
3081
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0 120 240 360 480 600 720
0
10
20
30
2719
2931
956
2701
477
2439
Days Since Procedure
Cu
mu
lati
ve In
cid
en
ce,
%
Adjusted Kaplan-Meier Curve
TVR
No. at Risk
PtCr-EES
CoCr-EES
0 120 240 360 480 600 720
TVR_du
0.0
0.1
0.2
0.3
1 -
누적
생존
함수
Group
2
3
1 - 생존함수
HR (95%CI) 1.13 (0.86-1.50), P=0.39
7.4
4.1 3.9
9.1
4.35.3
0
2
4
6
8
10
12
14
16
Any TLR NLR
P=0.30 P=0.14
2-Year Event Rate
P=0.51
CoCr-EES
PtCr -EES
2990
3081
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Stent Thrombosis at 24 Months*
15 (0.5)
7 (0.4)
0.0
0.2
0.4
0.6
0.8
1.0
%
P=0.33
* ARC defined definite and probable stent thrombosis
PtCr-EES (N=2990) CoCr-EES (N=3081)
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Percutaneous Treatment of LONG Native
Coronary Lesions with Drug-Eluting Stent-V:
Biolimus A9-Eluting (NOBORI) vs. Everolimus-
eluting (PROMUS-ELEMENT) Stent
A Randomized LONG-DES V Trial
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Primary endpoint: In-segment late loss at 9 months angiographic follow-up
9 months Angiographic follow-up12 months Clinical follow-up
Design
ClinicalTrials.gov Identifier: NCT01186120
Biolimus A9-eluting stent:Nobori(n=250)
Everolimus-eluting stent:Promus-Element
(n=250)
R
Patients requiring PCI with DES for long coronary lesions:
Lesion length ≥ 25mm (total stent length ≥ 28mm)
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Inclusion Criteria
Clinical Criteria
• Patients with sAP, ACS or inducible ischemia
• At least 18 years old
Angiographic Criteria
• De novo long coronary lesion suitable for stenting
• Diameter stenosis >50% by visual estimation
• Reference vessel size 2.5 mm by visual estimation
• Lesion length 25 mm by visual estimation
(planned total stent length 28mm)
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Baseline Characteristics
NOBORI
(N=245)
P-Element
(N=255 )P Value
Age 63.06±10.46 63.49±10.63 0.65
Male sex 167 (68.2) 184 (72.2) 0.38
Diabetes mellitus 79 (32.2) 89 (34.9) 0.33
Hypertension 161 (65.7) 154 (60.4) 0.23
Hyperlipidemia 131 (53.5) 145 (56.9) 0.36
Current smoker 63 (25.7) 74 (29.0) 0.42
Previous coronary angioplasty 16 (6.5) 26 (10.2) 0.15
Previous myocardial infarction 6 (2.4) 11 (4.3) 0.32
Left ventricular ejection fraction, % 60.29±7.56 60.23±7.48 0.93
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Baseline CharacteristicsNOBORI
(N=245)
P-Element
(N=255 )P Value
Clinical indication 0.80
Silent ischemia 22 (9.0) 17 (6.7)
Stable angina 120 (49.0) 128 (50.2)
Unstable angina 68 (27.8) 74 (29.0)
Myocardial infarction 35 (14.3) 36 (14.1)
Number of Diseased Vessel 0.34
1-vessel 121 (49.4) 115 (45.1)
2-vessel 76 (31.0) 95 (37.3)
3-vessel 48 (19.6) 45 (17.6)
multi-vessel disease 124 (50.6) 140 (54.9) 0.37
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Lesion Characteristics
NOBORI
(N=245)
P-Element
(N=255 )P Value
Target vessel 0.72
Left anterior descending 159 (64.9) 171 (67.1)
Left circumflex 33 (13.5) 32 (12.5)
Right coronary 53 (21.6) 52 (20.4)
TIMI flow grade=0 or 1 25 (10.2) 21 (8.2) 0.46
Bifurcation lesions 79 (32.2) 63 (24.7) 0.04
Thrombus 11 (4.5) 8 (3.1) 0.48
Severe tortuosity 3 (1.2) 4 (1.6) 0.93
Severe Calcification 26 (10.6) 32 (12.5) 0.10
Ulceration 16 (6.5) 16 (6.2) 0.95
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NOBORI
(N=245)
P-Element
(N=255 )P Value
No. of stents used at the target lesion 0.20
1 stent 115 (46.9) 117 (45.9)
2 stents 116 (47.3) 110 (43.1)
3 stents 13 (5.3) 26 (10.2)
4 stents 1 (0.4) 2 (0.8)
mean 1.59±0.61 1.65±0.69 0.25
Procedural Characteristics
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Nobori
(N=245)
P-Element
(N=255 )P Value
Stented Length at target, mm 36.06±11.48 39.32±13.82 0.005
Average stent diameter, mm 3.16±0.29 3.18±0.37 0.41
Maximal pressure, atm 12.05±4.01 13.51±3.51 <0.001
Direct stenting 16 (6.5) 12 (4.7) 0.44
Post-additional balloon inflation 190 (77.6) 178 (69.8) 0.06
Intravascular ultrasound guidance 189 (77.1) 188 (73.7) 0.41
Glycoprotein IIb/IIIa antagonists 5 (2.0) 6 (2.4) 0.99
Procedural Characteristics
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QCA Before Procedure
NOBORI
(N=245)
P-Element
(N=255 )P Value
Lesion length, mm 29.24±12.17 32.27±13.84 0.016
Reference vessel diameter, mm 3.02±0.46 3.03±0.45 0.80
Minimal luminal diameter, mm 0.85±0.42 0.83±0.42 0.41
Diameter stenosis, % 71.71±13.38 72.61±13.95 0.48
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NOBORI
(N=245)
P-Element
(N=255 )P Value
Minimal luminal diameter, mm
In segment 2.23±0.43 2.21±0.40 0.52
In stent 2.52±0.40 2.52±0.36 0.49
Proximal margin 3.01±0.56 3.07±0.52 0.33
Distal margin 2.26±0.45 2.24±0.43 0.48
Diameter stenosis, %
In segment 17.80±9.97 17.12±10.0 0.46
In stent 10.62±8.77 9.99±8.27 0.36
Proximal margin 12.28±9.18 11.15±9.14 0.20
Distal margin 15.18±9.73 14.90±10.20 0.76
Acute gain, mm
In segment 1.36±0.53 1.38±0.61 0.88
In stent 1.67±0.51 1.68±0.57 0.86
QCA After Procedure
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Primary Endpoint
• In-segment late luminal loss
At 9 months after the index procedure
Study Endpoint
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Nobori
N=245
Promus Element
N=255
9-month angiographic
follow-up
N=148 (60%)
9-month angiographic
follow-up
N=147 (58%)
12-month clinical follow-up
N=250 (100%)
12-month clinical follow-up
N=250 (100%)
107 pts refused follow-up
1 pts died
Follow-up Analysis
95 pts refused follow-up
2 pts died
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NOBORI
(N=148)
P-Element
(N=147)P Value
Minimal luminal diameter, mm
In segment 2.09±0.47 2.08±0.49 0.86
In stent 2.39±0.48 2.22±0.45 0.009
Proximal margin 2.89±0.60 2.82±0.60 0.33
Distal margin 2.15±0.44 2.22±0.45 0.27
Diameter stenosis , %
In segment 21.0±15.4 24.1±14.2 0.10
In stent 14.9±14.1 21.6±15.5 <0.001
Proximal margin 15.5±12.0 16.6±12.4 0.50
Distal margin 17.2±12.8 14.6±9.7 0.07
QCA at Follow-up
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Primary Endpoint: In-Segment Late Loss at 9 months
P-Element : 0.12±0.39 mm
Nobori : 0.11±0.40 mm
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MACE (death/MI/TVR)at 12 months
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Summary
• In the large, multi-center, prospective cohort study involving
“real-world” patients undergoing PCI with DES, PtCr-EES sh
owed the similar clinical efficacy and safety with CoCr-EES.
• In addition, In the prospective, randomized trial involving
patients with long coronary artery lesions, PtCr-EES and
BES showed similar 9 month angiographic in-segment late
luminal loss.