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Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
PCI for Lesion with In-stent Restenosis
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
The history of angioplasty The history of angioplasty is is ……
… The history of response to Restenosis
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
An Evolutionary Process of PCIAn Evolutionary Process of PCI
1977 – 1988 Balloon Angioplasty
1988 – 1993 New Device Angioplasty
1993 – Stent Era
1997 – Vascular brachytherapy2001 – Drug-Eluting Stent
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Balloon Angioplasty & Balloon Angioplasty & RestenosisRestenosis
NeointimalNeointimal hyperplasiahyperplasia
Recoil and remodelingRecoil and remodeling
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Intervention 2003Intervention 2003
0%
20%
40%
60%
80%
100%
1997 1998 1999 2000 2001 2002
Stents Balloon Angioplasty Atherectomy
49
25
70
45
1749
848049
13
86
12
In-Stent Restenosisis the most serious problem
(20-25%)
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
“ The dream ”of interventional cardiology will be …
No Restenosis !
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Solution• Stents will prevent vascular recoil and
remodeling• Active therapeutic agent is required to
block neointimal hyperplasia
CauseRecoil and remodeling Neointimal hyperplasia
RestenosisRestenosisRestenosis
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Treatment of Diffuse ISRTreatment of Diffuse ISREffective Treatment Tools?Effective Treatment Tools?
•Intracoronary Brachytherapy
•Drug-eluting stent
Intracoronary Brachytherapy
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Mechanism of Mechanism of Radiation
Prevent Restenosis
• Target : Adventitial myofibroblast
• Inhibition of neointima and negative remodeling
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BrachytherapyReported Clinical Trials for ISRTRIAL
SCRIPPSWRISTGAMMA 1GAMMA 2LONG WRISTB-WRISTSTARTINHIBITBRITE
Sourse
192Ir192Ir192Ir192Ir192Ir90YSr/90P32P32
Length(mm)15.323.720.21932
20.6171717
Pts(n)351302521251205047633226
Placebo70.558.350.5
71
42.248
Treated11.119
21.6233222
14.2160
Restenosis Restenosis %%
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Brachytherapy to Treat ISRReduction of Re-ISR
0
10
20
30
40
50
60
70
80
LongWRIST
WRISTGAMMA-1
SCRIPPSINHIBIT
STARTCon
Ir192Con
Ir192Con
Ir192Con
Ir192Con
P32Con
Sr/Y90
71
32
61
22
56
33
54
17
5245
29
36%50%64%41%64%
55%
26
%γ radiationβ radiation
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Vascular BrachytherapyVascular BrachytherapyCurrent Status
• Randomized trials showed a 35-70% reduction in the recurrence rate of instent restenosis
• The Late thrombosis phenomenon reported to resolved with prolonged antiplatelet therapy (WRIST PLUS, SCRIPPS III, START, INHIBIT)
What We need As a Pretreatment
Before Brachytherapy ?
Simple Balloon.Rotablation.
Cutting Balloon.
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188Re-MAG3 - Beta Radiation
• Rapid fall-off radiation dose within 2 mm • The increased chance of inhomogeneous
dose delivery to target tissue (esp. eccentric plaque)
Role of Rotablation
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Rotational Atherectomybefore Beta Radiation
Produce concentric and thinner neointima structure ; Radiation dose can be homogeneously delivered to target tissue
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AMC ExperienceR4 Trial
Radiation with188Re-MAG3-filled balloon afterRotablation for diffuse in-stentRestenosis
SW Park, et al. JACC 2001:38:631-7
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Inclusion Criteria
•Diffuse In-stent Restenosis(>10mm in length)
•Total occlusion
SW Park, et al. JACC 2001:38:631-7
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Subject
From March 1999 to May 2001From March 1999 to May 2001
103 patients (57 yrs, M/F: 80/20) Diffuse ISR (mean lesion length 24.1+21.9 mm)
SW Park, et al. JACC 2001:38:631-7
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Design
First 50 consecutive First 50 consecutive patients have been patients have been performed performed rotablationrotablationprior to radiation, prior to radiation,
and the remaining 53 and the remaining 53 consecutive patients consecutive patients received balloon + received balloon + radiation strategy. radiation strategy.
• Rota+RTN=50
• Balloon+RTN=53
SW Park, et al. JACC 2001:38:631-7
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Lesion Length
Rota +RT Balloon +RT(n=50) (n=53)
Mean Lesion Length 25.6±12.7 22.9±8.8 (mm)
>10,<20 (mm) 21(42) 20(38) >20,<30 13(26) 23(43)>30 16(32) 10(19)
*Total occlusion 10(20) 5(10)SW Park, et al. JACC 2001:38:631-7
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Minimal Lumen Diameter
Rota+RT Balloon+RT(n=50) (n=53) p-value
Baseline (mm) 0.60 ± 0.44 0.70 ± 0.37 0.159Final 2.68 ± 0.39 2.61 ± 0.44 0.355Follow-up 2.31 ± 0.60 1.94 ± 1.00 0.004*
Acute gain 2.08 ± 0.46 1.91 ± 0.48 0.875Late Loss 0.36 ± 0.64 0.66 ± 1.20 0.001*Loss index 0.17 ± 3.10 0.45 ± 0.57 0.001*
SW Park, et al. JACC 2001:38:631-7
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Immediate Results
Rota +RT Balloon +RT(n=50) (n=53)
100 86
6 (12%)1 (2 %)00
100 100
0 000
Clinical Success(%)Procedural Success(%)New Stent due to;
Edge dissection Intramural Hematoma
Major complicationIsotope leakage
SW Park, et al. JACC 2001:38:631-7
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6-month angiographic F/U
Rota +RT Balloon +RT(n=50) (n=53)
6 month angiographicF/U (%)
Restenosis Rate (%)
InstentEdge
50/50 (100) 5/50 (10%)
41
51/53 (98)17/51 (34%)
125
SW Park, et al. JACC 2001:38:631-7
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
6-month angiographicRestenosis Rate & TLR
(%)
0
10
20
30
40
50
Rota + RT Balloon + RT
RestenosisTLR
104
34
16
P=0.004P=0.060
1/50
8/53
17/51
5/50
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2 2 yearyear Clinical FollowClinical Follow--UpUpRota +RT Balloon +RT
(n=50) (n=50)
17/50 (34%)5 (10%)8/50 (16%)
3111110
5/50 (10%)2 (4%)2 (4%)
0110
1 (2%),Non-cardiac
Restenosis Rate (%)Symptom RecurrenceTLR (%)
PTCAStent CABGRotablationRTCutting balloon
DeathSW Park, et al. JACC 2001
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Survival CurveSurvival Curve
Follow-up duration (months)0 6 12 18 24
Perc
enta
ge
0
70
80
90
100100%
P=NS98.0 ± 0.2%
27.1±5.87 moRota + RT14.1±5.96 moBalloon +RT
SW Park, et al. JACC 2001:38:631-7
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
TLRTLR--free Survival Curvefree Survival Curve98.0 ± 0.2%
P = 0.046
0 6 12 18 24
Perc
enta
ge
70
80
90
100
84.8 ± 5.0%
27.1±5.87 moRota + RT14.1±5.96 moBalloon+RT
0
Follow-up duration (months)SW Park, et al. JACC 2001:38:631-7
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
MACEMACE--free Survival Curvefree Survival Curve
Follow-up duration (months)0 6 12 18 24
0
95.9 ± 2.9%
P = 0.040
Perc
enta
ge
70
80
90
100
84.1 ± 5.2%
27.1±5.87 moRota + RT14.1±5.96 moBalloon+RT
SW Park, et al. JACC 2001:38:631-7
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Conclusion
• Intracoronary brachytherapy using 188Re -MAG3 liquid filled balloon system for diffuse ISR is safe and feasible and, effective to prevent recurrent ISR
• Debulking using Rotablation prior to radiation seemed to be beneficial to the late clinical outcomes in restenosis rate and TLR.
SW Park, et al. JACC 2001:38:631-7
Role of Cutting Balloon
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Role of Cutting BalloonWithout Brachytherapy
RESCUT
Lesion characteristics
62.430.8Diffuse/Proliferative18.846.1Multifocal18.823.1Focal16.4%13.3 %> 20 mm single/multiple40.531.8Diffuse/Proliferative17.212.9Multifocal42.355.3Focal
0.4483.6%86.7 %≤ 20 mm single stent
P valuePTCA(n=237)
CB(n=229)
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Role of Cutting BalloonWithout Brachytherapy RESCUT
Binary Restenosis
0
10
20
30
(%)
CBT(n=229)
29.8% 31.3%
P=0.82
PTCA(n=237)
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Role of Cutting BalloonWithout Brachytherapy RESCUT
Balloon slippage
0
5
10
15
20
25
30(%)
CBT(n=229)
6.5%
25.1%
P<0.01
PTCA(n=237)
0
5
10(%)
CBT(n=229)
3.9%8.0%
P=0.07
Additional stenting
PTCA(n=237)
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RENO Registry (n=1111)Cutting Balloon before Brachyehrapy
6 Month MACE
0
5
10
15
20(%)
Balloon + RT(n=722)
19.2%
10.8%
P=0.01
CBA + RT(n=166)
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Cutting Balloon Angioplasty Vs.Rotational AtherectomyPerformed Before Beta Radiation Therapy for In-Stent Restenosis:
AMC Experience
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Cutting Balloon or Rotablation before RTx
0.031.17 ± 0.191.10 ± 0.16Balloon/Artery ratio
0.7221.6 ± 10.321.0 ± 10.2Lesion length, mm
0.602.88 ± 0.482.92 ± 0.40Ref artery size,mm
Cutting + RT(n=69)
2.02 ±0.210.70 ± 0.12
4.8 ±2.5
Rotablation Burr size(mm) Burr/Artery ratioFrequency
p-valueRota + RT (n=70)
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Subject
139 patients (M/F: 89/50, 59 yrs)
Diffuse ISR (mean lesion length 20.3±8.9 mm)
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DesignIn-Stent Restenosis
(N=139)
RandomizationRandomization
Rota + RTN=70
Cutting + RTN=69
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Procedure-related Data
0.031.17 ± 0.191.10 ± 0.16Balloon/Artery ratio
0.7221.6 ± 10.321.0 ± 10.2Lesion length, mm
0.602.88 ± 0.482.92 ± 0.40Ref artery size,mm
Cutting + RT(n=69)
2.02 ±0.210.70 ± 0.12
4.8 ±2.5
Rotablation Burr size(mm) Burr/Artery ratioFrequency
p-valueRota + RT (n=70)
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Procedure-related Data
0.27 0.22
71.4 ± 13.8 6.0 ± 17.3
74.0 ± 13.29.2 ± 12.9
Diameter stenosis BaselineFinal
0.215.7 ± 1.86.1 ± 2.2Pressure (atm)
0.35 0.50
0.83 ± 0.402.68 ± 0.50
0.76 ± 0.40 2.63 ± 0.40
MLD, mmBaselineFinal
Cutting + RT(n=69) p-valueRota + RT
(n=70)
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Radiation Coverage
27 (39%)32 (46%)8 (12%)2 (3%)
17 (24%)42 (60%)10 (14%)1 (1%)
≤ 30 mm30< ≤40 mm60 mm (overlap)80 mm (overlap)
0.69185±87191±86RT Time (sec)
0.4138.7±12.040.3±11.0Radiation Balloon Length (mm)
Cutting + RT(n=69)
p-value
Rota + RT (n=70)
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Immediate Results
00
00
Major complicationIsotope leakage
3 (4%)7 (10%)New Stent due to
Edge dissection
100 100Success rate (%)
Cutting + RT(n=69)
Rota + RT (n=70)
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
6-Month Angiographic F/U
• Eligible 101 patients • Angiographic follow-up rate = 76% (77/101)
- Rota + RT (69%, 35/51)
- Cutting + RT (84%, 42/50)
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6-Month Angiographic F/U
0.86±0.37 2.73±0.40 1.82±0.85
0.77±0.412.57±0.43 1.74±0.71
Pre MLD (mm)Post MLD (mm)F/U MLD (mm)
Rota + RT (n=35)
0.330.100.66
p-value
Cutting + RT (n=42)
Acute gain (mm)Late loss (mm)Loss index
1.74±0.49 0.84±0.83 0.44±0.48
1.87±0.42 0.91±0.79 0.53±0.47
0.210.680.45
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Restenosis Rate
0
10
20
30
40(%)
Cutting + RT Rota + RT
29 %(10/35)
36%(15/42)
P=0.51
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8-months TLR Rate
0
5
10
15
20(%)
Cutting + RT Rota + RT
13%(9/69)
P=0.08
4%(3/70)
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Conclusion
The cutting balloon angioplasty and rotational
atherectomy before brachytherapy using 188Re-MAG3 filled balloon showed similar
favorable acute and long-term outcomes.
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Brachytherapy Durable effect ?
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WRIST-Five year F/U (MACE)Freedom from death, MI , TLR
1.0P<0.002 Iridium
Prob
abili
ty
0.2
0.4
0.6
0.8 Placebo
0 3 6 9 12 24 36 48 60MACE Time in (Months)
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SCRIPPS-Late Catch-Up
0
10
20
30
40
50
60
70(%)
Placebon=28
54%
192 Irn=24
Placebon=22
192 Irn=21
64%
17%
33%
6-Month Follow-UP 3-Year Follow-UPLate catch-up (n=4)
P=0.01
P<0.0569%48%
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SCRIPPS-3 Years TLR
0
10
20
30
40
50
60(%)
Placebon=29
44.8%
192 Irn=26
Placebon=29
192 Irn=26
48.3%
11.5% 33%
6-Month Follow-UP 3-Year Follow-UP
P=0.01P<0.01
74%68%
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
SCRIPPS-Five year F/U (MACE)Freedom from death, MI , TLR
Prob
abili
ty
0.4
0.6
0.8
1.0
P=0.03
Treatment0.2
Placebo
0 12 24 36 48 60 72Time (Months)
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TwoTwo--YearYear Angiographic Angiographic FollowFollow--Up In Up In Rota Rota + RT Group+ RT Group
AMC Experience
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66--month & 2month & 2--yr yr angiographicangiographic FUFU
Total pts (n=50)
6-month FU50/50 (100%)
2-year FU26/45 (58%)
2 TLRs 5 Restenoses((RestenosisRestenosis=10%)=10%) 3 medicals
Patent (N=45)Patent (N=45)
4 late TLRs 6 late “catch-up”(Restenosis=23%) 2 medicals
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
6-month & 2-year angiographicRestenosis Rate
0
10
20
30
6-month 2-year
(%)
N = 50 patientsFU = 50/50 (100%)
N = 45 patientsFU = 26/45 (58%)
10%(5/50)
23%(6/26)
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2-year angiographicRestenosis & TLR Pattern
• Focal 2Intrastent 1 1 Cutting balloonEdge 1 1 Medical
• Diffuse 4Intra-stent 1 1 MedicalTotal occlusion 3 2 Cutting balloons
1 CABG
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66--month & 2month & 2--yr yr angiographicangiographic MLDMLD
0
1
2
3
4MLD(mm)
Postprocedural 6-month 2-year
2.682.31
1.81
P=0.018P=0.018P=0.011P=0.011
P<0.001P<0.001
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
66--month & 2month & 2--year IVUS Datayear IVUS Data
0
2
4
6
8
10
Ave
rage
CSA
(mm
2 )
Postprocedural 6-month 2-year
8.29 8.27 8.28
6.45 6.28 5.80
1.84 1.99 2.49
P=0.49P=0.49 P=0.73P=0.73
P=0.003P=0.003P=0.26P=0.26
P=0.003P=0.003P=0.32P=0.32
Stent Stent CSACSA
Lumen Lumen CSACSA
IH IH CSACSA
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
66--month & 2month & 2--year IVUS Datayear IVUS Data
0
4
8
12
16
20
Ave
rage
CSA
(mm
2 )
Postprocedural 6-month 2-year
16.3 16.5 16.2
9.0 9.4 9.1
7.3 7.1 7.0
P=0.25P=0.25 P=0.22P=0.22
P=0.26P=0.26
P=0.36P=0.36
EEM EEM CSACSA
Lumen Lumen CSACSAP+MP+MCSACSA
P=0.36P=0.36
P=0.86P=0.86
Proximal reference segment
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
66--month & 2month & 2--year IVUS Datayear IVUS Data
0
4
8
12
Ave
rage
CSA
(mm
2 )
Postprocedural 6-month 2-year
10.0 10.7 10.1
5.6 6.0 5.4
4.4 4.7 4.6
P=0.06P=0.06 P=0.03P=0.03
P=0.27P=0.27
P=0.21P=0.21
EEM EEM CSACSA
Lumen Lumen CSACSAP+MP+MCSACSA
Distal reference segment
P=0.03P=0.03
P=0.89P=0.89
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EventEvent--free Survival free Survival
0 6 12 18 24 30
Death-free Survival 98.0 ± 2.0%
MACE-free Survival 86.9 ± 5.0%Late
Catch-up
100
70
80
90
Perc
enta
ge
Mean follow-up duration = 32.2±4.5 months0
Follow-up duration (months)
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Conclusion
•• BetaBeta--irradiation using a irradiation using a 188188ReRe--MAGMAG33--filled filled balloon after rotational balloon after rotational atherectomyatherectomy is safe is safe and feasible in patients with diffuse ISR. and feasible in patients with diffuse ISR.
•• LongLong--term term angiographicangiographic and clinical outcome and clinical outcome appears favorable for this highly appears favorable for this highly restenosisrestenosisprone group.prone group.
• However, late “catch-up” phenomena were observed in some patients after brachytherapy.
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Drug-Eluting Stent forIn-Stent Restenosis
Safe and efficacious ?
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Paclitaxel Stent for ISRPilot Study (n=21 pts)
Re-Restenosis
9 pts with optimal coverage
12 pts with a mismatch between the injured zone and the paclitaxel stent
0 / 9 pts
3 / 12 pts
Overall : 14%
De Scheerder IK, TCT
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TAXUS III for ISR(N=27)
10 (35.8%)Focal
13 (46.4%)Diffuse
4 (14.3%)Proliferative
1 (3.6%)Total occlusion
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TAXUS III -MACE
8 (29%)06-Month MACE1 (3.6%)0CABG
6 (21.4%)0TLR1 (3.6%)1 (3.6%)Non Q-Wave MI
00Q-Wave MI00Death
6 month30 day
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TAXUS III for ISR2 Clinical Centers (n=28 pts)
Re-Restenosis = 4 / 25 (16%)
Post0
10
20
30
40%
13.917.4 19.3
14.3
30.8
14.8
6 Mos
Proximal In-Stent Distal
K Tanabe, Circulation 2003;107
Percent diameter stenosis
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
TAXUS III for ISRCharacteristics of TLR Patients
TLR6 Patients
2 Patients
Gap betweenTwo NIRx
Stents :
Geographic Miss
1 Patients
Restenosis in Bare stent next
To 2 NIRx
Mismatch
True Restenosis
2 Patients
TLR driven byIVUS showing
Incompleteexpansion
1 Patients
Anginal complains And smallMLD but
% DS > 50%
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TAXUS III for ISRRestenosis Pattern
16 % (4/25)0% (0/13) 33% (4/12)
4.5 % (1/22)
Restenosis rateSingle stentMultiple stents
Subanalysis excluding mismatch and GM
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Sirolimus-coated Stent for ISRSirolimus-coated Stent for ISR
Focal
Diffuse
Proliferative
Total occlusion
10 (40%)
Brazil (n=25)
3 (19%)
Netherlands(n=16)
8 (32%)
4 (31%)
7 (28%)
5 (31%)
0 (0%)
3 (19%)
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Sirolimus-coated Stent for ISRSirolimus-coated Stent for ISR
First-In-Man Experience (n=38/41)
%DS
0
1
2
3
0.90.9
2.72.7 2.62.6MLD(mm)
0.70.70.7
2.62.62.6 2.52.52.5
74.6
1.6 5.7
62.2
2.6 7.6 Late LossBrazil = 0.08mmNetherl = 0.11mm
80%DS (Brazil)
60 %DS (Netherl)MLD (Brazil)40 MLD (Netherl)
20
0Pre Post 4mo
AHA 2002
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Sirolimus-coated Stent for ISRSirolimus-coated Stent for ISR1-Year Clinical Events
0 (0%)
0 (0%)
0 (0%)
1 (4%)
BrazilN=25
2 (4.9%)
1 (2.4%)
2 (4.9%)
3 (7.3%)
2 (12.5%)
1 (6.3%)
2 (12.5%)
2 (12.5%)
Death
MI
TLR
Restenosis
PooledN=41
RotterdamN=16
AHA 2002
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IVUS Volumetric Analysis at Proximal Reference
IVUS Volumetric Analysis at Proximal Reference
Vessel volumeVessel volume 72±44
72±44
-0.44
-0.44
PostPost FUFU DeltaDelta
Lumen volumeLumen volume 50±550±5 -1.81-1.81
Plaque volume
Plaque volume
34±23
34±23
0.080.08
Proximal
Proximal
72±46
72±46
52±60
52±60
34±22
34±22p=NSp=NSAll values in mm2All values in mm2
Edge effect was not seen in Edge effect was not seen in Cypher stentCypher stent !!
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Late Lumen Loss in Drug-Eluting Stent vs. Radiation in ISR Trials
Late Lumen Loss in Drug-Eluting Stent vs. Radiation in ISR Trials
0.200.28
0.38
0.09
Sirolimus WRIST PREVENT START
Average Bare Stent Late Lumen Loss = 0.80
0.80
0.60
0.40 Angiographic Standard Deviation
of 0.1mm x 2
-0.60
-0.40
-0.20
0.00
Late
Los
s (m
m)
0.20
90Sr192I 32P6 mo4 mo 6 mo 8 mo
-0.80
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Drug-Eluting Stent forIn-Stent Restenosis
We need more data.However, we suppose that it may be an alternative standard therapy to intracoronary brachytherapy.