neointimal coverage of zotarolimus-eluting stent using optical coherence tomography · 2008. 12....
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Yonsei Cardiovascular Center
Kim, JungKim, Jung--Sun, M.D. Ph D. Sun, M.D. Ph D.
Yonsei University College of Medicine,Yonsei University College of Medicine,
Yonsei Cardiovascular Hospital, Yonsei Cardiovascular Hospital,
Cardiology DivisionCardiology Division
Neointimal Coverage of Zotarolimus-Eluting StentUsing Optical Coherence
Tomography
Yonsei Cardiovascular Center
Kim, JungKim, Jung--Sun, MD, Ph D Sun, MD, Ph D
I have no conflicts of interest.
Conflict of Interest Statement
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The most powerful histological predictor of stentthrombosis was endothelial coverage.
The best morphometric predictor of LST was the ratio of uncovered to total stent struts.
Finn AV, et al. Circulation 2007;115:2435-41
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IVUS vs. OCT
15 frame/s15 frame/s30 frame/s30 frame/sFrame rateFrame rate
9090--110 dB110 dB4040--60 dB60 dBDynamic rangeDynamic range
0.4 mm0.4 mm0.8 mm0.8 mmSize of imaging coreSize of imaging core
1515--20 20 μμmm2525--40 40 μμmm
Axial 100Axial 100--150 150 μμmmLateral 150Lateral 150--300 300 μμmm
ResolutionResolution
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Especially, Drug Eluting Stent ??
How long does it take to complete a NeointimalCoverage over stent ?
Question 1
Yonsei Cardiovascular Center1. Nikol et al: Atherosclerosis 123:17, 1996 2. Stone G: Presented at ACC, 20043. Ormiston J, Endeavor I Study: Presented at AHA, 2004
0
20
40
60
80
100
0 30 60 90
Dru
g re
leas
e (%
)D
rug
rele
ase
(%)
DaysDays
Extracellular matrix formation
PES
ZESSES
InflammationProliferation
Thrombosis
SESInitial small burst & controlledrelease over 90 days; 80% eluted at 30 days,complete at 90 days
PESBimodal release of 10% of the drug, completed in 2 weeks, 90% sequestered on stent
ZESNearly 100% of the drug elutes in the first 7 daysand complete at 12 days
Different Characteristics in DESs
Yonsei Cardiovascular CenterJoner M, et al. J Am Coll Cardiol 2008;52:333–42
Endothelial Cell Recovery BetweenComparator Polymer-Based Drug-Eluting Stents
14 days after implantation 28 days after implantation
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NIH thickness and percent NIH area were 29 ± 41 μm and 10 ±4%, respectively. Rates of exposed struts and exposed struts with malapposition were 15% and 6%, respectively. These were more frequent in patients with ACS than in those with non-ACS (18% vs. 13%, p <0.0001; 8% vs 5%, p <0.005, respectively). In conclusion, neointimal coverage in a SES at 3-month follow-up is incomplete in ACS and non-ACS. Our study suggests that dual antiplatelet therapy might be continued >3 months after SES implantation.
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AngioscopicClassification of
NeointimalCoverage at 8 months FU
Awata M, et al. J Am Coll Cardiol 2008:787–92
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YONSEI OCT RegistryYONSEI OCT Registry
From Aug, 2007 to Nov, 2008From Aug, 2007 to Nov, 2008
264 stents in 200 patients 264 stents in 200 patients
were enrolled and evaluatedwere enrolled and evaluated
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Thrombus
formation
during the
OCT
procedure
Kim JS, et al. Circulation 2008
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Study DesignStudy Design
SES
Patients with DES implantation at 9 months follow-up
PES
Perform IVUS and OCT at 9 month follow-up
Primary end-point: stent strut coverage
Secondary end-point: Percent of stent malapposition and thrombus at 9 month
ZESSES ZES
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9 Month Follow-Up OCT findingSES ZES
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1. 1. NeointimalNeointimal thicknessthicknessThe distances between the The distances between the endoendo--luminal surface of luminal surface of neointimalneointimal and and the strut reflection the strut reflection
2. Stent apposition2. Stent appositionThe distances between the The distances between the endoendo--luminal surface of the strut luminal surface of the strut reflection and the vessel wallreflection and the vessel wall
Optical Coherence Tomography Image Analysis
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0
10
20
30
40
50
60
70
Sten
tStr
ut C
over
age
(%)
SES ZES
Total Population Non-AMI AMI
P < 0.001P = 0.006
P <0.001
SES ZESSES ZES
IVUS Findings 58 patients (28 SES and 30 ZES)
using Miyazawa’s method (Am Heart J 2008;155:108-113)
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OCT findings 58 patients (28 SES and 30 ZES)
1306 mm in stent length including 13556 struts
50
60
70
80
90
100
Sten
tstr
ut c
over
age
(%)
SES ZES
Total Population Non-AMI AMI
P = 0.001 P = 0.002P =0.19
SES ZESSES ZES
ESC 2008, Submitted to Journal
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OCT findings 58 patients (28 SES and 30 ZES)
1306 mm in stent length including 13556 struts
0
1
2
3
4
5
6
7
8
Mal
appo
sitio
n(%
)
SES ZES
Total Population Non-AMI AMI
P = 0.003
P = 0.002
P =0.48
SES ZESSES ZES
ESC 2008, Submitted to Journal
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NeontintimaNeontintima coverage of stent struts at 9coverage of stent struts at 9--month was nearly month was nearly complete in complete in ZESsZESs. .
Important findings in this study
Therefore, in the cases of Therefore, in the cases of SESsSESs, prolonged use of dual anti, prolonged use of dual anti--platelet therapy may be required more than 9 months platelet therapy may be required more than 9 months
This means that 9 monthThis means that 9 month--maintenance of dual maintenance of dual antiplateletantiplatelettherapy may be enough for patients with ZES. therapy may be enough for patients with ZES.
But in But in SESsSESs, exposed struts and , exposed struts and malapposedmalapposed struts were struts were more frequently observed than in more frequently observed than in ZESsZESs. .
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How early does it take an Complete NeointimalCoverage in ZES ?
Question 2
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EEvaluation in 3 valuation in 3 moNthsmoNths DDuration of uration of nnEEointimointimAAll cocoVVererAAgegeafter after zzOOtataRRolimusolimus--eluting stent implantation by eluting stent implantation by OOptical ptical
CCoherence oherence TTomography omography (ENDEAVOR OCT)(ENDEAVOR OCT)
Stable angina (n = 15 )
Patients with Endeavor implantation in CAD
IVUS and OCT after stent implantation and at 3 months
Primary end-point: Percent neointima coverage at 3 months
Secondary end-point: percent of malapposition and thrombus at follow-up OCT
ACS (n = 15)
P.I: Yangsoo Jang
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Case 2Case 2
Initial 3 Month Follow-Up
ACS
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0
10
20
30
40
50
Sten
tStr
ut C
over
age
(%)
Total Population(N=30)
ACS (N=15) SA (N=15)
P = 0.648
IVUS Findings30 patients (19 stents in 15 ACS and 16 stents in 15 SA)
using Miyazawa’s method (Am Heart J 2008;155:108-113)
Preliminary results
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OCT findings 30 patients (20 stents in 15 ACS and 16 stents in 15 SA)
767 mm in stent length including 14017 struts
50
60
70
80
90
100
Sten
tstr
ut c
over
age
(%)
Total Population (N= 30)
ACS (N= 15) SA (N=15)
Preliminary results
Measured at every 0.5 mm
P = NS
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OCT findings30 patients (20 stents in 15 ACS and 16 stents in 15 SA)
767 mm in stent length including 14017 struts
0
0.2
0.4
0.6
0.8
1
Mal
appo
sitio
n(%
)
Total Population (N=30)
ACS (N=15) SA (N=15)
Measured at every 0.5 mm
Preliminary results
P = NS
Visible thrombus: 1/36 stent (2.8 %)
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Final Report will be available on early next year
OCT follow-up and measurement
of IVUS and OCT were finished
at Nov. 2008
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CComparisiomparisiOOnn of of neointimalneointimal cocoVVerageerage betwbetwEEenenzotazotaRRolimusolimus eluting stent and eluting stent and everolimuseverolimus eluting stent eluting stent
using using OOptical ptical CCoherence oherence TTomography at 9 months omography at 9 months (COVER OCT)(COVER OCT)
EES (n = 20 )10 SA and 10 ACS
Patients with EES or ZES resolute implantation in CAD
Perform IVUS and OCT at initial and 9 month
Primary end-point: Neointima coverage at 9 months
Secondary end-point: percent of stent malapposition and thrombus at 9 months
ZES resolute (n = 20)10 SA and 10 ACS
Prospective Multi-center
Trial
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Small population, but considerable struts were Small population, but considerable struts were evaluated in current study. evaluated in current study.
The detected The detected neointimaneointima does not fully reflect an intact does not fully reflect an intact functioning endothelium.functioning endothelium.
There were no data on clinical Implications of There were no data on clinical Implications of neoinitmalneoinitmal coverage detected by OCTcoverage detected by OCT..
Limitation
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In ConclusionIn ConclusionOCT is a powerful tool to study vascular biology and OCT is a powerful tool to study vascular biology and stent statusstent status
NeontimalNeontimal coverage of stent struts at 9coverage of stent struts at 9--month after month after stent implantation was nearly complete in stent implantation was nearly complete in ZESsZESs..
NeointimaNeointima over stent strut could be covered even in 3 over stent strut could be covered even in 3 months in months in ZESsZESs..
Optimal duration of dual antiOptimal duration of dual anti--platelet therapy might platelet therapy might be different in ZES compared to other be different in ZES compared to other DESsDESs..
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Back-up slide
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Measurements of strut apposition. The distance between the endo-luminal surface of the strut reflection and the vessel wall is measured.
Cypher Taxus Endeavor
180μm
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Percent of initial malapposition in STEMI
27.8
11.2 9.7
0
5
10
15
20
25
30
SES PES ZES
%
†
**
* represents statistically signifcant (p=0.001) and † represents statistically insignificant (p=0.124)Definition of malapposition : ≥ 160 μm for Cypher, ≥ 130 μm for Taxus, ≥ 110 μm for Endeavor
SES (Cypher) : sirolimus eluting stent, PES (Taxus) : paclitaxel eluting stent, ZES (Endeavor) : zotarolimus eluting stent
(N=1463) (N=1522) (N=1966)
Submitted to Journal