Neointimal Coverage of Zotarolimus-Eluting Stent Using Optical Coherence Tomography · 2008. 12....

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


Kim, JungKim, Jung--Sun, MD, Ph D Sun, MD, Ph D

I have no conflicts of interest.

Conflict of Interest Statement


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


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


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


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.


AngioscopicClassification of

NeointimalCoverage at 8 months FU

Awata M, et al. J Am Coll Cardiol 2008:787–92


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


Thrombus

formation

during the

OCT

procedure

Kim JS, et al. Circulation 2008


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


9 Month Follow-Up OCT findingSES ZES


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


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)


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


P = 0.001 P = 0.002P =0.19

SES ZESSES ZES

ESC 2008, Submitted to Journal


OCT findings 58 patients (28 SES and 30 ZES)


0

1

2

3

4

5

6

7

8

Mal

appo

sitio

n(%

)

SES ZES


P = 0.003

P = 0.002

P =0.48

SES ZESSES ZES

ESC 2008, Submitted to Journal


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. .


How early does it take an Complete NeointimalCoverage in ZES ?

Question 2


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


Case 2Case 2

Initial 3 Month Follow-Up

ACS


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


OCT findings 30 patients (20 stents in 15 ACS and 16 stents in 15 SA)


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


OCT findings30 patients (20 stents in 15 ACS and 16 stents in 15 SA)


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 %)


Final Report will be available on early next year

OCT follow-up and measurement

of IVUS and OCT were finished

at Nov. 2008


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


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


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..


Back-up slide


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


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

Neointimal Coverage of Zotarolimus-Eluting Stent Using Optical Coherence Tomography · 2008. 12....

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