Time course of stent endothelialization after intravascular radiation therapy

48A

ABSTRACTS

less. Conclusions:

- Angiography

This analysts confirms

at lower risk for in-hospital

adverse

& Interventional

that overweight

events and mortality

that, within this heterogeneous group, current smokers diac disease are especially at risk following PCI.

Cardiology

and obese pts having

PCI are

JACC

i 128-179

March 19,2003

Coronary Brachytherapy Is an Effective Treatment for Chronic In&tent Total Occlusions

at one year. Our data suggest and those with severe non-car-

Antonio P. Madrid Mark A. Grise, John P. Reilly, Jeffrey W. Moses, Martin B. Leon, Anca Tcelibi, Cristlan Cioar, Huan Giap, Shirish Jani, Steven Baiter, Prabhakar Tripuraneni,

Adverse Events Following PC1

Alexandra

Lansky, Manuela

Negoita,

Roxanna

Mehran,

Paul S. Teirstein,

Scripps Clinic,

La Jolla, CA, Lenox Hill, New York, NY

In-hospital

(BMI 25.0.

Obese (BMI >=

Normal

Overweight

(BMlc25.0)

29.9)

30.0)

Background: Brachytherapy has demonstrated benefit for in-stent restenosis, but results in patients with chronic total occlusions have not been reported. The objective of this

(rl=1118)

(n = 1998)

(n = 1496)

study

0.9%

occlusions. Methods: Of 746 patients treated

1.3%

2.5%

death’*

is to describe

outcomes

a total of 89 (11.9%)

In-hospital

MI’

one-year

3.7%

3.1%

1.9%

8.8%

4.3%

3.7%

following

brachytherapy

in the GAMMA

had chronic

in patients

I, GAMMA

total occlusions.

2, and SCRIPPS

All patients

received

after angioplasty with or without stenting for in-stent restenosis. Results: The two groups were well matched with respect to baseline comes for the two groups

death”’

are aisplayed

with chronic

total

Ill studies,

brachytherapy

characteristics.

Out-

below.

Conclusion: Treatment of chronic in-stent total occlusions with brachytherapy is associated with late target vessel revascularization rates similar to patients without total occlusions. The presence

of a chronic total occlusion

should not be considered

an obstacle for

brachytherapy. Excluding

smokers

and patients

with severe concomitant

disease

Table

(n = 457)

(n = 963)

(n = 749)

In-hospital

death’

2.1%

0.5%

0.7%

In-hospital

Ml

4.3%

3.1%

1 .9%

In-Hospital MI/‘i-VR

4.7%

3.2%

2.3%

Late Thrombosis

One-year

death *

Death

I

Total Occlusion

Non-Total

Occlusion

Relative Risk [95%C.I.]

3.4% (3/89)

2.3% (15/657)

1.48 [0.44,5.00]

1.1% (l/87)

1.6% (101639)

0.73 [0.10,5.67]

25.3% (22/87)

30.4% (194/639)

0.83 [0.57,1.22]

4.6% (4/87)

1.6% (10/639)

2.94 [0.94,9.17]

6.9% (6/87)

8.4% (561640)

0.82 [0.36,1.84]

32.2% (28187)

35.2% (2251640)

0.92 [0.66,1.26]

(31.270) *** p<=o.o01;

** p
NR

* p
Cardia

Death

Myocardial

POSTER SESSION

1128

Infarction

Death/Ml/lVR

iiza-ia0

Brachytherapy

lntracoronary

Mark A. Grise, Antonio

Monday, March 31, 2003, 3:00 p.m.-!500 p.m. McCormick Place, Hall A Presentation Hour: 3:00 p.m.-4:OO p.m.

Anca Tchelibi,

Gamma Radiation for Elderly Patients

P. Madrid, Jeffrey W. Moses, Martin B. Leon, Peter J. Casterella,

Cristian Cioar, Huan Giap, Shirish Jani, Steven Baker, John P. Reilly,

Prabhakar Tripuraneni, Alexandra Lansky. Manuela Neoglta, Roxanna Teirstein, Scripps Clinic, La Jolla, CA, Lenox Hill, New York, NY Background: of in-stent

lntracoronary restenosis,

brachytherapy

has been proven

but the results in older patients

Mehran,

efficacious

in the treatment

have not been characterized.

i i 28-178

Use of the Sirolimus-Eluting Bx VELOCITY Stent for Failed Brachytherapy in Recurrent In-Stent Restenosis: Results From the SECURE Registry

objective of this report is to evaluate patients 275 years of age.

Paul S. T&stein,

John Kao, Theodore

total of 115 patients (15.4%) were 2 75 years of age. All received intracoronary radiation after angioplasty with/without stenting for in-stent restenosis.

Andrew

Methods:

A. Bass, Marco A. Costa, Steven Yakubov,

J. Carter, Jeffrey W. Moses, Martin B. Leon. Tim A. Fischell,

Scripps Clinic, La

Results:

Jolla, CA

tion,

Of the 746 patients

The two groups

diabetes,

and

BACKGROUND: Brachytherapy is currently the only modality with proven efficacy for instent restenosis, but failure rates after brachytherapy approximate 25%. The sirolimus-

younger

eluting

graft interventions

Bx VELOCITY(tm)

sis. however

its efficacy

stent has shown promising in the setting of in-stent

results for de nova coronary

restenosis

stano-

and failed brachylherapy

is

unknown. Sirolimus-eluting

stents were implanted

in 40 patients who restenosed following treated at 5 study sites: Scripps Clinic, Health

Science

Center,

Riverside

under a compassionate

use protocol

treatment with brachytherapy. Patients were Lenox Hill Hospital, the University of Florida

Methodist

Hospital,

and the Providence

Health

treated in GAMMA

were well matched

hypertension.

There

which will be completed

by February,

coronary

1, GAMMA

2, and SCRIPPS

a higher

incidence

in the younger

as the index procedure

group. Outcomes lntracoronay

There was a lower rate

radiatron

is associated

below.

lenging patient population.

Table

2003. 75

Relative Risk

Age 275

[95% Cl.) 2.2% (141613)

3.5% (4/l 15)

0.64 [0.21,190]

2.0% (12/613)

0.0% (O/l 13)

4.64 [0.28,77.84]

Target vessel revascularization

31.3% (192/613)

21.2% (241113)

1.47 [1.01,2.14]

Cardiac

1.8% (11/613)

2.7% (3/l 13)

0.68 [0.19.2.38]

9.0% (55/613)

4.4% (51114)

2.05 [0.84,5.00]

36.1% (221/613)

28.1% (32/114)

1.28 [0.94,1.75]

In-hospital

Mean Age

63 years

Hypertension

Male

31(78%)

Angina

37(93%

RVD(visual)

)

20(50%)

Unstable

Angina

2.94m m 16.8m

34(85%

Lesion Length

)

(visual)

m

37(93%

LAD

26(33%

)

1 Prior Ml

6(16%)

RCA

22(28%

) Prior PTCA

4O(lcnl

Stable Angina

Prior CABG

Diabetes Smoking

Hx

16(40%)

31(84%

SVG

8(10%)

LCX

8(10%)

Number Lesions

Of

78

12(30%)

Lesions/Patient

1.95

LM

5(6%)

20(50%)

StentslPatients

2.58

Other Artery

7(9%)

Treated CONCLUSIONS:

An initial series of patients

DeathlMIflVR

Late thrombosis

(31-270 days)

death

Myocardial

infarction

Death/MI/TVR

iiza-181

Time Course of Stent Endothelialization Intravascular Radiation Therapy

EdouardF. Cheneau,

)

%)

revas-

Sys-

Age<

Hyperlipidemia

and less vein

with less target vessel

Baseline Demographics and Angiogmphlc Characteristics

40

infarcin the

cularization in older patients. It should be considered a viable therapy in this patient group, especially considering the increased surgical morbidity and mortality in this chal-

RESULTS:

Number of Patients

of smoking

gamma

(10.0% vs 17.5% relative risk 0.57 [0.36,0.91])

of the two groups are displayed

gamma

in

Ill trials, a

with respect to history of myocardial was

The

brachytherapy

bypass surgery (34.8% vs 46.5%, relative risk 0.75 [0.60,0.94]),

tem. Baseline characteristics collected include general demographics, lesion and procedural data. Per protocol, all patients with failed brachytherapy are scheduled for 8 month follow up angiograms,

followlng

cohort (49.4% vs 35.7%, relative risk 1.39 [1.07.1.79]).

of previous

Conclusions:

METHODS:

outcomes

Paul S.

who failed brachytherapy

high risk for recurrent restenosis have been treated with a sirolimus-eluting up clinical and angiographic outcomes will be presented

and who are at stent. Follow-

Michael

C. John, Jana Fournadjiev,

Kim, Rajbabu Pakala, Laurent Leborgne, Hospital Center, Washington, DC, Armed Background: serious

Late total occlusion

complication

C. Ghan, Han-!300

Renu Virmani, Ron Waksman, Washington Forces Institute of Pathology, Washington,

after vascular

of the technology.

Rosanna

After

Delayed

brachytherapy

(VBT) continues

re-endothelialization

DC

to be a

was suggested

as

a pivotal cause for this phenomenon, however the time course for complete healing is unknown. Assessing the rate of healing following VBT can be helpful in determining the risk of late thrombosis Methods

and

results:

and duration Seventy-two

of antiplatelet rabbit

therapy.

iliac arteries

underwent

stent implantation,

JACC

stent to artery ratio 1 .l :I .O to 1.2:l .O, and were subjected The prescribed

Cardiology

49A

enosis. Patients who did not receive a new stent were treated with cloprdogrel

for a mini-

ABSTRACTS

March 19,2003 doses were 0 Gy (controls),

to gamma-radiation

using ‘92ir.

15 Gy, or 30 Gy at 2 mm from the center of

mum

- Angiography

of 6 months.

Patients

who

& Interventional

required

a new stent

the swrce axis. Animals were sacrificed at 1, 3, and 6 months and arteries were analyzed for histomorphometry (n=36) or scanning electron microscopy (n=36). lntimal area

received clopidorgel for at least 12 months. Results: Of 492 patients enrolled, only 22.7% required

(IA) was reduced

421.9

and at 6 months

after VBT at 3 months with 30 Gy (Table).

15 Gy and controls.

with 15 Gy and 30 Gy es compared

There was no difference

The surface covered

by endothelium

ies at all time points and did not increase rophages, endothelial

and leucocytes cells.

were 1 month

Endothelialized

in IA at 6 months

was reduced

from 1 to 6 months.

see” in radiated

arteries

3 months

to controls arter-

Excess of platelets,

mac-

not completely

covered

days.

Clopidogrel

one late thrombosis

by

been

new stents. Mean follow-up

discontinued

for

at 20 months

>6

months

is associated

in

was only

prior to 30 There was

(0.2%) in a patient who did not receive a new stent and

who completed a six-month ccwrse of clopidogrel. Conclusions: A stragedy of avoiding new stem implantation antlplatelet

6 months

and prolonged

with a very low risk of late thrombosis

adjunctive

(0.2%). The zealous

use

of off-protocol clopidogrel makes it difficult to determine the optimal duration of anti-platelet therapy, particularly in patients receiving new stents. Until further data is obtained we

surface

recommend receiving

Control

92 * 4%

95 * 2%,

96 f 2%

15Gy

37 * 4%’

32 f 12%’

40 * 8%’

37 * 8%’

29 * 13%’

35 * 12%.

indefinite

clopidogrel

30 Gy area. mm2

Control

0.86 * 0.21

1 .Ol * 0.11

1.28 -t 0.26

15Gy

0.80 r 0.42

0.66 * 0.07’

1.35 + 0.37

30 Gy

0.57 * 0.27

0.66 * 0.04’

0.75 * 0.09

therapy

after intra-coronary

brachytherapy

in patients

new stents.

1

Table

lntimal

had

of brachyiherapy

67(13,6%)patie”ts (Table). Three patients sustained subacute thrombosis days. All three patients had received new stents during their index procedure.

between

in radiated

+148.4

at the time

Plavix Dicontinued

New Stent

>l

175

35

>3 Months

58

29

>6 Months

42

25

Month

1128-184

Longer

No New Stent

Sources

Stent

of lntracoronary

Restenosis

Reduces

Brachytherapy

Restenosis

for

in the

Real

In-

World

* pco.05 versus c0ntrOl Conclusions:

Re-endothelialization

after VBT IS not completed

Thus, special cars with prolonged time point.

antiplatelet

Stent Dean J. Kereiakes. Melissa

Mazzoni,

Cincinnati,

at 6 months

be considered

after VBT. beyond

Annapooma S. Kim, Ajay Agarwal, Shazia Mukaddam, Mary E. Duffy, Michael C. Kim, Mazullah Kamran. Warren Sherman, Samin K. Sharma, The Mount Sinai Medical

this

Experience Device

of the

Ron Waksman,

With for

Angiorad

Restenosis

a Novel

In-Stent

Mehra,

The Lindner

ir”’

Vascular

Restenosis:

Radiation

Therapy

lntracoronaries Anilkumar

Jeffrey J. Popma,

II (ARTISTIC Carlos E. Morales,

Center/Ohio

Final for

In-

Methods:

Ray Magorien,

swrce

Heart Health Center,

profile limit efficacy of currently

ter compatible),

which provides

available

randomized

(WRIST;

trial

and

n=50). Quantitatw

at 6 months;

coronary

clinical follow-up

angiography

evaluation

for In-stent

was performed

devices.

Restenosis

Trial

periprocedurally

and

was at 30 days and 6 months.

PRE PROCEDURE

lr192 (n=236)

Control (n=104)

RVD mm (SD)

2.71 (0.5)‘”

2.55 (0.4)

Lesion Length mm (SD)

14.36 (7.0)”

150 consecutive

in 68 lesions) and followed

in 15.8% patients,

patients

with in-stent

(ICBT)

revascularization

restenosis

(170 vessels

for mea” 6+3 months.

18.74 (8.4)

average

in-hospital

stay was 2.1e2.8 days, GP llbillla

use 65%. Plavix

low-up). Table of Contents

18 Gy at 2 mm from the source center, was used to treat

Radiation

We analyzed

brachytherapy lesion

was recommended for l-6 months. At follow-up: TVR 9.3% (14 pts, 11 TLR, and 3 “onTLR), delayed acute closure/subacute thrombosis 0%. death 2.7% (1 in-hospital, 3 at fol-

(AngioRadTM, Interventional Therapies, LLC, catheter/centering balloon (6 Fr guide cathe-

the Washington

intracoronary

Results: Mean age was 64+11 years, male sex 67%, CCS class III-IV 26%, z-1 prior restenosis 50%, restenosis interval 162+52 days. Periprocedural CK-MB elevation occurred

236 patients (age 62 years; 64% male; 38% diabetes) with ISR at 11 U.S. centers. Historical controls (no VBT) were derived from the following randomized trials: ARTISTIC (“=54)

from randomized

and 182 lesions) who had cutting balloon (CB PTCA) and/or rotational atherectomv followed by beta radiation using the Novoste system (30 mm source in 114 and 4d mm

II) Trial

Background: Although vascular brachytherapy (VBT) reduces restenosis (RES) and major adverse cardiovascular events (MACE) after therapy for in-stent restenosis (ISR), Methods: A novel 0.0136’ lr’= sourcewire Westport, CT) and a 0.032” proflle delivery

The major concern

trials was edge restenosis due to use of short source. Target (TLR) with use of longer ICBT swrces has not been studied.

OH

both dose (Gy) and VBT catheter

New York, NY

Background:

Brachytherapy Results

should

Center,

Multi-Center

1128-182

therapy

2 Procedural

Characteristics

& QCA

I Procedural

Characteristics

Lesion length

(mm)

LADILCWRCAI(%)

& QCA

17.5+8.9

Ref. vessel size (mm)

2.91*0.04

44/28/21

MLD-Pre

0.72+0.31

(mm)

Total occlusion

10%

MLD-Post

(mm)

2.21iO.42

CB PTCA+Rotablator

65%

MLD-Post

ICBT (mm)

2.12eO.32

Rotablator

30%

Re-dilatation

Re-stem

3.3%

Vessel

post ICBT

5% 4%

spasm

POSTPROCEDURE 1.93 (0.4)”

1.84 (0.4)

% stenosis

28.9%*

28.7% _+11.7%

Total MACE’ (30 day)

2.1%

MLD mm (SD)

11.5%**

Conclusion: Debulking followed by ICBT provides sustained long-term, acceptable restenosis in single digits. Compared to randomized trials, these favorable results in the real world are perhaps due to better understanding of the restenotic process after ICBT and represent the benefit of full lesion coverage by long source, leaving moderate residual stenosis and very low need for restenting.

1.9% 1128-185

RVD = reference

vessel diameter:

MLD = minimum

Late

lumen diameter;

*‘73%

data complete

analysis

Prolonged Brachytherapy:

Antiplatelet When

Therapy

After

Is It Safe

to Stop

Melapposition

Coronary Clopidogrel?

of the

Volumetric Jerzv Preaowski

at submission

Conclusions: Low profile and delwerability of this novel Ir’g’system facilitate VBT use. Effectiveness of the Angiorad TM, System is supported by low 30 day MACE, limited late loss and infrequent restenosis. Completed angiographic and clinical follow-up will be presented. 1128-183

Stent

Assessment

lVR = target vessel revascularization; TSR = target site revascularization ‘Death, myocardial infarction, emergent CABG or TLR

Lukasz

After

Incidence

Intravascular

Kallnczuk,

Late stent malapposition

Using

Ultrasound

(LSM) is a potential the incidence

An

Mechanisms

Gary S. Mintz, Christian

Ghan, Jun-ichi Kotani, Vivek Shah, Ron Waksman, Hospital Center, Washington, DC

spy (BT). We evaluated

Brachytherapy: and

E. Dilcher. Rosanna

Neil J. Weissman,

complication

and mechanism

C.

Washington

of intracoronary

brachyther-

of LSM after gamma-BT

(lr-192)

in 238 patients with in-stent restenosis (ISR) enrolled in the WRIST. Long WRIST. WRIST-PLUS, Gamma-l and ARTISTIC trials. Planar and volumetric IVUS analyses was performed

every lmm

troI” seaments

with

within the malapposed comr+ete

(EEM minus effective

Tripuraneni.

lated for LSM segment, the wall of the vessel with complete apposition opposite the arc of LSM, and the control segments. Results: There were 111152 LSM in the irradiated

Lansky,

Manuela

Negoita,

Roxanna

Mehran,

Paul S. Teirstein,

group

(7.2%)

area. Dose volume

vs only 2/86 in the placebo

(2.3%.

Background: The objective of SCRIPPS Ill study was to evaluate the impact of both extended antiplatelet therapy and reduced stenting on late target thrombosis following

stents and 5 in newly placed stents. The length and volume of malapposition

brachytherapy.

segments

Methods: At two centers (Scripps Clinic and Lenax Hill) attempts were made to avoid new Stent implantation at the time of intracoronary radiation for treatment of in-stem rest-

while control segments showed no change similar for LSM and control segments.

underwent

vessel enlargement

were 4.82*

(intrastent

membrane

plaque

lumen)

effective’ iurne”

elastic


Alexandra

LSM,

external

(EEM),

Clinic. La Jolla, CA, Lenox Hill, New York, NY

‘lumen,

as well as within 5mm long “con-

aooosition:

Antonio P. Madrid, Mark A. Grise, Jeffrey W. Moses, Martin B. Leon, Peter J. Casterella, Anca Tchelibi, Cristia” Cioar. Huan Giap. Shirish Jani, Steven Baker, Prabhakar Scripps

intra-stent

segment

circumferential

histograms

p=O.14). 7.44mm

that was greater

lumen+LSM), (DVH)

8 LSM occurred

within

and 9.52*10.31mm3. than the increase

in EEM or plaque.

and

were calcu-

old LSM

in plaque

DVH calculations

were