Stenting after cutting balloon versus plain old balloon angioplasty: Interim results of the REDUCE III trial

JACC

ABSTRACTS

March 19,2003

Conclusion:

CB

ROta

(Il=450)

(n=432)

P

s”ccess

(%)

MACE at 30 days (%)

The occurrence

intravascular

irradiation

& Interventional

of adventitial

might explain

thickening

the increased

Cardiology

and expanwe incidence

remodeling

of late MACE

98.7

99.1

0

0

22.6

24.5

NS

2.72

2.83

NS

2.20

2.73

p.zo.05

1099-l

92

Reference

(mean:

diameter

mm) (mean:

mm)

Roxana Abizaid.

Mehran, Eve D. Aymong, George Dangas, Andrea S. Abizaid, Gary S. Mint& Milena G. Adamian, lssam Moussa, Alexandra

NS

Cardiovascular

Alexandre A. J. Lansky. Gregg

mm)

Research

follow-up

Follow-upMLD Restenosis

at 6 months

(mean:

mm)

(%)

(PCl).Obiective:

(12 months)

(%)

.

to identify 9726 consecutive

pts undergoing

PCI. Univariate

predictors

for CIN (defined as 25% rise in baseline creatinlne) were identified. derived by selection of Independent prognostic variables using

The risk score was multivanate logistic

regression.

and 0 when

Assignment

of value

of 1 when

a factor

was present

it was

2.03

p
absent, and summing the number of factors present to categorize patients into risk strata. Results: The eight risk score predictor variables were: Chronic renal failure ((X2.0 mg/

41.6

27.6

pco.05

dl, or creatinine

pco.05

left ventricular ejection fraction < 40%, acute coronary syndrome presentation, contrast volume >15Occ, and IABP use. lncldence of CIN increased significantly as the risk score

20.6

increased

Event free suwival

To develoo a simole risk score that has broad apolicabilitv.

1.55

32.6

TLR (%)

Institute,

New York, NY

is easily calculated at presentation, and identifies pts with different responses to contrast exoosure. Methods: The Cardiovascular Research Foundation 1CRFI orosoective database was probed

Angiogaraphic

Foundation,

Background: Contrast induced nephropathy (GIN) IS a common cause of renal failure and correlates with higher in-hospital and late mortality after percutaneous coronary intervention

Post MLD (mean:

after

after coro-

A Risk Score for Prediction of Contrast Induced Nephropathy After Percutaneous Coronary Intervention

W. Stone, Jeffrey W. Moses, Martin B. Leon, Lenox Hill Heart and Vascular Lesion Length

37A

nary brachytherapy.

In-hospital

Procedural

- Angiography

56.9

71.5

clearance

<40cc/min),

I” this cohort.(Figure).

age > 70 yrs, diabetes

Conclusion:

mellitus,

In pts undergoing

female

gender,

PCI, the CRF risk score

is a simple prognostic scheme that categorizes a pt’s risk of CIN and provides a basis for important modifications in the procedural related factors which are controlled by the oper-

p
ator (ie: contrast volume). MACE:

Major Adverse

Cardiac

Event (death / CABG I Ml: Myocardial

Infarction)

MLD: Minimum Lumen Diameter TLR: Target Lesion Revascularizatlon

1099-l

90

Stenting After Cutting Balloon Versus Plain Old Balloon Angioplasty: Interim Results of the REDUCE Ill Trial

Tetsu Yamaauchi, Takahiko Masami Sakurada, Kazuhiro Osamu

Kate. Shinichl

Hospital,

Suzuki, Michlhiko Kitayama, Hideo Nishlkawa, Hara, Fumihiko Usuba, Kojiro Awano, Tetsuo

Momomura.

Tokyo, Japan, Various

Tatsuya Centers,

Yasukawa,

Teruo Inoue, Matsubara,

Yukio Ozaki, Toranomon

Japan

80x1

In-stent restenosis remains a major problem after coronary stenting. The Cutting BalloonTM (CB) is a new device which has shown promise in the reduction of in-stent restenosis.

We

report

here

interim

results

of the

REDUCE

Ill

study;

_

for the reduction

randomized follow-uo

to either CB angioplasty anaioarams

Results;

of in&ant

Analysis

restenosis. or POBA,

at 6 months.

Pnmarv

mellitus

followed endooint

for the initial 261 patient:

146 pts). There were no differences

Method:

A total of 523 patients

by stentlng. was TLR

Patients

underwent follow-uo.

(CB: 135 pts. POBA:

in patient or lesion characteristics;

tors, including

diabetes

dural success

rates (CB 99.2% vs. POBA 96.4%). The preliminary

coronary

risk fac-

(CB: 71/260, 27.3%; POBA: 671262, 33.2%); or in proceanalysis for the initial

261 patients shows no significant difference as yet for TLR (CB: 14/135, 10%; POBA: 201 146, 17%; p = 0.07); however, TLR tends to be higher for POBA than CB. Conclusion: CB angioplasty

followed

will be presented

by stenting

seems to decrease

TLR. The final QCA data results

at the next meeting.

Adventitial Response and Expansive Remodeling After Intravascular Brachytherapy in a Rabbit Model of Restenosis

1099-191

Paul Wexberq, Konrad Mueck, Ursula Windberger, Susanna Lang, Martin Osranek, Franz Weidinger, Gerald Maurer, Michael Gottsauner-Wolf. Uwersity of Vienna, Vienna, Austria,

Austrian

Background:

Research

Centre

The incidence

Seibersdorf,

of late major

Seibersdorf.

adverse

1099-l

Washington

Hospital

long-term

efficacy of gamma

Twenty One

nonolipidemic

artery

was

rabbits

randomly

underwent

assigned

in an animal

balloon

brachy-

model of rest-

Injury in both external

for subsequent

irradiation

with

iliac

an 9OY

sowce (15 Gy or 30 Gy at 0.5 mm in the vessel wall). After 4 weeks morphometnc measurements were performed and cell density, collagen amount, and the extent of alterial remodeling

were

determined.

Staining

for Ki67 identified

cells were identified by in situ end-labeling of fragmented lated as positive cells/total cell count x100. Results:

The

0.5550.2mm2 0.62+0.3mm2

neointlmal

area

in controls to 0.67+0.3mm2

diation correlated

directly

decreased

to

proliferating

cells:

apoptotic

DNA, and indices were calcu-

0.27*0.3mm2

after

irradiaiion

vs.

(p=O.O07), whereas the adventitia increased from (~~0.02). The expansive remodeling observed after irra-

with the adventitlal

area (p
neointimal 3.73t4.7,

area (p=O.OOOl, rz0.57). Irradiation reduced p=O.O26) and the apoptotic Index (0.006iO.02

neointima,

but not in the other arterial wall layers. There

and 30Gy in any of the parameters, nounced in the high-dose group

although

with

the proliferative (0.95+2.6 vs. vs. 0.107+0.2. p=O.O3) in the was no difference

adventitial

(IRT) has become

IRT in patients

with totally occluded

als designed

thickening

was

between mole

15 pro-

the treatment

strategy

ISR lesions.Methods

to assess the role of IRT for ISR. Of the total cohort,

comes

were equivalent

had successful

in both groups

recanalization

(Table).

with conventional

Eighty-two

66 (12.9%)

Late Loss, mm Binary Restenosis,

Q-wave Myocardial Target

Infarctton,

%

%

(95%) patients

percutaneous

TO ISR (N&2)

events after vascular

irradiation

DC

therapy

pts had

totally occluded (TO) ISR and had similar demographic and procedural characteristics to 587 pts with non-total occlusion (NTO) ISR. Six-month clinical and angiographic out-

Death, %

arteries.

radiation

and Results: Six hundred and sixty nine consecutive patlents (pts) were selected from the WRIST (Washington Radiation for In-Stent Restenosis Trial) series of gamma IRT tri-

changes

after intravascular

7rrs

of choice for in-stent restenosis (ISR). However, its role I” totally occluded ISR lesions has been poorly characterized. The objective of this study was to evaluate the safety and

Angiographic

and arterial remodeling

Center, Washington,

Background: lntracoronaly

Austria

cardiac

6

I

8corr

Awind K. Sharma. Andrew E. Aiani. Robert Lew, Augusta D. Pichard, Lowell F. Satler, Kenneth M. Kent, Ellen Pinnow, Regina Deible. George Aggrey. Ron Waksman,

therapy is higher than in controls. Because expansive remodeling has been shown to correlate with a poor clinical outcome after vascular interventions, we studied adventitial enosis. Methods:

4

Totally Occluded In-Stent Restenotic Lesions Treated With Gamma lntracoronarv Radiation: Six-Month Clinical and Angiographic-Outcomes

93

were

at 6 month

has been completed

3

GIN Rbk

a prospective,

randomized, multi-center trial to investigate the safety and effectiveness of CB angioplasty followed by stenting, compared to Plain Old Balloon Angioplasty (POBA) followed bv stentina,

2

coronary

with TO ISR

intervention.

NT0 ISR (N=587) P

0.6 * 0.9

0.4 * 0.7

0.12

32

21

0 12

4

3

0.71

3

1

0.36

Lesion Revascularizatlon,

%

2U

20

0.95

Target Vessel Revascularization.

%

24

28

0.41

6

4

0.13

21

22

0.92

Late Thrombosis, Major Adverse

% Cardiac

Events, %

Conclusions:Gamma with comparable become

IRT for ISR with total occlusion is feasible, safe, and associated outcomes as non-occlusive ISR. Totally occluded ISR lesions should

an important

indication

for gamma

intracoronary

radiation.