Kimihiko Kiyoshi Hajime

Kichikawa, Nishimine, Ohishi, MD

MD MD

#{149} Hideo

Uchida, Yasushi Kubota, #{149} Satoru Iwasaki, MD #{149}

MD MD

Iliac Artery Stenosis Results of Treatment Expandable Metallic Ten patients with atherosclerotic stenosis or occlusion of the iliac artery were treated with Gianturco cxpandable metallic stents. In the five cases of stenosis, only balloon dilation was performed prior to placement of stents. The five patients with occluded arteries were given intraarterial infusions of urokinase before balloon dilation and stent placement. Clinical symptoms improved in all patients, and no technical failures or complications occumred. Doppler ankle-brachial indcx studies were performed in nine cases, and in all nine cases the indexes improved after stent placement During follow-up of 2-18 months (mean, 10.3 months), all anteries remained patent. Follow-up angiograms showed slight intimal thickening and no restenosis. Longterm follow-up and more clinical experience will be necessary to evaluate the efficacy of this stent. However, preliminary results suggest that the Gianturco expandable metallic stent is of value in the treatment of arterial occlusive disease. Index

terms:

Arteries,

98.1299 #{149} Arteries, nosis or obstruction, minal angioplasty, 92.721, 98.721

Radiology

grafts

and prostheses,

iliac, 98.721 #{149} Arteries, ste98.721 #{149} Arteries, translu98.128 #{149} Arteriosclerosis,

1990; 177:799-802

P

Tetsuya

#{149}

#{149} Shoji

Yoshioka, Sakaguchi,

MD MD

and Occlusion: with Gianturco Stents’ ERCUTANEOUS

transluminal

its indications have been expanded by the combined use of intraarterial infusions of urokinase (2,3), laser angioplasty, andlor atherectomy cathe-

terization. However, at present, the long-term patency rate following PTA is not always satisfactory (4). Long-term patency is expected in cases with localized and concentric stenoses, while recurrence is frequent when long, irregular, ulcerated stenoses and occlusions, diabetes mellitus, present

or poor runoff (4). Currently,

vessels are new intravas-

the

clinical

use

of Gianturco

840 Shijo, Kashihara, Nara 634, Japan. Received March 7, 1990; revision requested April 24; revision dress C

received July reprint requests RSNA, 1990

30; accepted to K.K.

August

2. Ad-

PATIENTS

AND

METHODS

The study group consisted of 10 patients-nine men and one woman, ranging in age from 48 to 88 years (mean, 65.6 years)-with

chronic

atherosclerotic

rial stenosis and/or occlusion (Table). patients had symptoms of intermittent

Three

stenoses

and four oc-

clusions

were located in the common iliac artery, and one stenosis was located in the external iliac artery. Two patients had stenosis or occlusion of both the common and external iliac arteries. The length of the occlusions ranged from 3u/2 to 15 cm. The patient (case 3) with the external iliac artery stenosis had an additional 20-cm occlusion of the ipsilateral superficial femoral artery. Restenoses were noted 10 and 12 months after conventional PTA in cases 1 and 3, respectively. Informed consent was obtained from each patient, and

approval of the investigational protocol was obtained from our university before placement of stents. Five patients with

underwent

stenosis

balloon

before

stent

with

occlusion

after

stents for treatment of arterial obstructions, except for our initial meport of results (14). We inserted Giantunco expandable metallic stents into the iliac arteries of 10 patients to prevent restenosis after PTA. (The stents used-which are not commercially available-were made by ourselves, supported by Hirata Sangyo, Osaka, Japan.) The patients were followed up for 2-18 months. In this report, we present our initial and follow-up

MD

Preliminary

placement

cular stents are being developed to improve the immediate results and prognosis after PTA (5-9). Gianturco expandable metallic stents have been used clinically for treatment of obstructive lesions in the vena cava (10), tracheobronchial tree (1 1), and biliary tract (12,13), but, to our knowledge, no other reports have descnibed

Maeda,

claudication.

an-

gioplasty (PTA) has been advocated as a less invasive therapeutic method than surgical revasculanization for arterial occlusive disease (1). In recent years, the initial success rate of PTA has been improved and

results.

1 From the Departments of Radiology (K.K., H.U., T.Y., MM., Y.K., 5.5., 5.1.) and Oncoradiology (K.N., HO.), Nara Medical University,

Munehiro

#{149}

(cases

dilation

1-5)

immediately

placement. was

In three patients 6, 9, and 10), stent performed immediately

(cases

thrombolysis

Balloon

dilation

stainless

steel

and balloon

dilation.

and

stent placement were performed 8 and 13 days after thrombolysis in cases 7 and 8, respectively. Thrombolysis was performed with infusion of urokinase into the occluded lesion. The total dose of urokinase ranged from 300,000 to 1,020,000 IU (mean, 632,000 IU). Balloon dilation was performed with a 7-mm-diameter balloon. Stent placement was performed via the ipsilateral femoral artery. The stents were made of 0.01-inch (0.25-mm)-diameter

wire

bent

in a zigzag

con-

figuration containing six bends at each end. The diameter of the stent at full expansion was chosen to be about 1 .2 times that of the native iliac artery. We used 1.0-cm-diameter stents in nine cases and a 1.2-cm-diameter stent in one case (case 6). The length of the stent was 1 cm, and several stents were connected in tandem by metallic struts cut from the same wire. The stent was inserted so that the dilated segment was totally covered. We used three connected stents in cases 2, 4, 6, and 8 and five connected stents in cases 7 and 9. In cases 1 and 3, three connected stents and four connected stents overlapping by 0.5 cm were inserted. In case 5, four and

five connected

stents

were

inserted.

In

arte-

All

Abbreviation: minal

PTA

=

percutaneous

translu-

angioplasty.

799

Summary

of Cases An kle-Brachial Location of

Case

Age (y)

Sex

Lesion

1

55

M

CIA

2 3 4 5 6 8

48 65 70 59 69 53 71

M M M M M M M

CIA EIA CIA CIA, EIA CIA CIA CIA

9

88

F

10

78

M

7

Note-CIA

case

10, three,

four,

and

was

stents

(Cook,

inserted

were

five

across

No.

of

Before Stent

After Stent

Placement

Placement

At

Follow-up

Stents

Stenosis

NA

4 + 3

0.73

1.05

1.30

13

Stenosis Stenosis Stenosis Stenosis Occlusion Occlusion Occlusion

NA NA NA NA 5 10 3/2

3 4 + 3 3 5 + 4 3 5 3

0.93 0.46

1.17 0.81

1.21 0.79

4

Occlusion EIA

external

15 iliac

artery,

.

. .

Period

0.90 1.11 1.10 0.95

0.80 1.19 1.14 1.13

.

. .

.

Urokinase Dose (IU)

(mo)

14 11 10 4 18 13 10

. .

0.68 0.48 0.51 0.56

Follow-up

1,020,000 600,000 300,000

5

0.40

0.96

0.90

8

540,000

5 + 4 + 3

0.54

0.70

1.07

2

700,000

NA

not applicable.

connected Bloomington,

the

introduced

of

(cm)

Occlusion

EIA

iliac artery,

Length Occlusion

Lesion

CIA CIA,

common

=

stents were inserted. After a 7-F sheath

Ind)

Type of

Index

lesions,

at the

the

optimum

position with the cylinder of the 7-F sheath under fluoroscopic guidance with use of the road-map mode of digital subtraction angiography. The 7-F sheath was gradually removed, and the stents were expanded and fixed to the arterial wall. Immediately before balloon dilation and

stent

placement,

heparin

(50

lU/kg)

was injected during the of urokinase

through the catheter, and subsequent 3 days 120,000 IU was injected intravenously a day. Three patients were treated warfarin potassium (3 mg/d) and di-

twice

with

pyridamole

(300

cilostazol (200 and vasodilating tion

of these

mg/d)

mg/d), drug. drugs

and

Doppler

seven

with

an antithrombotic Oral administra-

was

least 6 months after Follow-up ranged (mean, 10.3 months). tions

and

continued

for

a. Figure nosis serted

are after

b.

c.

d.

1. Case 1. (a) Angiogram obtained 12 months with an ulceration is evident in the left common following balloon dilation in the stenotic lesion. marked with arrows and arrowheads, respectively.

stent

placement

at 5 months.

appeared.

Slight

shows intimal

The internal

good

patency

thickening

iliac

of the lesion.

over

artery-which

the

stents

after

conventional

PTA.

Recurrent

ste-

iliac artery. (b) Stents have been inProximal and distal ends of stunts (c) Angiogram obtained immediately

(d) Follow-up is evident,

is bridged

by the

c. 13 months

after

and stents-is

angiogram the

obtained

ulceration patent.

has

dis-

at

stent placement. from 2 to 18 months Clinical examinaankle-brachial

index

studies were performed every month, except in case 4. A plain radiograph of the pelvis was obtained at several days, 1 month, and 3 months after stent placement. Follow-up angiograms were obtamed in the seven patients who consented to the study.

RESULTS Stent placement was technically successful in all 10 cases, with improvement of clinical symptoms and elevation of the Doppler ankle-brachial indexes (Table). Angiograms obtained immediately after stent placement demonstrated no residual stenosis in all but one lesion (Figs 13). In an 88-year-old woman (case 9), five connected stents were placed in the incompletely dilated lesion after infusion of urokinase and balloon dilation. An angiogram obtained im-

mediately showed buried

800

after

stent

that the stents in the residual

Radiology

#{149}

placement were mural

partially clots,

a. Figure

2. Case

3.

b. (a) Angiogram

obtained

fibrinolysis

d. and

balloon

dilation.

Recurrent stenosis is seen in the right external iliac artery. (b) Three connected stents and four connected stents have been inserted into the lesion. Point of overlap is marked with arrow. (c) Angiogram obtained immediately after stent placement. Good patency is seen in the treated artery. (d) Follow-up angiogram obtained at 5 months. Slight neointimal thickening is evident.

which were continuous kinase (Fig Follow-up

completely lysed low-dose infusion 4). over 2-18 months

with a of urore-

vealed no occlusion or migration of stents, and all patients have been free of symptoms. The follow-up anklebnachial indexes did not change sig-

December

1990

a. Figure

b. 3. Case

c.

(a, b) Pelvic

7.

angiograms.

d.

Complete

e.

f.

occlusion

is evident in the left common iliac kinase infusion and balloon dilation. Recanalization of the common iliac artery has been achieved, portion is evident (arrow). (d) Five connected stents have been inserted. The curvilinear calcification the stents. (e) Proximal common iliac artery with localized irregular stenosis is dilated after insertion gram obtained at 7 months. The stenosis has completely disappeared, and good patency is evident. of the most distal stent.

artery. (c) Angiogram but irregular stenosis of the vessel wall of stents (arrow). Ulcerations (arrows)

patency (8). nent expansile

obtained after uroof the proximal is visualized along (f) Follow-up angioare seen at the level

Furthermore, the force prevents

recoil of the dilated The most important

permaelastic

vessel wall. problem

in

stent placement is early thrombotic occlusion and neointimal proliferation leading to late restenosis or occlusion. In case 9, the stent was

placed in an incompletely dilated tery and was buried in a residual ral thrombus immediately after placement. thrombotic balloon residual

For prevention of early occlusion, we performed dilation for elimination of stenosis and gave intraarteri-

a! fibrinolytic

a. Figure

b. 4. Case

9.

(a) Pelvic

c.

angiogram.

Complete

occlusion

is evident

in the left common

iliac artery. (b) Angiogram obtained after insertion of five connected stents following nase infusion and balloon dilation. Left iliac artery is patent, but luminal narrowing residual thrombus can be seen. (c) Additional urokinase infusion has lysed the mural bus, leading to good patency of the artery.

nificantly

compared

immediately (Table).

after Plain

with

stent

those

seen

placement

radiographs

of the

pel-

vis obtained several days after placement and several months after placement showed no migration of the stents. Follow-up angiograms showed full dilatation of the stents and no restenosis or occlusion. On follow-up angiograms, thin, unopacified layers that suggested neointimal thickening were seen between the stents and the opacified lumina. In case 1, the internal iliac arterywhich was bridged by the stent wire-was patent (Fig 1).

DISCUSSION Since Dotter of coil-shaped

Volume

177

first reported intravascular

Number

#{149}

3

the use stents

urokidue to throm-

various types of stents have been developed (16-22). Recently, clinical reports of the Palmaz stent and Wallstent device for treatment of arterial occlusive disease have been published (5-9). The Gianturco expandable metallic stent is a stainless steel wire bent in a zigzag configuration. This stent has such a high expansion ratio that it can be inserted through a relatively small sheath, as (15),

compared with Palmaz stents, and maintain a large diameter in the yessels. In our study, the stent could be easily inserted through a 7-F sheath for conventional angiography. Intravascular stent placement after balloon dilation reduces the pressure gradient and achieves a smooth sumface, which is one of the most important factors in maintaining long-term

tion stent nase days In timal

vere

ammu-

therapy

for elimina-

of the residual thrombus before placement. In addition, urokiwas injected intravenously for 3 after the procedure. animal experiments (23-25), inhyperplasia

luminal

has

not

narrowing

led

to se-

or occlusion.

However, in clinical reports of other types of stents (7,8), restenosis or reocclusion due to intimal hyperplasia has occurred. To keep intimal hyperplasia to a minimum, we selected a stent diameter that was about 1.2 times the diameter of the native iliac

artery,

based

et al (23).

wire (0.01

used inch

The

on the diameter

results

of Duprat

of the

stent

in this study was smaller [0.25 mm]) than that previ-

ously reported for the experimental use of this stent in arteries (16,23-25). On the basis of our results, we assume that 0.01-inch (0.25-mm)-diameter wire is suitable for maintenance of luminal patency after PTA. In the report of Palmaz et al (26), the amount of fibrin-platelet thrombus material deposited was proportional to the total metal surface of the stent. In this respect, the Gianturco stent has a small metallic surface area, which may reduce thrombogenicity

Radiology

801

#{149}

and the total amount rowing due to intimal experimental studies Gianturco bogenicity

stent even

showed without

of luminal hyperplasia. (16,24,25), low the

theless,

nanIn the

thromadmin-

istration of anticoagulant or antiplatelet drugs. However, the administration of anticoagulant or antiplatelet drugs should be continued for at least 6 months, until the stent is completely covered by neointima. Gunther et al (7) and Rousseau et al (8) describe how stent stenosis due to intimal hyperplasia can be treated with balloon dilation and atherectomy catheterization. This technique for treatment of intimal hyperplasia will expand the indications for stent placement and enhance long-term

ease.

pecially

where

into the peripheral that side branches remained patent, in experimental (7,8)

there

is good

occlusive

dis15.

BT, Dake MD.

onary angioplasty. 921-940.

2.

McNamara

TO.

“higher-dose”

vent 3.

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The Gianturco stent has a larger open surface area than other types of stents. When another stenosis of the bridged side branch develops after stent placement, it may be treated with balloon dilation via the side wall of the stent. This technique is probably more difficult in cases treated with other types of stents. In our study, no technical failures and no restenosis or reocclusion occurred. This report is based on experience with a small number of cases with an 18-month follow-up. More clinical experience and long-term follow-up will be required to evaluate the efficacy of this stent. Never-

of arterial

14.

stents

in the

#{149}

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to be of value

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#{149} Radiology

December

1990

Iliac artery stenosis and occlusion: preliminary results of treatment with Gianturco expandable metallic stents.

Ten patients with atherosclerotic stenosis or occlusion of the iliac artery were treated with Gianturco expandable metallic stents. In the five cases ...
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