Interventional Marc R. Sapoval, MD Jean-Noel Fiessinger,

Anne

#{149}

MD

Femoropopliteal Long-term Twenty-one

patients

percutaneous plasty (PTA) insertion

L. Long, Jean-Claude

who

F

underwent

#{149} Bernard

vascu-

procedure.

At

12 months, the patency rate without other interventions (the primary patency rate) was 49%. In patients who underwent secondary intervention (fibrinolysis, atherectomy, or PTA), the secondary patency rate was 67%, which fell to 56% after 18 months. At the end of the study, the overall rate of reocclusion was 43%. It is concluded that use of the self-expandable vascular endoprosthesis in the femoropopliteal region likely does not decrease the reocclusion rate after PTA alone. Its use is indicated for treatment of acute closures after fernoropopliteal PTA.

be achieved

by means

of sur-

gery or interventional radiology. Femoropopliteal bypass with saphenous vein graft has been a time-honored intervention. Because of the bow patency rate in patients who undergo treatment for claudication, it is presently reserved for treatment of severe ischemia

(1).

Percutaneous

transluminal

angio-

plasty (PTA) has been developed as an alternative to surgery with low mortality and morbidity and a lower cost than surgery. However, restenosis rates of 25%-35% have since been

reported (2-6). Thus, different types of vascular endoprostheses have been proposed

to improve

rate,

encouraging

with

results

the

patency

short-term

(7-10).

The purpose of our study was to evaluate the long-term results of percutaneous placement of stents for atherosclerotic occlusive lesions of the superficial

femoral

artery

(SFA).

We

report the results of bong-term foblow-up in 21 patients with symptoms who underwent treatment with a selfexpandable vascular endoprosthesis (Wallstent; Medinvent, Lausanne, Switzerland).

PATIENTS Study

Arteries, extremities, 92.1299, #{149} Arteries, grafts and prostheses, 91.1299,

revascularization

EMOROPOPLITEAL

AND

METHODS

Group

Arteries,

stenosis

Arteries,

transluminal

#{149} #{149}

Interventional

Radiology

or obstruction,

angioplasty,

procedures

#{149}

I

1992; 184:833-839

From the Departments

December

Between October 1987 and February 1990, almost 200 patients underwent percutaneous treatment in our department for a chronic obstructive lesion of the SFA. Stent placement was attempted in 21 patients.

These

21 patients,

seven

women

(mean

50-81

years),

had

14 men

age,

22 lesions

64 years; (one

and

range, patient

of Cardiovascular

Radiology

(MRS.,

ALL.,

A.C.R., B.M.B.,J.C.G.)

sis,

stent

et Dynamique

Cardiovasculaire).

Address

reprint

requests

to MRS.

placement

was

chosen

because

of

restenosis (three cases) or because the immediate result of PTA was a hemodynamically significant residual stenosis (one case).

In the

18 cases

of total

occlusion,

stent placement was chosen when the patient had already undergone treatment with PTA at the same site (one case) or when the angiogram obtained after recanalization and PTA showed either an occlusive dissection (seven cases) or a very irregular lumen with reduced blood flow (10 cases). All patients had associated risk factors: Thirteen patients (including the patient with bilateral SFA involvement) had arterial hypertension, 17 patients had a history of smoking (three patients continued to smoke after the procedure), seven patients had diabetes mellitus (one patient was

insulin-dependent),

and

eight

pa-

tients had hyperlipidemia (including one case of familial hyperchobesterolemia). Thirteen patients had one or two risk factors,

and

eight

patients,

three

or four

risk

factors. Of the 21 patients, seven had previously undergone vascular surgery or radiobogic intervention. Four patients had undergone previous PTA of the SFA; one patient, lumbar sympathectomy; one patient, surgical profundaplasty; and one patient, an aortobifemoral bypass and a femoropopliteal bypass that was thrombosed at the time of stent placement. The clinical stage of ischemia was asfor

each

limb.

It consisted

of gan-

grenous lesions in two limbs, rest pain in one limb, and intermittent claudication in 19 limbs. In one patient the claudication distance was greater than 500 m and less than or equal to 1,000 m; in six patients, greater than 100 m and less than or equal to 500 m; and in 11 patients (12 arteries), less

than

The

or equal

to 100

m.

systolic ankle-arm pressure was recorded in 10 patients

index (10 ar-

and

Disease (J.N.F.), Hopital Broussais, 96 Rue Didot, 75674 Paris Cedex 14, France. Received 4, 1991; revision requested January 10, 1992; revision received March 30; accepted April the 1991 RSNA scientific assembly. Supported in part by the Unite de Recherche Inserm

13. From 256 (Instrumentation C RSNA, 1992

MD

had bilateral SFA lesions), which consisted of 18 total occlusions and four stenoses. The indications for stent placement were as follows: In the four cases of steno-

(SAAI)

Vascular

Beyssen,

sessed

terms:

92.456 92.456 92.721 92.128

M.

Placement:

can

lar endoprosthesis for femoropopliteal lesions were prospectively followed up for an average of 17.6 months with angiographic, Doppler ultrasound, and clinical examinations. Stents were placed bilaterally in one patient. Of the 22 lesions, 18 were total occlusions and four, stenoses. Stent placement was successful in 21 of 22 lesions. Nine occlusions occurred: four in the first 30 days and five 1-5 months after PTA. Three patients developed intrastent intimal hyperplasia that necessitated an ad-

Index

MD

MD

Results’

transluminal angiofollowed by attempted

percutaneous

C. Raynaud,

#{149} Alain

Gaux,

Stent

of a self-expandable

ditional

MD

#{149}

Radiology

Abbreviations: minal

pressure tery.

PTA

angioplasty,

index,

=

SAAI

SFA

=

percutaneous =

systolic

superficial

transluankle-arm

femoral

ar-

833

teries) and was less than 0.75 in nine cases and 0.75-0.95 in one case. In the 11 other

infusion considered

patients

marked residual stenosis (stenosis bess than 30% of luminal diameter) and anglo-

(12 arteries),

the SAAI

was

not

recorded because the patients were referred from other institutions. All lesions were of atheromatous origin; 15 were located in the left SFA.

in the right SFA and seven Sixteen lesions were bo-

cated in the SFA only; five lesions, in the proximal popliteal artery; and one lesion, in the

distal

popliteal

had a lesion and

artery.

Four

that involved

popliteab

both

patients

the SFA

5 cm in eight

graphic holism

patients,

was shorter 5-10

than

cm long

in

stent

clinical

of more

than

the definition

of success,

bar and

been

day

Interventional

iliac arteries

were

homolateral

the

successfully for an acute

all normal.

In one

iliac artery

had

treated iatrogenic

on the previous dissection (af-

ter coronary arteriography) by means of placement of a Wallstent. The ostium of the deep femoral artery was visible in 19 patients; 17 ostia were normal, and two had hemodynamicalby significant stenosis. The distal runoff was considered good (ie, the patient had two or three arteries normally patent up to the ankle) in 19 patients

(20 arteries)

and

none normally two patients.

poor

patent

(one

artery

or

up to the ankle)

in

from

the

Placement

Technique

A self-expandable endoprosthesis (Wallstent) was used in all patients. Technical properties of this device have been previously described (1 1,12). The catheterization was performed by means of the ipsi-

lateral

femoral

patients.

antegrade

After

performed

the

with

approach

initial

a 5-F

chanical with PTA

hospital

with

catheter,

and,

France)

whenever

recanalization

a 0.035-inch

sheath

was adme-

was performed

(0.88-mm)

through

over

Leo,

necessary, guide

was always performed placement. The 7-F delivery introduced

a 5,000-LU

sodique;

before stent catheter was

a 7-F

a 0.035-inch

wire.

the basis

fined

wire

under

fluoroscopic guidance. Stent placement was performed to cover the entire length of the lesion, and whenever more than one stent was used, the consecutive stents were placed with slight overlapping. Immediately after each stent placement, an angiogram

was

obtained

neither peripheral nosis was present. stenosis was seen,

to ensure

of the

ratio

est caliber

of balloon

Follow-up

used

consisted

during

evalua-

in the SFA. Twenty

patients (21 arteries) were followed up from 4 days to 42 months (average followup, 17.6 months). The patient in whom stent implantation was a failure was fob-

bowed

up clinically

to ensure

cab deterioration

In all patients, was

that no cmi-

in his condition

occurred.

at least one arteriogram

obtained

during

the

1st year

of fob-

low-up. follow-up, was lack

cal success

functional

the criterion of claudication

improvement.

to show improvement lesions healed or if their

distance

improved

times.

Patients

stable

condition

distance

did

than

by more

were

whenever

failure

their

During

by

follow-up,

considered

to

have occurred whenever angiograms or Doppler US scans showed reocclusion or marked restenosis. Insufficient improvement or worsening of the symptoms was considered proof of clinical failure.

Analysis

Cumulative

patency

rates

were

calcu-

and

patency

834

started

#{149} Radiology

anticoagulation

by means

was

lesion

lower

popliteab

initial

lesion

artery

ratio,

im-

of continuous

tial PTA;

was defined secondary

as patency patency

(SFA

was

vs upper

artery), (occlusion

distal

popliteal

or

morphology

of the

vs stenosis),

runoff

(good

stent-

vs poor),

of more than 0.15 in the lack of improvement or im-

of less than

tinued

after

perplasia

stent

was

0.15 in the SAAI,

tested

placement. Intimab hywith the following

factors: stent-artery ratio, and medical treatment.

distal

runoff,

RESULTS Immediate

Results

Stent placement was successful in all patients except one, who had a recurrent severe and calcified stenosis of the SFA at presentation and in whom placement of a stent was impossible. Despite the use of balloons with a maximum diameter of 6 mm for PTA, the 7-F delivery catheter could not cross the dilated area. This patient did not have any worsening symptoms

and

was

medical treatment. In the 20 other a total

discharged

patients

of 38 stents

were

under

(21 arteries), placed

(mean

stent

after the

mipa-

placement,

one

patient

developed an acute spasm of the popliteal artery complicated by partial thrombosis that was successfully treated with local infusion of urokinase

(Actosobv;

Hoechst,

Puteaux,

France). complications

Eight

patients

spontaneously

Statistical

or four risk factors),

of the

Seven

bated with the method of life-table analysis used by the Ad Hoc Committee on Reporting Standards of the Society of Vascular Surgery (14). Both primary and secondary patency rates were calculated. Primary

intravenous

location

factors pres-

During

five

formed; whenever a peripheral embolism was seen, local fibrinolysis was performed during the same session. The sheath was removed immediately at the end of the procedure, without a test for coagulation, mediately

ence of three

or irreg-

walking

if ganwalking

that

emboli nor residual steWhenever a residual intrastent PTA was per-

of

indicaafter

to be in

were

or improved

was

length

number of stents placed per artery, 1.8). In three cases, complete opening of the stent was achieved by means of complementary intrastent PTA. The 38 stents were 5-7 mm in diameter. The mean stent-artery ratio was 1.16.

than

considered

not change

five times.

morphologic

for cmior

Patients

considered grenous

factors:

(de-

PTA.

of clinical

lesions

the following

to the larg-

lion, examination with Doppler ultrasound (US), and angiography. The following were systematically checked on the follow-up angiograms: restenosis inside or outside the stent, distal runoff, and occur-

of new

with

medical treatment (antiplatelet therapy vs administration of acenocoumarol or other medication), and a habit of smoking con-

Reuil

size

package)

tested

occlusion ( < 50 mm vs 50 mm), tion for stent placement (restenosis PTA vs occlusive acute dissection ubarity after stent placement), risk (the presence of one or two vs the

provement

K

Geigy,

of the stent

on the delivery

fewer

introducer

guide

antivitamin

[Sintron;

tency achieved after a complementary interventionab radiobogic procedure (14). Different pairs of variables were compared by means of the x2 test with the Yates correction. Long-term patency was

improvement SAAI versus

(13).

damobe [Clendium 150; Macrofine, Paris], 225 mg/d) medications. The stent:artery ratio was computed on

During

angiography,

bolus of heparin (Heparine Montigny be Bretonneux,

ministered

in all

Radiology

Malmaison, France]) or antiplatelet (acetylsalicylic acid [Aspegic; Synthebabo, Le Plessis, France], 300 mg/d, and dipyri-

rence Stent

as recom-

of Practice of Cardiovascu-

After 48 hours of continuous heparinization, the patients were discharged (acenocoumarob

patient,

defined

An im-

0.15 of the SAAI

occlusion occlusion

cases. The

was

criterion:

mended by the Standards Committee of the Society

SFA treated was 4.0 or 4.5 mm in six cases, 5 mm in 10 cases, and 6 or 7 mm in six

placement

success

a hemodynamic

provement was

17 cm. The mean length of 6.6 cm. The diameter of the

emand

was impossible or acute reocclusion could not be successfully treated by means of a percutaneous interventional procedure in spite of all attempts to do so.

seven patients, and 10 cm bong or longer in three patients. The maximum length of was was

was of

(ie, peripheral acute dissection)

whenever

unsuccessful

with

segment

The procedure in the absence

complications or persistent

Immediate

artery.

The occluded

of heparin. successful

had

occurred.

a hematoma

disappeared,

that and

one

patient developed a hematoma that necessitated surgical intervention. Of the eight patients in whom pre- and postoperative SAAIs were measured, seven patients (88%) showed immediate hemodynamic success. Eleven patients were discharged with acetylsalicylic acid and dipyridamole; seven patients, with acenoSeptember

1992

developed hemorrhages cated acenocoumarob patient, a hematoma tongue

with

that complitherapy. In one of the base of the acute

re-

nab failure on the 23rd day after gery necessitated intensive care prothrombin index was 10%); in other patient, a psoas hematoma medically treated. In both cases, recovery was good.

hematuria

sur(the anwas the

Long-term

and

Follow-up

One patient died of congestive heart failure at 23 months; the stent was patent. This patient had deveboped an acute upper gastrointestinal hemorrhage 22 months after the procedure. (He was under treatment with acenocoumarol.) Stenosis

a.

b.

1.

Intrastent PTA for intimal hyperplasia. ment of intimal hyperplasia, which caused severe angiogram shows intimal cleft (arrowhead). Figure

coumarol; cylic

one

acid

heparin out

patient,

only;

one

only;

with

acetylsali-

patient,

and

one

patient,

(a) Angiogram shows intrastent developstenosis (arrow). (b) After intrastent PTA,

with-

medication.

with

Early

30 days after stent period of early foblow-up--no patient died but four acute occlusions (19%) occurred. The first acute reocclusion occurred on the 4th day after stent placement in a patient who had undergone treatment

SFA

first

for

an

17 cm long.

occlusion

of the

During

the

two

stents

and

was

discharged

surgically

performed.

thrombosed. bosis,

left

next

days

amputation

performed. The third

mechani-

The

Eleven

after

below

the

day

it

thromknee

13 days

after

clusion

2 cm bong

occlusion

was

occurred

recanalization

of an

in the right

oc-

SFA and

cab recanalization, the guide wire created a subintimal tract, and placement of four stents was necessary to cover the entire length of the lesion. Despite treatment with acenocoumarol, reocclusion occurred, but because the pa-

placement of one stent. Anticoagulant treatment had been stopped a few days previously. This occlusion was successfully treated by means of local nase),

but

tient

without

did

progressive vention The

not

develop

was

symptoms

of

later

ischemia, necessary.

no

inter-

clinical The

acute

occlusion

second

curred on the 7th day placement in a woman who had been referred of distal ischemic choice of surgery

been

previously

saphenous Arteriograms Volume

ulcerations. for limb graft showed

#{149} Number

further

seen

oc-

after stent aged 79 years for treatment

rejected

vein

184

intraarterial

The salvage

because was unavailable. an occlusion 3

ment

status. fourth

on the

a of

two ful,

stents.

(with

acute

15th

uroki-

occurred

change

in a patient

occlusion and had

had

fibrinolysis reocclusion

in the

7 days

patient’s

occlusion

day who

after had

had

was

and the the end In the

reocclusion

occurred

10

later without clinical deterioIn the second of these two paa hemodynamically significant intimab hyperplasia was successfully treated, 6 months after stent placement, by means of atherectomy (performed with a Simpson catheter). Miexamination

confirmed

the

myointimal characteristics of the hyperplastic tissue. Total reocclusion occurred 6 months later without disabling claudication, and the patient was

discharged

under

medical

treat-

ment. Primary reocclusion (not believed to be associated with intimal hyperplasia) occurred in three other patients.

The

first

case

occurred

3

place-

ther

an

cause the patient’s cbaudication distance had improved. The second case occurred 9 months after two stents were placed for an occlusion of the SFA 9 cm bong. Because the patient no longer had claudication, no further intervention was needed. The third

of the right SFA 50 mm long undergone treatment with Fibrinolysis

performed, patent until (32 months).

months after placement of two stents for an occlusion 7.5 cm long. No fur-

was

stent

hyperpbasia

months ration. tients,

croscopic

acute

to intimab

two other patients, a complementary procedure was performed. In the first of these two patients, severe hyperplasia was present in the stent (maximum hyperplasia, 85%). Intrastent PTA was successfully performed (Fig 1), but

on a regimen of heparin therapy. Reocclusion occurred on the 7th day after stent placement, and a prosthetic femoropopliteal bypass was

Follow-up

During the placement-the

was successfully artery remained of the follow-up

the right SFA 5 cm long associated with two tight stenoses, one above and one below the occlusion. The patient underwent successful treatment

with

due

occurred in five patients. In two patients, it was not treated because the patients had no symptoms. Both arteries were patent at the end of foblow-up (19 and 46 months, respectiveby). In one patient, severe intrastent hyperplasia occurred 9 months after stent placement; intrastent PTA

success-

but reocclusion occurred 5 days later. His daudication distance did not change during immediate follow-up. During this period, two patients

case

intervention

occurred

was

after

performed

placement

Radiology

be-

of three #{149} 835

\\I)

II

4

a.

b.

Figure

2.

Successful

secondary

SFA. (b) Angiogram obtained of the new stent (arrowhead).

stents

for

an

occlusion

procedure.

c.

(a) Angiogram

after recanalization and (d) Angiogram obtained

of the

obtained

5 months

after

d. initial

stent

intrastent PTA shows stent disjunction 10 months after c was obtained shows

placement

(arrow). patency

shows

(c) Radiograph with intimal

total

reocclusion

of the

shows proper hyperplasia.

right

placement

right

SFA 11 cm long. Acute total reoccbusion occurred 5 months after stent placement. Mechanical recanalization and fibrinobysis was successfully performed; then intrastent PTA was performed with in diameter

a balloon that caused

catheter stent

6 mm disjunc-

tion. A new stent was placed to cover this gap (Fig 2). This patient (a marathon runner) has no symptoms, and his SFA is patent 19 months after mitiab stent placement (at the end of foblow-up). He is now considered to have secondary patency. The other patients showed no evidence of marked intimal hyperplasia during follow-up (Fig 3). A summary of the results of fobbow-up appears in Table 1. The primary patency rate at 1 year was 49% (Fig 4, Table 2); secondary patency rate at 1 year, 67%; and secondary patency rate at 18 months, 56% (Fig 5, Table 3). Of the 21 patients who underwent treatment, six patients (28%) had no symptoms at the end of follow-up and eight patients (38%) showed improvement. In six patients (28%) no improvement was seen, and in one patient (5%) amputation was necessary. Statistical

following 836

analysis

point:

Radiology

#{149}

The

highlighted

patency

the

rate

at

a.

b.

c.

Mild intimal hyperplasia at the end of follow-up. (a) Angiogram obtained after administration of ioxaglate (Hexabrix 320; Laboratoire Guerbet, Aubnay-sous-Bois, France) reveals an occlusion, 6.5 cm long, of the right upper popliteal artery. (b) Angiogram obtained 20 months after stent placement shows mild hyperplasia without hemodynamic importance. (c) Radiograph without opacification corresponds to b. Figure

3.

September

1992

% vessels

% vessels

100

100

90

90

80

80

70

70

60

60

13

50

50 3

4

40

40

30

30

20

20

10

10

0

I

months

6

12

18

24

below

dashed

30

36

42

months

5. Figures 4, 5. (4) Primary patency rates start of interval. (5) Secondary patency

(dashed

rates

line)

(dashed

of stents

line)

in the

SFA.

In 4 and

5, numbers

line

indicate

number

of arteries

at

in the SFA.

strated a 76% cumulative at 1 year; this rate was years (7). Even if their

cient son

to enable with

patency rate steady at 2

data

are insufficompari-

meaningful

ours

(especially

in the

ab-

sence of life-table analysis), the lower cumulative patency rate in our study can

perhaps

that

we treated

Rousseau

be

attributed

more

et al (75%

to the

occlusions vs 30%)

fact

than and

that

the occlusions in our patients were longer than those in their patients. Lower patency rates were recently reported that are closer to those in our study (16,17). To our knowledge, no data on the correlation of the diameter of the SFA treated and the cumulative patency rate have appeared in the radiology literature. We found that SFAs less than 5 mm (ie, 4.0 or 4.5 mm) in diameter have lower bong-term patency (P = .06). Even if the P value is at the limit of significance, the tendency the the

end of follow-up diameter of the

(x2 with P

=

.06).

mm

correlated with artery treated

with

reoccluded

more

fre-

The feasibility of stent placement in the SFA is herein demonstrated to be good. The radiopacity of the endonot

been

a problem

for

proper stent placement in the SFA, as it has been in the iliac artery (9,15). The high rate of initial groin hematomas Volume

(32%)

184

was

certainly

#{149} Number

3

associated

hematoma

as good

DISCUSSION

has

any

of a large amount of antiduring the procedure, the puncture, the advanced patients, and the fact that was

considered,

re-

gardbess to its size. Despite fairly good technical feasibility, the bong-term results were not

quently (five of six arteries) than arteries 5 mm or greater in diameter (four of 15 arteries) at the end of follow-up.

prosthesis

use

antegrade age of our

the Yates correction, 3.84; In fact, arteries less than 5

in diameter

the

coagulants

as we

expected.

sion occurred in four and late occlusion in Moreover, whenever formed, the secondary not greatly improve In fact, the secondary 1 year

was

67%

when

Early

occbu-

patients (19%) five cases (24%). it was perprocedure did the patency rates. patency rate at the

primary

patency rate at 1 year was 49%. The first report on follow-up after placement of a stent in the SFA was that of Rousseau et al, who demon-

of smaller

arteries

to reocclude

more

often than larger ones can be suspected. In fact, it can be assumed that the initial deposit of fibrin and platelets after stent placement is of a constant thickness of the artery

regardless

of the

size

treated. Because the deposit may cause secondary neointimab proliferation, it is also understandable that the larger the artery, the less the reduction of patent bumina and the higher the long-term patency rate. For the other factors, it was impossibbe to find an association with bongterm patency, perhaps because the population studied was small. The question of the use of medical treatment

during

management cause

restenosis

postprocedural

is still unanswered. after

angioplasty

Radiology

Beis

837

#{149}

2 Life-Table

Table

Data

for Initial

Stent

Placement

without

an Additional

Procedure

No. of Arteries Withdrawn No. of Arteries Interval

of

at Start

(mo)

Interval

0-1 1-6

Patient Was

Stents

Shortterm*

5 3 3 0 0 0 0 0

17 14

6-12

9

18-24 24-30 30-36 36-42

8 6 4 3

Note.-.SEM #{149} Number

=

standard

of arteries in

Table 3 Life-Table

Was Lost to Follow-up

Patient

0 0 0 0 2 2 1 3

error of the mean. who was not in study long enough

Stent

Placement

with

Interval (mo) 0-1 1-6

an Additional

Patient

Stents

Shortterm*

5 1 1 2 0 0 0 0

-

standard

error

of arteries in patient

action

and

agents,

who

was

not in

antiprolifer-

platebet-antiaggregating

In a small et al (7) concluded that patients who receive acenocoumarol, dipyridamol, and acetybsalicylic acid are at bower risk of acute reoccbusion than those who receive platebet-antiaggregating agents only. Strecker et al showed that patients treated with the balboon-expandable stent who received warfann had a higher patency rate than those who received platelet antiaggregating agents only (21). We could not find any significant difference in longterm patency between patients who received acenocoumarol only and those who received pbatebet-antiagregating agents. (However, these subgroup

groups

are

of the ciated 838

and

dextran

of patients,

high with

small.)

(20).

Rousseau

Moreover,

rate of complications the use of coumarins

#{149} Radiology

Rate (%)

(%)

(%)

0 0 0 1 0 0 0 0

77 82 78 100 100 100 100 100

100 77 63

0 9 10 12 12 14 17 20

49

49 49 49 49

from Study

Was

Patient

Was

Lost

Patient

to Follow-up

Patency

Interval

Patency

SEM

Rate

Died

Rate (%)

(%)

(%)

0 0 0 1 0 0 0 0

77 94 94 84 100 100 100 100

100 77 72 67 56 56 56 56

0 9 10 11 12 14 17 21

0 0 2 0 0 0 0 0

of the mean.

ative action) were proposed for prevention of restenosis (18,19). Palmaz showed in an experimental study that platelet deposition after stent placement was reduced with the use of heparin,

SEM

Rate

Died

Procedure Withdrawn

0 0 0 0 3 2 2 3

likely associated with thrombosis and recurrence of atherosclerosis, heparin and platelet antiaggregating agents (anticoagulant

Patency

Cumulative

Failed

17 16 13 10 7 5 3

Note.-SEM #{149} Number

Patency

No. of

22

6-12 12-18 18.-24 24-30 30-36 36-42

Interval

to reach the next interval.

No. of Arteries

No. of Arteries at Start of Interval

Patient

0 0 2 0 0 0 0 0

patient

for Initial

Data

Cumulative

Failed

22

12-18

from Study

No. of

because

assoin

study

long enough

to reach the next intervaL

our study, we now use only plateletantiaggregating agents. Whenever a patient has femoropopliteal occlusive disease, the clinician has two different therapeutic options to consider. If patients have no disabling claudication, they should undergo medical management with careful follow-up walking exercise risk factors with

men, This

and can

(ie, and diet,

appropriate be

progressive suppression an exercise

of regi-

medications).

sufficient

in most

patients

of a limb).

Arteriography

is neces-

sary in only 25% of the patients (1). Whenever aggressive treatment is indicated, one must choose surgery, PTA alone, or PTA followed by stent placement. The long-term results of PTA in the femoropopliteal artery and of bypass

surgery

with

saphenous

graft differ according to different authors. After surgery, the 1-year patency rate is reported to be 77% (22) to 96% (23), and the 5-year patency (24) to 90% (25). Mortality

rate, ranges

67%

1.4%

(25) to 3.4%

from

After tency

18%

PTA, rate

the

varies

(22)

(22), and to 27%

1-year from

mor-

(23).

primary 48%

and the 5-year patency to 58% (5,26-28). The

pa-

to 81%,

rate, from 40% mortality rate

has been reported to be as bow 0%-1% (26,28), and the morbidity

rate, 5%-10% among authors different

and

(1). Patients should undergo arteriography only if aggressive treatment is needed (ie, if they have disabling claudication or are threatened with boss

from bidity,

tency

(27,28). Such differences can be associated with

factors.

anatomic

ing and known

For

example,

factors

number

clinical

(eg, initial

of stenoses)

The

also has reported. Committee (14) defined

methodobogic

stag-

are

to influence long-term after PTA (2,27-29) and

(29,30).

as

pasurgery

approach

a crucial effect on the results Rutherford and the Ad Hoc on Reporting precise rules

Standards to report

results of surgery; in our opinion, those rules should also be used to report results of interventional radiology procedures, because the criteria used to define patency, failure, success,

and

inclusion

or exclusion

of

mi-

tial failures can have a striking effect on the results (14,27). When one considers these reported patency, mortality, and morbidity rates,

it is clear

that

PTA

is less

September

dang-

1992

erous and less complicated than surgery but that the bong-term patency rate after PTA seems to be lower than that

after

surgery.

achieved those

in our lower

than

PTA

those then,

7.

graft-

43%

rate

of occlusion

after

in diameter

could

term

patency.

#{149}

Acknowledgments:

We thank

for manuscript

Schoetter

preparation

and

for photography.

S. Indushekar,

for their

improve

MD,

8.

9.

Ragon

11.

M.

12.

13.

MD,

help. 14.

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WS.

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FJ, Schoop

W.

Results of percutaneous transluminal angioplasty. Radiology 1983; 146:57-60. Krepel VM, Van Andel GJ, Van Erp WFM, Breslau PJ. Percutaneous transluminal angioplasty of the femoropopliteal artery: initial and long-term results. Radiology 1985; 156:325-328.

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(abstr).

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Circulation

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RC, White

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We also thank

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19.

femoropopliteal stenoses: is or a bust? Radiology 1987; 162:473-476. Rousseau HP, Raillat CR,Joffre FG, Knight CJ, Ginestet MC. Treatment of femo-

1989;

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long-

Sylvie

RRJr,

pandable Radiology

placement

of stents in the femoral and popliteab arteries. Because of this high rate of reocclusion, we believe that placement of self-expandable stents in the femoral and popliteab arteries must now be proposed only in case of an acute occlusive complication during PTA or recanalization. It is possible that avoidance of arteries less than 5 mm

Murray

ropopliteal

place-

ment in this location is not better than surgery and that the only reasons to perform such a procedure are the lower penoperative morbidity and mortality. In conclusion, we have observed a

AJR 1986; 146:1025-

bosis

angioplasty

and

stent

angioplasty.

Long-segment

than

alone

of bypass

that

6.

rates

are lower

with

It is clear,

patency

study

achieved

even ing.

The

artery 1029.

30.

1972; Cutler

124:789-793. BS, Thompson

JE, Kleinsasser

U,

Hempel GK. femoropopliteal

Autologous saphenous vein bypass: analysis of 298

cases.

1976;

Surgery

79:325-331.

M, et at.

coro-

1987; 60:

Radiology

#{149} 839