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The lesion characteristic according to the TASC classiﬁ-

cation was ‘‘A’’ in 10, ‘‘B’’ in 49, and ‘‘C’’ in 33 patients.

Post dilation was performed only within the stent, avoiding

angioplasty of the vessel at either end (Mewissen 2004).

The immediate technical success rate was 98%, and patients

were followed for a mean of 263 days. At 12 months, the

restenosis rate (stenosis greater than 50%) was 22%, and at

24 months 44%. Interestingly, the TASC grade, stent length,

gender, and level of ischemia did not predict in-stent

restenosis. These high patency rates after SMART stent

implantation are in line with the observations of others.

Vogel described primary patency rates of 95, 84, and 84%

after 6 months, 1, and 2 years in a total of 41 patients

(Vogel 1994). The longest follow-up of nitinol stents in the

SFA is available from the SIROCCO one and two dat-

abases. Duda et al. (2002a, b) reported their results of 46

patients who had chronic limb ischemia and SFA occlusion

(57%) or stenosis (average lesion length, 81.4 ± 51.7 mm)

who received bare SMART stents (Duda et al. 2005). The

restenosis rate in the stent at 6 months was 11.6%. The

improvements in ankle brachial indices and symptoms of

claudication were maintained over 24 months. An example

of an excellent long-term result of a SMART stent is given

in Fig. 2. Thus initial data from the use of ﬂexible nitinol

stents was encouraging. However, there is further data

available from the newer second-generation SFA stents. For

example Schillinger’s comparison of PTA and Nitinol stent

placement in the SFA promoted the increasing use of self-

expanding Nitinol stents in the SFA (Schillinger et al.

2006). They randomly assigned 104 patients who had

severe claudication or chronic limb ischemia due to stenosis

or occlusion of the superﬁcial femoral artery to undergo

primary stent implantation (51 patients) or angioplasty

(53 patients). The mean (±SD) length of the treated segment

was 132 ± 71 mm in the stent group and 127 ± 55 mm in

the angioplasty group. Secondary stenting was performed in

17 of 53 patients (32%) in the angioplasty group, in most

cases because of a suboptimal result after angioplasty. At 6

months, the rate of restenosis on angiography was 24%

in the stent group and 43% in the angioplasty group

(P = 0.05); at 12 months the rates on duplex ultrasonog-

raphy were 37 and 63%, respectively (P = 0.01). Patients

in the stent group were able to walk signiﬁcantly farther on

a treadmill at 6 and 12 months than those in the angioplasty

group. These data have been supported by several other

SFA trails such as the FAST study (Krankenberg et al.

2007).

The FAST study compared PTA with stent placement for

the treatment of short lesions in the SFA, where 244 patients

(168 men; 66 ± 9 years) were randomized either to

implantation of a single Bard Luminexx stent (123 patients)

or stand-alone PTA (121 patients), the mean lesion length

was 45 mm. At 1 year, the primary endpoint of ultrasound-

assessed binary restenosis was reached in 39 of 101 PTA

Fig. 2 DSA of the superﬁcial

femoral artery of a patient with

intermittent claudication. The

occluded artery was successfully

crossed with a guidewire (a) and

one Nitinol stent was placed (b).

The follow-up angiogram after

6 months (c) showed no recurrent

restenosis. The patient had

unlimited walking distance

72 S. Mu

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group patients (38.6%) and 32 of 101 stent group patients

(31.7%; absolute treatment difference, -6.9%; 95% CI -

19.7 to 6.2%; P = 0.377). Target lesion revascularization

rates at 1 year were 18.3 and 14.9%, respectively (absolute

treatment difference, -3.3%; 95% CI -13.0 to 6.4%;

P = 0.595). No statistically signiﬁcant difference between

treatment groups was observed at 12 months in the

improvement by at least 1 Rutherford category of peripheral

arterial disease.

In contrast to short lesions, in DURABILITY (Bosiers

et al. 2009) a total of 161 stents (158 EverFlex) were

implanted in the 151 patients: single stents in 93.4%

(141/151) and a second stent in 6.6% (10/151). Freedom

from restenosis data were available for 99.3% (133/134) of

the subjects who completed a 12-month follow-up visit. The

mean Rutherford classiﬁcation fell from 2.8 ± 0.8 (range

1–5) at baseline to 0.6 ± 1.1 (range 0–5) at 12 months.

The mean ankle-brachial index rose from 0.6 ± 0.2 (range

0–1.4) at baseline to 0.9 ± 0.2 (range 0–1.2) at 12 months.

The rates for freedom from [50% restenosis at 6 and 12

months were 91.3% (95% CI 84.9–95.2%) and 72.2% (95%

CI 63.8–79.6%), respectively. The freedom from target

lesion revascularization rate at 12 months was 79.1% (95%

CI 71.2–85.6%). The 1-year stent fracture rate was 8.1%

(95% CI 4.0–14.4%). These data suggest that the PRO-

TEGE EverFlex stent offers a safe and acceptably efﬁca-

cious means of treating SFA lesions in symptomatic

subjects with PAD. Similar results were obtained by Misago

I (Schulte et al. 2010). MISAGO 1 clinical trial enrolled 55

patients undergoing percutaneous intervention of totally

occluded or stenotic lesions in SFA or popliteal arteries

treated with the implantation of 81 stents in ﬁve centers

across Europe. Average lesion length was 85 ± 50 mm,

64% was totally occluded and 38% classiﬁed as TASC C or

D. The technical success rate was 100% while the proce-

dural success rate was 98.2% without death, MI, stroke, or

major bleeding. At 6 months follow-up the restenosis rate

was 8.5%. One patient (1.8%) died of bronchial carcinoma

and two (3.6%) underwent target vessel revascularisation.

Mean ankle brachial index improved from 0.70 at baseline

to 0.95 at 6 months while walking capacity on treadmill test

improved with an average of 147 m. Rutherford index at 6

months demonstrated improvement of 72%, without any

patients having symptom deterioration. One case of stent

fracture was observed, indicating good safety and short- to

medium-term efﬁcacy proﬁle of the Misago nitinol stent.

A retrospective analysis called the J-SMART-Registry

(Suzuki et al. 2011) showed encouraging long-term data in

which the S.M.A.R.T. Control(TM) stent was used for

treatment of de novo SFA lesions. A total of 528 lesions

in 432 patients were included. Mean patient age was

72.5 ± 9.1 years; mean stent length was 15.7 ± 8.1 cm;

259 lesions (49%) were classiﬁed as C/D according to the

TASC II classiﬁcation. Primary and secondary patency

at 4 years was 66 and 87%, respectively. Omission of

cilostazol administration (41% re-stenosis group vs. 29%

no-restenosis group, P \0.01), female gender (42 vs. 26%,

P \0.01), younger age (70.7 ± 9.3 years vs. 72.9 ± 9.0

years, P \0.05), and chronic total occlusion (CTO; 72 vs.

52%, P \0.01) were independent predictors of re-stenosis.

Further, mainly driven by the industries, SFA trials

evaluating the efﬁcacy and safety of new stents are on the

way.

4.2 Drug-Eluting Stents in the SFA

Drug-eluting stents have been revolutionary in the ﬁeld of

coronary intervention. Owing to the dramatic reduction of

restenosis, both with sirolimus (rapamycin) and taxol

(paclitaxel) coated stents, increasing number of patients

receive those stents as ﬁrst line treatment for prevention of

restenosis after coronary intervention. To date, one trial has

been published which examines the potential role of drug-

eluting stents in preventing restenosis in the SFA, the

SIROCCO study (Duda et al. 2003. In SIROCCO I, 36

patients with symptomatic peripheral artery disease were

treated in a multicenter, prospective, randomized study

comparing sirolimus-eluting SMART stents with uncoated

SMART stents.

Sirolimus has a unique dual action mechanism involving

both anti-inﬂammatory and cytostatic antiproliferative

effects resulting from inhibition of a signal transduction

kinase, the mammalian target of rapamycin (mTOR) (Duda

et al. 2003; Tepe et al. 2005; Toutouzas et al. 2002). All

patients had de novo or restenotic lesions with a diameter

stenosis[70% over a length that ranged from 7 to 20 cm or

occlusions that ranged from 4 to 20 cm in length. The pri-

mary endpoint of this study was the in-stent mean percent

diameter stenosis by quantitative angiography at 6 months.

In addition, all patients received clinical follow-up and

Doppler ultrasound until 2 years. The results at 6 months

demonstrated inhibition of in-stent neointimal proliferation,

reﬂecting a trend toward a reduction in late loss. The rate of

binary restenosis (deﬁned as stenosis greater than 50%) was

0% in the sirolimus-eluting stent group and 23.5% in the

uncoated stent group. Interestingly, the restenosis rate for

the uncoated stents was much lower than had been expected

from results published in the literature with Wallstentss and

Palmaz stents. The SIROCCO I study also compared two

different types of drug-eluting stents, and found that the

results of slow-eluting stents were superior to fast-eluting

stents. Therefore, the SIROCCO II study was undertaken to

compare the slow-eluting stents with bare stents (Duda

et al. 2005). The 6-month analysis found similar results to

those of the drug-eluting stents of Sirocco I. Although not

Femoropopliteal Arterial Intervention 73

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published yet, the 2-year data have been recently reported.

At this time, there is no signiﬁcant difference between the

drug-eluting and bare stents. It seems, therefore, that the

beneﬁt of the drug elution may be lost after 2 years (Duda

et al. 2006).

A novelself-expanding drug-elutingstent was designedto

slowly release everolimus to prevent restenosis in the

STRIDES trial (Lammer et al. 2011). One hundred and four

patients wereenrolled at 11 European investigative centers in

a prospective, nonrandomized, single-arm trial. Primary

patency (freedom from C50% in-stent restenosis) was

94 ± 2.3% and 68 ± 4.6% at 6 and 12 months, respectively.

Plain radiographic examination of 122 implanted devices at

12 months revealed no evidence for stent fracture. The

authors concluded thatthe everolimus-elutingself-expanding

nitinol stent can be successfully implanted in patients with

severe peripheral arterial disease with favorable outcomes

and clinical improvement observed in the majority of

patients. However, the projectwas stopped andthe stent isnot

commercially available. New coating technologies as well as

drug release mechanisms are under evaluation.

4.3 Mechanical Limitations of Self-Expanding

Stents in the SFA

Until recently, fractures of nitinol stent struts have only

been reported in single cases after stent implantation across

ﬂexion points. However, during systematic angiographic

follow-up after long segment femoral artery stenting with

conventional and sirolimus-eluting nitinol stents, performed

in the SIROCCO I study, stent fractures were observed in

18.2% after 6 months and in 24% after 2 years of the cases

(Duda et al. 2003, 2005). In Sirocco I, the number of stents

to be used was limited to three, whereas in Sirocco II a

maximum of only two stents was allowed. In SIROCCO II

there was fracture rate of 11.6% at 6 months with only an

additional two-stent fractures at 24 months. No correlation

between the fracture rate and the incidence of restenosis has

been reported. However, there was one re-hospitalization

associated with a stent fracture. This patient, although

asymptomatic, underwent prophylactic placement of a stent

graft for vessel ulceration at the site of a strut fracture.

Scheinert et al. have undertaken a systematic X-ray follow-

up evaluation of all patients treated in their institution with

self-expanding nitinol stents in the SFA (Scheinert et al.

2005). Fractures were detected in 37.2% of the stents. The

incidence of fractures was higher after long segment fem-

oral artery stenting versus short segment stenting. The

fracture rates varied between the different stent designs,

with lower rates reported for the SMART and the SelfX

(Abbott Vascular, Beringen, Switzerland) stents and higher

rates for the Luminexx stent (BARD, Murray Hill, NJ).

Athough these ﬁndings raise concerns, their clinical sig-

niﬁcance remains unclear. Their valuations comparing

current design might be helpful in order to get some ex vivo

information from the bench about their mechanical behavior

and potential of strut fracture. An experimental paper

reports two methods of analysis, ﬁnite element analysis

(FEA) and mechanical fatigue testing to identify potential

fracture risks of some currently available SFA stent designs

(Müller-Hülsbeck et al. 2010). Seven SFA stents (Misago,

Absolute, Smart, Luminexx, Sentinol, Lifestent NT, and

Sinus-Superﬂex) showed differences in the incidence of

high strain zones, which indicates a potential for stent

fracture, as demonstrated by the mechanical fatigue tests.

Differences in stent design might play a major role in the

appearance of stent strut fracture related to restenosis and

reocclusion. Fracture rates during clinical settings registered

for second-generation stents are lower than reported in

earlier studies, i.e. 1.2% (MISAGO I) and 6% (DURA-

BILITY). Flexible stent designs providing a high hoop

strength might be indicated for the treatment of severely

calciﬁed lesion with high intraluminal plaque burden

(Fig. 3).

5 Stent Grafts

Stent grafts have been used in the SFA in the hopes of

preventing acute closure as a result of elastic recoil, and

inhibition of vascular smooth muscle cell proliferation, with

consequent restenosis, inside the lumen. Early results and

short-term follow-up data with Dacron-covered stent grafts

were promising (Ahmadi et al. 2002). However, signiﬁcant

clinical problems were encountered, including long known

postimplantation syndrome with fever and persistent pain

(Müller-Hülsbeck et al. 1997) in approximately 50% of the

patients, an early rethrombosis rate of 17% and a primary 2-

year patency rate below 50%. Therefore, Dacron-covered

stent grafts have not been further evaluated. In contrast to

Dacron, ePTFE (expanded polytetraﬂuoroethylene) coated

stent-grafts (Hemobahn endoprosthesis, W.L. Gore and

Associates) show much improved results. The largest study

to date is the International Feasibility Study. This study of

80 patients with SFA occlusive disease showed excellent

clinical results with 79% primary and 93% secondary

patency rates at one year (Bray et al. 2003). Even in long-

term follow-up, Saxon at al demonstrated primary patency

rate of 87% at 2 years follow-up, although this was a single

centre trial which enrolled only 15 patients (Saxon et al.

2003). The only negative results with this prosthesis were

published by Deutschman (Deutschmann et al. 2001). They

demonstrated a 49% patency rate; this might be attributable

to an edge effect due to both over sizing of the stent and

post dilation of the stent edges beyond the stented area.

74 S. Mu

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In addition, a randomized prospective study comparing

the treatment of superﬁcial femoral artery occlusive disease

percutaneously with an expanded polytetraﬂuoroethylene

(ePTFE)/nitinol self-expanding stent graft versus surgical

femoral to above-knee popliteal artery bypass with syn-

thetic graft material was performed in 100 limbs in 86

patients with superﬁcial femoral artery occlusive disease.

Mean total lesion length of the treated arterial segment in

the stent graft group was 25.6 cm (SD = 15 cm). The stent

graft group demonstrated a primary patency of 72, 63, 63,

and 59% with a secondary patency of 83, 74, 74, and 74% at

12, 24, 36, and 48 months, respectively. The surgical fem-

oral-popliteal group demonstrated a primary patency of 76,

63, 63, and 58% with a secondary patency of 86, 76, 76, and

71% at 12, 24, 36, and 48 months, respectively. No statis-

tical difference was found between the two groups with

respect to primary (P = 0.807) or secondary (P = 0.891)

patency. Based on these data the authors concluded that

management of superﬁcial femoral artery occlusive disease

with percutaneous stent grafts exhibits similar primary

patency at 4-year (48 months) follow-up when compared

with conventional synthetic femoralpopliteal artery bypass

grafting. They therefore suggest that it offers a treatment

alternative for SFA occlusion when prosthetic bypass is

being considered or when autologous conduit is unavailable

(McQuade et al. 2010). The results of the so-called VIAS-

TAR trial, which compared self-expanding uncovered niti-

nol stents with ePTFE nitinol self-expanding stent graft

with Propaten bioactive surface and may provide further

supportive evidence (Gore, Flagstaff, AZ, USA) are awai-

ted. (Fig. 4).

A different PTFE covered self-expanding nitinol pros-

thesis was evaluated in the COVENT study (Duda et al.

2002a, b). In total, 130 stents were placed in 98 patients.

Fig. 3 Severely calciﬁed lesion of the distal SFA, which was crossed

with a small-proﬁle balloon catheter in order to perform a long PTA

(6 9 120 mm at 8 atm) (a), which showed dissection and severe

residual stenosis (b). After additional stent placement (5 9 120 mm),

no signiﬁcant residual stenosis is visible in spite of the calciﬁed plaque

burden (c). Fluoroscopic view of the helical stent design, which seems

indicated for treatment of calciﬁed lesions while obtaining high hoop

strength of the stent (d)

Femoropopliteal Arterial Intervention 75

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Primary patency rates were 92% at 6 months and 90% at 1

year. Secondary patency rateswere 98 and96%, respectively.

Unfortunately, the so-called Covent stent was newer used

outside the trial. Although there would appear to be good

potential clinical outcomes from the use of stent grafts there

are limitations to their use due to the need for larger sheath

sizes required as well as their higher cost compared to

uncovered stents.

6 Drug-Eluting Balloons

Drug-eluting balloons (DEBs) have recently become

available and could be a promising new option in arterial

angioplasty. They offer the potential to reduce the rate of

reintervention and to avoid the need for stent insertion.

They may also be of beneﬁt in the treatment of in-stent

restenosis (IRS). At the moment it is not yet clear when to

use drug-eluting technology in the SFA. The only long-

term data available so far are from the THUNDER trial

(Tepe et al. 2008; Schnorr et al. 2011). They investigated

the use of paclitaxel-coated angioplasty balloons and

paclitaxel dissolved in the angiographic contrast medium

during lower limb angioplasty in a small, multicenter trial.

The investigators randomly assigned 154 patients with

stenosis or occlusion of a femoropopliteal artery to treat-

ment with standard balloon catheters coated with paclit-

axel, uncoated balloons with paclitaxel dissolved in the

contrast medium, or uncoated balloons without paclitaxel

(the control group). Twenty-seven percent of the lesions

were total occlusions, and 36% were restenotic lesions. The

mean lesion length was 7.4 ± 6.5 cm. There were no sig-

niﬁcant differences in baseline characteristics between the

groups. There were no adverse events attributable to the

paclitaxel-coated balloons. At 6 months, the mean late

lumen loss was 1.7 ± 1.8 mm in the control group, as

compared with 0.4 ± 1.2 mm (P \0.001) in the group

treated with paclitaxel-coated balloons and 2.2 ± 1.6 mm

(P = 0.11) in the group treated with paclitaxel in the

contrast medium. The rate of repeat intervention on the

target lesions at 6 months was 20 of 54 (37%) in the control

group, 2 of 48 (4%) in the group treated with paclitaxel-

coated balloons (P \0.001 vs control), and 15 of 52 (29%)

in the group treated with paclitaxel in the contrast medium

(P = 0.41 vs. control); at 24 months, the rates increased to

28 of 54 (52%), 7 of 48 (15%), and 21 of 52 (40%),

respectively. These data suggest that the use of paclitaxel-

coated angioplasty balloons during percutaneous treatment

of femoropopliteal disease is associated with a signiﬁcant

reduction in late lumen loss and the need for target-lesion

revascularization. Other trials evaluating the efﬁcacy of

drug-eluting technology are in progress.

Fig. 4 DSA of the left lower limb showing a 14 cm occlusion of the

SFA (a). Subintimal angioplasty was attempted (b). After long-term

PTA using a 5 9 150 mm balloon, ﬂow-limiting dissection was

visible (c) and a 6 9 200 cm ePTFE nitinol self-expanding stent graft

with Propaten bioactive surface was implanted (d). The ﬁnal

angiogram show the stent during 90° knee bending (e)

76 S. Mu

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7 Cryoplasty

The PolarCath peripheral balloon catheter (Boston Scien-

tiﬁc) is a novel angioplasty system that simultaneously

dilates and cools the plaque and the vessel wall in the

treated area. Cooling is achieved by inﬂating the balloon

with nitrous oxide rather than the usual saline/contrast

mixture. The surface of the balloon rapidly cools from 37 to

-10°C. It is believed that cooling induces an acute phase

change that triggers apoptosis in smooth muscle cells

(Grassl and Bischof 2005). The reduction in temperature

causes interstitial ﬂuid in the arterial wall to freeze. Ice

crystals form, generating high radial, longitudinal, and cir-

cumferential forces. This non-inﬂammatory form of cell

death can deliver a number of potential beneﬁts, including

reduced elastic recoil and constrictive remodeling as well as

reduced neointimal hyperplasia.

Despite FDA approval in late 2002 and availability on

the European market since the beginning of 2005, clinical

data on cryoplasty are limited. Fava et al. reported 15

patients with femoropopliteal arterial lesions which were

treated with cryoplasty (Fava et al. 2004). Cryoplasty was

performed at 6 atm of pressure and delivered at -10°C

for 60 s. Technical success was achieved in 93%, and

after 6 months there was 0% binary restenosis. Late

angiographic follow-up at 14 ± 4 months demonstrated

primary patency of 83.3%. In a multicenter registry, 102

patients were enroled at 15 sites in the US and Germany.

Stand-alone success of the PolarCath was achieved in

87%. In an interim analysis of 45 patients, the 9-month

clinical patency was 85% (Grassl and Bischof 2005;

Fava et al. 2004).

Samson et al. treated 92 lesions in 64 consecutive

patients were treated and followed up for a median of 16

months with statistically signiﬁcant follow-up at 24 months

(Samson et al. 2008). However, on an intention-to-treat

basis, freedom from restenosis was 47 and 38% at 12 and

24 months, and cryoplasty added approximately $1700 to

the cost of each procedure. Analysis of this expanded,

longer term data suggests that our earlier, smaller study

provided an overly optimistic appraisal of the beneﬁts of

cryoplasty. It is possible that a larger analysis might have

identiﬁed a subset of patients or lesions that would beneﬁt

from cryoplasty, but considering the additional cost, the

authors no longer use this technique in their practice.

Similar data were obtained in a prospective randomized

single center trial comparing cryoplasty with PTA alone

(40 patients were randomized to cryoplasty and 46 to

conventional angioplasty). Cryoplasty of the popliteal

artery alone showed a lower anatomic success when

compared with conventional angioplasty (Jahnke et al.

2010).

8 Peripheral Cutting Balloon

Cutting balloons are relatively new devices which were

originally designed for the percutaneous treatment of

recurrent stenosis due to neointimal hyperplasia within

coronary artery stents. The catheters have three to four

microsurgical blades mounted longitudinally on the balloon.

They are designed to cut directly into the stenotic lesion

during the initial balloon inﬂation (Ansel et al. 2004; Cejna

2005). The blades disrupt the ring of neointimal hyperpla-

sia, theoretically preventing elastic recoil, and allow dila-

tion of rigid stenoses that respond poorly to PTA alone.

Additionally, microincision produce a directed neointimal

disruption and less wall tension than the diffuse hoop stress

produced by conventional PTA, thereby minimizing intimal

trauma. The data with cutting balloons in the peripheral

vasculature are limited.

Engelke et al. reported 15 consecutive patients who were

treated with cutting balloons for 16 anastomotic stenoses

after infrainguinal bypass surgery (Engelke et al. 2002). The

technical success rate was 94% with cumulative patency

rates of 84 and 67% at 6 and 12–18 months follow-up,

respectively. In a randomized trial, which assigned 43

patients, who had 5 cm or shorter de novo SFA lesions in

association with intermittent claudication or chronic limb

ischemia, efﬁcacy of cutting balloon angioplasty (CBA) or

PTA was evaluated. The US-determined six month reste-

nosis rate was 32% in the PTA group versus 62% in the

CBA group (P = 0.048). There was no signiﬁcant differ-

ence in ankle-brachial index (median, 0.83 vs 0.77 for PTA

vs CBA group, respectively; P = 0.56) or pain-free

walking distance (median, [1000 vs 600 m for PTA vs

CBA group respectively; P = 0.17) between the two

groups. CBA did not prove to be superior to conventional

PTA for treatment of short de novo SFA lesions and yielded

increased restenosis rates at 6 months (Amighi et al. 2008).

On the other hand CBA seems to be a valuable tool for

endovascular treatment of short focal SFA stenoses at the

level femoral bifurcation in patients who are poor candi-

dates for surgery (Cotroneo and Iezzi 2010). The same

authors report on 84 consecutive patients with a total of 142

focal (\3 cm), calciﬁed femoropopliteal stenoses, in which

40 patients (67 lesions) were treated with PTA and 44

patients (75 lesions) underwent CBA. In the PTA group,

primary and secondary patency rates, respectively, were

91.0 and 95.5% at 6 months, 83.1 and 92.4% at 12 months,

and 66.6 and 76.5% at 2 years. In the CBA patients, the

primary and secondary patency rates, respectively, were

93.2 and 95.9% at 6 months, 90.4 and 94.5% at 12 months

(P \0.001), and 79.7% (P \0.001) and 85.6%

(P \0.001) at 2 years. These results would suggest that

CBA is a valuable tool in the endovascular treatment of

Femoropopliteal Arterial Intervention 77

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short femoropopliteal stenotic lesions, achieving better

patency at midterm compared to conventional PTA (Co-

troneo et al. 2008).

In treatment of in-stent restenosis, CBA failed to prove

superiority compared with PTA for treatment of femoro-

popliteal in-stent restenosis in a prospective randomized

study. In restenotic lesions with an average length of

approximately 8 cm, both treatment modalities yielded

disappointing 6-month patency rates (Dick et al. 2008).

9 Brachytherapy

Only a small number of trials have investigated the effec-

tiveness of endoluminal irradiation in femoropopliteal

arteries. The ﬁrst clinical data in peripheral arteries were

obtained in a non-randomized study on recurrent stenoses

initiated in 1990. Long-term results of up to 7.5 years after

treatment demonstrated a patency rate of 84% (Böttcher

et al. 1994, Liermann et al. 1994, 1997). The study was

limited, however, by the small number of patients, its non-

randomized nature, as well as follow-up with angiography

being obtained in only a limited number of patients.

In the Vienna-2 study, a total of 113 patients with long-

segment lesions of the superﬁcial femoropoliteal artery

were randomized either to receive PTA alone or brachy-

therapy with an Iridium-192 source (Pokrajac et al. 2000).

The restenosis rate at 6 months was 54% in the PTA arm

versus 28% in the PTA plus brachytherapy arm. Limitations

of this study were that it was non-blinded and the device for

radiation delivery was not centered within the vessel lumen.

Subsequently, brachytherapy was investigated in further

prospective blinded trials using a centered Iridium-192

source (Vienna-3 up to Vienna-5) (Pokrajac et al. 2005;

Wolfram et al. 2005a, b). Although endovascular brachy-

therapy with gamma radiation proved to reduce signiﬁ-

cantly the restenosis rate after femoropopliteal angioplasty

of recurrent lesions, it was of no beneﬁt in de novo lesions.

The Vienna-5 study was carried out to evaluate the effec-

tiveness of endovascular brachytherapy in the prevention of

restenosis after femoropopliteal stent implantation. Brach-

ytherapy together with stenting did not improve 6-month

patency because of a high incidence of early and late

thrombotic occlusions.

The recently reported ﬁnal results of the Peripheral

Artery Radiation Investigational Study (PARIS), a ran-

domized trial of peripheral brachytherapy performed in the

USA, showed no difference between the treatment and the

control group with respect to clinical and angiographic

end points. Despite the difﬁculties with patient recruit-

ment and follow-up in PARIS, these negative results

had the consequence of the abandonment of peripheral

endovascular irradiation by most interventionalists in the

US. In summary, although some data exist to support the

use of endovascular therapy being effective in reducing the

restenosis rate in peripheral arteries (Pokrajac et al. 2009)it

is not widely used, particularly because especially logistical

problems with the demand of different departments (inter-

ventionalist, radiation specialists) being available at the

same time, safety issues addressing the problem of the use

of radiation in a benign disease, as well as the availability of

alternative treatment modalities which produce similar

outcomes.

10 Conclusion and Future Considerations

Since the publication of the TASC document in 2000 and

the update of TASC II in 2007, several new devices have

been developed which may improve the outcome of en-

dovascular therapy in the SFA increasing the success rate

and in particular reducing the incidence of restenosis.

Therefore the use of endovascular treatment in TASC A, B

and C lesions may become the norm, especially once the

new TASC IIB document, which is currently under review,

has been published. Brachytherapy seems to reduce the

restenosis rate in restenotic lesions but, compared to other

approaches, such after loading therapy is very time-con-

suming and complicated. The literature on cutting balloons

and cryoplasty is very limited, so that ﬁnal conclusions

cannot be drawn. Self-expanding nitinol stents clearly

demonstrate improved patency rates compared to balloon

angioplasty. The clinical relevance of stent fractures seems

not to be a signiﬁcant issue with new generation stents due

to the low fracture rates. However, it may still be possible

to avoid implants due to the advent of drug-eluting tech-

nology. Indeed, DEBs offer the potential to become the

ﬁrst line in treatment of SFA and popliteal arterial disease,

if the early promising results are conﬁrmed by subsequent

trials.

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80 S. Mu

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lsbeck and H. Preuß

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Crural Arterial Interventions

J. Reekers

Contents

1 Introduction.......................................................................... 81

2 Epidemiology and Aetiology............................................... 82

3 Treatment Options .............................................................. 83

3.1 Indications for Treatment...................................................... 83

3.2 Equipment.............................................................................. 83

3.3 Basic Technique .................................................................... 84

3.4 Techniques in Specific Aetiologies ...................................... 84

4 Medication ............................................................................ 86

5 Conclusion ............................................................................ 86

References...................................................................................... 86

Abstract

Intervention within the crural vessels has advanced

considerably over the last few years. This is due to both

an increased focus on the management of critical lower

limb ischaemia along with the development of improved

guide wires and angioplasty balloons. With the increas-

ing prevalence of type II diabetes, diabetic foot problems

are also being seen more commonly. These can often be

managed successfully by balloon angioplasty, even

though this may require treatment of long segment

occlusions, as limb salvage can frequently be achieved

by use of a ‘‘temporary percutaneous bypass’’. Manage-

ment of atherosclerotic disease in the crural arteries

requires a more durable result in terms of vessel patency.

1 Introduction

In recent years intervention in the crural arteries has become

an area of increasing interest as indications have expanded

and better equipment in the form of specialised guide wires

and catheters has become available. In previous years

practice in peripheral angioplasty has been dominated by

treatment in the iliac and femoral vessels, mainly in the

treatment of intermittent claudication. Use of such inter-

ventions in this setting has declined with the growth in more

conservative management such as smoking cessation, life-

style changes and exercise programmes.

The focus has now moved much more to the manage-

ment of critical limb ischaemia, particularly in relation to

type II diabetes and the management of the diabetic foot

(DF). The DF is recognised as one of the most serious

complications of diabetes, with about 5% of all patients

with type II diabetes developing an arterial DF problem. Up

to 70% of all lower limb amputations are performed in

patients with diabetes and up to 85% of all amputations are

preceded by an ulcer (Prompers et al. 2008). It therefore

J. Reekers (&)

Department of Radiology,

Amsterdam Medical Centre, Miebergdreef 9,

1105 Amsterdam, The Netherlands

e-mail: j.a.reekers@amc.uva.nl

M. G. Cowling (ed.), Vascular Interventional Radiology, Medical Radiology. Diagnostic Imaging,

DOI: 10.1007/174_2012_596, Ó Springer-Verlag Berlin Heidelberg 2012

https://t.me/med1917

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