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MACE.
IV.InterventionsforPatientsWithPeripheralArterialDisease
A.PrinciplesofCatheter-BasedInterventions
1.ThemaintreatmentaimofEVTinterventionintheSFA/FPcirculationistorestoreunobstructedflow
tothe tibial trifurcation.There are standard definitionsfor success and patency. Angiographic success
refers toa residual diameter stenosis not morethan 30% and subsequent patency with less than 50%
recurrentstenosis.30Hemodynamically,thesuccessofaninterventionisindicatedbyanincreaseinABI
ofatleast0.15andanimprovementinRutherfordclass.30Restenosisoccursfrequentlyandcorrelates
directlywithlesionlength.
31
2.Intermittentclaudication(IC)maybecaused byocclusivelesionsintheaortoiliacsegment,common
femoralartery,SFA,andprofundalfemoralandpoplitealarteries.Inpatientswithmultisegmentdisease,
the more proximal disease should be treated first. This usually results in symptomatic improvement
without extending treatment todistal arteries.6There are multiple EVT options for SFA/FP occlusive
disease (FPOD),6 includingPTA alone,32 angioplasty with self-expanding stents,33 angioplasty with
balloon-expandable stents,
34
angioplasty with covered stent grafts,
35,36
atherectomy,
8
antimyoproliferative drug-coated balloons (DCBs),
37–39
and drug-eluting stents (DESs).40 Other
modalitiesincludethrombolysisthatuseslyticagentsactingonfibrinandthrombectomythatusesdirect
techniquestoremoveclot.
B.OverviewofGuidelines
6
1. According to the Society for Vascular Surgery (SVS) guidelines for atherosclerotic disease of the
lower extremities, EVTisrecommendedoveropensurgeryforfocal occlusivedisease ofthe SFA not
involving the origin (class IC). For focal lesions (<5 cm), with unsatisfactory results with balloon
angioplasty,selectivestentingissuggested(2C).Theuseofself-expandingnitinolstents(withorwithout
paclitaxel)isrecommendedforintermediatelengthlesions(1B).Surgicalbypassisrecommendedasthe
initialrevascularizationstrategyfordiffusefemoropolitealdisease,smallcaliber(<5mm),orextensive
calcificationoftheSFA.AccordingtotheAmericanCollegeofCardiology/AmericanHeartAssociation
(ACC/AHA)guidelines,revascularizationoftheFPsegmentisrecommendedforpatientswithCLIorfor
patientswhohavehadasuboptimalresponsetoatrialofexercise.41Anendovascularfirstapproachis
recommendedforTASCAthroughClesionsandisareasonableapproachforTASCDlesions(Table
10.1)asdeterminedbytheexperienceoftheoperator,andthepatient’scomorbidities.
Table10.1
ACC/AHARecommendationsforFemoropolitealInterventioninStableLimbIschemia
Class I,
Leve lof
Evidence:
A
■Endovascularproceduresareindicatedforpatientswithavocationalorlifestyle-limitingdisability
■Duetointermittentclaudicationwhenclinicalfeaturessuggestareasonablelikelihoodofsymptomaticimprovement
withendovascularinterventionand:(1)therehasbeenaninadequateresponsetoexerciseorpharmacologicaltherapy,
and/or(2)thereisaveryfavorablerisk-benefitratio(eg,focalstenosis)
Class IIa,
Leve lof
Evidence:
C
Stents(andotheradjunctivetechniquessuchaslasers,cuttingballoons,atherectomydevices,andthermaldevices)canbe
usefulinthefemoral,popliteal,andtibialarteriesassalvagetherapyforasuboptimalorfailedresultfromballoondilation(eg,
persistenttranslesionalgradient,residualdiameterstenosis>50%,orflow-limitingdissection)
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Class IIb,
Leve lof
Evidence:
A
Theeffectivenessofstents,atherectomy,cuttingballoons,thermaldevices,andlasersforthetreatmentoffemoral-popliteal
arteriallesionsisnotwellestablished(excepttosalvageasuboptimalresultfromballoondilation)
Class III,
Leve lof
Evidence:
C
Primarystentplacementisnotrecommendedinthefemoral,popliteal,ortibialarteries
Class III,
Leve lof
Evidence:
C
Endovascularinterventionisnotindicatedasprophylactictherapyinanasymptomaticpatientwithlowerextremityperipheral
arterialdisease(PAD)
Datafrom
AndersonJL,HalperinJL,AlbertNM,etal.Managementofpatientswithperipheralarterydisease(compilationof2005and2011
ACCF/AHAguidelinerecommendations):AreportoftheAmericanCollegeofCardiologyFoundation/AmericanHeartAssociationTask
Forceonpracticeguidelines.Circulation.2013;127(13):1425-1442.
2. The morphological classification for SFA/FP lesions and thereby treatment is also guided by the
recommendations made by the Trans-Atlantic Inter-Society Consensus document II (TASC II) (Table
10.2).42 TASC-A and B are managed with endovascular techniques; TASC-C are treated by either
endovascular revascularization or bypass based on individual risk stratification. TASC-D lesions are
generallysurgicallymanaged.
TABLE10.2
MorphologicalStratificationofFemoropoplitealLesions
42
Lesion
Type
StenosisorOcclusionPattern Procedure
A
Singlestenosislessthan3cmofthesuperficialfemoralarteryorpoplitealartery
Endovascular
B
Singlestenosis3-10cminlength,notinvolvingthedistalpoplitealartery
Heavilycalcifiedstenosesupto3cminlength
Multiplelesions,eachlessthan3cm(stenosesorocclusions)
Singleormultiplelesionsintheabsenceofcontinuoustibialrunofftoimproveinflowfordistal
surgicalbypass
Endovascular
C
Singlestenosisorocclusionlongerthan5cm
Multiplestenosesorocclusions,each3-5cminlength,withorwithoutheavycalcification
Endovascularor
surgicalbypass
D
Completecommonfemoralarteryorsuperficialfemoralarteryocclusionsorcompletepopliteal
andproximaltrifurcationocclusions
Surgicalbypass
3. Ingeneraltheoutcomes ofPTAandstentingdependonboth anatomicandclinicalcharacteristics.
7
PatencyafterPTAis greatestfor lesions in the common iliac artery, decreasing distally. Patency also
decreases with increasing length, multiple and diffuse lesions, presence of comorbidities including
diabetes, smokingandrenal failure.
43–49
Although there is no consensus on a diagnostic transstenotic
pressure gradient, intravascular pressure measurementshave been recommended to determine whether
lesions are significant—for example a stenoses of 50%-75% may or may not be hemodynamically
significant.Multiplecriteriahavebeensuggestedincludingameangradientof10mmHgbeforeorafter
vasodilatorsorapeaksystolicpressuregradientof15%afteradministrationofavasodilator.
50,51
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C.VascularAccess
1. Vascular access is the mostimportantpart ofanyendovascular intervention (Table10.3). Themost
commonaccessvesseliscommonfemoralartery(CFA).Thebrachialarterymaybeusedinsomecases;
leftbrachialaccessisusuallypreferred,astheriskofcerebralembolizationislessthanaccessviaright
brachial approach. Safest approach to obtaining access is by using ultrasound guidance and using a
micropuncture needle. The puncture site for CFA must be below theinguinal ligament andabove the
femoral bifurcation in the region overlying the femoral head. The puncture site should be confirmed
fluoroscopically/angiographically.Byangiography,thepuncturesite/needleentrysiteshouldbebetween
theoriginoftheinferiorepigastricartery/lateralcircumflexarteryandfemoralbifurcation.Contralateral
andipsilateral arterialaccesscanbothbe used. Generallycontralateral access siteis preferred which
requires an up-and-over techniquetocross thebifurcation.Contralateral approachmay notbe used in
case of tortuous iliac arteries, hostile aortic bifurcations,Y-prosthesis, orabdominal stentgrafts.53 In
casesoffailedantegradeapproachorflushSFAocclusion,ipsilateralretrogradepoplitealapproachmay
beused.LeftbrachialaccessisreservedforcasesofCFAandSFAlesionsinthepresenceofbilateral
iliacarteryocclusions.Itisassociatedwiththeriskofvertebrobasilarstroke.Researchhasrecentlybeen
publishedevaluatingtransradialandtransulnaraccessincombinationwithtranspedalaccessforfemoral
arteryangioplasty.
52
Table10.3
AccessSitesUsedforSuperficialFemoralArteryIntervention
AccessSite
Contralateralcommonfemoral
artery(CFA)
Mostcommonlyused.Technicallyfeasible
IpsilateralCFA/antegrade Inpatientswithsignificantiliacdisease.
Unsuitableforostialorproximalsuperficialfemoralartery(SFA)disease
Retrogradetranspopliteal Patientswithcontraindicationtobothcontralateralandipsilateralapproach.
Inpatientswithchronictotalocclusionswhenfailuretocrossproximalcap
Retrogradebrachial Inpatientswithiliacdiseaseorothercontraindicationstocontralateraloripsilateralapproach.Mostlyin
patientswithproximalormid-SFAdisease
Retrogradetranspedal Maybecombinedwithcontralateraloripsilateralapproach.Mainlyusedwhenfailuretocrossproximal
capofchronicocclusions
Retrogradetransradial Maybecombinedwithcontralateraloripsilateralapproach.Combinedwithtranspedalapproach
52
2. Once access is obtained, the micropuncture sheath is exchanged for an appropriate sized sheath
(ranging from 4 to 7 French). Digital subtraction angiography of the distal aorta and iliac arteries
followedbyangiographyofthetargetextremityisperformedusinga5Frenchflushcatheter.
3.Afterinflowassessment,theaorticbifurcationiscrossedwiththeflushcatheterand0.035-inchangled
glidewire(Terumo,Somerset,NJ).Thecatheteristhenpositionedattheinguinalligament,andselective
angiographyofthelowerextremityisperformed. 3-5mLinjections ofnonioniciso-osmolarcontrastis
injectedtoevaluatetheSFAandinfrapoplitealrunoff.Imagingisusuallydoneintwoobliquitiestofully
assessareasofstenosesandvisualizebifurcations.Oncelesionshave beenidentified,a 0.035 wireis
thenreinsertedandpositioned in theSFA.Theflush catheterisremoved,andthe wireisthenusedto
exchangethe5Frenchshortcatheter for6-7F45-55cmlongsheath.Thesesheathsprovidesupportfor
lesioncrossingandalsoallowforcontrastinjection.
4.Beforeanyintervention,patientsshouldbeanticoagulatedwithheparin.Inpatientsinwhomheparinis
contraindicated,directthrombininhibitorsincludingbivalirudin,hirudin,lepiruidin,andargatrobanmay
be used. Activated clotting time (ACT) is checked every 30-60 minutes for a goal ACT above
250 seconds. The advantage of heparin over direct thrombin inhibitors is that in case of access site
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complications,heparincanbereversedwithprotaminesulfate.
5.Afteranticoagulationisachieved,thelesionistraversedwithacombinationofadirectionalcatheter
anda0.035-inchguidewire.Ifthisisunabletocrosslesion,avaryingcombinationof0.018or0.014inch
guidewire and catheters may be used. The catheter is positioned just proximal to the target lesions
providing wiresupportandpushability. Iftheseoptionsfailduetoproximal capconfiguration,plaque
morphology or lesion composition, subintimal angioplasty (SIA) may be attempted. SIA refers to the
passage of wires and catheters into the wall of the occluded artery with reentry at a point of distal
patency. This technique, first popularized by Bolia, uses a short “prolapsed loop” configuration of a
hydrophilic wire extending from the tip of a guiding catheter to gain spontaneous reentry once the
reconstituted artery is reached. In addition to the hydrophilic wires, multiple commercially available
reentrydevicesareavailableincludingOutback&Pioneer(Coviden-Medtronic,Minneapolis,MN);OffRoad,BostonScientific(Watertown,MA);andEnteer(Covidient-Medtronic).SIAorrevascularizationis
associatedwithsimilar midtermpatencyratesasintraluminaltherapies andcan be usedwithexcellent
technical success. However, SIA should not be attempted in dense medial (Monckenberg type)
calcification,absenceofareentrysite,anda reentrysitethatistoosmallin diameter.Perforations or
rupturemaybetreatedwithcatheter-directedocclusionorexclusionwithastentgraftorsurgicalrepair.
AlthoughSIA isthe mostexpeditious formofinterventionfor long segment chronictotalocclusions,it
maypotentiallylimittheuseofothertherapiesincludingDCBsandatherectomy.
D.LesionCrossing
1. Lesion crossing is central to a successful intervention. Every attempt should be made to maintain
luminalpositionandavoiddissectionintothesubintimalspace.Subintimaldissectionincreasestimeand
complexityoftheprocedure.Toavoidsubintimaldissection,asteerableangledwire(0.035-inchangled
glidewire,Terumo), whichis a hydrophilic wireisusedwiththe help ofa torquedevice. Theangled
glidewirehasafloppytiptopreventdissectionwithenoughsupporttomaneuverthetip.Whenthetipof
thewiredeforms,thewireisusuallyretractedandturnedinadifferentdirectionfortruelumen.
2.Forhigh-gradestenoses,asmallerwiresuchasthe0.014-inchASAHIGrandSlam(AbbottVascular,
AbbottPark,IL)mayalsobeused.Chronictotalocclusionrequiresmorewiresandcatheters.InCTOs,it
isdifficulttoascertainwhetherthewireisluminalorhascrossedoverintothesubintimalspace.Inthose
cases, 0.035-inch Stiff Angled Glidewire (Terumo) in conjunction with a 0.035-inch Angled Glide
Catheter (AngioDynamics) or 0.035-inch Quick Cross catheter maybe used as they provide sufficient
support.ThetipofthewireisusuallygivenaJloopwhichthencurvesontoitselfandcreatesaloop,thus
allowing the body of the wire to enter subintimal space. The wire is then extended the lengthof the
occlusion, being supported by the catheter until reentry is identified. One can then determine luminal
reentry.Itisessentialtoidentifythemostproximalsiteoftargetvesselreconsititutionwhenperforming
interventionsonCTOs.Extensionbeyondthatjeopardizesbypasstargets.Once thispointis identified,
catheter is advancedandwire removed.Backbleeding is thenperformed toconfirm reentry into true
lumen.Injectionof1-2 mLofcontrastmayalso beusedtoconfirmthis. Incaseofmultipleattemptsat
reentry, reentry devices such as the Pioneer Catheter (Medtronic, Minneapolis, MN) may be used to
obtain luminal access. After lesion crossing, wire serves as a guide for balloon catheter and stent
deliverysystem.
E.PercutaneousTransluminalAngioplastyforSuperficialFemoralArtery
Disease(Table10.4)
1. The mechanism of angioplasty is controlled intimal dissection, disrupting luminal plaque and
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increasing diameter of the arterial flow. Barotrauma associated with PTA may provoke intimal
hyperplasiathroughacombinationofvesselwallinflammationandinjuryandalteredflowduetointimal
dehiscence.
a. Specialty balloons havebeen developed that can “cut,” “score,” or “modify”inflation profile of
balloons to prevent overexpansion and dissection. It has theadvantage of being inexpensive and
technicallysimplerthanprimarystenting.Italsoavoidsstentfatigueandfracturewhichmayresult
fromtorqueanddeformationoftheFParteriesduringflexionofthekneejoint.
b. Additionally, lower profile balloons may allow PTA of the SFA through sheaths as small as
4 French. PTA performs well for short lesions (<5 cm)54 that are noncalcified; restenosis rates
increaseaslesionlengthincreases.
33,37,55–58
c. IntheVIVAobjectiveperformancecriteria,theoverall12-monthpatencyrateforlesionsbetween4
and 15 cm treated with PTA alone ranged from 28% to 37%.59 PTA alone is associated with
complications including flow-limiting dissection, perforation, arterial rupture, and distal
embolization.Inonestudy,stentplacementforelasticrecoilorsignificantdissectionafterPTAhas
beenreportedinupto40%ofcases.
33
TABLE10.4
ClinicalTrialsinFemoropolitealDisease
60
ClinicalTrial Device NumberofPatients LesionLength(cm) IC/CLI TLR Restenosis
FAST
54
PTA
BMS
121
123
45±28
45±27
96.5/3.5
97.5/2.5
18.3
14.9
38.6
31.7
ABSOLUTE
61
PTA
BMS5351
92±75
101±75
87/13
88/12
31
28
63.0
37.0
ASTRON
62
PTA
BMS3934
65±46
82±67
97/3
91/9
–
–
61.1
34.4
ZILVER
63
PTA
DES
238
241
63±41
66±39
90.7/8.5
90.2/8.9
17.5
9.5
67.2
16.9
ZELLER
64
DES
DCB9731
195±65
194±86
91.7/7.2
81/16.8
21.5
19.3
30.4
23.9
FEMPAC
39
PTA
DCB5448
47±42
40±44
93/7
96/4
17
7
47.0
19.0
THUNDER
65
PTA
DCB5448
74±67
75±62
–
–
48
10
44.0
17.0
PACIFIER
66
PTA
DCB4741
66±55
70±53
95.7/4.3
95.5/4.5
21.4
7.1
32.5
8.6
IN.PACTSFA56PTA
DCB
111
220
88±51
89±48
93.7/6.3
95/5.0
20.6
2.4
47.6
17.8
LEVANT-2
67
PTA
DCB
160
316
63±40
63±41
91.9/8.1
92.1/7.9
37.53847.4
34.8
BMS,baremetalstent;CLI,criticallimbischemia;DCB,drug-coatedballoon;DES,drug-elutingstent;
IC,intermittentclaudication;PTA,percutaneoustransluminalangioplasty;TLR,targetvessel
revascularization.
2.Asdescribedintheprecedingsection,oncelesioniscrossedeitherintraluminallyorsubintimally,an
appropriateballoonisselected.Ballooncathetershavetwolumens;thelumenthroughwhichwirepasses
iscoaxial.
a. Thesecondlumenisconnectedtotheballoonandpermitsinflation.
b. Most useful ballooncathetershavelow profilewhichallowsforasmalldiameterwhendeflated,
minimizing entry-site complications and allowing easy maneuverability across tight and tortuous
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lesions.
c. Ballooncathetersshouldalsoideallybetrackable.Trackabilityallowsforeasypassageofballoon
cathetersoverwireswithoutpullingwiresoutofdesiredposition.
d. Most current balloons are made of polyethylene terephthalate or other low compliance, strong
plasticpolymers.
e. Balloons are available on 0.018-0.035-inch over-the-wire (OTW) and rapid-exchange (RX or
monorail)platforms. OTWcathetershavemorepushabilitywhile monorailballoonsuseashorter
wire.Generally,OTWballoonsmaybeusedascatheters.
f. Low-profile0.018-inchsystemsthatarecompatiblewith4Frsheathaccessaregenerallyadvocated
to minimize the risk of bleeding. Noncompliant balloons are preferred because they inflate to a
uniform diameter regardless of the amount of pressure and are less likely to cause injury to the
vessel.
g. High-gradeeccentricor cylindrical lesionsare related toincreased riskofballoonruptureduring
inflation.
h. Theidealballoonlengthismeasuredusinganexternalradiopaquerulerorcalibratedcatheter;the
properlengthmusttreattargetlesionwithoutdisruptionofthenormalvessel.
i. Ifa semicompliant balloon is used, greater pressure will overinflate theballoontoa larger
diameter.Thisproblemisnotencounteredwithnoncompliantballoons.Balloonoversizingas
well asoverinflationcancausearterial injuryorsignificantdissections.Balloonrupturecan
occur which may cause embolization of balloon fragments. If balloons are not properly
prepared,potential air embolization may alsooccur. As theballoonisinflatedtonominalor
rated burstpressure, a narrowing is seenat thesite of stenosis or occlusionwhichresolves
whenthestenosisisovercome.
ii. Longer inflationtimesare oftenused to stabilize the luminal surface of the arterial segment;
longer times may reduce the likelihood of flow-limiting dissections. We use inflation times
between60and180seconds.
i. For persistent stenoses that do not resolve with standard noncompliant balloons, cutting/scoring
balloonsmaybeused;thelatterareassociatedwithlesshemodynamicallysignificantdissections
F.PercutaneousTransluminalAngioplastyforSuperficialFemoralArtery
DiseaseWithDrug-CoatedBalloons(SeeTable10.4)
1.Drug-ElutingStentsandDrug-CoatedBalloons
Thedevelopmentofpaclitaxeldrug-elutingstents(DESs)anddrug-coatedballoons(DCBs)representsan
evolutionintheendovasculartreatmentofperipheralarterialdisease.
2.ClinicalTrials
RandomizedclinicaltrialshavedemonstratedthatangioplastywithaDCBissuperiortostandardballoon
angioplastyformoderate-lengthlesionsintheFPregion.
56,67
Multicenterregistrieshaveshownexcellent
primarypatencyofDCBsinanatomicallysimpleandcomplexlesionsboth
68,69
withreductioninratesof
restenosis,decreaseintargetvesselrevascularization,andeconomiccost-savingsdueinparttoreduced
need for repeatperipheral angiogramsandreintervention.
37,66,70
The principal mechanism of restenosis
withPTAandbaremetalstents(BMS)isthoughttobeneointimalhyperplasiaduetomechanicalinjuryto
vessel wall. Restensosis rates are also related todistribution of PADwith longer lesions with higher
restenosisratesfordiffuse,infrapopliteallesions.
19,71
CLI,representingthemostsevereformofPAD,is
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associatedwithlong-segmentFPlesions,multileveldisease,anddiffuseinfrapopliteallesions.
72
3.UnitedStatesFoodandDrugAdministrationApproval
Two DCBsare currently approved by the United States Food and Drug Administration(FDA)for the
treatment ofPADin SFA and popliteal artery. These includethe Lutonix035 DCBPTAcatheter with
paclitaxel and theIN.PACT Admiral DCBwith paclitaxel. More recently the FDA granted premarket
approvaltoanotherpaclitaxel-coatedballoon,theStellarexballoon.
a. In theILLUMENATEtrial, the Stellarexballoondemonstratedconsistently high patencyrates and
lowclinically driventargetrevascularization ratespatients withsuperficialfemoral arteryand/or
poplitealarterylesions.
73,74
b. DCBconsistsofaballooncatheterwhichiscoatedwithanantiproliferativedrug(paclitaxel)andan
excipient which controls drug release. Each DCB is unique with respect to the paclitaxel dose
(varying from 2 to 3.5 mg/mm2), the carrier molecule (excipient), the balloon material, and the
coatingtechnologyused.DCBshaveseveraladvantagesoverstents:theymaybeabletodistribute
drugsmorehomogenouslythatstentsandmayavoidmetalorpolymer-inducedstentrestenosisand
stentfracturesassociatedwithstentimplantationintheFPterritory.
c. DCBsmayalsobeusedpreferentiallyinscenarioswherestentimplantationisnotdesirable(in-stent
restenosis,bifurcationcarina,ordiffuseFPdisease).75LimitationsofDCBsaresimilartoballoon
angioplasty—namely lower acute gain and potentially more unstable acute results.75 The main
challengeofdeliveringDCBsareeffectivedrugtransferwithinaspecifiedtimeframeasdictatedby
asingleballooninflation(typicallyaround30s)
d. The antiproliferative drug paclitaxel is preferred due to its lipophilicity and prolonged tissue
retentionrates.Paclitaxelhasbeenshown topreventneointimalhyperplasia by disruptingnormal
microtubule function, thereby inhibiting smooth muscle cell migration, proliferation, and
extracellular matrix secretion.Some ongoing studies have however focused on theuse of limusbased DCBs due to their efficacy in preventing neointimal hyperplasia.76 Excipient enhances
transferofdrugfromballoontotissueandvarybetweenurea,iopromide,andpolysorbate/sorbitol,
whicharethemostcommonlyused.
71
G.TrialsComparingtheUseofDrug-CoatedBalloonWithPercutaneous
TransluminalAngioplastyinSuperficialFemoralArtery/Femoropopliteal
Disease(SeeTable10.4)
Asmentionedelsewhere,thereareincreasingdatasupportingthesuperiorityofDCBoverPTAforFPas
well as below-the-knee (BTK) disease. Four randomized control trials (THUNDER,38 FemPac,
66
LEVNATI37andPACIFIER66)demonstratedsignificantreductioninlatelumenloss,TLR,andbinary
restenosis at 6-month follow-up. A meta-analysis of these trials showed no difference in their safety
profiles.77At24months,TLRrateforpatientsintheDCBarmwasone-halfofthatinthePTAarminthe
THUNDERtrial.384%ofpatientsintheDCBarmreceivedadditionalstentscomparedwith22%inthe
PTAarm.InanotherprospectivestudyofDCBuseforFPdisease,the2-yearpatencyratewas72.4%and
TLRratewasreportedat14.3%(P<.001).
69
V.StentinginSuperficialFemoralArtery(SeeTable10.4)
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A.BareMetalStents
Allangioplastiescanbecomplicatedbyflow-limitingdissection,embolization,andacutearterialrecoil.
Theuseofself-expandingcoveredorbaremetalstents(BMS)hasbeenshowntoimprovepatencyand
maybe used totreatPTA-relatedcomplicationsincludingdissection.However,inthe earlystudies of
sirolimus- and everolimus-eluting self-expanding nitinol stent platforms for SFA, early efficacy was
followedbydisappointinglongertermresults.
B.BareMetalStentStudiesandTrials
1.IntheSirolimusCoatedCordisSmartNitinolSelf-expandableStentfortheSuperficialFemoralArtery
Disease (SIROCCO) randomized trial, the sirolimus-coated stent (Cordis, Miami Lakes, FL)
demonstrated improved patencyin comparison with the BMS at 6 months; however, in the follow-up
SIROCCOIItrial,therewasnosignificantdifferenceinoutcomesbetweenDESandBMSat18months.
78,79
IntheSuperficialFemoralArteryTreatmentwithDrug-ElutingStents(STRIDES)study,theDynalink
everolimus-elutingstentshoweda32%stentrestenosisrateat12months.
80
1.Efficacy
Severalstudies havedemonstratedthe efficacy of self-expanding stentsin thetreatmentof longer SFA
lesions. Self-expanding stents possess thermal shape memory and are more resistant to mechanical
stresses by expanding on deployment at body temperature and then reexpanding after external
compression.
In theVienna randomizedtrial, patientsreceiving self-expanding stentsforfemoral arterydisease
hadlowerratesofrestenosisandbetterwalkingcapacitythanthosetreatedwithballoonangioplasty
alone.
61
In the Randomized Study Comparing the Edwards Self-Expanding LifeStent versus AngioplastyaloneInLesionsInvolvingTheSFAand/orProximalPoplitealArtery(RESILIENT)study,33nitinol
BMSs were comparedwithangioplasty. The observedpatencyrateat1yearwas81.3%forstent
versus36.7%forangioplastygroup.Posthocanalysis,however,suggestedthatballoonangioplasty
alonewassimilartoself-expandingstentsinshortSFAlesions(<100mm)
C.Polytetrafluoroethylene(PTFE)-CoveredStents
1. PTFE-covered stentsmaybe usedtotreatlong SFAlesionsinpatients withclaudication;however,
theirsuperioritytoBMSisunproven.Studieshaveshownnosignificantlong-termdifferencesinpatency
rates between covered stents and bare metal (nitinol) stents.
35,81
Covered stents may have a role in
treatmentofin-stentrestenosisofSFA.However,coveredstentsareassociatedwithahigherrateofacute
limbischemia82comparedwithBMS,andatthispoint,aclearroleforcoveredstentsinSFAlesionshas
notbeenclearlydefined.
2.Drug-ElutingStents
Asmentionedintheprecedingsection,revascularizationintheSFAischallengingbecauseofextensive
plaque and complex mechanical forces including elongation, torsion and flexion, and so forth. The
presenceofnonresorbablepolymersinperipheralarteryDESsinduceinflammatorythromboticreactions,
whichmayleadtolatestenosisandthrombosis.
83
3.ZilverPTX(CookMedical,Bloomington,IN)istheonlyDEStodatethathasdemonstratedsuperior
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and sustained patency in comparison with its bare metal counterpart. It is an FDA-approved, selfexpanding,nitinolstentsystem.TheZilverPTAischaracterizedbydirectapplicationofpaclitaxeltothe
stentwithoutuseofapolymericcoating.Paclitaxelavidlybindstointracellulartargetproteins,allowing
fordruguptakeinthearterywithdetectableretentionforupto2months.Theabilityofpaclitaxeltobind
targetproteinsavidlyallowsZilverPTXtodeliverpaclitaxelfromtheabluminalsurfacewithouttheaid
of polymers, bindings, or carriers.40 Its flexible z-cell design provides for wall apposition and
conformability. Additionally, the presence of horizontal tiebars and z-cell decrease shortnening. The
Zilver 635series (6F, 0.035inch) and518 series (5F, 0.018inch) are bothavailable in6- to 10-mm
diameter,20-to80-mmlengths,and80-and125-cmdeliverysystems.Theindicationsforuseallowtwo
ZilverPTX80-mmstentstobeoverlappedtotreatlongerlesionsupto140mminlength.
D.Drug-ElutingStentStudiesandTrials
1.InarandomizedcontroltrialofZilverPTXDES,
40
thestentwascomparedwithPTAforlesionsupto
14 cm in length in the SFA/proximal popliteal arteries. If bail-out stenting was needed because of
suboptimalPTAor flow-limitingdissection,secondary randomizationtoeitherZilver PTXversusbare
metalZilverstentwasundertaken.At1year,ZilverPTZwassuperiortoPTAinpatencyrates(83%vs
33%primarypatency).ProvisionalDESwasalsosuperiortoprovisionalBMSwithaprimarypatency
rateof89.9%forprovisionalDESversus73.0%forprovisionalBMS.At2years,sustainedsuperiority
was demonstratedwithaprimarypatencyrateof83.4% forDESversus61.1% forBMS.63Afterfive
yearsoffollow-up,sustainedpatencywasagaindemonstratedforZilverDESversusPTAgroup(64.9%
vs19%forPTAgroup).Similarlyinthehead-to-headcomparisonofprovisionalDESversusprovisional
BMS,sustainedefficacywasdemonstrated(72.4%vs53.0%).84In asubgroupanalysis,treatmentwith
DESwasassociatedwithsuperioroutcomesforcomplexdisease,includingtotalocclusionsandlonger
lesionsaswellashigh-riskcohortssuchasthosewithdiabetesorCLI(Rutherford4-6).
2.In aEuropeanstudyinthe economicimpactofusing Zilver PTXstents,netcumulativesavingsof€
6,807,202weremade over5yearsmainly byreducingthe needfor futureinterventions.85To date,no
head-to-headcomparisonsexistbetweenprimaryDESandBMSorDCBintheFParteries.Apropensity
score-basedcomparisonofDESandDCBinconsecutivepatientswithTASCCandDlesionsthatwere
long(>10cm)foundnosignificantdifferencein1-yearpatencyrates.
64
VI.ClinicalTrialUpdateinSuperficialFemoralArteryDisease
An overview of randomized controlled trials of DCBs, DES, and covered stents in FP disease is
provided in Table 10.4. These trials demonstratebenefitfor DES, DCB, andcovered stents and may
resultinchangeinclinicalpractice.
A.Follow-Up
1. Afterinterventionfor lowerextremity disease,aggressivefollow-uptooptimizemedical therapy is
indicatedtopreventfuturecardiovasculareventsandtoimprovepatencyrates.Counselingonriskfactors
modification with initiation/continuation of pharmacologic treatment is important. The mainstay of
pharmacologictreatmentisstatins,antihypertensiveagents,andantiplatelettherapy.Previousstudieshave
indicated that patients with PAD are less likely to receive guideline-directed medical therapy than
patientswithotherformsofcardiovasculardiseaseincludingcoronaryarterydisease.
18,86,87
2.Atleast6monthsofaspirinand1monthofclopidogrelisrecommendedfollowingperipheralartery
DCB use; and at least 2 months of dual antiplatelet therapyafter peripheral artery drug (paclitaxel)–
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coatedstentimplantation.However,therearelimiteddataonthedurationofantiplatelettreatmentafter
endovascularintervention,withonesmallstudyshowingnodifferencesinoutcomesin12-monthfollowupbetweenprolonged(8-12wk)versusshortdurationofantiplatelettreatment(4-6wk)
88
3.Postoperativefollow-upforpatientsundergoingSFAinterventionisroutinelyperformedwithABIor
arterialduplexultrasoundwithinonemonthoftheintervention.Thisisfollowedbyimagingat3-6months
andthenyearlyafter.Ifsymptomsrecur,imagingmaybeconsideredearlier.
B.ACC/AHARecommendations
TheACC/AHA8hasa class IArecommendation for theuseofaspirinalone(range: 75-325mg/d) or
clopidogrelalone(75mg/d)toreduceMI,stroke,andvasculardeathinpatientswithsymptomaticPAD.
After revascularization, it may be reasonable to initiate DAPT to reduce risk of limb-related events
(Class: IIb). Treatment with statins is recommended in all patients with PAD (Class: IA, LOE: A).
Similarly,antihypertensivetherapyisrecommendedtoinpatientswithPADandHTNtoreduce riskof
MI,stroke,heartfailure,andcardiovasculardeath(IA).Furthermore,research studies
89,90
have shown
reduction in vascular events inpatients withboth clinical and subclinical PADwho havebeentreated
with either anangiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)
henceaclassIIA,LOEArecommendationfortheuseoftheseagents.
VII.Summary
PercutaneousinterventionforocclusivediseaseoftheFPregionhasbecomethemainstayoftreatmentfor
patientswith intermittent claudication andCLI.Thishasparalleled thedevelopmentofnew techniques
anddevices.Percutaneous interventions oftheFPregionareassociatedwithlowriskofmortalityand
morbidity.FuturegoalsinperipheralarterialdiseaseshouldfocusonidentifyingpatientswithFPdisease
earlyanduseofappropriatetreatmentstrategiestopreventCLIandamputation.
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