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Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3751_Библиотеки_им_академика_М_И_Перельмана

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complicationssuchas stentthrombosisduetoincompleteendothelialization.26Therehasbeenalotof researchintothebiomechanicalstressonthevesselwallcausedbystents,andduetoitslocationinthe FP territory, stent fracture has been described. It has also been shown that there is nonuniform drug elution,morepronouncedintheintimathatisincontactwiththestent.TheseissuesmakeDESalessthan idealstrategyforuniversalapplicationinpatientswithPAD.
VI.Drug-CoatedBalloon
A.Drug-CoatedBalloonsforFemoropoplitealDisease
1. DCBs have several advantages over standard PTA in regard to late lumen loss (LLL), TLR, and
improvedprimarypatencywithdecreasedrestenosis.Asreviewedearlierinthechapter,paclitaxelisthe mostcommonlyuseddruginDCBduetoitslipophilicpropertiesandtissuepenetration.Initialproofof concept studies done in swine showed that high concentrations of paclitaxel delivered by balloon angioplastyreduced intimalhyperplasia even though theduration of exposureofthevessel walltothe drugwasshort.
27,28
2.FEMPAC(Paclitaxel-CoatedvsUncoatedBalloon:FemoralPaclitaxelRandomizedPilotTrial)trial
randomized87patientswithFPdisease toeitherPTAorpaclitaxelDCB.Theprimaryoutcome oflate lumenlossat6-monthswassignificantlylowerintheDCBgroupwithreductioninTLRratesaswell. Thisbenefitcontinuedto18monthsaftertherapy.29THUNDER(LocalTaxanewithShortExposurefor ReductionofRestenosisinDistalArteries)trialrandomized∼150patientstostandardPTAorpaclitaxel DCBor paclitaxelwithcontrastmedium DCBanddemonstrateda significantlylowerLLL andTLRat 6 monthsinboth the paclitaxel arms compared with plain PTA. The additionofcontrasttopaclitaxel seemed to have no additionalbenefit in this trial. Freedom from TLR continuedup to 24monthsafter DCBtherapy.
30
3.ThePACIFIER(Paclitaxel-CoatedBalloonsinFemoralIndicationtoDefeatRestenosis)trialshowed
significantreductionin6-monthLLLandTLRinpatientsrandomizedtopaclitaxelDCB.Italsoshowed reduction inbinary restenosis and fewer targetlimb amputationsandTLR at12 months.31 LEVANT I (Lutonixpaclitaxel-coatedballoonforthepreventionofFPrestenosis)trialshowedsimilarresultswith paclitaxel DCB in patientswith FPdisease althoughthe doseusedwasless.32A meta-analysis ofall these fourtrials showedsignificantreductioninTLR, binaryrestenosis,andLLL withpaclitaxelDCB withnoreductioninmortality.33TheseresultsareshowninFigs.12.3and12.4.
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FIGURE12.3 Targetlesionrevascularizationinpaclitaxel-coatedballoonversusuncoatedballoonangioplasty.
Reproducedwithpermissionfrom
CasseseS,ByrneRA,OttI,etal.Paclitaxel-coatedversusuncoatedballoonangioplastyreducestargetlesionrevascularizationinpatientswith
femoropoplitealarterialdisease:ameta-analysisofrandomizedtrials.CircCardiovascInterv.2012;5(4):582-589.
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FIGURE12.4 Angiographicrestenosis(A),latelumenloss(B),andmortality(C)inpaclitaxel-coatedballoon
versusuncoatedballoonangioplasty.
Reproducedwithpermissionfrom
CasseseS,ByrneRA,OttI,etal.Paclitaxel-coatedversusuncoatedballoonangioplastyreducestargetlesionrevascularizationinpatientswith
femoropoplitealarterialdisease:ameta-analysisofrandomizedtrials.CircCardiovascInterv.2012;5(4):582-589.
4.TheIN.PACTSFAtrial(RandomizedTrialofIN.PACTAdmiralDrug ElutingBalloonvs Standard
PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease) was one of the largest randomizedtrialsthatincludedover300patientswithsymptomaticFPdisease,toeitherpaclitaxelDCB orPTAandconcludedthattherewasasignificantincrease in patencyrates andreductioninclinically drivenTLRat1year34Theseresultswerestillfavorableattheendof2years.35Table12.2summarizes importantDCBtrials.
Table12.2
DCBTrialsinPAD
Trial Sample
Size
Drug Excipient Dose
μg/mm
2
Control Territory PrimaryOutcome
THUNDER30154 Paclitaxel Iopramide 3 PTAonlyandPTAwith
contrast
FP 6moLLL
0.4±1.2vs1.7±1.8mm
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(P<0.001)
LEVANTI
32
101 Paclitaxel Polysorbate 3 PTA FP 6moLLL
0.5±1.1vs1.1±1.1mm (P=0.016)
PACIFIER
31
91 Paclitaxel Urea 3 PTA FP 6moLLL
−0.01±0.3vs0.7±0.3mm
(P=0.0014) IN.PACT SFA
34
331 Paclitaxel Urea 3.5 PTA FP 12moprimarypatency
82.2%vs52.4%;P<0.001 DEBATE BTK
36
132 Paclitaxel Urea 3 PTA BTK 12mobinaryrestenosis
27%vs74%(P<0.001) DEBATE SFA
110 Paclitaxel Urea 3 PTA+BMS BTK 12mobinaryrestenosis
17%vs47%(P=0.008)
DCB,drug-coatedballoon;FP,femoropopliteal;LLL,latelumenloss;PAD,peripheralarterydisease; PTA,percutaneoustransluminalangioplasty.
B.Drug-CoatedBalloonsinBelowKneeDisease
DCBshavebeenusedinbelowkneediseasewithmixedresults.TheinitialstudybySchmidtetalwasa prospectivesinglearmtrialthatexaminedtheuseofDCBinpatientswithbelowkneediseaseandCLI. Thisshowedsuperiorshort-andmid-termpatencyratescomparedwithhistoricalcontrolstreatedwith PTA.9These findings were then confirmedinthe DEBATE BTK(Drug Eluting Ballooninperipheral interventionforBelow TheKnee Angioplasty Evaluation) trial thatrandomized 132patients withCLI (Rutherford class 4 or above) andbelow knee disease. Itdemonstrated significantly lower restenosis rates,TLR,andtargetvessel occlusion inthe DCBarm.36However,the resultsfrom IN.PACTDEEP (RandomIzedAmPhirionDEEPDEBvsStAndardPTAforthetreatmentofbelowthekneeCriTicallimb ischemia) raised some concerns over DCB use in below knee disease. This study randomized 351 patientswithCLItoeitherDCBorPTAandshowednosignificantbenefitwithDCBintermsofclinically drivenTLRorLLL,buttherewasatrendtowardmoreamputationsintheDCBarm.
37
C.Drug-CoatedBalloonsforinStentRestenosis
Another unique application for DCB is the treatment ofISR, whichwas explored insome trials with encouraginglong-term results.Asingle center prospective registry included39 patients with SFA ISR whoweretreatedwithDCBanddemonstrateda1-yearpatencyrateofover90%witha10%needfor bailoutstenting.38Thepatencyratewasstillover70%at2years’follow-up.39TheDEBATEISR(Drug- ElutingBallooninPeripheralInterventionforIn-StentRestenosis)studyshowedasignificantreductionin restenosis and TLR rates at1 year withDCB compared with historical controls treated withPTA.
40
However,at3yearsnosignificantdifferencewasnotedinregardtoTLR.41Severalongoingtrailsaimto explorethisclinicalutilityinarigorousfashion.
ClinicalPearls
■When using DCB, adequate lesion preparationis critical before applyingDCB; thismay
includePTAoratherectomytoenhancedrugdeliverytothevesselwall.Italsogoeswithout sayingthatoneshouldavoidgeographicmissbyusing anatomic landmarksandglow tape. Thedrugstartselutingassoonastheballooncathetercomesincontactwiththeblood,and althoughtherateofdruglossissmall,itisrecommendedthattheDCBcatheterbeadvanced tothetreatmentsegmentasquicklyaspossible.Adequateinflationtimesarealsoimportantto
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ensuredrugdelivery,andinmostcasesthisrequires3minutes.
■There appears to be certainareas in which DCB wouldhavetheoretical advantageover
otherdevices;thisincludescommonfemoralartery,ostialSFA,andbypassgraftrestenosis.
VII.FutureDirections
Therearemanyunansweredquestionswithdrug-coatedtherapies,andconsequently,thereareanumber ofongoingtrialsinthisarea.Bioabsorbablevascularscaffolds(BVS)maybeasolutiontosomeofthe problemswithdrug-coateddevices.Itavoidstheelasticrecoilandflow-limitingdissectionsseenwith DCBs, and as the scaffold “disappears,” there is no long-term risk of shear stress on the vessel or persistentinflammationseenwithstents.Aftersomeinitialsuccessinthecoronaryrealm,itremainstobe seen if that can be reproduced in the PAD arena. The ESPRIT I trial was a single arm prospective multicenter trial thatshowed in carefullyselectedpatients withpredominantly focal SFA disease (30­40mm),theBVSstentwassafeandeffectivewith1-and2-yearbinaryrestenosisratesof12%and16% andTLRratesof∼9%and12%,respectively.
42
Therehasbeenaconsiderableinterestincombinationtherapiestoovercomesomeofthelimitationsof drug-coateddevicessuchasatherectomyfollowedbyDCB.Thiswasshowntobeanidealstrategywith early(30-day)highertechnicalsuccessandlowerresidualstenosisratescomparedwithDCBalone.
43
SeveralotherongoingtrialsareexaminingatherectomyorphotoablativestrategiescombinedwithDCBin PAD.
44,45
There have been no directcomparisonbetween DES andDCB,but the ongoing trials will
hopefullysettlethedebatesoon.
46,47
Fig.12.5showstheTLRratesforDCBandDES.
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FIGURE12.5 Freedomfromtargetlesionrevascularization(TLR)forDEScomparedwithdrug-coatedballoon
(DCB)infemoropoplitealtrials.
Reproducedwithpermissionfrom
SarodeK,SpelberDA,BhattDL,etal.Drugdeliveringtechnology forendovascularmanagementofinfrainguinalp eripheralarterydisease.JACC
CardiovascInterv .2014;7(8):827-839.
VIII.Conclusion
Drug-coateddevices(DESandDCB)havebeendemonstratedtobesafeandeffectiveinthetreatmentof FP andbelow knee PAD.Endovascular interventions ingeneral are limitedin this territory by lower patencyrates,andhenceitmakesperfectsensetoincorporatethesedevicesinthetreatmentalgorithmto decreaserestenosisrates.Themid-termresultsofDESlookverypromising,butthepatencyratesseemto be poor for longer lesions (>100 mm) and calcific stenosis. Moreover there still existsome concerns overstentscausingshearstressonthevesselwallanddelayedrestenosisduetothescaffold.DCBcan overcome most of these limitations and have shown to be an excellent addition to the PAD armamentarium.ThepatencyratesarecomparablewithDESwithlowerrestenosisrates.Moreover,this technologyhastheadvantageof“leavenothingbehind”strategyandtreatmentofdiseaseinthetraditional “no-stent zones.” The long-term efficacy of these devices is yet to be seen. Combining DCB with atherectomyhasitsadvantagesaswell.Lotsofongoingtrialswillshedmorelightinthisarea,andforthe timebeing,drug-coateddevicesaredefinitelyaforcetobereckonedwith.
References
1.NorgrenL,HiattWR,DormandyJA,etal.Inter-societyconsensusforthemanagementofperipheralarterialdisease.IntAngiol. 2007;26(2):81-157.PMID:17489079.
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42.LammerJ,BosiersM,DelooseK,etal.Bioresorbableeverolimus-elutingvascularscaffoldforpatientswithperipheralarterydisease (ESPRITI):2-yearclinicalandimagingresults.JACCCardiovascInterv.2016;9(11):1178-1187.doi:10.1016/j.jcin.2016.02.051.PMID:
27282601.
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2011.https://ClinicalTrials.gov/show/NCT01366482.
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45.Herz-ZentrumsBadKrozingen.PhotoablativeAtherectomyFollowedbyaPaclitaxel-CoatedBalloontoInhibitRestenosisinInstent Femoro-poplitealObstructions;2011.https://ClinicalTrials.gov/show/NCT01298947.
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https://t.me/med1917
C H A P T E R  1 3
StentTherapiesintheLowerExtremity:Bare­Metal,Drug-Eluting,andReabsorbableStents
KwanSLeeMBBCh,
AhmedHarhashMBBCh,andTze-WoeiTan,MBBS
I.Introduction
A.History
B.Technology
C.ChapterOutline
II.Bare-MetalBalloon-ExpandableStents
A.GeneralPrinciples
B.CommonIliacArtery
III.Balloon-ExpandableCoveredStents
A.GeneralPrinciples
B.ComparisonwithBare-MetalStents
C.Summary
IV.Self-ExpandingStents
A.Wallstent
B.NitinolSelf-ExpandingStents
C.Summary
V.Self-ExpandingCoveredStents
A.GeneralPrinciples
B.ClinicalUseinPeripheralArterialDisease
VI.SuperaNitinolSelf-ExpandingBareMetalStent
A.PeipheralStentsandRiskofStrutFracture
B.SuperaStent
VII.Drug-ElutingSelf-ExpandingStents
A.First-GenerationPeripheralDrug-ElutingStents(DES)
B.PaclitaxelPeripheralSelf-ExpandingStents(ZilverPTX)
C.Drug-ElutingSelf-ExpandingStentsIn-Development
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VIII.BioresorbableScaffolds
A.GeneralPrinciples
B.LowerExtremityClinicalTrials
C.Summary
I.Introduction
A.History
Percutaneous endovascular therapies for peripheral arterial disease have continued to evolve since CharlesDotterperformedthefirstpercutaneoustransluminalangioplasty(PTA)ofasuperficialfemoral artery(SFA)in 1964. Indeciding optimal therapyfromthe myriad ofdevicesandtechniquescurrently available, the unique properties of specific arterial distributions must also be accounted for. Balloon angioplastyisoveralleffectiveandhastheadvantageofsimplicityandcost-effectiveness,butresultsare limitedby recoil, acute dissection, and significant rates of restenosis. There are numerous adjunctive therapiestoangioplasty,includingscoringballoonangioplasty,atherectomyinitsmanyforms(rotational, excisional,laser), drug-coatedballoons,anda variety of stents. Many permutations therefore existfor therapyandcanbebothconfusingandcomplementary.FamiliaritywiththeInter-SocietyConsensusfor the Management of Peripheral Arterial Disease (TASC) guidelines is important, as they categorize heterogeneousanatomicalpresentationsofdiseaseandguidesuitabilityofsurgicalversusendovascular therapyandchoiceofendovascularintervention.
1
B.Technology
Giventhecentralandimportantroleofstentinginendovascularintervention,itis importanttohavean appreciationofthetechnologiesinvolvedandtherelativebenefitsanddrawbacksofeach.Stentswere developed toimproveoutcomes overangioplasty. Theyimprovevesselpatencybyacting asascaffold against recoil and dissection. The primary structural challenge in peripheral vascular disease is compressional and torsional forces acting upon the stent in specific anatomic territories during daily motion,whichmaycrushthestentorcontributetostrutfractures.Inadditiontothechallengesposedby dailyexternalforces,stentsinduceproliferativereactions,contributingtolong-termrestenosis.
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