IN.PACT™ Admiral™ drug-coated balloons in peripheral artery disease: current perspectives

References

• AboyansVRiccoJBBartelinkMEL2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society for Vascular Surgery (ESVS): document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries endorsed by: the European Stroke Organization (ESO) the task force for the diagnosis and treatment of peripheral arterial diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS)Eur Heart J201839976381628886620
   PubMed Web of Science ®Google Scholar
• Gerhard-HermanMDGornikHLBarrettC2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: executive summary: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelinesCirculation201713512e686e72527840332
   PubMed Web of Science ®Google Scholar
• FowkesFGRudanDRudanIComparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysisLancet201338299011329134023915883
   PubMed Web of Science ®Google Scholar
• NorgrenLHiattWRDormandyJAInter-society consensus for the management of peripheral arterial disease (TASC II)Eur J Vasc Endovasc Surg200733Suppl 1S1S7517140820
   PubMed Web of Science ®Google Scholar
• Writing Committee to Develop Clinical Data Standards for Peripheral Atherosclerotic Vascular DiseaseCreagerMABelkinM2012 ACCF/AHA/ACR/SCAI/SIR/STS/SVM/SVN/SVS key data elements and definitions for peripheral atherosclerotic vascular disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Clinical Data Standards for Peripheral Atherosclerotic Vascular Disease)Circulation2012125239546722144570
   PubMed Web of Science ®Google Scholar
• DiehmNShangASilvestroAAssociation of cardiovascular risk factors with pattern of lower limb atherosclerosis in 2659 patients undergoing angioplastyEur J Vasc Endovasc Surg2006311596316269257
   PubMed Web of Science ®Google Scholar
• LuJTCreagerMAThe relationship of cigarette smoking to peripheral arterial diseaseRev Cardiovasc Med20045418919315580157
   PubMedGoogle Scholar
• NarulaNDannenbergAJOlinJWPathology of peripheral artery disease in critical limb ischemiaJ Am Coll Cardiol201872182152216330166084
   PubMed Web of Science ®Google Scholar
• DakeMDAnselGMJaffMRDurable clinical effectiveness with paclitaxel-eluting stents in the femoropopliteal artery: 5-year results of the zilver PTX randomized trialCirculation2016133151472148326969758
   PubMed Web of Science ®Google Scholar
• IqbalJSerruysPWSilberSComparison of zotarolimus- and everolimus-eluting coronary stents: final 5-year report of the RESOLUTE all-comers trialCirc Cardiovasc Interv201586e00223026047993
   PubMed Web of Science ®Google Scholar
• IidaONantoSUematsuMEffect of exercise on frequency of stent fracture in the superficial femoral arteryAm J Cardiol200698227227416828607
   PubMed Web of Science ®Google Scholar
• SchlagerOZehetmayerSSeidingerDvan der LooBKoppensteinerRWall shear stress in the stented superficial femoral artery in peripheral arterial diseaseAtherosclerosis20142331768224529126
   PubMed Web of Science ®Google Scholar
• TepeGLairdJSchneiderPDrug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trialCirculation2015131549550225472980
   PubMed Web of Science ®Google Scholar
• BrodmannMKeirseKScheinertDDrug-coated balloon treatment for femoropopliteal artery disease: the IN.PACT global study de novo in-stent restenosis imaging cohortJACC Cardiovasc Interv201710202113212329050631
   PubMed Web of Science ®Google Scholar
• IidaOSogaYUrasawaKDrug-coated balloon vs standard per-cutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal arteries: one-year results of the MDT-2113 SFA Japan randomized trialJ Endovasc Ther201825110911729264999
   PubMed Web of Science ®Google Scholar
• StabileEVirgaVSalemmeLDrug-eluting balloon for treatment of superficial femoral artery in-stent restenosisJ Am Coll Cardiol201260181739174223040582
   PubMed Web of Science ®Google Scholar
• VirgaVStabileEBiaminoGDrug-eluting balloons for the treatment of the superficial femoral artery in-stent restenosis: 2-year follow-upJACC Cardiovasc Interv20147441141524630884
   PubMed Web of Science ®Google Scholar
• SchmidtAPiorkowskiMGörnerHDrug-coated balloons for complex femoropopliteal lesions: 2-year results of a real-world registryJACC Cardiovasc Interv20169771572427056311
   PubMed Web of Science ®Google Scholar
• MedtronicIN.PACT Admiral Drug-Coated Balloon: Overview2018 Available from: https://www.medtronic.com/us-en/healthcare-professionals/products/cardiovascular/drug-coated-balloons/inpact-drug-coated-balloon.htmlAccessed December 16, 2018
   Google Scholar
• ChaabaneCOtsukaFVirmaniRBochaton-PiallatMLBiological responses in stented arteriesCardiovasc Res201399235336323667187
   PubMed Web of Science ®Google Scholar
• PetersonSHasenbankMSilvestroCRainaSIN.PACT™ Admiral™ drug-coated balloon: Durable, consistent and safe treatment for femoropopliteal peripheral artery diseaseAdv Drug Deliv Rev2017112697727771367
   PubMed Web of Science ®Google Scholar
• TepeGZellerTAlbrechtTLocal delivery of paclitaxel to inhibit restenosis during angioplasty of the legN Engl J Med2008358768969918272892
   PubMed Web of Science ®Google Scholar
• KelschBSchellerBBiedermannMDose response to paclitaxel-coated balloon catheters in the porcine coronary overstretch and stent implantation modelInvest Radiol201146425526321285890
   PubMed Web of Science ®Google Scholar
• LiistroFGrottiSPortoIDrug-eluting balloon in peripheral intervention for the superficial femoral artery: the DEBATE-SFA randomized trial (drug eluting balloon in peripheral intervention for the superficial femoral artery)JACC Cardiovasc Interv20136121295130224239203
   PubMed Web of Science ®Google Scholar
• PalmeriniTBenedettoUBiondi-ZoccaiGLong-term safety of drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysisJ Am Coll Cardiol201565232496250726065988
   PubMed Web of Science ®Google Scholar
• LammerJBosiersMZellerTFirst clinical trial of nitinol self-expanding everolimus-eluting stent implantation for peripheral arterial occlusive diseaseJ Vasc Surg201154239440121658885
   PubMed Web of Science ®Google Scholar
• DudaSHBosiersMLammerJDrug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trialJ Endovasc Ther200613670171017154704
   PubMed Web of Science ®Google Scholar
• Müller-HülsbeckSKeirseKZellerTSchroëHDiaz-CartelleJTwelve-month results from the majestic trial of the eluvia paclitaxel-eluting stent for treatment of obstructive femoropopliteal diseaseJ Endovasc Ther201623570170727193308
   PubMed Web of Science ®Google Scholar
• Müller-HülsbeckSKeirseKZellerTSchroëHDiaz-CartelleJLong-term results from the majestic trial of the eluvia paclitaxel-eluting stent for femoropopliteal treatment: 3-year follow-upCardiovasc Intervent Radiol201740121832183828948322
   PubMed Web of Science ®Google Scholar
• ZhaoHQNikanorovAVirmaniRJonesRPachecoESchwartzLBLate stent expansion and neointimal proliferation of oversized Nitinol stents in peripheral arteriesCardiovasc Intervent Radiol200932472072619484292
   PubMed Web of Science ®Google Scholar
• ZhaoHQNikanorovAVirmaniRSchwartzLBInhibition of experimental neointimal hyperplasia and neoatherosclerosis by local, stent-mediated delivery of everolimusJ Vasc Surg20125661680168822841285
   PubMed Web of Science ®Google Scholar
• HabibAKarmaliVPolavarapuRSirolimus-FKBP12.6 impairs endothelial barrier function through protein kinase C-α activation and disruption of the p120-vascular endothelial cadherin interactionArterioscler Thromb Vasc Biol201333102425243123887639
   PubMed Web of Science ®Google Scholar
• CleverYPPetersDCalisseJNovel sirolimus-coated balloon catheter: in vivo evaluation in a porcine coronary modelCirc Cardio-vasc Interv201694e003543
   Web of Science ®Google Scholar
• KatsanosKKitrouPSpiliopoulosSDiamantopoulosAKarnabatidisDComparative effectiveness of plain BA, bare metal stents, drug-coated balloons, and drug-eluting stents for the treatment of infrapopliteal artery disease: systematic review and Bayesian network meta-analysis of randomized controlled trialsJ Endovasc Ther201623685186327708143
   PubMed Web of Science ®Google Scholar
• SchellerBSpeckUSchmittABöhmMNickenigGAddition of paclitaxel to contrast media prevents restenosis after coronary stent implantationJ Am Coll Cardiol20034281415142014563585
   PubMed Web of Science ®Google Scholar
• GongoraCAShibuyaMWesslerJDImpact of paclitaxel dose on tissue pharmacokinetics and vascular healing: a comparative drug-coated balloon study in the familial hypercholesterolemic swine model of superficial femoral in-stent restenosisJACC Cardiovasc Interv2015881115112326117470
   PubMed Web of Science ®Google Scholar
• SchneiderPALairdJRTepeGTreatment effect of drug-coated balloons is durable to 3 years in the femoropopliteal arteries: long-term results of the IN.PACT SFA randomized trialCirc Cardiovasc Interv2018111e00589129326153
   PubMed Web of Science ®Google Scholar
• KrishnanPFariesPNiaziKStellarex drug-coated balloon for treatment of femoropopliteal disease: twelve-month outcomes from the randomized ILLUMENATE pivotal and pharmacokinetic studiesCirculation2017136121102111328729250
   PubMed Web of Science ®Google Scholar
• SchroederHWernerMMeyerDRLow-dose paclitaxel-coated versus uncoated percutaneous transluminal balloon angioplasty for femoropopliteal peripheral artery disease: one-year results of the ILLU-MENATE European Randomized Clinical Trial (randomized trial of a novel paclitaxel-coated percutaneous angioplasty balloon)Circulation2017135232227223628424223
   PubMed Web of Science ®Google Scholar
• RosenfieldKJaffMRWhiteCJTrial of a paclitaxel-coated balloon for femoropopliteal artery diseaseN Engl J Med2015373214515326106946
   PubMed Web of Science ®Google Scholar
• BausbackYWillfort-EhringerASievertHSix-month results from the initial randomized study of the ranger paclitaxel-coated balloon in the femoropopliteal segmentJ Endovasc Ther201724445946728558502
   PubMed Web of Science ®Google Scholar
• ScheinertDSchulteKLZellerTLammerJTepeGPaclitaxel-releasing balloon in femoropopliteal lesions using a BTHC excipient: twelve-month results from the BIOLUX P-I randomized trialJ Endovasc Ther2015221142125775674
   PubMed Web of Science ®Google Scholar
• TepeGGögebakanÖRedlichUAngiographic and clinical outcomes after treatment of femoropopliteal lesions with a novel paclitaxel-matrix-coated balloon catheterCardiovasc Intervent Radiol201740101535154428660441
   PubMed Web of Science ®Google Scholar
• GiacoppoDCasseseSHaradaYDrug-coated balloon versus plain balloon angioplasty for the treatment of femoropopliteal artery disease: an updated systematic review and meta-analysis of randomized clinical trialsJACC Cardiovasc Interv20169161731174227539695
   PubMed Web of Science ®Google Scholar
• AlbrechtTWaliszewskiMRocaCTwo-year clinical outcomes of the CONSEQUENT trial: can femoropopliteal lesions be treated with sustainable clinical results that are economically sound?Cardiovasc Intervent Radiol20184171008101429589098
   PubMed Web of Science ®Google Scholar
• IbrahimTDirschingerRHeinRJaitnerJDownstream panniculitis secondary to drug-eluting balloon angioplastyJACC Cardiovasc Interv2016917e177e17927544006
   PubMed Web of Science ®Google Scholar
• ThomasSDMcDonaldRRVarcoeRLVasculitis resulting from a superficial femoral artery angioplasty with a paclitaxel-eluting balloonJ Vasc Surg201459252052323642919
   PubMed Web of Science ®Google Scholar
• LakeETwiggMFarquharsonFAcute hypersensitivity reaction to femoral drug-coated balloonsVasa201746322322528045341
   PubMed Web of Science ®Google Scholar
• KolodgieFDPachecoEYahagiKMoriHLadichEVirmaniRComparison of particulate embolization after femoral artery treatment with IN.PACT Admiral versus Lutonix 035 paclitaxel-coated balloons in healthy swineJ Vasc Interv Radiol201627111676168527641674
   PubMed Web of Science ®Google Scholar
• KrankenbergHTüblerTIngwersenMDrug-coated balloon versus standard balloon for superficial femoral artery in-stent restenosis: the randomized femoral artery in-stent restenosis (fair) trialCirculation2015132232230223626446728
   PubMed Web of Science ®Google Scholar
• LiistroFAngioliPPortoIPaclitaxel-eluting balloon vs. standard angioplasty to reduce recurrent restenosis in diabetic patients with in-stent restenosis of the superficial femoral and proximal popliteal arteries: the DEBATE-ISR studyJ Endovasc Ther20142111824502477
   PubMed Web of Science ®Google Scholar
• ThiemeMVon BilderlingPPaetzelCThe 24-month results of the Lutonix global SFA Registry: worldwide experience with Lutonix drug-coated balloonJACC Cardiovasc Interv201710161682169028780030
   PubMed Web of Science ®Google Scholar
• ZellerTBaumgartnerIScheinertDDrug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trialJ Am Coll Cardiol201464151568157625301459
   PubMed Web of Science ®Google Scholar
• ZellerTBeschornerUPilgerEPaclitaxel-coated balloon in infrapopliteal arteries: 12-month results from the BIOLUX P-II randomized trial (BIOTRONIK’S-First in Man Study of the Passeo-18 LUX drug releasing PTA balloon catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries)JACC Cardiovasc Interv20158121614162226493253
   PubMed Web of Science ®Google Scholar
• LairdJRArmstrongEJDrug-coated balloons for infrapopliteal disease: digging deep to understand the impact of a negative trialJ Am Coll Cardiol201464151577157925301460
   PubMed Web of Science ®Google Scholar
• ThiemeMLichtenbergMBrodmannMCioppaAScheinertDLutonix® 014 DCB global Below the Knee Registry Study: interim 6-month outcomesJ Cardiovasc Surg201859223223629363894
   PubMed Web of Science ®Google Scholar
• PopplewellMADaviesHJarrettHBypass versus angioplasty in severe ischaemia of the leg - 2 (BASIL-2) trial: study protocol for a randomised controlled trialTrials2016171126739146
   PubMed Web of Science ®Google Scholar
• MenardMTFarberAAssmannSFDesign and rationale of the best endovascular versus best surgical therapy for patients with critical limb ischemia (BEST-CLI) trialJ Am Heart Assoc201657e00321927402237
   PubMed Web of Science ®Google Scholar
• FanelliFCannavaleAGazzettiMCalcium burden assessment and impact on drug-eluting balloons in peripheral arterial diseaseCardiovasc Intervent Radiol201437489890724806955
   PubMed Web of Science ®Google Scholar
• IidaOTakaharaMSogaY1-year results of the ZEPHYR Registry (Zilver PTX for the Femoral Artery and Proximal Popliteal Artery): predictors of restenosisJACC Cardiovasc Interv2015881105111226117463
   PubMed Web of Science ®Google Scholar
• ToriiSYahagiKMoriHBiologic drug effect and particulate embolization of drug-eluting stents versus drug-coated balloons in healthy swine femoropopliteal arteriesJ Vasc Interv Radiol20182971041104929754850
   PubMed Web of Science ®Google Scholar
• ToriiSYahagiKMoriHSafety of Zilver PTX drug-eluting stent implantation following drug-coated balloon dilation in a healthy swine modelJ Endovasc Ther201825111812629161933
   PubMed Web of Science ®Google Scholar
• ScheinertDDudaSZellerTThe LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplastyJACC Cardiovasc Interv201471101924456716
   PubMed Web of Science ®Google Scholar
• SteinerSWillfort-EhringerASievertH12-month results from the first-in-human randomized study of the ranger paclitaxel-coated balloon for femoropopliteal treatmentJACC Cardiovasc Interv2018111093494129730375
   PubMed Web of Science ®Google Scholar
• ToriiSMustaphaJANarulaJHistopathologic Characterization of Peripheral Arteries in Subjects With Abundant Risk FactorsJACC Cardiovasc Imaging Epub2018126
   Web of Science ®Google Scholar
• Data Presented for Medtronic’s In.Pact Admiral DCB [webpage on the Internet]WayneEndovascular Today2017 Available from https://evtoday.com/2017/09/12/data-presented-for-medtronics-inpact-admiral-dcbAccessed December 21, 2018
   Google Scholar
• Bard’s LEVANT 21-Year Data Published in NEJM2-Year Data Presented at SVS [webpage on the Internet]WayneEndovascular Today2015 Available from https://evtoday.com/2015/06/bards-levant-2-1-year-data-published-in-nejm-2-year-data-presented-at-SVSAccessed December 21, 2018
   Google Scholar
• ToriiSJinnouchiHSakamotoAComparison of Biologic Effect and Particulate Embolization after Femoral Artery Treatment with Three Drug-Coated Balloons in Healthy Swine ModelJ Vasc Interv Radiol201930110310930527654
   PubMed Web of Science ®Google Scholar
• GranadaJFVirmaniRSchulz-JanderDTunevSMelderRJRate of drug coating dissolution determines in-tissue drug retention and durability of biological efficacyJ Drug Deliv2018
   Web of Science ®Google Scholar