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• W2911537999 abstract "HomeCirculation: Cardiovascular InterventionsVol. 11, No. 12Femoropopliteal In-Stent Restenosis Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBFemoropopliteal In-Stent RestenosisWhat Is the Standard of Care? Jennifer A. Rymer, MD, MBA and W. Schuyler Jones, MD Jennifer A. RymerJennifer A. Rymer The Duke Heart Center and Duke Clinical Research Institute, Durham, NC. Search for more papers by this author and W. Schuyler JonesW. Schuyler Jones W. Schuyler Jones, MD, Duke University Medical Center, Durham, NC 27705. Email E-mail Address: [email protected] The Duke Heart Center and Duke Clinical Research Institute, Durham, NC. Search for more papers by this author Originally published11 Dec 2018https://doi.org/10.1161/CIRCINTERVENTIONS.118.007559Circulation: Cardiovascular Interventions. 2018;11:e007559This article is a commentary on the followingDrug-Coated Balloon Angioplasty for Femoropopliteal In-Stent RestenosisSee Article by Cassese et alClassic peripheral interventional training, supported by the consensus guidelines for lower extremity peripheral artery disease, has included standard percutaneous transluminal angioplasty (PTA) alone as a primary treatment of femoropopliteal disease.1 In contemporary practice, the use of standard PTA with atherectomy, drug-coated balloon (DCB) angioplasty, and the provisional use of drug-eluting stents occur frequently and wide variation exists. A recent analysis of all Medicare patients undergoing peripheral vascular intervention for femoropopliteal disease demonstrated that >30% of patients received a stent in combination with DCB or standard PTA.2 With continued stenting of femoropopliteal disease, the issue of in-stent restenosis (ISR) will likely continue to grow. Nearly 30% to 40% of patients who undergo stent implantation for femoropopliteal disease will experience ISR within 2 years of implantation.3–5With a clear need for devices and strategies to combat this problem, the US Food and Drug Administration has approved multiple devices to treat femoropopliteal ISR, including DCB, laser atherectomy, and the Viabahn endoprosthesis based on admittedly limited data from clinical trials.6–8 With this scant data, the 2016 American College of Cardiology/American Heart Association guidelines for the management of lower extremity peripheral artery disease provide no recommendations for the management of femoropopliteal ISR,1 and the 2017 European Society of Cardiology guidelines have a single recommendation that rates drug-eluting balloons as a class IIb, level B evidence for the treatment of femoropopliteal ISR.9 As such, there remains a vast array of purported treatments for femoropopliteal ISR, including standard PTA, DCB angioplasty, drug-eluting stents, laser atherectomy with or without PTA, and excisional atherectomy with or without standard PTA.5In this issue of Circulation: Cardiovascular Interventions, Cassese et al10 present the results of a meta-analysis of 3 randomized controlled trials examining the outcomes of 263 patients with femoropopliteal ISR who underwent DCB angioplasty compared with standard PTA. As the authors note, each of these randomized controlled trials individually were appropriately powered for surrogate end points and not the primary end point of the meta-analysis, target lesion revascularization. After pooling the data from FAIR (Femoral Artery In-Stent Restenosis), ISAR PEBIS (Intracoronary Stenting and Antithrombotic Regimen Paclitaxel-Eluting Balloon Versus Conventional Balloon Angioplasty for In-Stent Restenosis of Superficial Femoral Artery), and PACUBA (Paclitaxel-Eluting Balloon Versus Standard Balloon Angioplasty in In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Artery), the risks of target lesion revascularization and recurrent ISR were significantly reduced in patients who underwent treatment of femoropopliteal ISR with DCB angioplasty when compared with standard PTA (hazard ratio [95% CI] for target lesion revascularization: 0.25 [0.14, 0.46], P<0.001; hazard ratio [95% CI] for ISR: 0.21 [0.10, 0.47], P<0.001). There was no significant difference between DCB and PTA among the secondary end points, including improvement in Rutherford classification, ankle-brachial index, all-cause death, and amputation. Importantly, the authors were able to demonstrate a reduced risk of recurrent ISR even in high-risk subgroups, including patients with diabetes mellitus, heavily calcified lesions, and longer lesions.While the hazard ratios for target lesion revascularization and recurrent ISR are impressive, there are several important limitations of the current analysis that should be noted. As the primary end point was recurrent ISR between 6 and 12 months after index peripheral vascular intervention in the 3-pooled randomized controlled trials, this follow-up window may be inadequate to capture the totality of recurrent ISR events. Indeed, in a recent analysis of DCBs in femoropopliteal ISR, the rates of primary patency after ISR were 76% at 1 year but dropped to below 50% at 2 years after treatment.11 As the authors note, the rates of femoropopliteal ISR after 1 year differ across the literature, but most studies with follow-up out to 2 years demonstrate a clear decline in rates of primary patency.12 Additionally, the authors highlight that while DCB angioplasty did not improve Rutherford classification or ankle-brachial index at 1 year, this is likely because of the underlying bias of symptom classification systems and potentially a lack of patient-reported symptoms. In addition to longer follow-up as noted above, future trials in peripheral artery disease need to examine the impact of various interventions on some measure of patient-reported outcomes, functional measures (eg, 6-minute walk test), or ankle-brachial index. Lastly, it is necessary to note that the results in the present meta-analysis do not differ significantly from a prior meta-analysis of DCB angioplasty in femoropopliteal ISR.13As the American College of Cardiology/American Heart Association and European Society of Cardiology guidelines currently do not offer strong recommendations and expert opinion is not entirely clear on how to most appropriately treat femoropopliteal ISR, more research is needed to define what the standard of care should be, and which treatments should be adopted for certain angiographic characteristics (eg, longer lesions, calcified lesions). To completely address the issue surrounding what the standard of care for femoropopliteal ISR should be, an adequately powered trial examining the currently approved treatments for femoropopliteal ISR should be performed. This would include an arm of patients treated with laser atherectomy with or without standard PTA versus DCB. A study comparing the Viabahn stent versus laser atherectomy plus PTA or DCB would also be prudent. Ultimately, it is possible that one of these strategies will improve clinical outcomes in an overall population of patients with femoropopliteal ISR while another one will be shown to be more effective in subpopulations of patients with femoropopliteal ISR (eg, longer lesions, calcified lesions). However, without direct comparisons of these treatment strategies, the waters will remain murky on how best to treat the growing population of patients with femoropopliteal ISR.DisclosuresNone.FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.W. Schuyler Jones, MD, Duke University Medical Center, Durham, NC 27705. Email schuyler.[email protected]eduReferences1. Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FG, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RA, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat-Jacobson D, Walsh ME. 2016 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 Guidelines.Circulation. 2017; 135:e686–e725. doi: 10.1161/CIR.0000000000000470LinkGoogle Scholar2. Jones WS. Use and outcomes with drug-coated balloons in patients with lower extremity peripheral artery disease.Oral Presentation at: Transcatheter Cardiovascular Therapeutics (TCT) 2018; September 22, 2018; San Diego, CA.Google Scholar3. Lichtenberg MK, Carr JG, Golzar JA. Optical coherence tomography: guided therapy of in-stent restenosis for peripheral arterial disease.J Cardiovasc Surg (Torino). 2017; 58:518–527. doi: 10.23736/S0021-9509.17.09946-3MedlineGoogle Scholar4. Tosaka A, Soga Y, Iida O, Ishihara T, Hirano K, Suzuki K, Yokoi H, Nanto S, Nobuyoshi M. Classification and clinical impact of restenosis after femoropopliteal stenting.J Am Coll Cardiol. 2012; 59:16–23. doi: 10.1016/j.jacc.2011.09.036CrossrefMedlineGoogle Scholar5. Singh GD, Armstrong EJ, Laird JR. Femoropopliteal in-stent restenosis: current treatment strategies.J Cardiovasc Surg (Torino). 2014; 55:325–333.MedlineGoogle Scholar6. Brodmann M, Keirse K, Scheinert D, Spak L, Jaff MR, Schmahl R, Li P, Zeller T; IN.PACT Global Study Investigators. Drug-coated balloon treatment for femoropopliteal artery disease: the IN.PACT Global Study de novo in-stent restenosis imaging cohort.JACC Cardiovasc Interv. 2017; 10:2113–2123. doi: 10.1016/j.jcin.2017.06.018CrossrefMedlineGoogle Scholar7. Dippel EJ, Makam P, Kovach R, George JC, Patlola R, Metzger DC, Mena-Hurtado C, Beasley R, Soukas P, Colon-Hernandez PJ, Stark MA, Walker C; EXCITE ISR Investigators. Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis).JACC Cardiovasc Interv. 2015; 8(1pt A):92–101. doi: 10.1016/j.jcin.2014.09.009CrossrefMedlineGoogle Scholar8. Bosiers M, Deloose K, Callaert J, Verbist J, Hendriks J, Lauwers P, Schroë H, Lansink W, Scheinert D, Schmidt A, Zeller T, Beschorner U, Noory E, Torsello G, Austermann M, Peeters P. Superiority of stent-grafts for in-stent restenosis in the superficial femoral artery: twelve-month results from a multicenter randomized trial.J Endovasc Ther. 2015; 22:1–10. doi: 10.1177/1526602814564385CrossrefMedlineGoogle Scholar9. Aboyans V, Ricco JB, Bartelink MEL, Björck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Röther J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I; ESC Scientific Document Group. 2017 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 arteriesEndorsed 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 J. 2018; 39:763–816. doi: 10.1093/eurheartj/ehx095CrossrefMedlineGoogle Scholar10. Cassese S, Wolf F, Ingwersen M, Kinstner CM, Fusaro M, Ndrepepa G, Ibrahim T, Ott I, Lammer J, Krankenberg H, Fusaro M. Drug-coated balloon angioplasty for femoropopliteal in-stent restenosis: the REPAIR cooperation. A meta-analysis of individual participant data from 3 randomized trials.Circ Cardiovasc Interv. 2018; 11:e007055. doi: 10.1161/CIRCINTERVENTIONS.118.007055LinkGoogle Scholar11. Schmidt A, Piorkowski M, Görner H, Steiner S, Bausback Y, Scheinert S, Banning-Eichenseer U, Staab H, Branzan D, Varcoe RL, Scheinert D. Drug-coated balloons for complex femoropopliteal lesions: 2-year results of a real-world registry.JACC Cardiovasc Interv. 2016; 9:715–724. doi: 10.1016/j.jcin.2015.12.267CrossrefMedlineGoogle Scholar12. Gur I, Lee W, Akopian G, Rowe VL, Weaver FA, Katz SG. Clinical outcomes and implications of failed infrainguinal endovascular stents.J Vasc Surg. 2011; 53:658–666; discussion 667. doi: 10.1016/j.jvs.2010.09.069CrossrefMedlineGoogle Scholar13. Cassese S, Ndrepepa G, Kufner S, Byrne RA, Giacoppo D, Ott I, Laugwitz KL, Schunkert H, Kastrati A, Fusaro M. Drug-coated balloon angioplasty for in-stent restenosis of femoropopliteal arteries: a meta-analysis.EuroIntervention. 2017; 13:483–489. doi: 10.4244/EIJ-D-16-00735CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Colombo M, Corti A, Gallo D, Colombo A, Antognoli G, Bernini M, McKenna C, Berceli S, Vaughan T, Migliavacca F and Chiastra C (2022) Superficial femoral artery stenting: Impact of stent design and overlapping on the local hemodynamics, Computers in Biology and Medicine, 10.1016/j.compbiomed.2022.105248, 143, (105248), Online publication date: 1-Apr-2022. Shamaki G, Markson F, Soji-Ayoade D, Agwuegbo C, Bamgbose M and Tamunoinemi B (2021) Peripheral Artery Disease: A Comprehensive Updated Review, Current Problems in Cardiology, 10.1016/j.cpcardiol.2021.101082, (101082), Online publication date: 1-Dec-2021. Colombo M, Luraghi G, Cestariolo L, Ravasi M, Airoldi A, Chiastra C and Pennati G (2020) Impact of lower limb movement on the hemodynamics of femoropopliteal arteries: A computational study, Medical Engineering & Physics, 10.1016/j.medengphy.2020.05.004, 81, (105-117), Online publication date: 1-Jul-2020. Kalinin R, Suchkov I, Klimentova E and Shchulkin A (2022) Markers of the Development of the Reconstruction Area Restenosis After Endovascular Interventions in Lower Limbs Arteries, Russian Sklifosovsky Journal Emergency Medical Care, 10.23934/2223-9022-2021-10-4-669-675, 10:4, (669-675) Related articlesDrug-Coated Balloon Angioplasty for Femoropopliteal In-Stent RestenosisSalvatore Cassese, et al. Circulation: Cardiovascular Interventions. 2018;11 December 2018Vol 11, Issue 12 Advertisement Article InformationMetrics © 2018 American Heart Association, Inc.https://doi.org/10.1161/CIRCINTERVENTIONS.118.007559PMID: 30562092 Originally publishedDecember 11, 2018 Keywordsperipheral vascular diseaserestenosisvascular diseaseEditorialsPDF download Advertisement SubjectsPeripheral Vascular DiseaseRestenosis" @default.
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