Safety and efficacy of paclitaxel drug-coated balloon in femoropopliteal in-stent restenosis

References

• Shu J , Santulli G. Update on peripheral artery disease: epidemiology and evidence-based facts. Atherosclerosis. 2018;275:379–381.
   PubMed Web of Science ®Google Scholar
• Hirsch AT , Criqui MH , Treat-Jacobson D , et al. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA. 2001;286(11):1317–1324.
   PubMed Web of Science ®Google Scholar
• Van Den Berg JC. Management of in-stent restenosis in the superficial femoral artery. J Cardiovasc Surg (Torino). 2016;57(2):248–256.
   PubMed Web of Science ®Google Scholar
• European Stroke O , Tendera M , Aboyans V , et al. ESC guidelines on the diagnosis and treatment of peripheral artery diseases: document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the task force on the diagnosis and treatment of peripheral artery diseases of the european society of cardiology (ESC). Eur Heart J. 2011;32(22):2851–2906. DOI:10.1093/eurheartj/ehr211
   PubMed Web of Science ®Google Scholar
• Katsanos K , Tepe G , Tsetis D , et al. Standards of practice for superficial femoral and popliteal artery angioplasty and stenting. Cardiovasc Intervent Radiol. 2014;37(3):592–603.
   PubMed Web of Science ®Google Scholar
• Bosiers M , Deloose K , Callaert J , et al. Results of the Protege EverFlex 200-mm-long nitinol stent (ev3) in TASC C and D femoropopliteal lesions. J Vasc Surg. 2011;54(4):1042–1050. DOI:10.1016/j.jvs.2011.03.272
   PubMed Web of Science ®Google Scholar
• Cleveland T . Comment on: below-knee bare nitinol stent placement in high-risk patients with critical limb ischemia and unlimited supragenicular inflow as treatment of choice “K.P. Donas, A. Schwindt, T. Schonefeld, J. Tessarek, G. Torsello”. Eur J Vasc Endovasc Surg. 2009;37(6):694–695.
   PubMed Web of Science ®Google Scholar
• Yahagi K , Otsuka F , Sakakura K , et al. Pathophysiology of superficial femoral artery in-stent restenosis. J Cardiovasc Surg (Torino). 2014;55(3):307–323.
   PubMed Web of Science ®Google Scholar
• Cassese S , Wolf F , Ingwersen M , et al. Drug-coated balloon angioplasty for femoropopliteal in-stent restenosis. Circ Cardiovasc Interv. 2018;11(12):e007055. DOI:10.1161/CIRCINTERVENTIONS.118.007055
   PubMed Web of Science ®Google Scholar
• Tosaka A , Soga Y , Iida O , et al. Classification and clinical impact of restenosis after femoropopliteal stenting. J Am Coll Cardiol. 2012;59(1):16–23. DOI:10.1016/j.jacc.2011.09.036
   PubMed Web of Science ®Google Scholar
• Armstrong EJ , Singh S , Singh GD , et al. Angiographic characteristics of femoropopliteal in-stent restenosis: association with long-term outcomes after endovascular intervention. Catheter Cardiovasc Interv. 2013;82(7):1168–1174. DOI:10.1002/ccd.24983
   PubMed Web of Science ®Google Scholar
• Bard . Bard peripheral vascular. 2018 [cited 2019 Nov 17 ]. Available from: https://www.crbard.com/Peripheral-Vascular/product-search?category=Vascular+Patency
   Google Scholar
• Anantha-Narayanan M , Shah SM , Jelani QU , et al. Drug-coated balloon versus plain old balloon angioplasty in femoropopliteal disease: an updated meta-analysis of randomized controlled trials. Catheter Cardiovasc Interv. 2019;94(1):139–148. DOI:10.1002/ccd.28176
   PubMed Web of Science ®Google Scholar
• Giacoppo D , Cassese S , Harada Y , et al. Drug-coated balloon versus plain balloon angioplasty for the treatment of femoropopliteal artery disease: an updated systematic review and meta-analysis of randomized clinical trials. JACC Cardiovasc Interv. 2016;9(16):1731–1742. DOI:10.1016/j.jcin.2016.06.008
   PubMed Web of Science ®Google Scholar
• Schneider PA , Laird JR , Tepe G , et al. Treatment effect of drug-coated balloons is durable to 3 years in the femoropopliteal arteries: long-term results of the IN.PACT SFA randomized trial. Circ Cardiovasc Interv. 2018;11(1):e005891. DOI:10.1161/CIRCINTERVENTIONS.118.006388
   PubMed Web of Science ®Google Scholar
• Zeller T , Micari A , Scheinert D , et al. The IN.PACT DEEP clinical drug-coated balloon trial: 5-year outcomes. JACC Cardiovasc Interv. 2020;13(4):431–443. DOI:10.1016/j.jcin.2019.10.059
   PubMed Web of Science ®Google Scholar
• Schroeder H , Werner M , Meyer DR , et al. Low-dose paclitaxel-coated versus uncoated percutaneous transluminal balloon angioplasty for femoropopliteal peripheral artery disease: one-year results of the ILLUMENATE European randomized clinical trial (randomized trial of a novel paclitaxel-coated percutaneous angioplasty balloon). Circulation. 2017;135(23):2227–2236.
   PubMed Web of Science ®Google Scholar
• Scheinert D , Duda S , Zeller T , et al. The 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 angioplasty. JACC Cardiovasc Interv. 2014;7(1):10–19. DOI:10.1016/j.jcin.2013.05.022
   PubMed Web of Science ®Google Scholar
• Rosenfield K , Jaff MR , White CJ , et al. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med. 2015;373(2):145–153. DOI:10.1056/NEJMoa1406235
   PubMed Web of Science ®Google Scholar
• Krankenberg H , Tubler T , Ingwersen M , et al. Drug-coated balloon versus standard balloon for superficial femoral artery in-stent restenosis: the randomized femoral artery in-stent restenosis (FAIR) trial. Circulation. 2015;132(23):2230–2236. DOI:10.1161/CIRCULATIONAHA.115.017364
   PubMed Web of Science ®Google Scholar
• Kinstner CM , Lammer J , Willfort-Ehringer A , et al. Paclitaxel-eluting balloon versus standard balloon angioplasty in in-stent restenosis of the superficial femoral and proximal popliteal artery: 1-year results of the PACUBA trial. JACC Cardiovasc Interv. 2016;9(13):1386–1392. DOI:10.1016/j.jcin.2016.04.012
   PubMed Web of Science ®Google Scholar
• Ott I , Cassese S , Groha P , et al. ISAR-PEBIS (paclitaxel-eluting balloon versus conventional balloon angioplasty for in-stent restenosis of superficial femoral artery): a randomized trial. J Am Heart Assoc. 2017;6(7). DOI:10.1161/JAHA.117.006321
   PubMed Web of Science ®Google Scholar
• G T. Cotavance paclitaxel-coated balloon vs. Uncoated balloon angioplasty for treatment of in-stent restenosis in SFA and the popliteal arteries: 2-year results of the COPA CABANA trial . Leipzig Interventional course. Leipzig, Germany; 2017.
   Google Scholar
• Liao CJ , Song SH , Li T , et al. Randomized controlled trial of orchid drug-coated balloon versus standard percutaneous transluminal angioplasty for treatment of femoropopliteal artery in-stent restenosis. Int Angiol. 2019;38(5):365–371.
   PubMed Web of Science ®Google Scholar
• Schmidt A , Piorkowski M , Görner H , et al. Drug-coated balloons for complex femoropopliteal lesions: 2-year results of a real-world registry. JACC Cardiovasc Interv. 2016;9(7):715–724. DOI:10.1016/j.jcin.2015.12.267
   PubMed Web of Science ®Google Scholar
• Brodmann M , Keirse K , Scheinert D , et al. 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(20):2113–2123.
   PubMed Web of Science ®Google Scholar
• Bague N , Julia P , Sauguet A , et al. Femoropopliteal In-stent restenosis repair: midterm outcomes after paclitaxel eluting balloon use (plaisir trial). Eur J Vasc Endovasc Surg. 2017;53(1):106–113.
   PubMed Web of Science ®Google Scholar
• Stabile E , Virga V , Salemme L , et al. Drug-eluting balloon for treatment of superficial femoral artery in-stent restenosis. J Am Coll Cardiol. 2012;60(18):1739–1742. DOI:10.1016/j.jacc.2012.07.033
   PubMed Web of Science ®Google Scholar
• Virga V , Stabile E , Biamino G , et al. Drug-eluting balloons for the treatment of the superficial femoral artery in-stent restenosis: 2-year follow-up. JACC Cardiovasc Interv. 2014;7(4):411–415. DOI:10.1016/j.jcin.2013.11.020
   PubMed Web of Science ®Google Scholar
• Liistro F , Angioli P , Porto I , et al. Paclitaxel-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 study. J Endovasc Ther. 2014;21(1):1–8.
   PubMed Web of Science ®Google Scholar
• Thieme M , Von Bilderling P , Paetzel C , et al. The 24-month results of the lutonix global SFA registry: worldwide experience with lutonix drug-coated balloon. JACC Cardiovasc Interv. 2017;10(16):1682–1690.
   PubMed Web of Science ®Google Scholar
• Sixt S , Carpio Cancino OG , Treszl A , et al. Drug-coated balloon angioplasty after directional atherectomy improves outcome in restenotic femoropopliteal arteries. J Vasc Surg. 2013;58(3):682–686. DOI:10.1016/j.jvs.2013.02.019
   PubMed Web of Science ®Google Scholar
• Milnerowicz A , Kuliczkowski W , Protasiewicz M . Rotational atherectomy plus drug-coated balloon angioplasty for the treatment of total in-stent occlusions in iliac and infrainguinal arteries. J Endovasc Ther. 2019;26(3):316–321.
   PubMed Web of Science ®Google Scholar
• Giannopoulos S , Kokkinidis DG , Jawaid O , et al. Turbo-power™ laser atherectomy combined with drug-coated balloon angioplasty is associated with improved one-year outcomes for the treatment of Tosaka II and III femoropopliteal in-stent restenosis. Cardiovasc Revasc Med. 2019. DOI:10.1016/j.carrev.2019.10.006.
   Google Scholar
• Kokkinidis DG , Hossain P , Jawaid O , et al. Laser Atherectomy combined with drug-coated balloon angioplasty is associated with improved 1-year outcomes for treatment of femoropopliteal in-stent restenosis. J Endovasc Ther. 2018;25(1):81–88. DOI:10.1177/1526602817745668
   PubMed Web of Science ®Google Scholar
• Kokkinidis DG , Behan S , Jawaid O , et al. Laser atherectomy and drug-coated balloons for the treatment of femoropopliteal in-stent restenosis: 2-Year outcomes. Catheter Cardiovasc Interv. 2020;95(3):439–446. DOI:10.1002/ccd.28636
   PubMed Web of Science ®Google Scholar
• Katsanos K , Spiliopoulos S , Kitrou P , et al. Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc. 2018;7(24):e011245.
   PubMed Web of Science ®Google Scholar