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Review

Newly approved devices for endovascular treatment of femoropopliteal disease: a review of clinical evidence

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Pages 729-740 | Received 27 Jul 2019, Accepted 30 Sep 2019, Published online: 28 Oct 2019

References

  • Fowkes FG, Rudan D, Rudan I, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet). 2013;382(9901):1329–1340.
  • Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA 2005 practice guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the american association for vascular surgery/society for vascular surgery, society for cardiovascular angiography and interventions, society for vascular medicine and biology, society of interventional radiology, and the ACC/aha task force on practice guidelines (writing committee to develop guidelines for the management of patients with peripheral arterial disease): endorsed by the american association of cardiovascular and pulmonary rehabilitation; national heart, lung, and blood institute; society for vascular nursing; transatlantic inter-society consensus; and vascular disease foundation. Circulation. 2006;113(11):e463–654 .
  • Rooke TW, Hirsch AT, Misra S, et al. 2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (updating the 2005 guideline): a report of the american college of cardiology foundation/american heart association task force on practice guidelines. J Am Coll Cardiol. 2011;58(19):2020–2045.
  • Tendera M, Aboyans V, Bartelink ML, 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.
  • Goodney PP, Beck AW, Nagle J, et al. National trends in lower extremity bypass surgery, endovascular interventions, and major amputations. J Vasc Surg. 2009;50(1):54–60 .
  • Bishu K, Armstrong EJ Supera self-expanding stents for endovascular treatment of femoropopliteal disease: a review of the clinical evidence. Vasc Health Risk Manag. 2015;11:387–395.
  • Ansari F, Pack LK, Brooks SS, et al. Design considerations for studies of the biomechanical environment of the femoropopliteal arteries. J Vasc Surg. 2013;58(3):804–813.
  • Poulson W, Kamenskiy A, Seas A, et al. Limb flexion-induced axial compression and bending in human femoropopliteal artery segments. J Vasc Surg. 2018;67(2):607–613.
  • Ni Ghriallais R, Bruzzi M A computational analysis of the deformation of the femoropopliteal artery with stenting. J Biomech Eng. 2014;136(7).
  • Park JY, Jeon YS, Cho SG, et al. Stent fractures after superficial femoral artery stenting. J Korean Surg Soc. 2012;83(3):183–186.
  • Muller-Hulsbeck S, Keirse K, Zeller T, et al. From the MAJESTIC trial of the eluvia paclitaxel-eluting stent for treatment of obstructive femoropopliteal disease. J Endovas Ther. 2016;23(5):701–707.
  • Bisdas T, Beropoulis E, Argyriou A, et al. 1-year all-comers analysis of the eluvia drug-eluting stent for long femoropopliteal lesions after suboptimal angioplasty. JACC Cardiovasc Interv. 2018;11(10):957–966.
  • Gray WA, Keirse K, Soga Y, et al. A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet. 2018;392(10157):1541–1551.
  • Muller-Hulsbeck S Eluvia peripheral stent system for the treatment of peripheral lesions above the knee. Expert Opin Drug Deliv. 2016;13(11):1639–1644.
  • Sarode K, Spelber DA, Bhatt DL, et al. Drug delivering technology for endovascular management of infrainguinal peripheral artery disease. JACC Cardiovasc Interv. 2014;7(8):827–839.
  • Deloose K, Callaert J Less is more: the “as less as reasonably achievable stenting” (ALARAS) strategy in the femoropopliteal area. J Cardiovasc Surg (Torino). 2018;59(4):495–503.
  • Laird JR, Singh GD Leaving nothing behind: bioresorbable vascular scaffolds for femoropopliteal disease. JACC Cardiovasc Interv.2016;9(11):1188–1190.
  • 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.
  • Laird JR, Schneider PA, Tepe G, et al. Durability of treatment effect using a drug-coated balloon for femoropopliteal lesions: 24-month results of IN.PACT SFA. J Am Coll Cardiol. 2015;66(21):2329–2338 .
  • Boston Scientific Corporation. Eluvia drug-eluting vascular stent system; U.S. food and drug administration; [ cited 2018 September 18]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180011B.pdf
  • IDEV Technologies Inc. Stent, superficial femoral artery; U.S. food and drug administration; [ cited 2014 March 28]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf12/P120020b.pdf
  • The Spectranetics Corporation (SPNC). Stellarex™ 0.035” OTW drug-coated angioplasty balloon; U.S. Food and Drug Administration; [ cited 2017 July 26]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160049B.pdf
  • Schillinger M, Minar E Percutaneous treatment of peripheral artery disease: novel techniques. Circulation. 2012;126(20):2433–2440.
  • Krishnan P, Faries P, Niazi K, et al. Stellarex drug-coated balloon for treatment of femoropopliteal disease: twelve-month outcomes from the randomized ILLUMENATE pivotal and pharmacokinetic studies. Circulation. 2017;136(12):1102–1113.
  • Fanelli F, Cannavale A, Gazzetti M, et al. Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Intervent Radiol. 2014;37(4):898–907.
  • Halwani DO, Anderson PG, Brott BC, et al. The role of vascular calcification in inducing fatigue and fracture of coronary stents. J Biomed Mater Res B Appl Biomater. 2012;100(1):292–304.
  • Adlakha S, Sheikh M, Wu J, et al. Stent fracture in the coronary and peripheral arteries. J Interv Cardiol. 2010;23(4):411–419.
  • Shammas NW, Lam R, Mustapha J, et al. Comparison of orbital atherectomy plus balloon angioplasty vs. balloon angioplasty alone in patients with critical limb ischemia: results of the CALCIUM 360 randomized pilot trial. J Endovas Ther 2012;19(4):480–488.
  • Mattesini A, Di Mario C Calcium: A predictor of interventional treatment failure across all fields of cardiovascular medicine. Int J Cardiol. 2017;231:97–98.
  • Kaladji A, Vent PA, Danvin A, et al. Impact of vascular calcifications on long femoropopliteal stenting outcomes. Ann Vasc Surg. 2018;47:170–178.
  • Tepe G, Beschorner U, Ruether C, et al. Drug-eluting balloon therapy for femoropopliteal occlusive disease: predictors of outcome with a special emphasis on calcium. J Endovas Ther. 2015;22(5):727–733.
  • Fitzgerald PJ, Ports TA, Yock PG Contribution of localized calcium deposits to dissection after angioplasty. An observational study using intravascular ultrasound. Circulation. 1992;86(1):64–70.
  • Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007;45 Suppl S:S5–67.
  • Werk M, Albrecht T, Meyer DR, et al. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv. 2012;5(6):831–840.
  • Tepe G, Zeller T, Schnorr B, et al. High-grade, non-flow-limiting dissections do not negatively impact long-term outcome after paclitaxel-coated balloon angioplasty: an additional analysis from the THUNDER study. J Endovas Ther. 2013;20(6):792–800.
  • Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med, 2008;358(7):689–699.
  • Kobayashi N, Hirano K, Yamawaki M, et al. Simple classification and clinical outcomes of angiographic dissection after balloon angioplasty for femoropopliteal disease. J Vasc Surg. 2018;67(4):1151–1158.
  • Intact Vascular, Inc. Tack endovascular system® (6F) (Scaffold, dissection repair); U.S. food and drug administration; [ cited 2019 Mar 11]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180034B.pdf
  • Goltz JP, Ritter CO, Kellersmann R, et al. Endovascular treatment of popliteal artery segments P1 and P2 in patients with critical limb ischemia: initial experience using a helical nitinol stent with increased radial force. J Endovas Ther. 2012;19(3):450–456.
  • Scheinert D, Grummt L, Piorkowski M, et al. A novel self-expanding interwoven nitinol stent for complex femoropopliteal lesions: 24-month results of the SUPERA SFA registry. J Endovas Ther. 2011;18(6):745–752.
  • Dumantepe M, Seren M, Fazliogullari O, et al. Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding interwoven nitinol stent: midterm results. Vascular, 2015.
  • Garcia LA, Rosenfield KR, Metzger CD, et al. SUPERB final 3-year outcomes using interwoven nitinol biomimetic supera stent. Catheter Cardiovasc Interv. 2017;89(7):1259–1267.
  • Garcia L, Jaff MR, Metzger C, et al. Wire-interwoven nitinol stent outcome in the superficial femoral and proximal popliteal arteries: twelve-month results of the SUPERB Trial. Circ Cardiovasc Interv. 2015;8(5).
  • Bhatt H, Kovach R, Janzer S, et al. SUPERA stent outcomes in above-the-Knee interventions: effects of COMPression and ELongation (SAKE-COMPEL) Sub-study. Cardiovasc Revasc Med. 2018;19(5Pt A):512–515.
  • Palena LM, Diaz-Sandoval LJ, Sultato E, et al. Feasibility and 1-Year outcomes of subintimal revascularization with supera((R)) stenting of long femoropopliteal occlusions in critical limb ischemia: the “Supersub” Study. Catheter Cardiovasc Interv. 2017;89(5):910–920.
  • Teymen B, Akturk S, Akturk U, et al. Comparison of drug-eluting balloon angioplasty with self-expanding interwoven nitinol stent deployment in patients with complex femoropopliteal lesions. Vascular. 2018;26(1):54–61.
  • Scheinert D, Werner M, Scheinert S, et al. Treatment of complex atherosclerotic popliteal artery disease with a new self-expanding interwoven nitinol stent: 12-month results of the Leipzig SUPERA popliteal artery stent registry. JACC Cardiovasc Interv. 2013;6(1):65–71.
  • George JC, Rosen ES, Nachtigall J, et al. SUPERA interwoven nitinol stent outcomes in above-Knee interventions (SAKE) study. J Vasc Interv Radiol. 2014;25(6):954–961.
  • Leon LR Jr., Dieter RS, Gadd CL, et al. Preliminary results of the initial United States experience with the Supera woven nitinol stent in the popliteal artery. J Vasc Surg. 2013;57(4):1014–1022.
  • Werner M, Paetzold A, Banning-Eichenseer U, et al. Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding interwoven nitinol stent: midterm results from the Leipzig SUPERA 500 registry. EuroIntervention. 2014;10(7):861–868.
  • Chan YC, Cheng S. Angioplasty and stenting of distal anastomotic stenosis of femoropopliteal bypass graft using helical interwoven nitinol stents. Int J Angiol. 2016;25(5):e25–e28 .
  • Brescia AA, Wickers BM, Correa JC, et al. Stenting of femoropopliteal lesions using interwoven nitinol stents. J Vasc Surg. 2015;61(6):1472–1478.
  • San Norberto EM, Fidalgo-Domingos LA, Garcia-Saiz I, et al. Endovascular treatment of popliteal artery occlusion caused by a ruptured supera interwoven nitinol stent. Ann Vasc Surg. 2019;59:308.e309–308.e313.
  • Muller-Hulsbeck S, Keirse K, Zeller T, et al. Long-term results from the MAJESTIC trial of the eluvia paclitaxel-eluting stent for femoropopliteal treatment: 3-year follow-up. Cardiovasc Intervent Radiol. 2017;40(12):1832–1838.
  • Muller-Hulsbeck S, Hopf-Jensen S, Keirse K, et al. Eluvia drug-eluting vascular stent system for the treatment of symptomatic femoropopliteal lesions. Future Cardiol. 2018;14(3):207–213.
  • Trial comparing eluvia versus bare metal stent in treatment of superficial femoral and/or proximal popliteal artery (EMINENT); [ cited 2019 may 30]. Available from: https://clinicaltrials.gov/ct2/show/NCT02921230
  • a real world evaluation of the ELUVIA stent in subjects with lesions located in the femoropopliteal arteries (REGAL); [ cited 2019 may 30]. Available from: https://clinicaltrials.gov/ct2/show/NCT03037411
  • Venkatasubbu GD, Ramasamy S, Avadhani GS, et al. Surface modification and paclitaxel drug delivery of folic acid modified polyethylene glycol functionalized hydroxyapatite nanoparticles. Powder Technol. 2013;235:437–442.
  • Tepe G, Laird J, Schneider P, et al. Drug-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 trial. Circulation. 2015;131(5):495–502.
  • Vardi M, Novack V, Pencina MJ, et al. Safety and efficacy metrics for primary nitinol stenting in femoropopliteal occlusive disease: a meta-analysis and critical examination of current methodologies. Catheter Cardiovasc Interv. 2014;83(6):975–983.
  • Armstrong EJ, Saeed H, Alvandi B, et al. Nitinol self-expanding stents vs. balloon angioplasty for very long femoropopliteal lesions. J Endovas Ther. 2014;21(1):34–43.
  • Schillinger M, Sabeti S, Loewe C, et al. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006;354(18):1879–1888.
  • Iida O, Nanto S, Uematsu M, et al. Influence of stent fracture on the long-term patency in the femoro-popliteal artery: experience of 4 years. JACC Cardiovasc Interv. 2009;2(7):665–671.
  • Scheinert D, Scheinert S, Sax J, et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol, 2005;45(2):312–315.
  • 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.
  • Schroeder H, Meyer DR, Lux B, et al. Two-year results of a low-dose drug-coated balloon for revascularization of the femoropopliteal artery: outcomes from the ILLUMENATE first-in-human study. Catheter Cardiovasc Interv. 2015;86(2):278–286.
  • Brodmann M, Werner M, Meyer DR, et al. Sustainable antirestenosis effect with a low-dose drug-coated balloon: the ILLUMENATE European randomized clinical trial 2-year results. JACC Cardiovasc Interv. 2018;11(23):2357–2364.
  • Schroe H, Holden AH, Goueffic Y, et al. Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease-the ILLUMENATE global study: 12-month results from a prospective, multicenter, single-arm study. Catheter Cardiovasc Interv. 2018;91(3):497–504.
  • 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.
  • Shockwave Medical, Inc.. Shockwave medical Intravascular Lithotripsy (IVL) system; U.S. food and drug administration; [ cited 2018 June 27]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180454.pdf
  • Holden A The use of intravascular lithotripsy for the treatment of severely calcified lower limb arterial CTOs. J Cardiovasc Surg (Torino). 2019;60(1):3–7.
  • Brodmann M, Werner M, Brinton TJ, et al. Safety and Performance of Lithoplasty for Treatment of Calcified Peripheral Artery Lesions. J Am Coll Cardiol. 2017;70(7):908–910.
  • Brodmann M, Holden A, Zeller T Safety and Feasibility of intravascular lithotripsy for treatment of below-the-Knee arterial stenoses. J Endovas Ther. 2018;25(4):499–503.
  • Brodmann M, Werner M, Holden A, et al. Primary outcomes and mechanism of action of intravascular lithotripsy in calcified, femoropopliteal lesions: results of Disrupt PAD II. Catheter Cardiovasc Interv. 2019;93(2):335–342.
  • Patel MR, Conte MS, Cutlip DE, et al. Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC). J Am Coll Cardiol. 2015;65(9):931–941.
  • Shockwave medical peripheral lithoplasty system study for PAD (disrupt PAD III); [ cited 2019 May 30]. Retrieved from: https://clinicaltrials.gov/ct2/show/NCT02923193
  • Holden A. Intravascular Lithotripsy (IVL): study status (DISRUPT PAD II and III) and lessons from real world registry; 2019. Availabel from: https://shockwavemedical.com/wp-content/uploads/2019/04/Disrupt-PAD-III-OS_Holden_Cx-2019.pdf
  • Bosiers M, Scheinert D, Hendriks JM, et al. Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty. J Vasc Surg. 2016;64(1):109–116.
  • Brodmann M, Wissgott C, Holden A, et al. Treatment of infrapopliteal post-PTA dissection with tack implants: 12-month results from the TOBA-BTK study. Catheter Cardiovasc Interv. 2018;92(1):96–105.
  • Duda SH, Bosiers M, Lammer J, et al. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial. J Endovas Ther. 2006;13(6):701–710.
  • Dake MD, Ansel GM, Jaff MR, et al. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011;4(5):495–504.
  • Baril DT, Chaer RA, Rhee RY, et al. Endovascular interventions for TASC II D femoropopliteal lesions. J Vasc Surg, 2010;51(6):1406–1412.
  • Yin MY, Jiang ME, Huang XT, et al. Endovascular interventions for TransAtlantic InterSociety Consensus II C and D femoropopliteal lesions. Chin Med J (Engl). 2013;126(3):415–420.
  • Sabeti S, Mlekusch W, Amighi J, et al. Primary patency of long-segment self-expanding nitinol stents in the femoropopliteal arteries. J Endovas Ther. 2005;12(1):6–12.
  • Phillips JA, Falls A, Kolluri R, et al. Full drug-eluting stent jacket: two-year results of a single-center experience with zilver PTX stenting for long lesions in the femoropopliteal arteries. J Endovas Ther. 2018;25(3):295–301.
  • Schmidt A, Piorkowski M, Gorner 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.
  • 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.
  • Micari A, Cioppa A, Vadala G, et al. Clinical evaluation of a paclitaxel-eluting balloon for treatment of femoropopliteal arterial disease: 12-month results from a multicenter Italian registry. JACC Cardiovasc Interv. 2012;5(3):331–338.

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