Zilver PTX peripheral paclitaxel-eluting stent: a technology evaluation

References

• White C. Clinical practice. Intermittent claudication. N Engl J Med. 2007;356(12):1241–1250.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics 2011 update: a report from the american heart association. Circulation. 2011;123(4):e18–e209.
   PubMed Web of Science ®Google Scholar
• Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015;116(9):1509–1526.
   PubMed Web of Science ®Google Scholar
• Murphy TP, Cutlip DE, Regensteiner JG, et al. Supervised exercise, stent revascularization, or medical therapy for claudication due to aortoiliac peripheral artery disease: the CLEVER study. J Am Coll Cardiol. 2015;65(10):999–1009.
   PubMed Web of Science ®Google Scholar
• Rocha-Singh K, Jaff MR, Crabtree TR, et al. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Cathet Cardiovasc Interv. 2007;69(6):910–919.
   PubMed Web of Science ®Google Scholar
• Werner M, Piorkowski M, Thieme M, et al. SUMMIT registry: one-year outcomes after implantation of the EPIC self-expanding nitinol stent in the femoropopliteal segment. J Endovasc Ther. 2013;20(6):759–766.
   PubMed Web of Science ®Google Scholar
• Laird JR, Jain A, Zeller T, et al. Nitinol stent implantation in the superficial femoral artery and proximal popliteal artery: twelve-month results from the complete SE multicenter trial. J Endovasc Therapy. 2014;21(2):202–212.
   PubMed Web of Science ®Google Scholar
• Davaine JM, Quillard T, Chatelais M, et al. Bone like arterial calcification in femoral atherosclerotic lesions: prevalence and role of osteoprotegerin and pericytes. Eur J Vasc Endovasc Surg. 2016;51(2):259–267.
   PubMed Web of Science ®Google Scholar
• Iida O, Takahara M, Soga Y, et al. ZEPHYR investigators. 1-year results of the ZEPHYR registry (zilver PTX for the femoral artery and proximal popliteal artery): predictors of restenosis. JACC Cardiovasc Interv. 2015;8(8):1105–1112.
   PubMed Web of Science ®Google Scholar
• Bausback Y, Wittig T, Schmidt A, et al. Drug-eluting stent versus drug-coated balloon revascularization in patients with femoropopliteal arterial disease. J Am Coll Cardiol. 2019;73(6):667–679.
   PubMed Web of Science ®Google Scholar
• Laird JR. Limitations of percutaneous transluminal angioplasty and stenting for the treatment of disease of the superficial femoral and popliteal arteries. J Endovasc Ther. 2006;13(Suppl2):II30–II40.
   PubMedGoogle Scholar
• Kastrati A, Schömig A, Dietz R, et al. Time course of restenosis during the first year after emergency coronary stenting. Circulation. 1993;87(5):1498–1505.
   PubMed Web of Science ®Google Scholar
• Serruys PW, Jaegere P, Kiemeneij F, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent study group. N Engl J Med. 1994;331(8):489–495.
   PubMed Web of Science ®Google Scholar
• Iida O, Uematsu M, Soga Y, et al. Timing of the restenosis following nitinol stenting in the superficial femoral artery and the factors associated with early and late restenoses. Catheter Cardiovasc Interv. 2011;78(4): 611–617.
   PubMed Web of Science ®Google Scholar
• Duda SH, Bosiers M, Lammer J, et al. Drug-eluting and bare metal nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial. J Endovasc Ther. 2006;13(6):701–710.
   PubMed Web of Science ®Google Scholar
• Bosiers M, Cagiannos C, Deloose K, et al. Drug-eluting stents in the management of peripheral arterial disease. Vasc Health Risk Manag. 2008;4(3):553–559.
   PubMedGoogle Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Axel DI, Kunert W, Göggelmann C, et al. Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery. Circulation. 1997;96(6):636–645.
   PubMedGoogle Scholar
• Wiskirchen J, Schöber W, Schart N, et al. The effects of paclitaxel on the three phases of restenosis: smooth muscle cell proliferation, migration, and matrix formation: an in vitro study. Invest Radiol. 2004;39(9):565–571.
   PubMed Web of Science ®Google Scholar
• Mills J, Conte M, Murad M. Critical review and evidence implications of paclitaxel drug-eluting balloons and stents in peripheral artery disease. J Vasc Surg. 2019;70(1):3–7.
   PubMed Web of Science ®Google Scholar
• Van der Giessen WJ, Lincoff AM, Schwartz RS, et al. Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries. Circulation. 1996;94(7):1690–1697.
   PubMed Web of Science ®Google Scholar
• Virmani R, Guagliumi G, Farb A, et al. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004;109(6):701–705.
   PubMed Web of Science ®Google Scholar
• Artzi N, Tzafiriri AR, Faucher KM, et al. Sustained efficacy and arterial drug retention by a fast drug eluting cross-linked fatty acid coronary stent coating. Ann Biomed Eng. 2015;44(2):276–286.
   PubMed Web of Science ®Google Scholar
• Dake MD, Van Alstine WG, Zhou Q, et al. Polymer-free paclitaxel-coated Zilver PTX stents—evaluation of pharmacokinetics and comparative safety in porcine arteries. J Vasc Interv Radiol. 2011;22(5): 603–610.
   PubMed Web of Science ®Google Scholar
• Dake MD, Gary M, Michael A, et al. Durable clinical effectiveness with paclitaxel-eluting stents in the femoropopliteal artery: 5-year results of the Zilver PTX randomized trial. Circulation. 2016;133(15):1472–1483.
   PubMed Web of Science ®Google Scholar
• Dake MD, Scheinert D, Tepe G, et al. Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee: twelve-month safety and effectiveness results from the Zilver PTX single-arm clinical study. J Endovasc Ther. 2011;18(5):613–623.
   PubMed Web of Science ®Google Scholar
• Bosiers M, Peeters P, Tessarek J, et al. The zilver PTX single arm study: 12-month results from the TASC C/D lesion subgroup. J Cardiovasc Surg. 2013;54(1):115–122.
   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. Am Heart Assoc. 2018;7:e011245l.
   Web of Science ®Google Scholar
• Dake MD, Ansel GM, Bosiers M, et al. Paclitaxel-coated zilver PTX drug-eluting stent treatment does not result in increased long-term all-cause mortality compared to uncoated devices. Cardiovasc Intervent Radiol. 2020;43(1): 8–19.
   PubMed Web of Science ®Google Scholar
• Albrecht T, Schnorr B, Kutschera M, et al. Two-year mortality after angioplasty of the femoro-popliteal artery with uncoated balloons and paclitaxel-coated balloons – a pooled analysis of four randomized controlled multicenter trials. Cardiovasc Intervent Radiol. 2019;45(7):949–955.
   Google Scholar
• Müller-Hülsbeck S, Keirse K, Zeller T, et al. Twelve-month results from the MAJESTIC trial of the eluvia paclitaxel-eluting stent for treatment of obstructive femoropopliteal disease. J Endovasc Ther. 2016;23(5):701–707.
   PubMed Web of Science ®Google Scholar
• Gray W, Keirse K, Saga 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 randomized, non-inferiority trial. Lancet. 2018;392(10157): 1541–1551.
   PubMed Web of Science ®Google Scholar
• Krishnan P, Faries P, Niazi K, et al. Stellarex drug-coated balloon for treatment of femoropopliteal disease. Circulation. 2017;136(12):1102–1113.
   PubMed Web of Science ®Google Scholar
• Tepe G, Laird J, Schneider P, et al. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and/or popliteal peripheral artery disease: 12- month results from the IN.PACT SFA randomized trial. Circulation. 2015;131(5):495–502.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Stone GW, Teirstein PS, Meredith IT, et al. A prospective, randomized evaluation of a novel everolimus-eluting coronary stent: the PLATINUM (a prospective, randomized, multicenter trial to assess an everolimus-eluting coronary stent system [PROMUS element] for the treatment of up to two de novo coronary artery lesions) trial. J Am Coll Cardiol. 2011;57(16):1700–1708.
   PubMed Web of Science ®Google Scholar
• Kelly CR, Teirstein PS, Meredith IT, et al. Long-term safety and efficacy of platinum chromium everolimus-eluting stents in coronary artery disease: 5-year results from the PLATINUM trial. JACC Cardiovasc Interv. 2017;10(23):2392–2400.
   PubMed Web of Science ®Google Scholar
• Schillinger M, Sabeti S, Dick P, et al. Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting. Circulation. 2007;115(21):2745–2749.
   PubMed Web of Science ®Google Scholar
• Micari A, Vadala G, Castriota F, et al. 1-Year results of paclitaxel-coated balloons for long femoropopliteal artery disease: evidence from the SFA-Long study. JACC Cardiovasc Interv. 2016;9(9):950–956.
   PubMed Web of Science ®Google Scholar