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Review

A New Category Stent With Novel Polyphosphazene Surface Modification

, , , , , , & show all
Pages 225-235 | Received 17 Nov 2017, Accepted 01 Mar 2018, Published online: 27 Mar 2018

References

  • WHO . The top 10 causes of death: Fact sheet . World Health Organisation . www.who.int/mediacentre/factsheets/fs310/en/ .
  • Urban P , MeredithIT, AbizaidAet al. Polymer-free drug-coated coronary stents in patients at high bleeding risk . N. Engl. J. Med.373 ( 21 ), 2038 – 2047 ( 2015 ).
  • Natsuaki M , MorimotoT, YamamotoEet al. Cardiovasc. Interv. Ther. 31 ( 3 ), 196 – 209 ( 2016 ).
  • Faxon DP , EikelboomJW, BergerPBet al. Antithrombotic therapy in patients with atrial fibrillation undergoing coronary stenting: a North American perspective: executive summary . Circ. Cardiovasc. Interv.4 ( 5 ), 522 – 534 ( 2011 ).
  • Wang TY , RobinsonLA, OuFSet al. Discharge antithrombotic strategies among patients with acute coronary syndrome previously on warfarin anticoagulation: physician practice in the CRUSADE registry . Am. Heart J.155 ( 2 ), 361 – 368 ( 2008 ).
  • Kastrati A , MehilliJ, DirschingerJet al. Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO) trial . Circulation103 ( 23 ), 2816 – 2821 ( 2001 ).
  • Pache J , KastratiA, MehilliJet al. Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO-2) trial . J. Am. Coll. Cardiol.41 ( 8 ), 1283 – 1288 ( 2003 ).
  • Applegate R , HermillerJ, WilliamsJet al. Evaluation of the effects of everolimus-eluting and paclitaxel-eluting stents on target lesions with jailed side branches: 2-year results from the SPIRIT III randomized trial . Catheter. Cardiovasc. Interv.76 ( 5 ), 644 – 651 ( 2010 ).
  • Lansky AJ , YaqubM, HermillerJBet al. Side branch occlusion with everolimus-eluting and paclitaxel-eluting stents: three-year results from the SPIRIT III randomised trial . Eurointervention Suppl. J.6, 44 – 52 ( 2010 ).
  • Otsuka F , ChengQ, YahagiKet al. Acute thrombogenicity of a durable polymer everolimus-eluting stent relative to contemporary drug-eluting stents with biodegradable polymer coatings assessed ex vivo in a swine shunt model . JACC Cardiovasc. Interv.8 ( 9 ), 1248 – 1260 ( 2015 ).
  • Koppara T , ChengQ, YahagiKet al. Thrombogenicity and early vascular healing response in metallic biodegradable polymer-based and fully bioabsorbable drug-eluting stents . Circ. Cardiovasc. Interv.8 ( 6 ), e002427 – e002427 ( 2015 ).
  • Virmani R , GuagliumiG, FarbAet al. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation 109 ( 6 ), 701 – 705 ( 2004 ).
  • Carter AJ , AggarwalM, KopiaGAet al. Long-term effects of polymer-based, slow-release, sirolimus-eluting stents in a porcine coronary model . Cardiovasc. Res.63 ( 4 ), 617 – 624 ( 2004 ).
  • Finn AV , NakazawaG, KolodgieFDet al. Temporal course of neointimal formation after drug-eluting stent placement: is our understanding of restenosis changing? JACC Cardiovasc. Interv. 2 ( 4 ), 300 – 302 ( 2009 ).
  • Thyssen JP , MennéT . Metal allergy – a review on exposures, penetration, genetics, prevalence, and clinical implications . Chem. Res. Toxicol.23 ( 2 ), 309 – 318 ( 2010 ).
  • Köster R , VielufD, KiehnMet al. Nickel and molybdenum contact allergies in patients with coronary in-stent restenosis . Lancet (London, England)356 ( 9245 ), 1895 – 1897 ( 2000 ).
  • Iijima R , IkariY, AmiyaEet al. The impact of metallic allergy on stent implantation: metal allergy and recurrence of in-stent restenosis . Int. J. Cardiol.104 ( 3 ), 319 – 325 ( 2005 ).
  • Saito T , HokimotoS, OshimaS, NodaK, KojyoY, MatsunagaK . Metal allergic reaction in chronic refractory in-stent restenosis . Cardiovasc. Revasc. Med.10 ( 1 ), 17 – 22 ( 2009 ).
  • Halwani DO , AndersonPG, LemonsJE, JordanWD, AnayiotosAS, BrottBC . In vivo corrosion and local release of metallic ions from vascular stents into surrounding tissue . J. Invasive Cardiol.22 ( 11 ), 528 – 535 ( 2010 ).
  • Hsu HC , YenSK . Evaluation of metal ion release and corrosion resistance of ZrO2 thin coatings on the dental Co-Cr alloys . Dent. Mater.14 ( 5 ), 339 – 346 ( 1998 ).
  • Shimokado A , KuboT, UtsunomiyaHet al. Scanning electron microscopic analysis of polymer damage in drug-eluting stents during multiple stenting . Int. J. Cardiovasc. Imaging29 ( 8 ), 1909 – 1913 ( 2013 ).
  • Yazdani SK , SheehyA, PacettiS, RittlemeyerB, KolodgieFD, VirmaniR . Stent coating integrity of durable and biodegradable coated drug eluting stents . J. Interv. Cardiol.29 ( 5 ), 483 – 490 ( 2016 ).
  • Otsuka F , VorpahlM, NakanoMet al. Pathology of second-generation everolimus-eluting stents versus first-generation sirolimus- and paclitaxel-eluting stents in humans . Circulation129 ( 2 ), 211 – 223 ( 2014 ).
  • Okazoe T . Overview on the history of organofluorine chemistry from the viewpoint of material industry . Proc. Jpn. Acad. Ser. B Phys. Biol. Sci.85 ( 8 ), 276 – 289 ( 2009 ).
  • Garfinkle AM , HoffmanAS, RatnerBD, ReynoldsLO, HansonSR . Effects of a tetrafluoroethylene glow discharge on patency of small diameter dacron vascular grafts . Trans. Am. Soc. Artif. Intern. Organs30, 432 – 439 ( 1984 ).
  • Guidoin R , MaroisY, ZhangZet al. The benefits of fluoropassivation of polyester arterial prostheses as observed in a canine model . ASAIO J.40 ( 3 ), M870 – M879 ( 1994 ).
  • Chinn JA , SauterJA, PhillipsREet al. Blood and tissue compatibility of modified polyester: thrombosis, inflammation, and healing . J. Biomed. Mater. Res.39 ( 1 ), 130 – 140 ( 1998 ).
  • Lin JC , TiongSL, ChenCY . Surface characterization and platelet adhesion studies on fluorocarbons prepared by plasma-induced graft polymerization . J. Biomater. Sci. Polym. Ed.11 ( 7 ), 701 – 714 ( 2000 ).
  • Hasebe T , ShimadaA, SuzukiTet al. Fluorinated diamond-like carbon as antithrombogenic coating for blood-contacting devices . J. Biomed. Mater. Res. A76 ( 1 ), 86 – 94 ( 2006 ).
  • Hasebe T , YohenaS, KamijoAet al. Fluorine doping into diamond-like carbon coatings inhibits protein adsorption and platelet activation . J. Biomed. Mater. Res. A83 ( 4 ), 1192 – 1199 ( 2007 ).
  • Massa TM , YangML, HoJYC, BrashJL, SanterreJP . Fibrinogen surface distribution correlates to platelet adhesion pattern on fluorinated surface-modified polyetherurethane . Biomaterials26 ( 35 ), 7367 – 7376 ( 2005 ).
  • Massa TM , McClungWG, YangML, HoJYC, BrashJL, SanterreJP . Fibrinogen adsorption and platelet lysis characterization of fluorinated surface-modified polyetherurethanes . J. Biomed. Mater. Res. A81 ( 1 ), 178 – 185 ( 2007 ).
  • Mori H , AtmakuriDR, ToriiSet al. Very late pathological responses to cobalt-chromium everolimus-eluting, stainless steel sirolimus-eluting, and cobalt-chromium bare metal stents in humans . J. Am. Heart Assoc.6 ( 11 ), pii:e007244 ( 2017 ) ( Epub ahead of print ).
  • Sunny MC , SharmaCP . Titanium-protein interaction: changes with oxide layer thickness . J. Biomater. Appl.6 ( 1 ), 89 – 98 ( 1991 ).
  • Courtney JM , LambaNM, SundaramS, ForbesCD . Biomaterials for blood-contacting applications . Biomaterials15 ( 10 ), 737 – 744 ( 1994 ).
  • Sheppard JI , McClungWG, FeuersteinIA . Adherent platelet morphology on adsorbed fibrinogen: effects of protein incubation time and albumin addition . J. Biomed. Mater. Res.28 ( 10 ), 1175 – 1186 ( 1994 ).
  • Gorbet MB , SeftonMV . Biomaterial-associated thrombosis: roles of coagulation factors, complement, platelets and leukocytes . Biomaterials25 ( 26 ), 5681 – 5703 ( 2004 ).
  • Whicher SJ , BrashJL . Platelet-foreign surface interactions: release of granule constituents from adherent platelets . J. Biomed. Mater. Res.12 ( 2 ), 181 – 201 ( 1978 ).
  • Lyman DJ , MetcalfLC, AlboD, RichardsKF, LambJ . The effect of chemical structure and surface properties of synthetic polymers on the coagulation of blood. III. In vivo adsorption of proteins on polymer surfaces . Trans. Am. Soc. Artif. Intern. Organs20, 474 – 478 ( 1974 ).
  • Szott LM , IrvinCA, TrollsasM, HossainyS, RatnerBD . Blood compatibility assessment of polymers used in drug eluting stent coatings . Biointerphases11 ( 2 ), 029806 ( 2016 ).
  • Richter GM , StampflU, StampflSet al. A new polymer concept for coating of vascular stents using PTFEP (poly(bis(trifluoroethoxy)phosphazene) to reduce thrombogenicity and late in-stent stenosis . Invest. Radiol.40 ( 4 ), 210 – 218 ( 2005 ).
  • Satzl S , HennC, ChristophPet al. The efficacy of nanoscale poly[bis(trifluoroethoxy) phosphazene] (PTFEP) coatings in reducing thrombogenicity and late in-stent stenosis in a porcine coronary artery model . Invest. Radiol.42 ( 5 ), 303 – 311 ( 2007 ).
  • Henn C , SatzlS, ChristophPet al. Efficacy of a polyphosphazene nanocoat in reducing thrombogenicity, in-stent stenosis, and inflammatory response in porcine renal and iliac artery stents . J. Vasc. Interv. Radiol.19 ( 3 ), 427 – 437 ( 2008 ).
  • Radeleff B , ThierjungH, StampflUet al. Restenosis of the CYPHER-Select, TAXUS-Express, and Polyzene-F nanocoated cobalt-chromium stents in the minipig coronary artery model . Cardiovasc. Intervent. Radiol.31 ( 5 ), 971 – 980 ( 2008 ).
  • Koppara T , SakakuraK, PachecoEet al. Preclinical evaluation of a novel polyphosphazene surface modified stent . Int. J. Cardiol.222, 217 – 225 ( 2016 ).
  • Tamburino C , La MannaA, Di SalvoMEet al. First-in-man 1-year clinical outcomes of the catania coronary stent system with nanothin Polyzene-f in de novo native coronary artery lesions . JACC Cardiovasc. Interv.2 ( 3 ), 197 – 204 ( 2009 ).
  • Capodanno D , La MannaA, Di SalvoME, SanfilippoA, CorcosT, TamburinoC . Early and mid-term clinical outcomes with the CATANIA coronary stent system vs. bare metal stents in patients with coronary artery disease . Cardiovasc. Revasc. Med.10 ( 4 ), 216 – 220 ( 2009 ).
  • La Manna A , CapodannoD, CeraMet al. Optical coherence tomographic results at six-month follow-up evaluation of the CATANIA coronary stent system with nanothin Polyzene-F surface modification (from the Assessment of The LAtest Non-Thrombogenic Angioplasty Stent [ATLANTA] Trial) . Am. J. Cardiol.103 ( 11 ), 1551 – 1555 ( 2009 ).
  • Tamburino C , CapodannoD, Di SalvoMEet al. Safety and effectiveness of the Catania Polyzene-F coated stent in real world clinical practice: 12-month results from the ATLANTA 2 registry . EuroIntervention7 ( 9 ), 1062 – 1068 ( 2012 ).
  • Cutlip DE , GarrattKN, NovackVet al. 9-Month clinical and angiographic outcomes of the COBRA Polyzene-F NanoCoated coronary stent system . JACC Cardiovasc. Interv.10 ( 2 ), 160 – 167 ( 2017 ).
  • Maillard L presented in EuroPCR 2017 . Evaluation of the safety and efficacy of the Cobra-PzF™ NanoCoated Coronary Stent (NCS) in 1 000 all-comers, consecutive, prospective, high risk patients: The e-Cobra Registry (30-Day analysis) . https://abstractbook.pcronline.com/export/pdf/id/988 .
  • Costa RA , AbizaidA, MehranRet al. Polymer-free biolimus A9-coated stents in the treatment of <i>de novo</i> coronary lesions . JACC Cardiovasc. Interv.9 ( 1 ), 51 – 64 ( 2016 ).
  • Naber CK , UrbanP, OngPJet al. Biolimus-A9 polymer-free coated stent in high bleeding risk patients with acute coronary syndrome: a Leaders Free ACS sub-study . Eur. Heart J.38 ( 13 ), 961 – 969 ( 2016 ).
  • Garot P , MoriceM-C, TresukosolDet al. 2-year outcomes of high bleeding risk patients after polymer-free drug-coated stents . J. Am. Coll. Cardiol.69 ( 2 ), 162 – 171 ( 2017 ).
  • Morice M-C , TalwarS, GaemperliOet al. Drug-coated versus bare-metal stents for elderly patients: a predefined sub-study of the LEADERS FREE trial . Int. J. Cardiol.243 ( 15 ), 110 – 115 ( 2017 ).
  • Sigwart U , PuelJ, MirkovitchV, JoffreF, KappenbergerL . Intravascular stents to prevent occlusion and re-stenosis after transluminal angioplasty . N. Engl. J. Med.316 ( 12 ), 701 – 706 ( 1987 ).
  • Serruys PW , de JaegereP, KiemeneijFet al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group . N. Engl. J. Med.331 ( 8 ), 489 – 495 ( 1994 ).
  • Schömig ALS , EumannFRON, AstratiADKet al. A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary-artery stents . N. Engl. J. Med.334 ( 17 ), 1084 – 1089 ( 1996 ).
  • Colombo A , HallP, NakamuraSet al. Intracoronary stenting without anticoagulation accomplished with intravascular ultrasound guidance . Circulation91 ( 6 ), 1676 – 1688 ( 1995 ).
  • Bittl JA , BaberU, BradleySMet al. Duration of dual antiplatelet therapy: a systematic review for the 2016 ACC/AHA Guideline focused update on duration of dual antiplatelet therapy in patients with coronary artery disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines . J. Am. Coll. Cardiol.68 ( 10 ), 1116 – 1139 ( 2016 ).
  • Virmani R , KolodgieFD, FarbA, LafontA . Drug eluting stents: are human and animal studies comparable?Heart89 ( 2 ), 133 – 138 ( 2003 ).

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