To reduce in-stent restenosis rates we have developed newly designed covered stents, in which a stent strut is buried into a microporous elastomeric cover film to provide a physical barrier against tissue ingrowth and a pharmacological reservoir for drug-eluting.
The covered stents were prepared by dip-coating balloon expandable stents mounted on a stainless steel rod in a segmented polyurethane (SPU) solution, and were subsequently subjected to laser-processed microporing (pore diameter, 100 μm; interpore distance, 200 μm). The covered stents, which possessed flat luminal surfaces and micropores that were homogeneously arranged on the whole surface of the covering film, were deployed into the bilateral common carotid arteries of normal New Zealand white rabbits. Angiography after one month of implantation showed all stents were patent with little thrombus formation. The mean thickness of the formed neointimal layers was 292 ± 177 μm (n=8), which was close to the size in non-covered bare stent (231 ± 58 μm, n=7), but markedly decreased (about 2/3) from that in the previously developed wrapping-type covered stents (415 ± 173 μm, P<0.01, n=8).
LeeG., IkedaR.M., JoyeJ.A., BogrenH.G., DeMariaA.N., MasonD.T.. Evaluation of transluminal angioplasty of chronic coronary artery stenosis. Value and limitations assessed in fresh human cadaver hearts.Circulation1980; 61: 77–83.
3.
SigwartU., PuelJ., MirkovitchV., JoffreF., KappenbergerL.. Intervascular stents to prevent occlusion and restenosis after transluminal angioplasty.N Engl J Med1987; 316: 701–6.
4.
SerruysP.W., de JaegereP., KiemeneijF., MacayaC., RutschW., HeyndrickxG., EmanuelssonH., MarcoJ., LegrandV., MaterneP., BelardiJ., SigwartU., ColomboA., GoyJ.J., van der HeuvelP., DelcanJ., MorelM.A.. A comparison of balloon-expandable stent implantation with balloon angioplasty in patients with coronary artery disease.N Engl J Med1994; 331: 489–95.
5.
FiscmanD.L., LeonM.B., BaimD.S., SchatzR.A., SavageM.P., PennI., DetreK., VeltriL., RicciD., NobuyoshiM., ClemanM., HeuserR., AlmondD., TeirsteinP.S., FishR.D., ColomboA., BrinkerJ., MosesJ., ShaknovichA., HirshfeldJ., BaileyS., EllisS., RakeR., GoldbergS.. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease.N Engl J Med1994; 331: 496–501.
6.
ErbelR., HaudeM., HoppH.W., FranzenD., RupprechtH.J., HeubleinB., FisherK., de JaegereP., SerruysP., RutschW., ProbstP.. Coronary-artery stenting compared with balloon angioplasty for restenosis after intimal balloon angioplasty.N Engl J Med1998; 339: 1672–8.
7.
NakayamaY., Ji-YounK., NishiS., UenoH., MatsudaT.. Development of high-performance stent: Gelatinous photogel-coated stent that permits drug delivery and 12 gene transfer.J Biomed Mater Res2001; 57: 559–66.
8.
HolmesD.R., CamrudA.R., JorgensonM.A., EdwardsW.D., SchwartzR.S.. Polymeric stenting in the porcine coronary artery model: Differential outcome of exogenous fibrin sleeves versus polyurethane-coated stents.J Am Coll Cardiol1994; 24: 525–31.
CastanedaF., BallS.M., WyffelsP.L., YoungK., LiR.. Assessment of a polyester-covered nitinol stent in an atherosclerotic swine model.J Vasc Interv Radiol2000; 11: 483–91.
11.
SchellhammerF., BerlisA., BlossH., PagenstecherA., SchumacherM.. Poly-lactic-acid coating for endovascular stents. Preliminary results in canine experimental arteriovenous fistulae.Invest Radiol1997; 32: 180–6.
12.
HietalaE.M., SalminenU.S., StahlsA., ValimaaT., MaasiltaP., TormalaP., NieminenM.S., HarjulaA.L.. Biodegradation of the copolymeric polylactide stent. Long-term follow-up in a rabbit aorta model.J Vasc Res2001; 38: 361–9.
13.
TamaiH., IgakiK., KyoE., KosugaK., KawashimaA., MatsuiS., KomoriH., TsujiT., MotoharaS., UehataH.. Initial and 6-month results of biodegradable poly-l-lactic acid coronary stents in humans.Circulation2000; 102: 399–404.
14.
PetasA., Vuopio-VarkilaJ., SiitonenA., ValimaaT., TaljaM., TaariK.. Bacterial adherence to self-reinforced polyglycolic acid and self-reinforced polylactic acid 96 urological spiral stents in vitro.Biomaterials1998; 19: 677–81.
15.
OzbekC., HeiselA., GrossB., BayW., SchiefferH.. Coronary implantation of siliconecarbide-coated Palmaz-Schatz stents in patients with high risk of stent thrombosis without oral anticoagulation.Cathet Cardiovasc Diagn1997; 41: 71–8.
16.
LahannJ., KleeD., PluesterW., HoeckerH.. Bioactive immobilization of γ-hirudin on CVD-coated metallic implant devices.Biomaterials2001; 22: 817–26.
17.
de SmetB.J., de KleijnD., HanemaaijerR., VerheijenJ.H., RobertusL., van Der HelmY.J., BorstC., PostM.J.. Metalloproteinase inhibition reduces constrictive arterial remodeling after balloon angioplasty: A study in the atherosclerotic Yucatan micropig.Circulation2000; 101, 2962–7.
18.
CherrG.S., MotewS.J., TravisJ.A., FingerleJ., FisherL., BrandlM., WilliamsJ.K., GearyR.L.. Metalloproteinase inhibition and the response to angioplasty and stenting in atherosclerotic primates.Arterioscler Thromb Vasc Biol2002; 22: 161–6.
19.
LincoffA.M., FurstJ.G., EllisS.G., TuchR.J., TopolE.J.. Sustained local delivery of dexamethasone by a novel intravascular eluting stent to prevent restenosis in the porcine coronary injury model.J Am Coll Cardiol1997; 29: 808–16.
20.
YamawakiT., ShimokawaH., KozaiT., MiyataK., HigoT., TanakaE., EgashiraK., ShiraishiT., TamaiH., IgakiK., TakrshitaA.. Intramural delivery of a specific tyrosine kinase inhibitor with biodegradable stent suppresses the restenotic changes of the coronary artery in pigs in vivo.J Am Coll Cardiol1998; 32: 780–6.
21.
LambertT.L., DevV., RechaviaE., ForresterJ.S., LitvackF., EiglerN.L.. Localized arterial wall drug delivery from a polymer-coated removable metallic stent. Kinetics, distribution, and bioactivity of forskolin.Circulation1994; 90: 1003–11.
22.
FarbA., HellerP.F., ShroffS., ChengL., KolodgieF.D., CarterA.J., ScottD.S., FroehlichJ., VirmaniR.. Pathological analysis of local delivery of paclitaxel via a polymer-coated stent.Circulation2001; 104: 473–9.
23.
HeldmanA.W., ChengL., JenkinsG.M., HellerP.F., KimD.W., WareM.Jr., NaterC., HrubanR.H., RezaiB., AbellaB.S., BungeK.E., KinsellaJ.L., SollottS.J., LakattaE.G., BrinkerJ.A., HunterW.L., FroehlichJ.P.. Paclitaxel stent coating inhibits neointimal hyperplasia at 4 weeks in a porcine model of coronary restenosis.Circulation2001; 103: 2289–95.
24.
HardhammarP.A., van BeusekomH.M.M., EmanuelessonH.U., HofmaS.H., AlbertssonP.A., VerdouwP.D., BoersmaE., SerruysP.W., van der GiessenW.J.. Reduction in thrombotic events with heparin-coated Palmaz-Schatz stents in normal porcine coronary arteries.Circulation1996; 93: 423–30.
25.
BlezerR., CahalanL., CahalanP.T., LindhoutT.. Heparin coating of tantalum coronary stents reduces surface thrombin generation but not factor IXa generation.Blood Coagul Fibrinolysis1998; 9: 435–40.
26.
van Der GiessenW.J., van BeusekomH.M., LarssonR., SerruysP.. Heparin-coated coronary stents.Curr Interv Cardiol Rep1999; 1: 234–40.
27.
BeythienC., GutensohnK., BauJ., HammC.W., KuhnlP., MeinertzT., TerresW.. Influence of stent length and heparin coating on platelet activation: A flow cytometric analysis in a pulsed floating model.Thromb Res1999; 94: 79–86.
SousaJ.E., CostaM.A., AbizaidA.C., RensingB.J., AbizaidA.S., TanajuraL.F., KozumaK., Van LangenhoveG., SousaA.G., FaloticoR., JaegerJ., PopmaJ.J., SerruysP.W.. Sustained suppression of neointimal proliferation by sirolimus-eluting stents: One year angiographic and intravascular ultrasound follow-up.Circulation2001; 104: 2007–11.
30.
SousaJ.E., CostaM.A., AbizaidA., AbizaidA.S., FeresF., PintoI.M., SeixasA.C., StaicoR., MattosL.A., SousaA.G., FaloticoR., JaegerJ., PopmaJ.J., SerruysP.W.. Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: A quantitative coronary angiography and three-dimensional intravascular ultrasound study.Circulation2001; 103: 192–5.
31.
KastratiA., SchomigA., DirschingerJ., MehilliJ., von WelserN., PacheJ., SchuhlenH., SchillingT., SchmittC., NeumannF.J.. Increased risk of restenosis after placement of gold-coated stents: Results of a randomized trial comparing gold-coated with uncoated steel stents in patients with coronary artery disease.Circulation2000; 30: 2478–83.
MoriceM.C., SerruysP.W., SousaJ.E., FajadetJ., Ban HayashiE., PerinM., ColomboA., SchulerG., BarraganP., GuagliumiG., MolnarF., FaloticoR., RAVEL Study Group. Randomized study with the sirolimus-coated Bx velocity balloon-expandable stent in the treatment of patients with de novo native coronary artery lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization.N Engl J Med2002; 346: 1773–80.
34.
SonodaS., MorinoY., AkoJ., TerashimaM., HassanA.H., BonneauH.N., LeonM.B., MosesJ.W., YockP.G., HondaY., KuntzR.E., FitzgeraldP.J.. SIRIUS Investigators. Impact of final stent dimensions on long-term results following sirolimus-eluting stent implantation: Serial intravascular ultrasound analysis from the sirius trial.J Am Coll Cardiol2004; 43: 1959–63.
35.
DoggrellS.A.. Sirolimus- versus paclitaxel-eluting stents in patients with stenosis in a native coronary artery.Expert Opin Pharmacother2004; 5: 1431–4.
36.
StoneG.W., EllisS.G., CoxD.A., HermillerJ., O'ShaughnessyC., MannJ.T., TurcoM., CaputoR., BerginP., GreenbergJ., PopmaJ.J., RussellM.E.. TAXUS-IV Investigators. One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent: The TAXUS-IV trial.Circulation2004; 109: 1942–7.
37.
TanabeK., SerruysP.W., DegertekinM., GuagliumiG., GrubeE., ChanC., MunzelT., BelardiJ., RuzylloW., BilodeauL., KelbaekH., OrmistonJ., DawkinsK., RoyL., StraussB.H., DiscoC., KoglinJ., RussellM.E., ColomboA.. TAXUS II Study Group. Chronic arterial responses to polymer-controlled paclitaxel-eluting stents: Comparison with bare metal stents by serial intravascular ultrasound analyses: Data from the randomized TAXUS-II trial.Circulation2004; 109: 196–200.
38.
FattoriR., PivaT.. Drug-eluting stents in vascular intervention.Lancet2003; 361: 247–9.
IshidaM., KatoN., HiranoT., SuzukiT., ShomuraY., YadaI., TakedaK.. Dissecting aneurysm of the superior mesenteric artery successfully treated by endovascular stent-graft placement.Cardiovasc Intervent Radiol2003; 26: 403–6.
41.
KatoM., ImanakaK., KyoS., OhuchiH., AsanoH., TakamotoS.. Successful treatment of ascending aortic graft infection after operation for acute aortic dissection with peripheral malperfusion.Ann Thorac Surg2004; 77: 2194–5.
42.
StankovicG., ColomboA., PresbiteroP., van den BrandenF., IngleseL., CernigliaroC., NiccoliL., BartorelliA.L., RubartelliP., ReifartN., HeyndrickxG.R., SaunamakiK., MoriceM.C., SguraF.A., Di MarioC.. Randomized evaluation of polytetrafluoroethylene-covered stent in saphenous vein grafts: The randomized evaluation of polytetrafluoroethylene covered stent in saphenous vein grafts (RECOVERS) Trial.Circulation2003; 108: 37–42.
43.
GerckenU., LanskyA.J., BuellesfeldL., DesaiK., BadereldinM., MuellerR., SelbachG., LeonM.B., GrubeE.. Results of the Jostent coronary stent graft implantation in various clinical settings: Procedural and follow-up results.Catheter Cardiovasc Interv2002; 56: 353–60.
44.
NakayamaY., NishiS., Ishibashi-UedaH., MatsudaT.. Surface microarchitectural design in biomedical applications: In vivo analysis of tissue ingrowth in excimer laser-directed micropored scaffold for cardiovascular tissue engineering.J Biomed Mater Res2000; 51: 520–8.
45.
NakayamaY., NishiS., Ueda-IshibashiH., MatsudaT.. Fabrication of micropored elastomeric film-covered stents and aute-phase performances.J Biomed Mater Res2003, 64A: 52–61.
46.
NakayamaY., NishiS., Ueda-IshibashiH.. Fabrication of drug-eluting covered stents with micropores and differential coating of heparin and FK506.Cardiovas Rad Med2003 (in press).
47.
NishiS., NakayamaY., Ishibashi-UedaH., MatsudaT.. Embolization of experimental aneurysms using a heparin-loaded stent graft with micropores.Cardiovasc Rad Med2003; 4: 29–33.
48.
De ScheerderI., VerbekenE., Van HumbeeckJ.. Metallic surface modification.Semin Interv Cardiol1998; 3: 139–144.
49.
BarF.W., van der VeenF.H., BenzinaA., HabetsJ., KooleL.H.. New biocompatible polymer surface coating for stents results in a low neointimal response.J Biomed Mater Res2000; 52: 193–8.
50.
WindeckerS., MayerI., De PasqualeG., MaierW., DirschO., De GrootP., WuY.P., NollG., LeskosekB., MeierB., HessO.M.. Working Group on Novel Surface Coating of Biomedical Devices (SCOL). Stent coating with titanium-nitride-oxide for reduction of neointimal hyperplasia.Circulation2001; 104: 928–33.
51.
DoiK., MatsudaT.. Significance of porosity and compliance of microporous, polyurethane-based microarterial vessel on neoarterial wall regeneration.J Biomed Mater Res1997; 37: 573–84.
52.
NakayamaY., MatsudaT.. Surface microarchitectural design on biomedical applications: Preparation of microporous polymer surfaces by an excimer laser ablation technique.J Biomed Mater Res1995; 29: 1295–301.
53.
LiuJ.. FK506 and cyclosporin, molecular probes for studying intracellular signal transduction.Immuno Today1993; 14: 290–5.
54.
FrumanD.A., KleeC.B., BiererB.E., BurakoffS.J.. Calcineurin phosphatase activity in T lymphocytes is inhibited by FK 506 and cyclosporin A.Proc Natl Acad Sci USA1992; 89: 3686–90.
