Phosphorylcholine-coated dexamethasone eluting stent in the prevention of restenosis: A randomized trial in a single hospital

Acta Cardiologica Sinica

Volumn 23, Issue 1, 2007, Pages 35-42

  Li, Ai Hsien ^a,b   Liau, Chiau Suong ^b   Chuang, Wen Po ^c   Yeih, Dong Feng ^a   Chu, Shu Hsun ^a  

^a FAR EASTERN MEMORIAL HOSPITAL   (Taiwan)

^b NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

^c NONE

Author keywords

Dexamethasone; Drug eluting stents; In stent restenosis

Indexed keywords

DEXAMETHASONE; PHOSPHORYLCHOLINE; THALLIUM;

ANGIOCARDIOGRAPHY; ARTICLE; BLOOD VESSEL DIAMETER; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY DISEASE; DRUG ELUTING STENT; FOLLOW UP; HEART MUSCLE PERFUSION; HUMAN; IN STENT RESTENOSIS; LOADING DRUG DOSE; RANDOMIZED CONTROLLED TRIAL; RESTENOSIS; REVASCULARIZATION; TREATMENT REFUSAL;

EID: 34248650986     PISSN: 10116842     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (33)

1. Al Suwaidi J, Berger PB, Holmes DR Jr. Coronary artery stents. JAMA. 2000;284:1828-36.
2. Sousa JE, Costa MA, Abizaid A, Sousa AG, Feres F, Mattos LA, Centemero M, Maldonado G, Abizaid AS, Pinto I, Falotico R, Jaeger J, Popma JJ, Serruys PW. Sirolimus-eluting stent for the treatment of in-stent restenosis: a quantitative coronary angiography and three-dimensional intravascular ultrasound study. Circulation 2003;107:24-7.
3. Degertekin M, Saia F, Lemos PA, Arampatzis CA, Serruys PW. Sirolimus-eluting stents for the treatment of in-stent restenosis. Minerva Cardioangiol 2003;51:475-84.
4. Regar E, Serruys PW, Bode C, Holubarsch C, Guermonprez JL, Wijns W, Bartorelli A, Constantini C, Degertekin M, Tanabe K, Disco C, Wuelfert E, Morice MC. RAVEL Study Group. Angiographic findings of the multi-center Randomized Study With the Sirolimus-Eluting Bx Velocity Balloon-Expandable Stent (RAVEL): sirolimus-eluting stents inhibit restenosis irrespective of the vessel size. Circulation 2002;106:1949-56.
5. Abizaid A, Costa MA, Blanchard D, Albertal M, Eltchaninoff H, Guagliumi G, Geert-Jan L, Abizaid AS, Sousa AG, Wuelfert E, Wietze L, Sousa JE, Serruys PW, Morice MC; Ravel Investigators. Sirolimus-eluting stents inhibit neointimal hyperplasia in diabetic patients. Insights from the RAVEL Trial. Eur Heart J 2004;25:107-12.
6. Schofer J, Schluter M, Gershlick AH, Wijns W, Garcia E, Schampaert E, Breithardt G. E-SIRIUS Investigators. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomized controlled trial (E-SIRIUS). Lancet 2003;362:1093-9.
7. Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 2003;349:1315-23.
8. Degertekin M, Serruys PW, Foley DP, Tanabe K, Regar E, Vos J, Smits PC, van der Giessen WJ, van den Brand M, de Feyter P, Popma JJ. Persistent inhibition of neointimal hyperplasia after sirolimus-eluting stent implantation: long-term (up to 2 years) clinical, angiographic, and intravascular ultrasound follow-up. Circulation 2002;106:1610-3.
9. Sousa JE, Costa MA, Abizaid A, Feres F, Seixas AC, Tanajura LF, Mattos LA, Falotico R, Jaeger J, Popma JJ, Serruys PW, Sousa AG.. Four-year angiographic and intravascular ultrasound follow-up of patients treated with sirolimus-eluting stents. Circulation 2005;111:2326-9.
10. Colombo A, Drzewiecki J, Banning A, Grube E, Hauptmann K, Silber S, Dudek D, Fort S, Schiele F, Zmudka K, Guagliumi G, Russell ME. TAXUS II Study Group. Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxol-eluting stents for coronary artery lesions. Circulation. 2003;108:788-94.
11. Tanabe K, Serruys PW, Grube E, Smits PC, Selbach G, van der Giessen WJ, Staberock M, de Feyter P, Muller R, Regar E, Degertekin M, Ligthart JM, Disco C, Backx B, Russell ME. TAXUS III Trial: in-stent restenosis treated with stent-based delivery of paclitaxol incorporated in a slow-release polymer formulation. Circulation 2003;107:559-64.
12. Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME. TAXUS-IV Investigators. A polymer-based, eluting-eluting stent in patients with coronary artery disease. N Engl J Med 2004;350:221-31.
13. Stone GW, Ellis SG, O'Shaughnessy CD, Martin SL, Satler L, McGarry T, Turco MA, Kereiakes DJ, Kelley L, Popma JJ, Russell ME; TAXUS V ISR Investigators. Eluting-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the TAXUS V ISR randomized trial. JAMA 2006;295:1253-63.
14. Palmer RR, Lewis AL, Kirkwood LC, Rose SF, Lloyd AW, Vick TA, Stratford PW. Biological evaluation and drug delivery application of cationic ally modified phospholipid polymers. Biomaterials 2004;25:4785-96.
15. Lewis AL, Vick TA, Collias AC, Hughes LG, Palmer RR, Leppard SW, Furze JD, Taylor AS, Stratford PW. Phosphorylcholine-based polymer coatings for stent drug delivery. J Mater Sci Mater Med 2001;12:865-70.
16. Armstrong J, Gunn J, Arnold N, Malik N, Chan KH, Vick T, Stratford P, Cumberland DC, Holt CM. Angiopeptin-eluting stents: observations in human vessels and pig coronary arteries. J Invasive Cardiol 2002;14:230-8.
17. Swanson N, Javed Q, Hogrefe K, Gershlick A. Human internal mammary artery organ culture model of coronary stenting: a novel investigation of smooth muscle cell response to drug-eluting stents. Clin Sci (Lond). 2002:347-53.
18. New G, Moses JW, Roubin GS, Leon MB, Colombo A, Iyer SS, Tio FO, Mehran R, Kipshidze N. Estrogen-eluting, phosphorylcholine-coated stent implantation is associated with reduced neointimal formation but no delay in vascular repair in a porcine coronary model. Catheter Cardiovasc Interv 2002;57:266-71.
19. Kipshidze NN, Iversen P, Kim HS, Yiazdi H, Dangas G, Seaborn R, New G, Tio F, Waksman R, Mehran R, Tsapenko M, Stone GW, Roubin GS, Iyer S, Leon MB, Moses JW. Advanced c-myc antisense (AVI-4126)-eluting phosphorylcholine-coated stent implantation is associated with complete vascular healing and reduced neointimal formation in the porcine coronary restenosis model. Catheter Cardiovasc Interv 2004;61:518-27.
20. Zhang Z, Cao X, Zhao X, Withers SB, Holt CM, Lewis AL, Lu JR. Controlled delivery of antisense oligodeoxynucleotide from cationically modified phosphorylcholine polymer films. Biomacromolecules 2006;7:784-91.
21. Kim W, Jeong MH, Cha KS, Hyun DW, Hur SH, Kim KB, Hong YJ, Park HW, Kim JH, Ann YK, Kim MH, Cho JG, Park JT, Park JC, Kang JC. Effect of anti-oxidant (carvedilol and probucol) loaded stents in a porcine coronary restenosis model. Circ J 2005;69:101-6.
22. Garcia-Touchard A, Burke SE, Toner JL, Cromack K, Schwartz RS. Zotarolimus-eluting stents reduce experimental coronary artery neointimal hyperplasia after 4 weeks. Eur Heart J 2006;27:988-93.
23. Walter DH, Cejna M, Diaz-Sandoval L, Willis S, Kirkwood L, Stratford PW, Tietz AB, Kirchmair R, Silver M, Curry C, Wecker A, Yoon YS, Heidenreich R, Hanley A, Kearney M, Tio FO, Kuenzler P, Isner JM, Losordo DW. Local gene transfer of phVEGF-2 plasmid by gene-eluting stents: an alternative strategy for inhibition of restenosis. Circulation 2004;110:36-45.
24. Shinozaki N, Yokoi H, Iwabuchi M, Nosaka H, Kadota K, Mitsudo K, Nobuyoshi M. Initial and follow-up results of the BiodivYsio phosphorylcholine coated stent for treatment of coronary artery disease. Circ J 2005;69:295-300.
25. Bakhai A, Booth J, Delahunty N, Nugara F, Clayton T, McNeill J, Davies SW, Cumberland DC, Stables RH. SV Stent Investigators. The SV stent study: a prospective, multi-centre, angiographic evaluation of the BiodivYsio phosphorylcholine coated small vessel stent in small coronary vessels. Int J Cardiol 2005; 102:95-102.
26. Kwok OH, Chow WH, Law TC, Chiu A, Ng W, Lam WF, Hong MK, Popma JJ. First human experience wim angiopeptin-eluting stent: a quantitative coronary angiography and three-dimensional intravascular ultrasound study. Catheter Cardiovasc Interv 2005;66:541-6.
27. Edelman ER, Rogers C. Pathobiologic response to stenting. Am J Cardiol 1998;81:4-6E.
28. de Scheerder I, Wang K, Wilczek K, van Dorpe J, Verbeken E, Desmet W, Schacht E, Piessens J. Local methylprednisolone inhibition of foreign body response to coated intracoronary stents. Coron Artery Dis 1996;7:161-6.
29. Voisard R, Seitzer U, Baur R, Dartsch PC, Osterhues H, Hoher M, Hombach V. Corticosteroid agents inhibit proliferation of smooth muscle cells from human atherosclerotic arteries in vitro. Int J Cardiol 1994;43:257-67.
30. Strecker EP, Gabelmann A, Boos I, Lucas C, Xu Z, Haberstroh J, Freudenberg N, Stricker H, Langer M, Betz E. Effect on intimal hyperplasia of dexamethasone released from coated metal stents compared with non-coated stents in canine femoral arteries. Cardiovasc Intervent Radiol 1998;21:487-96.
31. Stone GW, Rutherford BD, McConahay DR, Johnson WL, Giorgi LV, Ligon RW, Hartzler GO. A randomized trial of corticosteroids for the prevention of restenosis in 102 patients undergoing repeat coronary angioplasty. Cathet Cardiovasc Diagn 1989;18:227-31.
32. Hoffmann R, Langenberg R, Radke P, Franke A, Blindt R, Ortlepp J, Popma JJ, Weber C, Hanrath P. Evaluation of a high-dose dexamethasone-eluting stent. Am J Cardiol 2004;94:193-5.
33. Liu X, Huang Y, Hanet C, Vandormael M, Legrand V, Dens J, Vandenbossche JL, Missault L, Vrints C, De Scheerder I. Study of anti-restenosis with the BiodivYsio dexamethasone-eluting stent (STRIDE): a first-in-human multicenter pilot trial. Catheter Cardiovasc Interv 2003;60:172-8.