Paclitaxel-eluting stents in coronary artery disease

American Journal of Health-System Pharmacy

Volumn 62, Issue 21, 2005, Pages 2241-2251

  Nawarskas, James J ^a   Osborn, Larry A ^b,c  

^a UNIVERSITY OF NEW MEXICO   (United States)

^b UNIVERSITY OF NEW MEXICO SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF NEW MEXICO HOSPITAL   (United States)

Author keywords

Antineoplastic agents; Coronary disease; Costs; Economics; Mechanism of action; Mortality; Paclitaxel; Restenosis; Stents

Indexed keywords

PACLITAXEL;

ANGIOCARDIOGRAPHY; CELL MIGRATION; CELL PROLIFERATION; CLINICAL TRIAL; CORONARY ARTERY; CORONARY ARTERY DISEASE; COST EFFECTIVENESS ANALYSIS; DRUG ELUTING STENT; EXTRACELLULAR MATRIX; HEART INFARCTION; HEART MUSCLE REVASCULARIZATION; HUMAN; INTIMA; PERCUTANEOUS CORONARY INTERVENTION; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY; PRIORITY JOURNAL; RESTENOSIS; REVIEW; SMOOTH MUSCLE FIBER; TREATMENT OUTCOME;

EID: 27644531017     PISSN: 10792082     EISSN: None     Source Type: Journal    
DOI: 10.2146/ajhp040621     Document Type: Review

References (61)

1. Vishnevetsky D, Patel P, Tijerino H et al. Sirolimus-eluting coronary stent. Am J Health-Syst Pharm. 2004; 61:449-56.
2. Gruntzig AR, Senning A, Siegenthaler WE. Nonoperative dilatation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty. N Engl J Med. 1979; 301:61-8.
3. Smith SC Jr, Dove JT, Jacobs AK et al. ACC/AHA guidelines for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee To Revise the 1993 Guidelines for Percutaneous Transluminal Coronary Angioplasty). J Am Coll Cardiol 2001; 37: 2215-39.
4. Kent KM, Bentivoglio LG, Block PC et al. Percutaneous transluminal coronary angioplasty: report from the registry of the National Heart, Lung, and Blood Institute. Am J Cardiol 1982; 49:2011-20.
5. Williams DO, Riley RS, Singh AK et al. Restoration of normal coronary hemodynamics and myocardial metabolism after percutaneous transluminal coronary angioplasty. Circulation. 1980; 62:653-6.
6. Holmes DR Jr. State of the art in coronary intervention. Am J Cardiol. 2003; 91(suppl 3A):50A-3A.
7. Levine GN, Kern MJ, Berger PB et al. Management of patients undergoing percutaneous coronary revascularization. Ann Intern Med. 2003; 139:123-36.
8. Fischman DL, Leon MB, Baim DS et al. A randomized comparison of coronary stent placement and balloon angioplasty in the treatment of coronary artery disease: Stent Restenosis Study Investigators. N Engl J Med. 1994; 331:496-501.
9. Serruys PW, de 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; 331:489-95.
10. Bennett MR. In-stent restenosis: pathology and implications for the development of drug-eluting stents. Heart. 2003; 89: 218-24.
11. Welt FG, Rogers C. Inflammation and restenosis in the stent era. Arterioscler Thromb Vasc Biol. 2002; 22:1769-76.
12. Waller BF, Pinkerton CA, Orr CM et al. Restenosis 1 to 24 months after clinically successful coronary balloon angioplasty: a necropsy study of 20 patients. J Am Coll Cardiol. 1991; 17(suppl B):58B-70B.
13. Mintz GS, Popma JJ, Pichard AD et al. Arterial remodeling after coronary angioplasty. A serial intravascular ultrasound study. Circulation. 1996; 94:35-43.
14. Fattori R, Piva T. Drug-eluting stents in vascular intervention. Lancet. 2003; 361:247-9
15. Wiskirchen J, Schober W, Schart N et al. The effects of paclitaxel on the three phases of restenosis. Invest Radiol. 2004; 39:565-71.
16. Rowinsky EK, Donehower RC. Paclitaxel (Taxol). N Engl J Med. 1995; 332:1004-14.
17. Wani MC, Taylor HL, Wall ME et al. Plant antitumor agents. VI. The isolation and structure of taxol, a novel antileukemic and antitumor agent from Taxus brevifolia. J Am Chem Soc. 1971; 93:2325-7.
18. Blagosklonny MV, Darzynkiewicz Z, Halicka HD et al. Paclitaxel induces primary and postmitotic G1 arrest in human arterial smooth muscle cells. Cell Cycle. 2004; 3:1050-6.
19. Giannakakou P, Robey R, Fijo T et al. Low concentrations of paclitaxel induce cell type-dependent p53, p21 and G1/G2 arrest instead of mitotic arrest: molecular determinants of paclitaxel-induced cytotoxicity. Oncogene. 2001; 20:3806-13.
20. Axel DI, Kunert W, Goggelmann C et al. Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery. Circulation. 1997; 96:636-45.
21. 2 drug-eluting stent. J Biomed Mater Res. 2004; 71A:625-34.
22. Halkin A, Stone GW. Polymer-based paclitaxel-eluting stents in percutaneous coronary intervention: a review of the Taxus trials. J Interv Cardiol 2004; 17: 271-82.
23. Creel CJ, Lovich MA, Edelman ER. Arterial paclitaxel distribution and deposition. Circ Res. 2000; 86:879-84.
24. Hwang CW, Wu D, Edelman ER. Physiological transport forces govern drug distribution for stent-based delivery. Circulation. 2001; 104:600-5.
25. Grube E, Lansky A, Hauptmann KE et al. High-dose 7-hexanoyltaxol-eluting stent with polymer sleeves for coronary revascularization. One-year results from the SCORE randomized trial. J Am Coll Cardiol 2004; 44:1368-72.
26. Grube E, Silber S, Hauptmann KE et al. Six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions. Circulation. 2003; 107:38-42.
27. Colombo A, Drzewiecki J, Banning A et al. Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation. 2003; 108:788-94.
28. Tanabe K, Serruys PW, Grube E et al. Taxus III trial: in-stent restenosis treated with stent-based delivery of paclitaxel incorporated in a slow-release polymer formulation. Circulation. 2003; 107:559-64.
29. Stone GW, Ellis SG, Cox DA et al. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004; 350:221-31.
30. Taxus V: overlapping a problem with multiple stents in complex lesions? www.theheart.org/viewArticle.do? primaryKey=398153 (accessed 2005 May 20).
31. Wood S. Moderate-release paclitaxel-eluting stent outshines bare metal in Taxus VI. www.theheart.org/viewArticle. do?simpleName=568470 (accessed 2005 May 20).
32. Park SJ, Shim WH, Ho DS et al. A paclitaxel-eluting stent for the prevention of coronary restenosis. N Engl J Med. 2003; 348:1537-45.
33. Gershlick A, De Scheerder I, Chevalier B et al. Inhibition of restenosis with a paclitaxel-eluting polymer-free coronary stent. The European Evaluation of Paclitaxel Eluting Stent (ELUTES) trial. Circulation. 2004; 109:487-93.
34. Lansky AJ, Costa RA, Mintz GS et al. Non-polymer-based paclitaxel-coated coronary stents for the treatment of patients with de novo coronary lesions. Angiographic follow-up of the DELIVER clinical trial. Circulation. 2004; 109:1948-54.
35. O'Riordan M. DELIVER II: treating high-risk patients with the nonpolymeric paclitaxel-eluting stent. www.theheart. org/viewArticle.do? primaryKey=241825 (accessed 2005 May 20).
36. Silber S. Paclitaxel-eluting stents: are they all equal? An analysis of six randomized controlled trials in the de novo lesions of 3,319 patients. J Interv Cardiol. 2003; 16: 485-90.
37. 2 paclitaxel-eluting coronary stent system directions for use. Natick, MA: Boston Scientific Corp.
38. Hong MK, Kornowski R, Bramwell O et al. Paclitaxel-coated Gianturco-Roubin II (GR II) stents reduce neointimal hyperplasia in a porcine coronary in-stent restenosis model. Coron Artery Dis. 2001; 12:513-5.
39. Heldman AW, Cheng L, Jenkins GM et al. Paclitaxel stent coating inhibits neointimal hyperplasia at 4 weeks in a porcine model of coronary restenosis. Circulation. 2001; 103:2289-95.
40. Kolodgie FD, John M, Khurana C et al. Sustained reduction of in-stent neointimal growth with the use of a novel systemic nanoparticle paclitaxel. Circulation. 2002; 106:1195-8.
41. Herdeg C, Oberhoff M, Baumbach A et al. Local paclitaxel delivery for the prevention of restenosis: biological effects and efficacy in vivo. J Am Coll Cardiol. 2000; 35:1969-76.
42. Farb A, Heller PF, Shroff S et al. Pathological analysis of local delivery of paclitaxel via a polymer-coated stent. Circulation. 2001; 104:473-9.
43. Sollott SJ, Cheng L, Pauly RR et al. Taxol inhibits neointimal smooth muscle cell accumulation after angioplasty in the rat. J Clin Invest. 1995; 95:1869-76.
44. Kastrati A, Mehilli J, von Beckerath N et al. Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis. A randomized controlled trial. JAMA. 2005; 293:165-71.
45. Goy JJ, Stauffer JC, Siegenthaler M et al. A prospective randomized comparison between paclitaxel and sirolimus stents in the real world of interventional cardiology. The TAXI trial. J Am Coll Cardiol. 2005;45:308-11.
46. Wood S. Reality at last? REALITY, ISAR-DIABETES, and SIRTAX give Cypher an edge, but debate still clouds comparisons, www.theheart.org/viewArticle.do? primaryKey=397957 (ac-cessed 2005 May 20).
47. Gruberg L. REALITY: prospective, randomized, multicenter head-to-head comparison of Cypher and Taxus stent systems. www.medscape.com/viewarticle/ 501393 (accessed 2005 May 20).
48. Dibra A, Kastrati A, Mehilli J et al. Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients. N Engl J Med. 2005; 353:663-70.
49. Windecker S, Remondino A, Eberli FR et al. Sirolimus-eluting and paclitaxel-eluting stents for coronary revascularization. N Engl J Med. 2005; 353:653-62.
50. Bullesfeld L, Gerckens U, Muller R et al. Long-term evaluation of paclitaxel-coated stents for treatment of native coronary lesions. First results of both the clinical and angiographic 18 month follow-up of Taxus I. Z Kardiol. 2003; 92:825-32.
51. Tanabe K, Serruys W, Degertekin M et al. Chronic arterial responses to polymer-controlled paclitaxel-eluting stents. Circulation. 2004; 109:196-200.
52. Stone GW, Ellis SG, Cox DA et al. One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting Taxus stent. The Taxus-IV trial. Circulation. 2004; 109:1942-7.
53. Moses JW, Mehran R, Mikolsky E et al. Outcomes with the paclitaxel-eluting stent in patients with acute coronary syndromes. Analysis from the Taxus-IV trial. J Am Coll Cardiol 2005; 45:1165-71.
54. Boston Scientific Corp. Taxus V-ISR. www.bostonscientific.com/ templatedata/imports/collateral/Coronary/TAXUSVISR_ClinicalSumm_030605.pdf (accessed 2005 May 20).
55. Hong MK, Mintz GS, Lee CW et al. Paclitaxel coating reduces in-stent intimal hyperplasia in human coronary arteries. A serial volumetric intravascular ultrasound analysis from the Asian Paclitaxel-Eluting Stent Clinical Trial (ASPECT). Circulation. 2003; 107:517-20.
56. Ong AT, Serruys PW, Aoki J et al. The unrestricted use of paclitaxel versus sirolimus-eluting stents for coronary artery disease in an unselected population. J Am Coll Cardiol. 2005; 45:1135-41.
57. Shafiq N, Malhotra S, Pandhi P et al. A meta-analysis of clinical trials of paclitaxel- and sirolimus-eluting stents in patients with obstructive coronary artery disease. Br J Clin Pharmacol. 2005; 59:94-101.
58. Soran O, Feldman AM, Cohen HA. Oculostenotic reflex and iatrogenosis fulminans. Circulation. 2000; 101:e198-9.
59. Topol EJ, Nissen SE. Our preoccupation with coronary luminology. The dissociation between clinical and angiographic findings in ischemic heart disease. Circulation. 1995; 92:2333-42.
60. Lacey MJ, Clark MA, Halpern MT et al. Estimated cost-effectiveness of the Taxus paclitaxel-eluting coronary stent. Am J Cardiol 2003; 92(suppl 6A):26L. Abstract.
61. Mittmann N, Brown A, Seung SJ et al. Economic evaluation of drug eluting stents. Ottawa, Canada: Canadian Coordinating Office for Health Technology Assessment, 2005; technology report no. 53.