Local drug delivery for treatment of coronary and peripheral artery disease

Cardiovascular Therapeutics

Volumn 29, Issue 6, 2011, Pages

  Gertz, Zachary M ^a   Wilensky, Robert L ^a  

^a HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

Diabetic cardiovascular disease; Interventional cardiology; Ischemic heart disease; Vascular biology

Indexed keywords

EVEROLIMUS; PACLITAXEL; RAPAMYCIN; ZOTAROLIMUS;

BALLOON CATHETER; CELL HYPERPLASIA; CELL MIGRATION; CORONARY ARTERY DISEASE; CORONARY STENT; DEATH; DRUG DELIVERY SYSTEM; DRUG ELUTING STENT; HEART INFARCTION; HUMAN; NONHUMAN; PERCUTANEOUS CORONARY INTERVENTION; PERIPHERAL OCCLUSIVE ARTERY DISEASE; PRIORITY JOURNAL; RESTENOSIS; REVIEW; STENT THROMBOSIS; VASCULAR SMOOTH MUSCLE;

ABSORBABLE IMPLANTS; ANGIOPLASTY, BALLOON; ANGIOPLASTY, BALLOON, CORONARY; ANIMALS; CARDIOVASCULAR AGENTS; CATHETERS; COATED MATERIALS, BIOCOMPATIBLE; CORONARY ARTERY DISEASE; DRUG DELIVERY SYSTEMS; DRUG-ELUTING STENTS; EQUIPMENT DESIGN; HUMANS; PERIPHERAL ARTERIAL DISEASE; PROSTHESIS DESIGN; TREATMENT OUTCOME;

EID: 82355169169     PISSN: 17555914     EISSN: 17555922     Source Type: Journal    
DOI: 10.1111/j.1755-5922.2010.00187.x     Document Type: Review

References (134)

1. Goldman B, Blanke H, Wolinsky H. Influence of pressure on permeability of normal and diseased muscular arteries to horseradish peroxidase: A new catheter approach. Atherosclerosis 1987;65:215-225.
2. Wolinsky H, Thung SN. Use of a perforated balloon catheter to deliver concentrated heparin into the wall of the normal canine artery. J Am Coll Cardiol 1990;15:475-481.
3. Wilensky RL, March KL, Gradus-Pizlo I, Spaedy AJ, Hathaway DR. Methods and devices for local drug delivery in coronary and peripheral arteries. Trends Cardiovasc Med 1993;3:163-170.
4. Fram DB, Mitchel JF, Azrin MA, et al. Local delivery of heparin to balloon angioplasty sites with a new delivery catheter: Pharmacokinetics and effect on platelet deposition in a porcine model. Cathet Cardiovasc Diagn 1997;41:275-286.
5. Muller DWM, Topol EJ, Abrams GD, Gallagher KP, Ellis SG. Intramural methotrexate therapy for the prevention of neointimal thickening after balloon angioplasty. J Am Coll Cardiol 1992;20:460-466.
6. Gradus-Pizlo I, Wilensky RL, March KL, et al. Local delivery of biodegradable microparticles containing colchicine or a colchicine analoge: Effects on restenosis and implications for catheter-based drug delivery. J Am Coll Cardiol 1995;26:1549-1557.
7. 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;35:1969-1976.
8. Azrin MA, Mitchel JF, Fram DB, et al. Decreased platelet deposition and smooth muscle cell proliferation after intramural heparin delivery with hydrogel-coated balloons. Circulation 1994;90:433-441.
9. Fram DB, Aretz T, Azrin MA, et al. Localized intramural drug delivery during balloon angioplasty using hydrogel-coated balloons and pressure-augmented diffusion. J Am Coll Cardiol 1994;23:1570-1577.
10. Mitchel JF, Azrin MA, Fram DB, et al. Inhibition of platelet deposition and lysis of intracoronary thrombus during balloon angioplasty using urokinase-coated hydrogel balloons. Circulation 1994;90:1979-1988.
11. Wilensky RL, March KL, Gradus-Pizlo I, et al. Regional and arterial localization of radioactive microparticles after local delivery by unsupported or supported porous balloon catheters. Am Heart J 1995;129:852-859.
12. Camenzind E, Bakker WH, Reijs A, et al. Site-specific intracoronary heparin delivery in humans after angioplasty: A radioisotopic assessment of regional pharmacokinetics. Circulation 1997;96:154-165.
13. Wilensky RL, Mehdi K, Sowinski KM, Baek SH, March KL. Increased intramural retention after local delivery of molecules with increased binding properties: Implications for regional delivery of pharmacologic agents. J Cardiovasc Pharm Ther 1999;4:103-112.
14. Nasser TK, Wilensky RL, Mehdi K, March KL. Microparticle deposition in periarterial microvasculature and intramural dissection after porous balloon delivery into atherosclerotic vessels: Quantitation and localization by confocal scanning laser microscopy. Am Heart J 1996;131:892-898.
15. 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;96:636-645.
16. Oberhoff M, Kunert W, Herdeg C. Inhibition of smooth muscle cell proliferation after local drug delivery of the antimitotic drug paclitaxel using a porous balloon catheter. Basic Res Cardiol 2001;96:275-282.
17. Wilensky RL, March KL, Hathaway DR. Direct intraarterial wall injection of microparticles via a catheter: A potential drug delivery strategy following angioplasty. Am Heart J 1991;122:1136-1140.
18. Guzman LA, Labhasetwar V, Song C, et al. Local intramural infusion of polymeric nanoparticles: A novel approach for prolonged drug delivery after balloon angioplasty. Circulation 1996;94:1441-1448.
19. Winter PM, Neubauer AM, Caruthers SD, et al. Endothelial alpha(v)beta3 integrin targeted fumagillin nanoparticles inhibit angiogenesis in atherosclerosis. Arterioscler Thromb Vasc Biol 2006;26:2103-2109.
20. Kaneda MM, Caruthers S, Lanza GM, Wickline SA. Perfluorocarbon nanoemulsions for quantitative molecular imaging and targeted therapeutics. Ann Biomed Eng 2009;37:1922-1933.
21. March KL, Mohanraj S, Ho PPK, Wilensky RL, Hathaway DR. Biodegradable microspheres containing a colchicines analog inhibit DNA synthesis in vascular smooth muscle cells. Circulation 1994;89:1929-1934.
22. Wilensky RL, Tanguay JF, Ito S, et al. Heparin infusion prior to stenting (HIPS) trial: Final results of a prospective, randomized, controlled trial evaluating the effects of local vascular delivery on intimal hyperplasia. Am Heart J 2000;139:1061-1070.
23. Mitchel JF, Fram DB, Palme II DF, et al. Enhanced intracoronary thrombolysis with urokinase using a novel, local drug delivery system: In vitro, in vivo, and clinical studies. Circulation 1995;91:785-793.
24. Glazier JJ, Kiernan FJ, Bauer HH, et al. Treatment of thrombotic saphenous vein bypass grafts using local urokinase infusion therapy with the Dispatch catheter. Cathet Cardiovasc Diagn 1997;41:261-267.
25. Wilensky RL, Pyles JM, Fineberg N. Increased thrombin activity correlates with increased ischemic event rate after percutaneous transluminal coronary angioplasty: Lack of efficacy of locally delivered urokinase. Am Heart J 1999;138:319-325.
26. Barsness GW, Buller C, Ohman EM, et al. Reduced thrombus burden with abciximab delivered locally before percutaneous intervention in saphenous vein grafts. Am Heart J 2000;139:824-829.
27. Rathi S, Latif F, Exaire JE, Hennebry TA. Use of simultaneous angioplasty and in situ thrombolysis with a specialized balloon catheter for peripheral interventions. J Thromb Thrombolysis 2009;28:77-82.
28. Use of Clearway balloon vs. Mechanical thrombectomy as initial treatment for acute limb ischemia. Available at: Accessed September 29, 2009.
29. The INFUSE- Anterior Myocardial Infarction (AMI) study. Available at: Accessed September 29, 2009.
30. Intracoronary abciximab with Clearway catheter (IC-CLEARLY). Available at: Accessed September 29, 2009.
31. Lehmann KG, Popma JJ, Werner JA, Lansky AJ, Wilensky RL. Vascular remodeling and the local delivery of cytochalasin B after coronary angioplasty in humans. J Am Coll Cardiol 2000;35:583-591.
32. Scheller B, Hehrlein C, Bocksch W, et al. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. New Eng J Med 2006;355:2113-2124.
33. Scheller B, Hehrlein C, Bocksch W, et al. Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. Clin Res Cardiol 2008;97:773-781.
34. Unverdorben M, Vallbracht C, Cremers B, et al. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation 2009;119:2986-2994.
35. Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Eng J Med 2008;358:689-699.
36. Werk M, Langner S, Reinkensmeier B, et al. Inhibition or restenosis in femoropopliteal arteries: Paclitaxel-coated versus uncoated balloon: Femoral paclitaxel randomized pilot trial. Circulation 2008;118:1358-1365.
37. Lambert TL, Dev V, Rechavia E, Forrester JS, Litvack F, Eigler N. Localized arterial wall drug delivery from a polymer-coated removable metallic stent: Kinetics, distribution, and bioactivity of forskolin. Circulation 1994;90:1003-1011.
38. Lincoff AM, Furst JG, Ellis SG, Topol EJ. Sustained local delivery of dexamethasone by a novel intravascular eluting stent to prevent restenosis in the porcine coronary injury model. J Am Coll Cardiol 1997;29:808-816.
39. Cox DA, Anderson PG, Roubin GS, Chou C-Y, Agrawal SK, Cavender JB. Effect of local delivery of heparin and methotrexate on neointimal proliferation in stented porcine coronary arteries. Coronary Artery Disease 1992;3:237-248.
40. Hardhammer PA, van Beusekom HMM, Emanuelsson HU, et al. Reduction in thrombotic events with heparin-coated Palmaz-Schatz stents in normal porcine coronary arteries. Circulation 1996;93:423-430.
41. De Scheerder I, Wang K, Wilczek K, et al. Experimental study of thrombogenicity and foreign body reaction induced by heparin-coated coronary stents. Circulation 1997;95:1549-1553.
42. Suzuki T, Kopia G, Hayashi S, et al. Stent-based delivery of sirolimus reduced neointimal formation in a porcine coronary model. Circulation 2001;104:1188-1193.
43. Drachman DE, Edelman ER, Seifert P. Neointimal thickening after stent delivery of paclitaxel: Change in composition and arrest of growth over six months. J Am Coll Cardiol 2000;36:2325-2332.
44. Farb A, Heller PF, Shroff S, et al. Pathological analysis of local delivery of paclitaxel via a polymer-coated stent. Circulation 2001;104:473-479.
45. Klugherz BD, Llanos G, Lieuallen W, et al. Twenty-eight-day efficacy and pharacokinetics of the sirolimus-eluting stent. Coronary Artery Disease 2002;13:183-188.
46. Grube E, Silber S, Hauptmann KE, et al. TAXUS I: 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.
47. Hwang CW, Wu D, Edelman ER. Physiologic transport forces govern drug distribution for stent-based delivery. Circulation 2001;104:600-605.
48. Morice M-C, Serruys PW, Sousa JE, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Eng J Med 2002;346:1773-1780.
49. Moses JW, Leon MB, Popma JJ, et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Eng J Med 2003;349:1315-1323.
50. 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;108:788-794.
51. Stone GW, Ellis SG, Cox DA, et al. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Eng J Med 2004;350:221-231.
52. Pache J, Dibra A, Mehilli J, Dirschinger J, Schomig A, Kastrati A. Drug-eluting stents compared with thin-strut bare stents for the reduction of restenosis: A prospective, randomized trial. Eur Heart J 2005;26:1262-1268.
53. Schofer J, Schluter M, Gershlick AH, et al. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: Double-blind, randomised controlled trial (E-SIRIUS). Lancet 2003;362:1093-1099.
54. Ardissino D, Cavallini C, Bramucci E, et al. Sirolimus-eluting vs uncoated stents for prevention of restenosis in small coronary arteries: A randomized trial. JAMA 2004;292:2727-2734.
55. Schampaert E, Cohen EA, Schluter M, et al. The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS). J Am Coll Cardiol 2004;43:1110-1115.
56. Kelbaek H, Thuesin L, Helqvist S, et al. The stenting coronary arteries in non-stress/benestent disease (SCANDSTENT) trial. J Am Coll Cardiol 2006;47:449-455.
57. Suttorp MJ, Laarman GJ, Rahel BM, et al. Primary stenting of totally occluded native coronary arteries II (PRISON II): A randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions. Circulation 2006;114:921-928.
58. Sabate M, Jimenez-Quevedo P, Angiolillo DJ, et al. Randomized comparison of sirolimus-eluting stent versus standard stent for percutaneous coronary revascularization in diabetic patients: The diabetes and sirolimus-eluting stent (DIABETES) trial. Circulation 2005;112:2175-2183.
59. Baumgart D, Klauss V, Baer F, et al. One-year results of the SCORPIUS study: A German multicenter investigation on the effectiveness of sirolimus-eluting stents in diabetic patients. J Am Coll Cardiol 2007;50:1627-1634.
60. Maresta A, Varani E, Balducelli M, et al. Comparison of effectiveness and safety of sirolimus-eluting stents versus bare-metal stents in patients with diabetes mellitus (from the Italian multicenter randomized DESSERT study). Am J Cardiol 2008;101:1560-1566.
61. Spaulding C, Henry P, Teiger E, et al. Sirolimus-eluting versus uncoated stents in acute myocardial infarction. N Eng J Med 2006;355:1093-1104.
62. Gao H, Yan HB, Zhu XL, et al. Firebird sirolimus eluting stent versus bare metal stent in patients with ST-segment elevation myocardial infarction. Chin Med J 2007;120:863-867.
63. Menichelli M, Parma A, Pucci E, et al. Randomized trial of sirolimus-eluting stent versus bare-metal stent in acute myocardial infarction (SESAMI). J Am Coll Cardiol 2007;49:1924-1930.
64. Van Der Hoeven BL, Liem SS, Jukema JW, et al. Sirolimus-eluting stents versus bare-metal stents in patients with ST-segment elevation myocardial infarction: 9-month angiographic and intravascular ultrasound results and 12-month clinical outcome: Results from the MISSION! Intervention study. J Am Coll Cardiol 2008;51:618-626.
65. Kelbaek H, Thuesin L, Helqvist S, et al. Drug-eluting versus bare metal stents in patients with ST-segment-elevation myocardial infarction: 8-month follow-up in the drug eluting and distal protection in acute myocardial infarction (DEDICATION) trial. Circulation 2008;118:1155-1162.
66. Stone GW, Ellis SG, Cannon L, et al. Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: A randomized controlled trial. JAMA 2005;294:1215-1223.
67. Dawkins KD, Grube E, Guagliumi G, et al. Clinical efficacy of polymer-based paclitaxel-eluting stents in the treatment of long, complex coronary artery lesions from a multi-center randomized trial: Support for the use of drug-eluting stents in contemporary clinical practice. Circulation 2005;112:3306-3313.
68. Laarman GJ, Suttorp MJ, Dirksen MT, et al. Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention. N Eng J Med 2006;355:1105-1113.
69. Stone GW, Lansky AJ, Pocock SJ, et al. Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction. N Eng J Med 2009;360:1946-1959.
70. Fajadet J, Wijns W, Laarman G-J, et al. Randomized, double-blind multicenter trial of the endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent system for treatment of native coronary artery lesions: Clinical and angiographic results of the ENDEAVOR II trial. Circulation 2006;114:798-806.
71. Goy JJ, Stauffer JC, Siegenthaler M, Benoit A, Seydoux C. A prospective randomized comparison between paclitaxel and sirolimus stents in the real world of interventional cardiology: The TAXi trial. J Am Coll Cardiol 2005;45:308-311.
72. Galloe AM, Thuesen L, Kelbaek H, et al. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: The SORT OUT II randomized trial. JAMA 2008;299:409-416.
73. Windecker S, Remondino A, Eberli FR, et al. Sirolimus-eluting and paclitaxel-eluting stents for coronary revascularization. N Eng J Med 2005;353:653-662.
74. Morice M-C, Colombo A, Meier B, et al. Sirolimus- versus paclitaxel-eluting stents in de novo coronary artery lesions: The REALITY trial: A randomized controlled trial. JAMA 2006;295:895-904.
75. Zhang Q, Zhang RY, Zhang JS, et al. One-year clinical outcomes of Chinese sirolimus-eluting stent in the treatment of unselected patients with coronary artery disease. Chin Med J 2006;119:165-168.
76. Kim YH, Park SW, Lee SW, et al. Sirolimus-eluting stent versus paclitaxel-eluting stent for patients with long coronary artery disease. Circulation 2006;114:2148-2153.
77. Mehilli J, Dibra A, Kastrati A, et al. Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels. Eur Heart J 2006;27:260-266.
78. Petronio AS, De Carlo M, Branchitta G, et al. Randomized comparison of sirolimus and paclitaxel drug-eluting stents for long lesions in the left anterior descending artery: An intravascular ultrasound study. J Am Coll Cardiol 2007;49:539-546.
79. Mehilli J, Kastrati A, Byrne RA, et al. Paclitaxel- versus sirolimus-eluting stents for unprotected left main coronary artery disease. J Am Coll Cardiol 2009;53:1760-1768.
80. Kastrati A, Mehilli J, von Beckerath N, et al. Sirolimus-eluting stent or paclitaxel-eluting stent vs. angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: A randomized controlled trial. JAMA 2005;293:165-171.
81. Dibra A, Kastrati A, Mehilli J, et al. Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients. N Eng J Med 2005;353:663-670.
82. Lee SW, Park SW, Kim YH, et al. A randomized comparison of sirolimus- versus paclitaxel-eluting stent implantation in patients with diabetes mellitus. J Am Coll Cardiol 2008;52:727-733.
83. Kim MH, Hong SJ, Cha KS, et al. Effect of paclitaxel-eluting versus sirolimus-eluting stents on coronary restenosis in Korean diabetic patients. J Interven Cardiol 2008;21:225-231.
84. Maeng M, Jensen LO, Galloe AM, et al. Comparison of the sirolimus-eluting versus paclitaxel-eluting coronary stent in patients with diabetes mellitus: The diabetes and drug-eluting stent (DiabeDES) randomized angiography trial. Am J Cardiol 2009;130:345-349.
85. Lee JH, Kim HS, Lee SW, et al. Prospective randomized comparison of sirolimus- versus paclitaxel-eluting stents for the treatment of acute ST-elevation myocardial infarction: PROSIT trial. Cathet Cardiovasc Interv 2008;72:25-32.
86. Juwana YB, Suryapranata H, Ottervanger JP, et al. Comparison of rapamcyin- and paclitaxel-eluting stents in patients undergoing primary percutaneous coronary intervention for ST-elevation myocardial infarction. Am J Cardiol 2009;104:205-209.
87. Lorenzo ED, Sauro R, Varricchio A, et al. Long-term outcome of drug-eluting stents compared with bare metal stents in ST-segment elevation myocardial infarction: Results of the paclitaxel- or sirolimus-eluting stent versus bare metal stent in primary angioplasty (PASEO) randomized trial. Circulation 2009;120:964-972.
88. Kandzari DE, Leon MB, Popma JJ, et al. Comparison of zotarolimus-eluting and sirolimus-eluting stents in patients with native coronary artery disease: A randomized controlled trial. J Am Coll Cardiol 2006;48:2440-2447.
89. Chevalier B, Di Mario C, Neumann FJ, et al. A randomized, controlled, multicenter trial to evaluate the safety and efficacy of zotarolimus- versus paclitaxel-eluting stents in de novo occlusive lesions in coronary arteries: The ZoMaxx I trial. J Am Coll Cardiol Intv 2008;1:524-532.
90. Lee CW, Park DW, Lee SH, et al. Comparison of the efficacy and safety of zotarolimus-, sirolimus- and paclitaxel-eluting stents in patients with ST-elevation myocardial infarction. Am J Cardiol 2009;104:1370-1376.
91. Serruys PW, Ruygrok P, Neuzner J, et al. A randomized comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent: The SPIRIT II trial. Eurointervention 2006;2:286-294.
92. Stone GW, Midei M, Newman W, et al. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: A randomized trial. JAMA 2008;299:1903-1913.
93. Krucoff MW, Kereiakes DJ, Petersen JL, et al. A novel bioresorbable polymer paclitaxel-eluting stent for the treatment of single and multivessel coronary disease: Primary results of the COSTAR (cobalt chromium stent with antiproliferative for restenosis) II trial. J Am Coll Cardiol 2008;51:1543-1552.
94. Windecker S, Serruys PW, Wandel S, et al. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularization (LEADERS): A randomized non-inferiority trial. Lancet 2008;372:1163-1173.
95. Byrne RA, Kastrati A, Kufner S, et al. Randomized, non-inferiority trial of three limus agent-eluting stents with different polymer coatings: The intracoronary stenting angiographic results: Test efficacy of 3 limus-eluting stents (ISAR-TEST-4) trial. Eur Heart J 2009;30:2441-2449.
96. Lemos PA, Moulin B, Perin MA, et al. Randomized evaluation of two drug-eluting stents with identical metallic platform and biodegradable polymer but different agents (paclitaxel or sirolimus) compared against bare stents: 1-year results of the PAINT trial. Cathet Cardiovasc Interv 2009;74:665-673.
97. 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;109:1948-1954.
98. Gershlick A, De Scheerder I, Chevalier B, et al. Inhibition or restenosis with a paclitaxel-eluting, polymer-free coronary stent: The European evaLUation of pacliTaxel Eluting Stents (ELUTES) trial. Circulation 2004;109:487-493.
99. Mehilli J, Kastrati A, Wessely R, et al. Randomized trial of a nonpolymer-based rapamycin-eluting stent versus a polymer-based paclitaxel-eluting stent for the reduction of late lumen loss. Circulation 2006;113:273-279.
100. Mehilli J, Byrne RA, Wieczorek A, et al. Randomized trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis. Eur Heart J 2008;29:1975-1982.
101. Byrne RA, Mehilli J, Iijima R, et al. A polymer-free dual drug-eluting stent in patients with coronary artery disease: A randomized trial vs. polymer-based drug-eluting stents. Eur Heart J 2009;30:923-931.
102. Schomig A, Dibra A, Windecker S, et al. A meta-analysis of 16 randomized trails of sirolimus-eluting stents versus paclitaxel-eluting stents in patients with coronary artery disease. J Am Coll Cardiol 2007;50:1373-1380.
103. Serruys PW, Ong ATL, Piek JJ, et al. A randomized comparison of a durable polymer everolimus-eluting stent with a bare metal coronary stent: The SPIRIT First trial. Eurointervention 2005;1:58-65.
104. Stone GW, Midei M, Newman W, et al. Randomized comparison of everolimus-eluting and paclitaxel-eluting stents: Two-year clinical follow-up from the clinical evaluation of the Xience V everolimus eluting coronary stent system in the treatment of patients with de novo native coronary artery lesions (SPIRIT) III trial. Circulation 2009;119:680-686.
105. Vermeersch P, Agostoni P, Verheye S, et al. Randomized double-blind comparison of sirolimus-eluting stent versus bare-metal stent implantation in diseased saphenous vein grafts: Six month angiographic, intravascular ultrasound, and clinical follow-up of the RRISC trial. J Am Coll Cardiol 2006;48:2423-2431.
106. Brilakis ES, Lichtenwalter C, de Lemos JA, et al. A randomized controlled trial of a paclitaxel-eluting stents versus a similar bare-metal stent in saphenous vein graft lesions: The SOS (stenting of saphenous vein grafts) trial. J Am Coll Cardiol 2009;53:919-928.
107. Duda SH, Pusich B, Richter G, et al. Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: Six month results. Circulation 2002;106:1505-1509.
108. Duda SH, Bosiers M, Lammer J, et al. Sirolimus-eluting versus bare nitinol stent for obstructive superficial femoral artery disease: The SIROCCO II trial. J Vasc Interv Radiol 2005;16:331-338.
109. Ong ATL, McFadden EP, Regar E, de Jaegere PPT, van Domburg RT, Serruys PW. Late angiographic stent thrombosis (LAST) events with drug-eluting stents. J Am Coll Cardiol 2005;45:2088-2092.
110. Beohar N, Davidson CJ, Kip KE, et al. Outcomes and complications associated with off-label and untested use of drug-eluting stents. JAMA 2007;297:1992-2000.
111. Daemen J, Wenaweser P, Tsuchida K, et al. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel eluting stents in routine clinical practice: Data from a large two-institutional cohort study. Lancet 2007;369:667-678.
112. Win HK, Caldera AE, Maresh K, et al. Clinical outcomes and stent thrombosis following off-label use of drug-eluting stents. JAMA 2007;297:2001-2009.
113. Jeremias A, Sylvia B, Bridges J, et al. Stent thrombosis after successful sirolimus-eluting stent implantation. Circulation 2004;109:1930-1932.
114. McFadden EP, Stabile E, Regar E, et al. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet 2004;364:1519-1521.
115. Camenzind E, Steg PG, Wijns W. Stent thrombosis late after implantation of first-generation drug-eluting stents: A cause for concern. Circulation 2007;115:1440-1455.
116. Pfisterer M, Brunner-La Rocca HP, Buser PT. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: An observational study of drug-eluting versus bare-metal stents. J Am Coll Cardiol 2006;48:2584-2591.
117. Stone GW, Moses JW, Ellis SG, et al. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Eng J Med 2007;356:998-1008.
118. Mauri L, Hsieh W, Massaro JM, Ho KKL, D'Agostino R, Cutlip DE. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Eng J Med 2007;356:1020-1029.
119. James SK, Stenestrand U, Lindback J, et al. Long-term safety and efficacy of drug-eluting versus bare-metal stents in Sweden. N Eng J Med 2009;360:1933-1945.
120. Van Werkum JW, Heestermans AA, Zomer AC, et al. Predictors of coronary stent thrombosis: The Dutch stent thrombosis registry. J Am Coll Cardiol 2009;53:1399-1409.
121. Marroquin OC, Selzer F, Mulukutla SR, et al. A comparison of bare-metal and drug-eluting stents for off-label indications. N Eng J Med 2008;358:342-352.
122. Iakovou I, Schmidt T, Bonizzoni E, et al. Incidence, predictors, and outcomes of thrombosis after successful implantation of drug-eluting stents. JAMA 2005;293:2126-2130.
123. Eisenstein EL, Anstrom KJ, Kong DF, et al. Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. JAMA 2007;297:159-168.
124. Kotani J, Awata M, Nanto S, et al. Incomplete neointimal coverage of sirolimus-eluting stents: Angioscopic findings. J Am Coll Cardiol 2006;47:2108-2111.
125. Awata M, Kotani J, Uematsu M, et al. Serial angioscopic evidence of incomplete neointimal coverage after sirolimus-eluting stent implantation: Comparison with bare-metal stents. Circulation 2007;116:910-916.
126. Joner M, Finn AK, Farb A, et al. Pathology of drug-eluting stents in humans: Delayed healing and late thrombotic risk. J Am Coll Cardiol 2006;48:193-202.
127. Finn AV, Joner M, Nakazawa G, et al. Pathological correlates of late drug-eluting stent thrombosis: Strut coverage as a marker of endothelialization. Circulation 2007;115:2435-2441.
128. Matsumoto D, Shite J, Shinke T, et al. Neointimal coverage of sirolimus-eluting stents at 6-month follow-up: Evaluated by optical coherence tomography. Eur Heart J 2007;28:961-967.
129. Murphy JG, Schwartz RS, Edwards WD, Camrud AR, Vlietstra RE, Holmes DR, Jr. Percutaneous polymeric stents in porcine coronary arteries: Initial experience with polyethylene terephthalate stents. Circulation 1992;86:1596-1604.
130. 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;94:1690-1697.
131. Wilson GJ, Nakazawa G, Schwartz RS, et al. Comparison of inflammatory response after implantation of sirolimus- and paclitaxel-eluting stents in porcine coronary arteries. Circulation 2009;120:141-149.
132. Nebeker JR, Virmani R, Bennett CL, et al. Hypersensitivity cases associated with drug-eluting coronary stents: A review of available cases from the research on adverse drug events and reports (RADAR) project. J Am Coll Cardiol 2006;47:175-181.
133. Ormiston JA, Serruys PW, Regar E, et al. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): A prospective open-label trial. Lancet 2008;371:899-907.
134. Serruys PW, Ormiston JA, Onuma Y, et al. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet 2009;373:897-910.