Advances in stent technologies and their effect on clinical efficacy and safety

Medical Devices: Evidence and Research

Volumn 7, Issue 1, 2014, Pages 165-178

  Nikam, Navin ^a   Steinberg, Toby B ^a   Steinberg, Daniel H ^a  

^a MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

Author keywords

Bioabsorbable polymers; Bioabsorbable struts; Coronary artery disease; Drug eluting stents percutaneous coronary intervention; Polymer free

Indexed keywords

ARTIFICIAL ORGANS; DISEASES; POLYMERS;

BIOABSORBABLE; BIOABSORBABLE POLYMER; CORONARY ARTERY DISEASE; DRUG-ELUTING STENTS; INTERVENTIONAL CARDIOLOGY; INTIMAL HYPERPLASIA; INTRA-CORONARY STENTS; PERCUTANEOUS CORONARY INTERVENTION;

STENTS;

CHROMIUM DERIVATIVE; COBALT CHROMIUM; EVEROLIMUS; PACLITAXEL; PLATINUM CHROMIUM; POLYMER; RAPAMYCIN; UMIROLIMUS; UNCLASSIFIED DRUG; ZOTAROLIMUS;

BARE METAL STENT; BIODEGRADABLE IMPLANT; BIOMEDICAL ENGINEERING; BIORESORBABLE SCAFFOLD; CLINICAL EFFECTIVENESS; CORONARY ARTERY DISEASE; CORONARY STENT; DEVICE SAFETY; DEVICE THERAPY; DRUG DELIVERY DEVICE; DRUG ELUTING STENT; EQUIPMENT DESIGN; INTERVENTIONAL CARDIOVASCULAR PROCEDURE; META ANALYSIS (TOPIC); OUTCOME ASSESSMENT; PERCUTANEOUS CORONARY INTERVENTION; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; STENT THROMBOSIS; THERAPY EFFECT;

EID: 84901910416     PISSN: None     EISSN: 11791470     Source Type: Journal    
DOI: 10.2147/MDER.S31869     Document Type: Review

References (91)

1. 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(8):2011-2020.
2. Chamberlain DA, Fox KAA, Henderson RA, Julian DG, Parker DJ, Pocock SJ. Coronary angioplasty versus medical therapy for angina: the second Randomised Intervention Treatment of Angina (RITA-2) trial. RITA-2 trial participants. Lancet. 1997;350(9076):461-468.
3. Parisi AF, Folland ED, Hartigan P. A comparison of angioplasty with medical therapy in the treatment of single-vessel coronary artery disease. Veterans Affairs ACME Investigators. N Engl J Med. 1992;326(1):10-16.
4. 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(8):496-501.
5. 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(8):489-495.
6. Lemos PA, Serruys PW, van Domburg RT, et al. Unrestricted utilization of sirolimus-eluting stents compared with conventional bare stent implantation in the "real world": the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. Circulation. 2004;109(2):190-195.
7. Moses JW, Leon MB, Popma JJ, et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003;349(14):1315-1323.
8. 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(3):221-231.
9. Lagerqvist B, James SK, Stenestrand U, Lindback J, Nilsson T, Wallentin L. Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. N Engl J Med. 2007;356(10):1009-1019.
10. Stone GW, Moses JW, Ellis SG, et al. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med. 2007;356(10): 998-1008.
11. Mani G, Feldman MD, Patel D, Agrawal CM. Coronary stents: a materials perspective. Biomaterials. 2007;28(9):1689-1710.
12. Kastrati A, Mehilli J, Dirschinger J, et al. Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO) trial. Circulation. 2001;103(23):2816-2821.
13. Pache J, Kastrati A, Mehilli J, et al. Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO-2) trial. J Am Coll Cardiol. 2003;41(8):1283-1288.
14. Rittersma SZ, de Winter RJ, Koch KT, et al. Impact of strut thickness on late luminal loss after coronary artery stent placement. Am J Cardiol. 2004;93(4):477-480.
15. Kereiakes DJ, Cox DA, Hermiller JB, et al. Usefulness of a cobalt chromium coronary stent alloy. Am J Cardiol. 2003;92(4):463-466.
16. O'Brien BJ, Stinson JS, Larsen SR, Eppihimer MJ, Carroll WM. A platinum-chromium steel for cardiovascular stents. Biomaterials. 2010;31(14):3755-3761.
17. Menown IB, Noad R, Garcia EJ, Meredith I. The platinum chromium element stent platform: from alloy, to design, to clinical practice. Adv Ther. 2010;27(3):129-141.
18. Turco MA. The Integrity bare-metal stent made by continuous sinusoid technology. Expert Rev Med Devices. 2011;8(3):303-306.
19. Kereiakes DJ, Cannon LA, Feldman RL, et al. Clinical and angiographic outcomes after treatment of de novo coronary stenoses with a novel platinum chromium thin-strut stent: primary results of the PERSEUS (Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System) trial. J Am Coll Cardiol. 2010;56(4):264-271.
20. Stone GW, Teirstein PS, Meredith IT, et al. A prospective, randomized evaluation of a novel everolimus-eluting coronary stent: the PLATINUM (a Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of Up to Two de Novo Coronary Artery Lesions) trial. J Am Coll Cardiol. 2011;57(16):1700-1708.
21. Mortier P, De Beule M. Stent design back in the picture: an engineering perspective on longitudinal stent compression. EuroIntervention. 2011;7(7):773, 775.
22. Ormiston JA, Webber B, Webster MW. Stent longitudinal integrity bench insights into a clinical problem. JACC Cardiovasc Interv. 2011;4(12):1310-1317.
23. Ormiston J. Clinical, angiographic and IVUS outcomes of the NG PROMUS clinical trial evaluating the novel Promus Premier stent. Paper presented at the EuroPCR meeting, May 21-24, 2013, Paris, France.
24. Nishio S, Kosuga K, Igaki K, et al. Long-term (.10 years) clinical outcomes of first-in-human biodegradable poly-l-lactic acid coronary stents: Igaki-Tamai stents. Circulation. 2012;125(19):2343-2353.
25. Tamai H, Igaki K, Kyo E, et al. Initial and 6-month results of biodegradable poly-l-lactic acid coronary stents in humans. Circulation. 2000;102(4):399-404.
26. Ormiston JA, Serruys PW. Bioabsorbable coronary stents. Circ Cardiovasc Interv. 2009;2(3):255-260.
27. Pendyala L, Jabara R, Robinson K, Chronos N. Passive and active polymer coatings for intracoronary stents: novel devices to promote arterial healing. J Interv Cardiol. 2009;22(1):37-48.
28. O'Brien B, Carroll W. The evolution of cardiovascular stent materials and surfaces in response to clinical drivers: a review. Acta Biomater. 2009;5(4):945-958.
29. 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(1):175-181.
30. Virmani R, Guagliumi G, Farb A, et al. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004;109(6):701-705.
31. Joner M, Finn AV, Farb A, et al. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006;48(1):193-202.
32. 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(7):1690-1697.
33. Lewis AL, Tolhurst LA, Stratford PW. Analysis of a phosphorylcholine-based polymer coating on a coronary stent pre- and post-implantation. Biomaterials. 2002;23(7):1697-1706.
34. Fajadet J, Wijns W, Laarman GJ, et al. Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial. Circulation. 2006;114(8):798-806.
35. Guagliumi G, Ikejima H, Sirbu V, et al. Impact of drug release kinetics on vascular response to different zotarolimus-eluting stents implanted in patients with long coronary stenoses: the LongOCT study (Optical Coherence Tomography in Long Lesions). JACC Cardiovasc Interv. 2011;4(7):778-785.
36. Morice MC, Serruys PW, Sousa JE, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002;346(23):1773-1780.
37. 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(18):2289-2295.
38. Finn AV, Nakazawa G, Joner M, et al. Vascular responses to drug eluting stents: importance of delayed healing. Arterioscler Thromb Vasc Biol. 2007;27(7):1500-1510.
39. Burke SE, Kuntz RE, Schwartz LB. Zotarolimus (ABT-578) eluting stents. Adv Drug Deliv Rev. 2006;58(3):437-446.
40. Claessen BE, Henriques JP, Dangas GD. Clinical studies with sirolimus, zotarolimus, everolimus, and biolimus A9 drug-eluting stent systems. Curr Pharm Des. 2010;16(36):4012-4024.
41. Waksman R, Pakala R, Baffour R, et al. Optimal dosing and duration of oral everolimus to inhibit in-stent neointimal growth in rabbit iliac arteries. Cardiovasc Revasc Med. 2006;7(3):179-184.
42. Fajadet J, Wijns W, Laarman GJ, et al. Long-term follow-up of the randomised controlled trial to evaluate the safety and efficacy of the zotarolimus-eluting driver coronary stent in de novo native coronary artery lesions: five year outcomes in the ENDEAVOR II study. EuroIntervention. 2010;6(5):562-567.
43. Leon MB, Mauri L, Popma JJ, et al. A randomized comparison of the Endeavor zotarolimus-eluting stent versus the TAXUS paclitaxel-eluting stent in de novo native coronary lesions 12-month outcomes from the ENDEAVOR IV trial. J Am Coll Cardiol. 2010;55(6):543-554.
44. Leon MB, Nikolsky E, Cutlip DE, et al. Improved late clinical safety with zotarolimus-eluting stents compared with paclitaxel-eluting stents in patients with de novo coronary lesions: 3-year follow-up from the ENDEAVOR IV (Randomized Comparison of Zotarolimus- and Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease) trial. JACC Cardiovasc Interv. 2010;3(10):1043-1050.
45. 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(12):2440-2447.
46. Rasmussen K, Maeng M, Kaltoft A, et al. Efficacy and safety of zotarolimus-eluting and sirolimus-eluting coronary stents in routine clinical care (SORT OUT III): a randomised controlled superiority trial. Lancet. 2010;375(9720):1090-1099.
47. Maeng M, Tilsted HH, Jensen LO, et al. 3-Year clinical outcomes in the randomized SORT OUT III superiority trial comparing zotarolimus- and sirolimus-eluting coronary stents. JACC Cardiovasc Interv. 2012;5(8):812-818.
48. Kandzari DE, Mauri L, Popma JJ, et al. Late-term clinical outcomes with zotarolimus- and sirolimus-eluting stents. 5-year follow-up of the ENDEAVOR III (A Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions). JACC Cardiovasc Interv. 2011;4(5):543-550.
49. Brugaletta S, Burzotta F, Sabate M. Zotarolimus for the treatment of coronary artery disease: pathophysiology, DES design, clinical evaluation and future perspective. Expert Opin Pharmacother. 2009;10(6):1047-1058.
50. Banerjee S. The Resolute Integrity zotarolimus-eluting stent in coronary artery disease: a review. Cardiology and Therapy. 2013;2(1):9.
51. Belardi JA, Albertal M. Integrity(R) coronary stent: a very limber bare-metal stent. Catheter Cardiovasc Interv. 2011;78(6):909.
52. Bennett J, Dubois C. A novel platinum chromium everolimus-eluting stent for the treatment of coronary artery disease. Biologics. 2013;7:149-159.
53. Verheye S, Martinet W, Kockx MM, et al. Selective clearance of macrophages in atherosclerotic plaques by autophagy. J Am Coll Cardiol. 2007;49(6):706-715.
54. Ding N, Pacetti S, Tang F-W, Gada M, Roorda W. Xience V stent design and rationale. J Interv Cardiol. 2009;22(s1):s18-s27.
55. Serruys PW, Ong AT, 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(1):58-65.
56. Sabate M, Cequier A, Iniguez A, et al. Everolimus-eluting stent versus bare-metal stent in ST-segment elevation myocardial infarction (EXAMINATION): 1 year results of a randomised controlled trial. Lancet. 2012;380(9852):1482-1490.
57. Serruys PW, Ruygrok P, Neuzner J, et al. A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent: the SPIRIT II trial. Euro Intervention. 2006;2(3):286-294.
58. 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(16):1903-1913.
59. 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(5):680-686.
60. Stone GW, Rizvi A, Newman W, et al. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med. 2010;362(18):1663-1674.
61. Stone GW, Rizvi A, Sudhir K, et al. Randomized comparison of everolimus- and paclitaxel-eluting stents. 2-year follow-up from the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) IV trial. J Am Coll Cardiol. 2011;58(1):19-25.
62. Kedhi E, Joesoef KS, McFadden E, et al. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010;375(9710):201-209.
63. Smits PC, Kedhi E, Royaards KJ, et al. 2-year follow-up of a randomized controlled trial of everolimus- and paclitaxel-eluting stents for coronary revascularization in daily practice. COMPARE (Comparison of the everolimus eluting XIENCE-V stent with the paclitaxel eluting TAXUS LIBERTE stent in all-comers: a randomized open label trial). J Am Coll Cardiol. 2011;58(1):11-18.
64. Planer D, Smits PC, Kereiakes DJ, et al. Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes: pooled results from the SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) Trials. JACC Cardiovasc Interv. 2011;4(10):1104-1115.
65. Park KW, Chae IH, Lim DS, et al. Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention: the EXCELLENT (Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting) randomized trial. J Am Coll Cardiol. 2011;58(18):1844-1854.
66. Kaiser C, Galatius S, Erne P, et al. Drug-eluting versus bare-metal stents in large coronary arteries. N Engl J Med. 2010;363(24):2310-2319.
67. Jensen LO, Thayssen P, Hansen HS, et al. Randomized comparison of everolimus-eluting and sirolimus-eluting stents in patients treated with percutaneous coronary intervention: the Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV). Circulation. 2012;125(10):1246-1255.
68. Serruys PW, Silber S, Garg S, et al. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med. 2010;363(2): 136-146.
69. Silber S, Windecker S, Vranckx P, Serruys PW, investigators RAC. Unrestricted randomised use of two new generation drug-eluting coronary stents: 2-year patient-related versus stent-related outcomes from the RESOLUTE All Comers trial. Lancet. 2011;377(9773):1241-1247.
70. Tandjung K, Sen H, Lam MK, et al. Clinical outcome following stringent discontinuation of dual antiplatelet therapy after 12 months in real-world patients treated with second-generation zotarolimus-eluting resolute and everolimus-eluting Xience V stents: 2-year follow-up of the randomized TWENTE trial. J Am Coll Cardiol. 2013;61(24):2406-2416.
71. von Birgelen C, Basalus MW, Tandjung K, et al. A randomized controlled trial in second-generation zotarolimus-eluting Resolute stents versus everolimus-eluting Xience V stents in real-world patients: the TWENTE trial. J Am Coll Cardiol. 2012;59(15):1350-1361.
72. Damman P, Abdel-Wahab M, Mollmann H, et al. Comparison of twelve-month outcomes after percutanous coronary intervention with everolimus-eluting versus zotarolimus-eluting or sirolimus-eluting stents from the PROENCY (PROmus ENdeavor CYpher) registry. J Invasive Cardiol. 2012;24(10):495-502.
73. Park KW, Lee JM, Kang SH, et al. Safety and efficacy of second-generation everolimus-eluting Xience V stents versus zotarolimus-eluting resolute stents in real-world practice: patient-related and stent-related outcomes from the multicenter prospective EXCELLENT and RESOLUTE-Korea registries. J Am Coll Cardiol. 2013;61(5):536-544.
74. Palmerini T, Kirtane AJ, Serruys PW, et al. Stent thrombosis with everolimus-eluting stents: meta-analysis of comparative randomized controlled trials. Circ Cardiovasc Interv. 2012;5(3):357-364.
75. Boston Scientific. Landmark analysis of year two data from PLATINUM Workhorse Trial demonstrates superior efficacy of PROMUS Element platinum chromium stent compared with Promus (Xience V) Stent. 2012. Available from: http://bostonscientific.mediaroom.com/index.php?s=24889&item=125347. Accessed November 12, 2013.
76. von Birgelen C, Sen H, Lam MK, et al. Third-generation zotarolimus-eluting and everolimus-eluting stents in all-comer patients requiring a percutaneous coronary intervention (DUTCH PEERS): a randomised, single-blind, multicentre, non-inferiority trial. Lancet. 2014;383(9915): 413-423.
77. Byrne RA, Mehilli J, Iijima R, et al. A polymer-free dual drug-eluting stent in patients with coronary artery disease: a randomized trial versus polymer-based drug-eluting stents. Eur Heart J. 2009;30(8):923-931.
78. Carrie D. NEXT A prospective, randomized trial comparing Cre8, a polymer-free stent eluting sirolimus, to a paclitaxel-eluting stent. Paper presented at the Transcatheter Cardiovascular Therapeutics 23rd Annual Scientific Symposium, November 7-11, 2011, San Francisco, CA, USA.
79. Grube E. BIOFREEDOM: a prospective randomized trial of polymer-free bioliums a9-eluting stents and paclitaxel-eluting stents in patients with coronary artery disease. Paper presented at at the Transcatheter Cardiovascular Therapeutics 22rd Annual Scientific Symposium, September 23-25, 2010, Washington, DC, USA.
80. Stella PR. Demonstr8 randomized trial results: Cre8: reduced antiplatelet therapy with effective DES. Paper presented at the EuroPCR meeting, May 21-24, 2013, Paris, France.
81. Han YL, Zhang L, Yang LX, et al. A new generation of biodegradable polymer-coated sirolimus-eluting stents for the treatment of coronary artery disease: final 5-year clinical outcomes from the CREATE study. EuroIntervention. 2012;8(7):815-822.
82. Windecker S, Serruys PW, Wandel S, et al. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet. 2008;372(9644):1163-1173.
83. Stefanini GG, Kalesan B, Serruys PW, et al. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer sirolimus-eluting stents in patients with coronary artery disease (LEADERS): 4 year follow-up of a randomised non-inferiority trial. Lancet. 2011;378(9807):1940-1948.
84. Raber L, Kelbaek H, Ostojic M, et al. Effect of biolimus-eluting stents with biodegradable polymer vs bare-metal stents on cardiovascular events among patients with acute myocardial infarction: the COMFORTABLE AMI randomized trial. JAMA. 2012;308(8):777-787.
85. Christiansen EH, Jensen LO, Thayssen P, et al. Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V): a randomised non-inferiority trial. Lancet. 2013;381(9867):661-669.
86. Smits PC, Hofma S, Togni M, et al. Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): a randomised, controlled, non-inferiority trial. Lancet. 2013;381(9867):651-660.
87. Meredith IT, Verheye S, Dubois CL, et al. Primary endpoint results of the EVOLVE trial: a randomized evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent. J Am Coll Cardiol. 2012;59(15):1362-1370.
88. Meredith IT, Verheye S, Weissman NJ, et al. Six-month IVUS and two-year clinical outcomes in the EVOLVE FHU trial: a randomised evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting stent. EuroIntervention. 2013;9(3):308-315.
89. 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(9616):899-907.
90. Onuma Y, Dudek D, Thuesen L, et al. Five-year clinical and functional multislice computed tomography angiographic results after coronary implantation of the fully resorbable polymeric everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB Cohort A trial. JACC Cardiovasc Interv. 2013;6(10):999-1009.
91. Diletti R, Serruys PW, Farooq V, et al. ABSORB II randomized controlled trial: a clinical evaluation to compare the safety, efficacy, and performance of the Absorb everolimus-eluting bioresorbable vascular scaffold system against the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions: rationale and study design. Am Heart J. 2012;164(5):654-663.