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Erschienen in: Current Atherosclerosis Reports 3/2015

01.03.2015 | Coronary Heart Disease (E Gianos and B Shah, Section Editor)

Drug-Eluting Stents: the Past, Present, and Future

verfasst von: Gregory Katz, Bhisham Harchandani, Binita Shah

Erschienen in: Current Atherosclerosis Reports | Ausgabe 3/2015

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Abstract

Since the advent of percutaneous coronary intervention, enormous advances have been made in the treatment of coronary artery disease. Angioplasty and bare metal stents were plagued by high rates of restenosis leading to repeat revascularization procedures. Examination of the underlying pathophysiology of restenosis led to the development of drug-eluting stents to reduce neointimal hyperplasia. However, as restenosis rates declined, length of dual antiplatelet therapy use and risk of long-term stent thrombosis associated with drug-eluting stents increased. Subsequent generations have improved each facet of stent design. Novel alloys maintain durability and reduce strut thickness to increase deliverability, biocompatible polymers decrease the inflammatory response and improve drug elution kinetics, and new generations of drugs predictably inhibit restenosis. Developments on the horizon include stents with bioabsorbable polymers and platforms. The purpose of this review is to assess the evolution of stent design and the evidence behind each generation and to peer into the future of stent technology.
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47.•
Zurück zum Zitat Park KW, Lee JM, Kang SH, Ahn HS, Yang HM, Lee HY, 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;61:536–44. Demonstrated that everolimus-eluting stents and Resolute zotarolimus-eluting stents have similar safety and efficacy over 1 year follow up.CrossRefPubMed Park KW, Lee JM, Kang SH, Ahn HS, Yang HM, Lee HY, 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;61:536–44. Demonstrated that everolimus-eluting stents and Resolute zotarolimus-eluting stents have similar safety and efficacy over 1 year follow up.CrossRefPubMed
48.•
Zurück zum Zitat von Birgelen C, Basalus MW, Tandjung K, van Houwelingen KG, Stoel MG, Louwerenburg JH, 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;59:1350–61. Demonstrated that Resolute zotarolimus-eluting stents are noninferior to everolimus-eluting stents in a real world population of patients with complex lesions.CrossRef von Birgelen C, Basalus MW, Tandjung K, van Houwelingen KG, Stoel MG, Louwerenburg JH, 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;59:1350–61. Demonstrated that Resolute zotarolimus-eluting stents are noninferior to everolimus-eluting stents in a real world population of patients with complex lesions.CrossRef
49.
Zurück zum Zitat Serruys PW, Silber S, Garg S, van Geuns RJ, Richardt G, Buszman PE, et al. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med. 2010;363:136–46.CrossRefPubMed Serruys PW, Silber S, Garg S, van Geuns RJ, Richardt G, Buszman PE, et al. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med. 2010;363:136–46.CrossRefPubMed
50.•
Zurück zum Zitat von Birgelen C, Sen H, Lam MK, Danse PW, 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;383:413–23. Demonstrated, again, that Resolute zotarolimus-eluting stents and everolimus-eluting stents perform comparably with regards to safety and efficacy with no significant difference in rates of stent thrombosis.CrossRef von Birgelen C, Sen H, Lam MK, Danse PW, 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;383:413–23. Demonstrated, again, that Resolute zotarolimus-eluting stents and everolimus-eluting stents perform comparably with regards to safety and efficacy with no significant difference in rates of stent thrombosis.CrossRef
51.•
Zurück zum Zitat Palmerini T, Biondi-Zoccai G, Della Riva D, Stettler C, Sangiorgi D, D’Ascenzo F, et al. Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. Lancet. 2012;379:1393–402. Demonstrated that colbalt chromium everolimus-eluting stents have the lowest rate of stent thrombosis in this comparison of bare metal stent and various drug-eluting stents.CrossRefPubMed Palmerini T, Biondi-Zoccai G, Della Riva D, Stettler C, Sangiorgi D, D’Ascenzo F, et al. Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. Lancet. 2012;379:1393–402. Demonstrated that colbalt chromium everolimus-eluting stents have the lowest rate of stent thrombosis in this comparison of bare metal stent and various drug-eluting stents.CrossRefPubMed
52.
Zurück zum Zitat Palmerini T, Biondi-Zoccai G, Della Riva D, Mariani A, Sabaté M, Valgimigli M, et al. Clinical outcomes with drug-eluting and bare-metal stents in patients with ST-segment elevation myocardial infarction: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol. 2013;62:496–504.CrossRefPubMed Palmerini T, Biondi-Zoccai G, Della Riva D, Mariani A, Sabaté M, Valgimigli M, et al. Clinical outcomes with drug-eluting and bare-metal stents in patients with ST-segment elevation myocardial infarction: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol. 2013;62:496–504.CrossRefPubMed
53.•
Zurück zum Zitat Bangalore S, Kumar S, Fusaro M, Amoroso N, et al. Short- and long-term outcomes with drug-eluting and bare-metal coronary stents: a mixed-treatment comparison analysis of 117 762 patient-years of follow-up from randomized trials. Circulation. 2012;125:2873–91. This metaanalysis evaluating the safety and efficacy of various drug-eluting stents and bare metal stents demonstrated that everolimus-eluting stents, sirolimus-eluting stents, and Resolute zotarolimus-eluting stents have the greatest efficacy and everolimus-eluting stents may be the safest.CrossRefPubMed Bangalore S, Kumar S, Fusaro M, Amoroso N, et al. Short- and long-term outcomes with drug-eluting and bare-metal coronary stents: a mixed-treatment comparison analysis of 117 762 patient-years of follow-up from randomized trials. Circulation. 2012;125:2873–91. This metaanalysis evaluating the safety and efficacy of various drug-eluting stents and bare metal stents demonstrated that everolimus-eluting stents, sirolimus-eluting stents, and Resolute zotarolimus-eluting stents have the greatest efficacy and everolimus-eluting stents may be the safest.CrossRefPubMed
54.
Zurück zum Zitat Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, et al. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007;115:2435–41.CrossRefPubMed Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, et al. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007;115:2435–41.CrossRefPubMed
55.•
Zurück zum Zitat Serruys PW, Farooq V, Kalesan B, de Vries T, Buszman P, Linke A, et al. Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial. JACC Cardiovasc Interv. 2013;6:777–89. Demonstrated that biodegradable polymers may reduce the risk of very late stent thrombosis associated with first generation drug-eluting stents.CrossRefPubMed Serruys PW, Farooq V, Kalesan B, de Vries T, Buszman P, Linke A, et al. Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial. JACC Cardiovasc Interv. 2013;6:777–89. Demonstrated that biodegradable polymers may reduce the risk of very late stent thrombosis associated with first generation drug-eluting stents.CrossRefPubMed
56.
Zurück zum Zitat Smits PC, Hofma S, Togni M, Vázquez N, Valdés M, Voudris V, et al. Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): a randomised, controlled, non-inferiority trial. Lancet. 2013;381:651–60.CrossRefPubMed Smits PC, Hofma S, Togni M, Vázquez N, Valdés M, Voudris V, et al. Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): a randomised, controlled, non-inferiority trial. Lancet. 2013;381:651–60.CrossRefPubMed
57.
Zurück zum Zitat Natsuaki M, Kozuma K, Morimoto T, Kadota K, Muramatsu T, Nakagawa Y, et al. Biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent: a randomized, controlled, noninferiority trial. J Am Coll Cardiol. 2013;62:181–90.CrossRefPubMed Natsuaki M, Kozuma K, Morimoto T, Kadota K, Muramatsu T, Nakagawa Y, et al. Biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent: a randomized, controlled, noninferiority trial. J Am Coll Cardiol. 2013;62:181–90.CrossRefPubMed
58.
Zurück zum Zitat Byrne RA, Kastrati A, Kufner S, Massberg S, Birkmeier KA, Laugwitz KL, et al. Randomized, non-inferiority trial of three limus agent-eluting stents with different polymer coatings: the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) Trial. Eur Heart J. 2009;30:2441–9.CrossRefPubMed Byrne RA, Kastrati A, Kufner S, Massberg S, Birkmeier KA, Laugwitz KL, et al. Randomized, non-inferiority trial of three limus agent-eluting stents with different polymer coatings: the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) Trial. Eur Heart J. 2009;30:2441–9.CrossRefPubMed
59.
Zurück zum Zitat Meredith IT, Verheye S, Dubois CL, Dens J, Fajadet J, Carrié D, 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;59:1362–70.CrossRefPubMed Meredith IT, Verheye S, Dubois CL, Dens J, Fajadet J, Carrié D, 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;59:1362–70.CrossRefPubMed
60.
Zurück zum Zitat Christiansen EH, Jensen LO, Thayssen P, Tilsted HH, Krusell LR, Hansen KN, 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;381:661–9.CrossRefPubMed Christiansen EH, Jensen LO, Thayssen P, Tilsted HH, Krusell LR, Hansen KN, 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;381:661–9.CrossRefPubMed
61.
Zurück zum Zitat Krucoff MW, Kereiakes DJ, Petersen JL, Mehran R, Hasselblad V, Lansky AJ, 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 study. J Am Coll Cardiol. 2008;51:1543–52.CrossRefPubMed Krucoff MW, Kereiakes DJ, Petersen JL, Mehran R, Hasselblad V, Lansky AJ, 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 study. J Am Coll Cardiol. 2008;51:1543–52.CrossRefPubMed
62.•
Zurück zum Zitat Bangalore S, Toklu B, Amoroso N, Fusaro M, Kumar S, Hannan EL, et al. Bare metal stents, durable polymer drug eluting stents, and biodegradable polymer drug eluting stents for coronary artery disease: mixed treatment comparison meta-analysis. BMJ. 2013;347:f6625. This meta-analysis evaluating bare metal stents, drug-eluting stents, and drug-eluting stents with bioresorbable polymers demonstrated that everolimus-eluting stents and Resolute zotarolimus-eluting stents have the best combination of safety and efficacy.CrossRefPubMedCentralPubMed Bangalore S, Toklu B, Amoroso N, Fusaro M, Kumar S, Hannan EL, et al. Bare metal stents, durable polymer drug eluting stents, and biodegradable polymer drug eluting stents for coronary artery disease: mixed treatment comparison meta-analysis. BMJ. 2013;347:f6625. This meta-analysis evaluating bare metal stents, drug-eluting stents, and drug-eluting stents with bioresorbable polymers demonstrated that everolimus-eluting stents and Resolute zotarolimus-eluting stents have the best combination of safety and efficacy.CrossRefPubMedCentralPubMed
63.•
Zurück zum Zitat Navarese EP, Tandjung K, Claessen B, Andreotti F, Kowalewski M, Kandzari DE, et al. Safety and efficacy outcomes of first and second generation durable polymer drug eluting stents and biodegradable polymer biolimus eluting stents in clinical practice: comprehensive network meta-analysis. BMJ. 2013;347:f6530. Demonstrated that bioresorbable polymers have a significantly higher rate of myocardial infarction when compared to everolimus-eluting stents and Resolute zotarolimus-eluting stents.CrossRefPubMedCentralPubMed Navarese EP, Tandjung K, Claessen B, Andreotti F, Kowalewski M, Kandzari DE, et al. Safety and efficacy outcomes of first and second generation durable polymer drug eluting stents and biodegradable polymer biolimus eluting stents in clinical practice: comprehensive network meta-analysis. BMJ. 2013;347:f6530. Demonstrated that bioresorbable polymers have a significantly higher rate of myocardial infarction when compared to everolimus-eluting stents and Resolute zotarolimus-eluting stents.CrossRefPubMedCentralPubMed
64.
Zurück zum Zitat Palmerini T, Biondi-Zoccai G, Della Riva D, Mariani A, Sabaté M, Smits PC, et al. Clinical outcomes with bioabsorbable polymer- versus durable polymer-based drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol. 2014;63:299–307.CrossRefPubMed Palmerini T, Biondi-Zoccai G, Della Riva D, Mariani A, Sabaté M, Smits PC, et al. Clinical outcomes with bioabsorbable polymer- versus durable polymer-based drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol. 2014;63:299–307.CrossRefPubMed
65.•
Zurück zum Zitat Nishio S, Kosuga K, Igaki K, Okada M, Kyo E, Tsuji T, et al. Long-term (>10 years) clinical outcomes of first-in-human biodegradable poly-l-lactic acid coronary stents: Igaki-Tamai stents. Circulation. 2012;125:2343–53. This 10 year investigation of bioresorbable stents demonstrated a good safety and efficacy profile with the stent struts mostly disappearing by 3 years follow-up.CrossRefPubMed Nishio S, Kosuga K, Igaki K, Okada M, Kyo E, Tsuji T, et al. Long-term (>10 years) clinical outcomes of first-in-human biodegradable poly-l-lactic acid coronary stents: Igaki-Tamai stents. Circulation. 2012;125:2343–53. This 10 year investigation of bioresorbable stents demonstrated a good safety and efficacy profile with the stent struts mostly disappearing by 3 years follow-up.CrossRefPubMed
66.
Zurück zum Zitat Diletti R, Serruys PW, Farooq V, Sudhir K, Dorange C, Miquel-Hebert K, 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;164:654–63.CrossRefPubMed Diletti R, Serruys PW, Farooq V, Sudhir K, Dorange C, Miquel-Hebert K, 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;164:654–63.CrossRefPubMed
67.
Zurück zum Zitat Capodanno D, Gori T, Nef H, Latib A, Mehilli J, Lesiak M, Caramanno G, Naber C, Di Mario C, Colombo A, Capranzano P, Wiebe J, Araszkiewicz A, Geraci S, Pyxaras S, Mattesini A, Naganuma T, Münzel T, Tamburino C. Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry. EuroIntervention. 2014 Jul 18. [Epub ahead of print] Capodanno D, Gori T, Nef H, Latib A, Mehilli J, Lesiak M, Caramanno G, Naber C, Di Mario C, Colombo A, Capranzano P, Wiebe J, Araszkiewicz A, Geraci S, Pyxaras S, Mattesini A, Naganuma T, Münzel T, Tamburino C. Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry. EuroIntervention. 2014 Jul 18. [Epub ahead of print]
68.
Zurück zum Zitat Rasmussen K, Maeng M, Kaltoft A, Thayssen P, Kelbaek H, Tilsted HH, 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;375:1090–9.CrossRefPubMed Rasmussen K, Maeng M, Kaltoft A, Thayssen P, Kelbaek H, Tilsted HH, 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;375:1090–9.CrossRefPubMed
Metadaten
Titel
Drug-Eluting Stents: the Past, Present, and Future
verfasst von
Gregory Katz
Bhisham Harchandani
Binita Shah
Publikationsdatum
01.03.2015
Verlag
Springer US
Erschienen in
Current Atherosclerosis Reports / Ausgabe 3/2015
Print ISSN: 1523-3804
Elektronische ISSN: 1534-6242
DOI
https://doi.org/10.1007/s11883-014-0485-2

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