Durable Polymer Everolimus Eluting Stents
Vikas Thondapu
Search for more papers by this authorNalin H. Dayawansa
Search for more papers by this authorBimmer Claessen
Search for more papers by this authorGeorge D. Dangas
Search for more papers by this authorPeter Barlis
Search for more papers by this authorVikas Thondapu
Search for more papers by this authorNalin H. Dayawansa
Search for more papers by this authorBimmer Claessen
Search for more papers by this authorGeorge D. Dangas
Search for more papers by this authorPeter Barlis
Search for more papers by this authorGeorge D. Dangas MD, MACC, MSCAI, FAHA, FESC
Professor of Medicine (Cardiology) & Surgery (Vascular) Professor of Cardiology Adjunct Professor of Internal Medicine
Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, New York, NY, USA
National Kapodistrian University of Athens, Greece
Medical University of Vienna, Austria
Search for more papers by this authorCarlo Di Mario MD, PhD, FRCP, FACC, FSCAI, FESC
Professor of Cardiology Director of the Structural Interventional Cardiology Division Honorary Consultant
University of Florence
University Hospital Careggi, Florence, Italy
Cardiologist Royal Brompton Hospital, London, UK
Search for more papers by this authorHolger Thiele MD
Professor of Cardiology at University of Leipzig
Heart Center Leipzig at University of Leipzig, Leipzig, Germany
Search for more papers by this authorPeter Barlis MBBS, MPH, PHD, FACC, FESC, FRACP
Professor of Cardiology Interventional Cardiologist
University of Melbourne, Melbourne, Victoria, Australia
St Vincent's & Northern Hospitals Victoria, Australia
Search for more papers by this authorSummary
The durable polymer everolimus eluting stents of the Xience and Promus families have become the benchmark of safety and efficacy in the drug eluting stent field. Building on the benefits of first-generation DES, the second-generation DP-EES stents reduced incidence of early restenosis and early stent failure by making improvements to the stent platform, polymer and delivered drug. The Xience and Promus families are characterised by the use of thinner cobalt-chromium or platinum-chromium struts, non-resorbable polymers and by elution of the mTOR inhibitor Everolimus. A robust body of clinical trial evidence has established their superiority over previous BMS and DES and have established these stent families as the gold standard drug-eluting stents with low rates of target vessel failure, target lesion revascularisation and stent thrombosis.
References
- Windecker S , Remondino A , Eberli FR , et al . Sirolimus-eluting and paclitaxel-eluting stents for coronary revascularization . N Engl J Med. 2005 ; 353 ( 7 ): 653 – 62 .
- 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 . The Lancet. 2007 ; 369 ( 9562 ): 667 – 78 .
- Pfisterer M , Brunner-La Rocca HP , Buser PT , et al . 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 ( 12 ): 2584 – 91 .
- Kolandaivelu K , Swaminathan R , Gibson WJ , et al . Stent thrombogenicity early in high-risk interventional settings is driven by stent design and deployment and protected by polymer-drug coatings . Circulation. 2011 ; 123 ( 13 ): 1400 – 9 .
- Foin N , Gutierrez-Chico JL , Nakatani S , et al . Incomplete stent apposition causes high shear flow disturbances and delay in neointimal coverage as a function of strut to wall detachment distance: implications for the management of incomplete stent apposition . Circ Cardiovasc Interv. 2014 ; 7 ( 2 ): 180 – 9 .
- LaDisa JF , Jr. , Olson LE , Douglas HA , et al . Alterations in regional vascular geometry produced by theoretical stent implantation influence distributions of wall shear stress: analysis of a curved coronary artery using 3D computational fluid dynamics modeling . Biomed Eng Online. 2006 ; 5 : 40 .
- Tanigawa J , Barlis P , Dimopoulos K , et al . The influence of strut thickness and cell design on immediate apposition of drug-eluting stents assessed by optical coherence tomography . Int J Cardiol. 2009 ; 134 ( 2 ): 180 – 8 .
- Wentzel JJ , Whelan DM , van der Giessen WJ , et al . Coronary stent implantation changes 3-D vessel geometry and 3-D shear stress distribution . J Biomechanics. 2000 ; 33 : 1287 – 95 .
- Hara H , Nakamura M , Palmaz JC , Schwartz RS . Role of stent design and coatings on restenosis and thrombosis . Adv Drug Deliv Rev. 2006 ; 58 ( 3 ): 377 – 86 .
- Sullivan TM , Ainsworth SD , Langan EM , et al . Effect of endovascular stent strut geometry on vascular injury, myointimal hyperplasia, and restenosis . J Vasc Surg. 2002 ; 36 ( 1 ): 143 – 9 .
- Papayannis AC , Cipher D , Banerjee S , Brilakis ES . Optical coherence tomography evaluation of drug-eluting stents: a systematic review . Catheter Cardiovasc Interv. 2013 ; 81 ( 3 ): 481 – 7 .
- Chen Q , Thouas GA . Metallic implant biomaterials . Materials Science and Engineering: R: Reports. 2015 ; 87 : 1 – 57 .
- Hanawa T . Materials for metallic stents . J Artif Organs. 2009 ; 12 ( 2 ): 73 – 9 .
- He Y , Maehara A , Mintz GS , et al . Intravascular ultrasound assessment of cobalt chromium versus stainless steel drug-eluting stent expansion . Am J Cardiol. 2010 ; 105 ( 9 ): 1272 – 5 .
- Kapnisis K , Constantinides G , Georgiou H , et al . Multi-scale mechanical investigation of stainless steel and cobalt-chromium stents . J Mech Behav Biomed Mater. 2014 ; 40 : 240 – 51 .
- Lewis G . Materials, fluid dynamics, and solid mechanics aspects of coronary artery stents: a state-of-the-art review . J Biomed Mater Res B Appl Biomater. 2008 ; 86 ( 2 ): 569 – 90 .
- Ormiston JA , Webber B , Webster MW . Stent longitudinal integrity bench insights into a clinical problem . JACC Cardiovasc Interv. 2011 ; 4 ( 12 ): 1310 – 7 .
- Ormiston JA , Webber B , Ubod B , et al . Stent longitudinal strength assessed using point compression: insights from a second-generation, clinically related bench test . Circ Cardiovasc Interv. 2014 ; 7 ( 1 ): 62 – 9 .
- Mitsis A , Valgimigli M . Device profile of the XIENCE V and XIENCE Sierra stents for the treatment of coronary artery disease: an overview of safety and efficacy . Expert Review of Medical Devices. 2020 ; 17 ( 5 ): 383 – 90 .
- Bennett J , Dubois C . A novel platinum chromium everolimus-eluting stent for the treatment of coronary artery disease . Biologics. 2013 ; 7 : 149 – 59 .
- Ota T , Ishii H , Sumi T , et al . Impact of coronary stent designs on acute stent recoil . J Cardiol. 2014 ; 64 ( 5 ): 347 – 52 .
- Livingston M , Tan A . Coating techniques and release kinetics of drug-eluting stents . J Med Dev. 2016 ; 10 ( 1 ).
- 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 – 81 .
- Chin-Quee SL , Hsu SH , Nguyen-Ehrenreich KL , et al . Endothelial cell recovery, acute thrombogenicity, and monocyte adhesion and activation on fluorinated copolymer and phosphorylcholine polymer stent coatings . Biomaterials. 2010 ; 31 ( 4 ): 648 – 57 .
- Gutierrez-Chico JL , van Geuns RJ , Regar E , et al . Tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent vs a fluoropolymer-coated everolimus-eluting stent at 13-month follow-up: an optical coherence tomography substudy from the RESOLUTE All Comers trial . Eur Heart J. 2011 ; 32 ( 19 ): 2454 – 63 .
- Xie X , Guidoin R , Nutley M , Zhang Z . Fluoropassivation and gelatin sealing of polyester arterial prostheses to skip preclotting and constrain the chronic inflammatory response . Journal of biomedical materials research Part B, Applied biomaterials . 2010 ; 93 ( 2 ): 497 – 509 .
- Tada T , Byrne RA , Simunovic I , et al . Risk of stent thrombosis among bare-metal stents, first-generation drug-eluting stents, and second-generation drug-eluting stents: results from a registry of 18,334 patients . JACC: Cardiovascular Interventions. 2013 ; 6 ( 12 ): 1267 – 74 .
- Guidoin R , Marois T , Zhang Z , et al . The Benefits of Fluoropassivation of Polyester Arterial Prostheses as Observed in a Canine Model . ASAIO Journal. 1994 ; 40 : M870 – 9 .
- Räber L , Magro M , Stefanini GG , et al . Very late coronary stent thrombosis of a newer-generation everolimus-eluting stent compared with early-generation drug-eluting stents: a prospective cohort study . Circulation. 2012 ; 125 ( 9 ): 1110 – 21 .
- 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 – 15 .
- 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: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2005 ; 1 ( 1 ): 58 – 65 .
- Wiemer M , Serruys PW , Miquel-Hebert K , et al . Five-year long-term clinical follow-up of the XIENCE V everolimus eluting coronary stent system in the treatment of patients with de novo coronary artery lesions: the SPIRIT FIRST trial . Catheter Cardiovasc Int. 2010 ; 75 ( 7 ): 997 – 1003 .
- 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 . EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2006 ; 2 ( 3 ): 286 – 94 .
- Claessen BE , Beijk MA , Legrand V , et al . Two-year clinical, angiographic, and intravascular ultrasound follow-up of the XIENCE V everolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions: the SPIRIT II trial . Circ Cardiovasc Interv. 2009 ; 2 ( 4 ): 339 – 47 .
- Onuma Y , Miquel-Hebert K , Serruys PW . Five-year long-term clinical follow-up of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with de novo coronary artery disease: the SPIRIT II trial . EuroIntervention. 2013 ; 8 : 1047 – 51 .
- Stone GW , Midei MG , 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 – 13 .
- Gada H , Kirtane AJ , Newman W , et al . 5-year results of a randomized comparison of XIENCE V everolimus-eluting and TAXUS paclitaxel-eluting stents: final results from the SPIRIT III trial (clinical evaluation of the XIENCE V everolimus eluting coronary stent system in the treatment of patients with de novo native coronary artery lesions) . JACC Cardiovasc Interv . 2013 ; 6 ( 12 ): 1263 – 6 .
- Brener SJ , Kereiakes DJ , Simonton CA , et al . Everolimus-eluting stents in patients undergoing percutaneous coronary intervention: final 3-year results of the Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions trial . Am Heart J. 2013 ; 166 ( 6 ): 1035 – 42 .
- Ellis SG , Vandormael MG , Cowley MJ , et al . Coronary morphologic and clinical determinants of procedural outcome with angioplasty for multivessel coronary disease. Implications for patient selection. Multivessel Angioplasty Prognosis Study Group . Circulation. 1990 ; 82 ( 4 ): 1193 – 202 .
- Kedhi E , Joesoef KS , McFadden E , et al . Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial . The Lancet. 2010 ; 375 : 205 – 9 .
- Smits PC , Kedhi E , Royaards K-J , 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 LIBERTÉ stent in all-comers: a randomized open label trial) . J Am Coll Cardiol. 2011 ; 58 ( 1 ): 11 – 8 .
- Sabate M , Cequier A , Iñiguez 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 . The Lancet. 2012 ; 380 ( 9852 ): 1482 – 90 .
- Sabaté M , Brugaletta S , Cequier A , et al . The EXAMINATION trial (everolimus-eluting stents versus bare-metal stents in ST-segment elevation myocardial infarction): 2-year results from a multicenter randomized controlled trial . JACC: Cardiovascular Interventions. 2014 ; 7 ( 1 ): 64 – 71 .
- 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 – 54 .
- Serruys PW , Morice M-C , Kappetein AP , et al . Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease . N Engl J Med. 2009 ; 360 ( 10 ): 961 – 72 .
- Ribichini F , Romano M , Rosiello R , et al . A clinical and angiographic study of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with multivessel coronary artery disease: the EXECUTIVE trial (EXecutive RCT: evaluating XIENCE V in a multi vessel disease) . JACC Cardiovascular interventions. 2013 ; 6 ( 10 ): 1012 – 22 .
- 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 – 61 .
- 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 – 16 .
- Cassese S , Byrne RA , Tada T , et al . Clinical impact of extended dual antiplatelet therapy after percutaneous coronary interventions in the drug-eluting stent era: a meta-analysis of randomized trials . Eur Heart J . 2012 ; 33 ( 24 ): 3078 – 87 .
- Valgimigli M , Park S-J , Kim H-S , et al . Tricoci P, et al . Benefits and risks of long-term duration of dual antiplatelet therapy after drug-eluting stenting: a meta-analysis of randomized trials . International journal of cardiology. 2013 ; 168 ( 3 ): 2579 – 87 .
- Gwon HC , Hahn JY , Park KW , et al . Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: the Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) randomized, multicenter study . Circulation. 2012 ; 125 ( 3 ): 505 – 13 .
- Naidu SS , Krucoff MW , Rutledge DR , et al . Contemporary incidence and predictors of stent thrombosis and other major adverse cardiac events in the year after XIENCE V implantation: results from the 8,061-patient XIENCE V United States study . JACC Cardiovasc Interv. 2012 ; 5 ( 6 ): 626 – 35 .
- Silber S , Kirtane AJ , Belardi JA , et al . Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation . Eur Heart J. 2014 ; 35 ( 29 ): 1949 – 56 .
- Meredith I , Whitbourn R , Scott D , et al . PLATINUM QCA: a prospective, multicentre study assessing clinical, angiographic, and intravascular ultrasound outcomes with the novel platinum chromium thin-strut PROMUS Element everolimus-eluting stent in de novo coronary stenoses . EuroIntervention. 2011 ; 7 : 84 – 90 .
- 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 – 8 .
- Meredith IT , Teirstein PS , Bouchard A , et al . Three-year results comparing platinum-chromium PROMUS element and cobalt-chromium XIENCE V everolimus-eluting stents in de novo coronary artery narrowing (from the PLATINUM Trial) . Am J Cardiol. 2014 ; 113 ( 7 ): 1117 – 23 .
- Serruys PW , Silber S , Garg S , et al . Comparison of Zotarolimus-Eluting and Everolimus-Eluting Coronary Stents . NEJM. 2010 ; 363 : 136 – 46 .
- Cannon LA , Kereiakes D , Mann T , et al . A prospective evaluation of the safety and efficacy of TAXUS Element paclitaxel-eluting coronary stent implantation for the treatment of de novo coronary artery lesions in small vessels: the PERSEUS Small Vessel trial . EuroIntervention. 2011 ; 6 : 920 – 7 .
- Cannon LA , Simon DI , Kereiakes D , et al . The XIENCE nano everolimus eluting coronary stent system for the treatment of small coronary arteries: the SPIRIT Small Vessel trial . Catheter Cardiovasc Interv. 2012 ; 80 ( 4 ): 546 – 53 .
- Wykrzykowska JJ , Serruys PW , Onuma Y , et al . Impact of vessel size on angiographic and clinical outcomes of revascularization with biolimus-eluting stent with biodegradable polymer and sirolimus-eluting stent with durable polymer the LEADERS trial substudy . JACC Cardiovasc Interv. 2009 ; 2 ( 9 ): 861 – 70 .
- Teirstein PS , Meredith IT , Feldman RL , et al . Two-year safety and effectiveness of the platinum chromium everolimus-eluting stent for the treatment of small vessels and longer lesions . Catheterization and cardiovascular interventions: official journal of the Society for Cardiac Angiography & Interventions. 2015 ; 85 ( 2 ): 207 – 15 .
-
Teirstein P
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Stone GW
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Meredith IT
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et al
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TCT-236 Four-Year Outcomes Following Implantation of the Promus Element® Platinum Chromium Everolimus-Eluting Stent in De Novo Coronary Artery Lesions in Small Vessels and Long Lesions: Results of the PLATINUM Small Vessel and Long Lesion Trials
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J Am Coll Cardiol.
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10.1016/j.jacc.2014.07.922 Google Scholar
- 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 ( 20 ): 2148 – 53 .
- Wykrzykowska J , Raber L , de Vries T , et al . Biolimus-eluting biodegradable polymer versus sirolimus-eluting permanent polymer stent performance in long lesions: results from the LEADERS multicentre trial substudy . EuroIntervention. 2009 ; 5 : 310 – 7 .
- 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 . The Lancet. 2014 ; 383 ( 9915 ): 413 – 23 .
- Park KW , Kang SH , Kang HJ , et al . A randomized comparison of platinum chromium-based everolimus-eluting stents versus cobalt chromium-based Zotarolimus-Eluting stents in all-comers receiving percutaneous coronary intervention: HOST-ASSURE (harmonizing optimal strategy for treatment of coronary artery stenosis-safety & effectiveness of drug-eluting stents & anti-platelet regimen), a randomized, controlled, noninferiority trial . J Am Coll Cardiol. 2014 ; 63 ( 25 Pt A ): 2805 – 16 .
- Sarno G , Lagerqvist B , Carlsson J , et al . Initial clinical experience with an everolimus eluting platinum chromium stent (Promus Element) in unselected patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) . Int J Cardiol. 2013 ; 167 ( 1 ): 146 – 50 .