Safety and Efficacy of New Sirolimus-eluting Stent Models in a Preclinical Study
Initial preclinical studies are required during the process of improving polymers, platforms, and drug-eluting systems for new coronary stent designs. Our objective was to analyze the efficacy and safety of new drug-eluting stent models compared with a conventional stent and commercialized drug-elut...
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Veröffentlicht in: | Revista española de cardiología (English ed.) 2015-12, Vol.68 (12), p.1118-1124 |
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creator | Estévez-Loureiro, Rodrigo Pérez de Prado, Armando Pérez-Martínez, Claudia Cuellas-Ramón, Carlos Regueiro-Purriños, Marta Gonzalo-Orden, José M López-Benito, María Molina-Crisol, María Duocastella-Codina, Luis Fernández-Vázquez, Felipe |
description | Initial preclinical studies are required during the process of improving polymers, platforms, and drug-eluting systems for new coronary stent designs. Our objective was to analyze the efficacy and safety of new drug-eluting stent models compared with a conventional stent and commercialized drug-eluting stents in an experimental model with healthy porcine coronary arteries.
Sixty stents (conventional stent, new sirolimus-eluting stents: drug-eluting stents 1, 2 and 3; Cypher(®) and Xience(®)) were randomly placed in the coronary arteries of 20 Large White domestic pigs. Angiographic and histomorphometric studies were done 28 days later.
The stents were implanted at a stent/artery ratio of 1.34±0.15, with no significant differences between groups. The new stents showed less late loss and angiographic restenosis than conventional stents (P=.006 and P |
doi_str_mv | 10.1016/j.rec.2015.02.028 |
format | Article |
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Sixty stents (conventional stent, new sirolimus-eluting stents: drug-eluting stents 1, 2 and 3; Cypher(®) and Xience(®)) were randomly placed in the coronary arteries of 20 Large White domestic pigs. Angiographic and histomorphometric studies were done 28 days later.
The stents were implanted at a stent/artery ratio of 1.34±0.15, with no significant differences between groups. The new stents showed less late loss and angiographic restenosis than conventional stents (P=.006 and P<.001, respectively). Histologically, restenosis and neointimal area were lower with all the new platforms than with the conventional stents (P<.001 for each variable), and no differences were found vs the drug-eluting stents on the market. Safety data showed that endothelialization was lower with drug-eluting stents than with conventional stents, except for drug-eluting stent 3 (P=.084). Likewise, inflammation was lower with drug-eluting stent 3 than with other stents.
The new drug-eluting stent platforms studied are associated with less restenosis than conventional stents and showed no significant differences in safety or efficacy vs commercialized drug-eluting stents.</description><identifier>ISSN: 1885-5857</identifier><identifier>EISSN: 1885-5857</identifier><identifier>DOI: 10.1016/j.rec.2015.02.028</identifier><identifier>PMID: 26206247</identifier><language>eng</language><publisher>Spain</publisher><subject>Animals ; Coronary Angiography ; Coronary Restenosis - diagnostic imaging ; Coronary Restenosis - prevention & control ; Coronary Vessels - diagnostic imaging ; Disease Models, Animal ; Drug-Eluting Stents ; Immunosuppressive Agents - administration & dosage ; Immunosuppressive Agents - pharmacology ; Prosthesis Design ; Random Allocation ; Sirolimus - administration & dosage ; Sirolimus - pharmacology ; Sus scrofa ; Swine</subject><ispartof>Revista española de cardiología (English ed.), 2015-12, Vol.68 (12), p.1118-1124</ispartof><rights>Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c231t-7024d4e9bb51e7b2b761976844e97c506b1fbb9a001d923d2041e68f71b11c8a3</citedby><cites>FETCH-LOGICAL-c231t-7024d4e9bb51e7b2b761976844e97c506b1fbb9a001d923d2041e68f71b11c8a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26206247$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Estévez-Loureiro, Rodrigo</creatorcontrib><creatorcontrib>Pérez de Prado, Armando</creatorcontrib><creatorcontrib>Pérez-Martínez, Claudia</creatorcontrib><creatorcontrib>Cuellas-Ramón, Carlos</creatorcontrib><creatorcontrib>Regueiro-Purriños, Marta</creatorcontrib><creatorcontrib>Gonzalo-Orden, José M</creatorcontrib><creatorcontrib>López-Benito, María</creatorcontrib><creatorcontrib>Molina-Crisol, María</creatorcontrib><creatorcontrib>Duocastella-Codina, Luis</creatorcontrib><creatorcontrib>Fernández-Vázquez, Felipe</creatorcontrib><title>Safety and Efficacy of New Sirolimus-eluting Stent Models in a Preclinical Study</title><title>Revista española de cardiología (English ed.)</title><addtitle>Rev Esp Cardiol (Engl Ed)</addtitle><description>Initial preclinical studies are required during the process of improving polymers, platforms, and drug-eluting systems for new coronary stent designs. Our objective was to analyze the efficacy and safety of new drug-eluting stent models compared with a conventional stent and commercialized drug-eluting stents in an experimental model with healthy porcine coronary arteries.
Sixty stents (conventional stent, new sirolimus-eluting stents: drug-eluting stents 1, 2 and 3; Cypher(®) and Xience(®)) were randomly placed in the coronary arteries of 20 Large White domestic pigs. Angiographic and histomorphometric studies were done 28 days later.
The stents were implanted at a stent/artery ratio of 1.34±0.15, with no significant differences between groups. The new stents showed less late loss and angiographic restenosis than conventional stents (P=.006 and P<.001, respectively). Histologically, restenosis and neointimal area were lower with all the new platforms than with the conventional stents (P<.001 for each variable), and no differences were found vs the drug-eluting stents on the market. Safety data showed that endothelialization was lower with drug-eluting stents than with conventional stents, except for drug-eluting stent 3 (P=.084). Likewise, inflammation was lower with drug-eluting stent 3 than with other stents.
The new drug-eluting stent platforms studied are associated with less restenosis than conventional stents and showed no significant differences in safety or efficacy vs commercialized drug-eluting stents.</description><subject>Animals</subject><subject>Coronary Angiography</subject><subject>Coronary Restenosis - diagnostic imaging</subject><subject>Coronary Restenosis - prevention & control</subject><subject>Coronary Vessels - diagnostic imaging</subject><subject>Disease Models, Animal</subject><subject>Drug-Eluting Stents</subject><subject>Immunosuppressive Agents - administration & dosage</subject><subject>Immunosuppressive Agents - pharmacology</subject><subject>Prosthesis Design</subject><subject>Random Allocation</subject><subject>Sirolimus - administration & dosage</subject><subject>Sirolimus - pharmacology</subject><subject>Sus scrofa</subject><subject>Swine</subject><issn>1885-5857</issn><issn>1885-5857</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpNUF1LwzAUDaK4Of0BvkgefWnNTZsmfZQxP2DqYPockjSRjK6dTYv035uxKcKBe7n3nMO9B6FrICkQKO42aWdNSgmwlNAIcYKmIARLmGD89F8_QRchbAhhmeD5OZrQgpKC5nyKVmvlbD9i1VR44Zw3yoy4dfjVfuO179rab4eQ2HroffOJ171tevzSVrYO2DdY4VW8oPZN1NVxO1TjJTpzqg726lhn6ONh8T5_SpZvj8_z-2ViaAZ9wgnNq9yWWjOwXFPNCyh5IfI444aRQoPTulSEQFXSrKIkB1sIx0EDGKGyGbo9-O669muwoZdbH4yta9XYdggSOCN5BpSUkQoHqunaEDrr5K7zW9WNEojcByk3Mr4h90FKQiNE1Nwc7Qe9tdWf4je57AcCTm4b</recordid><startdate>201512</startdate><enddate>201512</enddate><creator>Estévez-Loureiro, Rodrigo</creator><creator>Pérez de Prado, Armando</creator><creator>Pérez-Martínez, Claudia</creator><creator>Cuellas-Ramón, Carlos</creator><creator>Regueiro-Purriños, Marta</creator><creator>Gonzalo-Orden, José M</creator><creator>López-Benito, María</creator><creator>Molina-Crisol, María</creator><creator>Duocastella-Codina, Luis</creator><creator>Fernández-Vázquez, Felipe</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201512</creationdate><title>Safety and Efficacy of New Sirolimus-eluting Stent Models in a Preclinical Study</title><author>Estévez-Loureiro, Rodrigo ; Pérez de Prado, Armando ; Pérez-Martínez, Claudia ; Cuellas-Ramón, Carlos ; Regueiro-Purriños, Marta ; Gonzalo-Orden, José M ; López-Benito, María ; Molina-Crisol, María ; Duocastella-Codina, Luis ; Fernández-Vázquez, Felipe</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c231t-7024d4e9bb51e7b2b761976844e97c506b1fbb9a001d923d2041e68f71b11c8a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Animals</topic><topic>Coronary Angiography</topic><topic>Coronary Restenosis - diagnostic imaging</topic><topic>Coronary Restenosis - prevention & control</topic><topic>Coronary Vessels - diagnostic imaging</topic><topic>Disease Models, Animal</topic><topic>Drug-Eluting Stents</topic><topic>Immunosuppressive Agents - administration & dosage</topic><topic>Immunosuppressive Agents - pharmacology</topic><topic>Prosthesis Design</topic><topic>Random Allocation</topic><topic>Sirolimus - administration & dosage</topic><topic>Sirolimus - pharmacology</topic><topic>Sus scrofa</topic><topic>Swine</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Estévez-Loureiro, Rodrigo</creatorcontrib><creatorcontrib>Pérez de Prado, Armando</creatorcontrib><creatorcontrib>Pérez-Martínez, Claudia</creatorcontrib><creatorcontrib>Cuellas-Ramón, Carlos</creatorcontrib><creatorcontrib>Regueiro-Purriños, Marta</creatorcontrib><creatorcontrib>Gonzalo-Orden, José M</creatorcontrib><creatorcontrib>López-Benito, María</creatorcontrib><creatorcontrib>Molina-Crisol, María</creatorcontrib><creatorcontrib>Duocastella-Codina, Luis</creatorcontrib><creatorcontrib>Fernández-Vázquez, Felipe</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Revista española de cardiología (English ed.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Estévez-Loureiro, Rodrigo</au><au>Pérez de Prado, Armando</au><au>Pérez-Martínez, Claudia</au><au>Cuellas-Ramón, Carlos</au><au>Regueiro-Purriños, Marta</au><au>Gonzalo-Orden, José M</au><au>López-Benito, María</au><au>Molina-Crisol, María</au><au>Duocastella-Codina, Luis</au><au>Fernández-Vázquez, Felipe</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and Efficacy of New Sirolimus-eluting Stent Models in a Preclinical Study</atitle><jtitle>Revista española de cardiología (English ed.)</jtitle><addtitle>Rev Esp Cardiol (Engl Ed)</addtitle><date>2015-12</date><risdate>2015</risdate><volume>68</volume><issue>12</issue><spage>1118</spage><epage>1124</epage><pages>1118-1124</pages><issn>1885-5857</issn><eissn>1885-5857</eissn><abstract>Initial preclinical studies are required during the process of improving polymers, platforms, and drug-eluting systems for new coronary stent designs. Our objective was to analyze the efficacy and safety of new drug-eluting stent models compared with a conventional stent and commercialized drug-eluting stents in an experimental model with healthy porcine coronary arteries.
Sixty stents (conventional stent, new sirolimus-eluting stents: drug-eluting stents 1, 2 and 3; Cypher(®) and Xience(®)) were randomly placed in the coronary arteries of 20 Large White domestic pigs. Angiographic and histomorphometric studies were done 28 days later.
The stents were implanted at a stent/artery ratio of 1.34±0.15, with no significant differences between groups. The new stents showed less late loss and angiographic restenosis than conventional stents (P=.006 and P<.001, respectively). Histologically, restenosis and neointimal area were lower with all the new platforms than with the conventional stents (P<.001 for each variable), and no differences were found vs the drug-eluting stents on the market. Safety data showed that endothelialization was lower with drug-eluting stents than with conventional stents, except for drug-eluting stent 3 (P=.084). Likewise, inflammation was lower with drug-eluting stent 3 than with other stents.
The new drug-eluting stent platforms studied are associated with less restenosis than conventional stents and showed no significant differences in safety or efficacy vs commercialized drug-eluting stents.</abstract><cop>Spain</cop><pmid>26206247</pmid><doi>10.1016/j.rec.2015.02.028</doi><tpages>7</tpages></addata></record> |
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subjects | Animals Coronary Angiography Coronary Restenosis - diagnostic imaging Coronary Restenosis - prevention & control Coronary Vessels - diagnostic imaging Disease Models, Animal Drug-Eluting Stents Immunosuppressive Agents - administration & dosage Immunosuppressive Agents - pharmacology Prosthesis Design Random Allocation Sirolimus - administration & dosage Sirolimus - pharmacology Sus scrofa Swine |
title | Safety and Efficacy of New Sirolimus-eluting Stent Models in a Preclinical Study |
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