Metallic Limus‐Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra‐Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial
Summary Aims To evaluate the outcomes of patients treated with a new drug‐eluting stent formulation with low doses of sirolimus, built in an ultra‐thin‐strut platform coated with biodegradable abluminal coating. Methods This study is a randomized trial that tested the main hypothesis that the angiog...
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| Veröffentlicht in: | Cardiovascular therapeutics 2015-12, Vol.33 (6), p.367-371 |
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| creator | Lemos, Pedro A. Abizaid, Alexandre A. C. Meireles, George C. Sarmento‐Leite, Rogério Prudente, Mauricio Cantarelli, Marcelo Dourado, Adriano D. Mariani, Jose Perin, Marco A. Costantini, Costantino Costa, Ricardo A. Costa, José Ribamar Chamie, Daniel Campos, Carlos A. Ribeiro, Expedito |
| description | Summary
Aims
To evaluate the outcomes of patients treated with a new drug‐eluting stent formulation with low doses of sirolimus, built in an ultra‐thin‐strut platform coated with biodegradable abluminal coating.
Methods
This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus‐eluting stent is noninferior compared with commercially available biolimus‐eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus‐eluting stent or biolimus‐eluting stent, respectively. The primary endpoint was 9‐month angiographic in‐stent late lumen loss. Adverse clinical events were prospectively collected for 1 year.
Results
After 9 months, the novel sirolimus‐eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in‐stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority |
| doi_str_mv | 10.1111/1755-5922.12159 |
| format | Article |
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Aims
To evaluate the outcomes of patients treated with a new drug‐eluting stent formulation with low doses of sirolimus, built in an ultra‐thin‐strut platform coated with biodegradable abluminal coating.
Methods
This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus‐eluting stent is noninferior compared with commercially available biolimus‐eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus‐eluting stent or biolimus‐eluting stent, respectively. The primary endpoint was 9‐month angiographic in‐stent late lumen loss. Adverse clinical events were prospectively collected for 1 year.
Results
After 9 months, the novel sirolimus‐eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in‐stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority <0.001). The 1‐year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups.
Conclusions
The present randomized trial demonstrates that the tested novel sirolimus‐eluting stent was angiographically noninferior in comparison with a last‐generation biolimus‐eluting stent.</description><identifier>ISSN: 1755-5914</identifier><identifier>EISSN: 1755-5922</identifier><identifier>DOI: 10.1111/1755-5922.12159</identifier><identifier>PMID: 26352896</identifier><language>eng</language><publisher>England: Hindawi Limited</publisher><subject>Absorbable Implants ; Aged ; Atherosclerosis ; Brazil ; Cardiovascular Agents - administration & dosage ; Coated Materials, Biocompatible ; Coronary ; Coronary Angiography ; Coronary Artery Disease - diagnostic imaging ; Coronary Artery Disease - mortality ; Coronary Artery Disease - therapy ; Coronary Restenosis - etiology ; Coronary Thrombosis - etiology ; Coronary Vessels - diagnostic imaging ; Drug-Eluting Stents ; Female ; Humans ; Male ; Middle Aged ; Myocardial Infarction - etiology ; Percutaneous Coronary Intervention - adverse effects ; Percutaneous Coronary Intervention - instrumentation ; Percutaneous Coronary Intervention - mortality ; Predictive Value of Tests ; Prospective Studies ; Prosthesis Design ; Sirolimus - administration & dosage ; Sirolimus - analogs & derivatives ; Stent ; Time Factors ; Treatment Outcome</subject><ispartof>Cardiovascular therapeutics, 2015-12, Vol.33 (6), p.367-371</ispartof><rights>2015 John Wiley & Sons Ltd</rights><rights>2015 John Wiley & Sons Ltd.</rights><rights>Copyright © 2015 John Wiley & Sons Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4129-ea85013481047d701edac780a07ee3eb49750d6172bbcbdf231aaff07f5991aa3</citedby><cites>FETCH-LOGICAL-c4129-ea85013481047d701edac780a07ee3eb49750d6172bbcbdf231aaff07f5991aa3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2F1755-5922.12159$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2F1755-5922.12159$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1427,11543,27903,27904,46030,46387,46454,46811</link.rule.ids><linktorsrc>$$Uhttps://onlinelibrary.wiley.com/doi/abs/10.1111%2F1755-5922.12159$$EView_record_in_Wiley-Blackwell$$FView_record_in_$$GWiley-Blackwell</linktorsrc><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26352896$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lemos, Pedro A.</creatorcontrib><creatorcontrib>Abizaid, Alexandre A. C.</creatorcontrib><creatorcontrib>Meireles, George C.</creatorcontrib><creatorcontrib>Sarmento‐Leite, Rogério</creatorcontrib><creatorcontrib>Prudente, Mauricio</creatorcontrib><creatorcontrib>Cantarelli, Marcelo</creatorcontrib><creatorcontrib>Dourado, Adriano D.</creatorcontrib><creatorcontrib>Mariani, Jose</creatorcontrib><creatorcontrib>Perin, Marco A.</creatorcontrib><creatorcontrib>Costantini, Costantino</creatorcontrib><creatorcontrib>Costa, Ricardo A.</creatorcontrib><creatorcontrib>Costa, José Ribamar</creatorcontrib><creatorcontrib>Chamie, Daniel</creatorcontrib><creatorcontrib>Campos, Carlos A.</creatorcontrib><creatorcontrib>Ribeiro, Expedito</creatorcontrib><title>Metallic Limus‐Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra‐Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial</title><title>Cardiovascular therapeutics</title><addtitle>Cardiovasc Ther</addtitle><description>Summary
Aims
To evaluate the outcomes of patients treated with a new drug‐eluting stent formulation with low doses of sirolimus, built in an ultra‐thin‐strut platform coated with biodegradable abluminal coating.
Methods
This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus‐eluting stent is noninferior compared with commercially available biolimus‐eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus‐eluting stent or biolimus‐eluting stent, respectively. The primary endpoint was 9‐month angiographic in‐stent late lumen loss. Adverse clinical events were prospectively collected for 1 year.
Results
After 9 months, the novel sirolimus‐eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in‐stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority <0.001). The 1‐year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups.
Conclusions
The present randomized trial demonstrates that the tested novel sirolimus‐eluting stent was angiographically noninferior in comparison with a last‐generation biolimus‐eluting stent.</description><subject>Absorbable Implants</subject><subject>Aged</subject><subject>Atherosclerosis</subject><subject>Brazil</subject><subject>Cardiovascular Agents - administration & dosage</subject><subject>Coated Materials, Biocompatible</subject><subject>Coronary</subject><subject>Coronary Angiography</subject><subject>Coronary Artery Disease - diagnostic imaging</subject><subject>Coronary Artery Disease - mortality</subject><subject>Coronary Artery Disease - therapy</subject><subject>Coronary Restenosis - etiology</subject><subject>Coronary Thrombosis - etiology</subject><subject>Coronary Vessels - diagnostic imaging</subject><subject>Drug-Eluting Stents</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Myocardial Infarction - etiology</subject><subject>Percutaneous Coronary Intervention - adverse effects</subject><subject>Percutaneous Coronary Intervention - instrumentation</subject><subject>Percutaneous Coronary Intervention - mortality</subject><subject>Predictive Value of Tests</subject><subject>Prospective Studies</subject><subject>Prosthesis Design</subject><subject>Sirolimus - administration & dosage</subject><subject>Sirolimus - analogs & derivatives</subject><subject>Stent</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>1755-5914</issn><issn>1755-5922</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkcFu1DAQhiMEoqVw5oYsceGyrZ3EccxtSReotBTU3SJxipx4suvKiRc7oVpOPALPxiPwJExIWSEu-OLx6Jv_H_mPoqeMnjI8Z0xwPuMyjk9ZzLi8Fx0fOvcPNUuPokch3FCaUZmxh9FRnCU8zmV2HP14B72y1tRkadoh_Pz2fWGH3nQbsuqh6wOZV3ZoTYfMnhRO9aDJrem35JVxGjZeaVVZIB-c3bfgw0sy7zbGYX-3RU3VaVJY05laWZxud8qb4DriGqLIpfsCllzb3iu0XW9NR1bGOzvuMbmTjyiJD_T6u4tgvwVyvlitLy4_kSt0ca35iputvVH2cfSgUTbAk7v7JLp-vVgXb2fL928uivlyVqcsljNQOacsSXNGU6EFZaBVLXKqqABIoEql4FRnTMRVVVe6iROmVNNQ0XApsUxOoheT7s67zwOEvmxNqMFa1YEbQslElnMuaJYj-vwf9MYNHj91pOIcYxFSIHU2UbV3IXhoyp03rfL7ktFyjLscAy3HcMvfcePEszvdoWpBH_g_-SLAJ-DWWNj_T68szq8m4V-wLbl2</recordid><startdate>201512</startdate><enddate>201512</enddate><creator>Lemos, Pedro A.</creator><creator>Abizaid, Alexandre A. C.</creator><creator>Meireles, George C.</creator><creator>Sarmento‐Leite, Rogério</creator><creator>Prudente, Mauricio</creator><creator>Cantarelli, Marcelo</creator><creator>Dourado, Adriano D.</creator><creator>Mariani, Jose</creator><creator>Perin, Marco A.</creator><creator>Costantini, Costantino</creator><creator>Costa, Ricardo A.</creator><creator>Costa, José Ribamar</creator><creator>Chamie, Daniel</creator><creator>Campos, Carlos A.</creator><creator>Ribeiro, Expedito</creator><general>Hindawi Limited</general><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>K9.</scope><scope>7X8</scope></search><sort><creationdate>201512</creationdate><title>Metallic Limus‐Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra‐Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial</title><author>Lemos, Pedro A. ; Abizaid, Alexandre A. C. ; Meireles, George C. ; Sarmento‐Leite, Rogério ; Prudente, Mauricio ; Cantarelli, Marcelo ; Dourado, Adriano D. ; Mariani, Jose ; Perin, Marco A. ; Costantini, Costantino ; Costa, Ricardo A. ; Costa, José Ribamar ; Chamie, Daniel ; Campos, Carlos A. ; Ribeiro, Expedito</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4129-ea85013481047d701edac780a07ee3eb49750d6172bbcbdf231aaff07f5991aa3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Absorbable Implants</topic><topic>Aged</topic><topic>Atherosclerosis</topic><topic>Brazil</topic><topic>Cardiovascular Agents - administration & dosage</topic><topic>Coated Materials, Biocompatible</topic><topic>Coronary</topic><topic>Coronary Angiography</topic><topic>Coronary Artery Disease - diagnostic imaging</topic><topic>Coronary Artery Disease - mortality</topic><topic>Coronary Artery Disease - therapy</topic><topic>Coronary Restenosis - etiology</topic><topic>Coronary Thrombosis - etiology</topic><topic>Coronary Vessels - diagnostic imaging</topic><topic>Drug-Eluting Stents</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Myocardial Infarction - etiology</topic><topic>Percutaneous Coronary Intervention - adverse effects</topic><topic>Percutaneous Coronary Intervention - instrumentation</topic><topic>Percutaneous Coronary Intervention - mortality</topic><topic>Predictive Value of Tests</topic><topic>Prospective Studies</topic><topic>Prosthesis Design</topic><topic>Sirolimus - administration & dosage</topic><topic>Sirolimus - analogs & derivatives</topic><topic>Stent</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lemos, Pedro A.</creatorcontrib><creatorcontrib>Abizaid, Alexandre A. C.</creatorcontrib><creatorcontrib>Meireles, George C.</creatorcontrib><creatorcontrib>Sarmento‐Leite, Rogério</creatorcontrib><creatorcontrib>Prudente, Mauricio</creatorcontrib><creatorcontrib>Cantarelli, Marcelo</creatorcontrib><creatorcontrib>Dourado, Adriano D.</creatorcontrib><creatorcontrib>Mariani, Jose</creatorcontrib><creatorcontrib>Perin, Marco A.</creatorcontrib><creatorcontrib>Costantini, Costantino</creatorcontrib><creatorcontrib>Costa, Ricardo A.</creatorcontrib><creatorcontrib>Costa, José Ribamar</creatorcontrib><creatorcontrib>Chamie, Daniel</creatorcontrib><creatorcontrib>Campos, Carlos A.</creatorcontrib><creatorcontrib>Ribeiro, Expedito</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Cardiovascular therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext_linktorsrc</fulltext></delivery><addata><au>Lemos, Pedro A.</au><au>Abizaid, Alexandre A. C.</au><au>Meireles, George C.</au><au>Sarmento‐Leite, Rogério</au><au>Prudente, Mauricio</au><au>Cantarelli, Marcelo</au><au>Dourado, Adriano D.</au><au>Mariani, Jose</au><au>Perin, Marco A.</au><au>Costantini, Costantino</au><au>Costa, Ricardo A.</au><au>Costa, José Ribamar</au><au>Chamie, Daniel</au><au>Campos, Carlos A.</au><au>Ribeiro, Expedito</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Metallic Limus‐Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra‐Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial</atitle><jtitle>Cardiovascular therapeutics</jtitle><addtitle>Cardiovasc Ther</addtitle><date>2015-12</date><risdate>2015</risdate><volume>33</volume><issue>6</issue><spage>367</spage><epage>371</epage><pages>367-371</pages><issn>1755-5914</issn><eissn>1755-5922</eissn><abstract>Summary
Aims
To evaluate the outcomes of patients treated with a new drug‐eluting stent formulation with low doses of sirolimus, built in an ultra‐thin‐strut platform coated with biodegradable abluminal coating.
Methods
This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus‐eluting stent is noninferior compared with commercially available biolimus‐eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus‐eluting stent or biolimus‐eluting stent, respectively. The primary endpoint was 9‐month angiographic in‐stent late lumen loss. Adverse clinical events were prospectively collected for 1 year.
Results
After 9 months, the novel sirolimus‐eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in‐stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority <0.001). The 1‐year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups.
Conclusions
The present randomized trial demonstrates that the tested novel sirolimus‐eluting stent was angiographically noninferior in comparison with a last‐generation biolimus‐eluting stent.</abstract><cop>England</cop><pub>Hindawi Limited</pub><pmid>26352896</pmid><doi>10.1111/1755-5922.12159</doi><tpages>5</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 1755-5914 |
| ispartof | Cardiovascular therapeutics, 2015-12, Vol.33 (6), p.367-371 |
| issn | 1755-5914 1755-5922 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1768557068 |
| source | Wiley Online Library Open Access |
| subjects | Absorbable Implants Aged Atherosclerosis Brazil Cardiovascular Agents - administration & dosage Coated Materials, Biocompatible Coronary Coronary Angiography Coronary Artery Disease - diagnostic imaging Coronary Artery Disease - mortality Coronary Artery Disease - therapy Coronary Restenosis - etiology Coronary Thrombosis - etiology Coronary Vessels - diagnostic imaging Drug-Eluting Stents Female Humans Male Middle Aged Myocardial Infarction - etiology Percutaneous Coronary Intervention - adverse effects Percutaneous Coronary Intervention - instrumentation Percutaneous Coronary Intervention - mortality Predictive Value of Tests Prospective Studies Prosthesis Design Sirolimus - administration & dosage Sirolimus - analogs & derivatives Stent Time Factors Treatment Outcome |
| title | Metallic Limus‐Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra‐Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial |
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