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
The aim of this study was to evaluate the safety and efficacy of the novel platinum chromium TAXUS Element paclitaxel-eluting stent (PES) compared with the TAXUS Express PES (Boston Scientific, Natick, Massachusetts) in treating coronary artery stenoses. The TAXUS Element is a novel thin-strut (81 m...
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| Veröffentlicht in: | Journal of the American College of Cardiology 2010-07, Vol.56 (4), p.264-271 |
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| creator | KEREIAKES, Dean J CANNON, Louis A KABOUR, Ameer FOSTER, Michael C WANG, John C UNDERWOOD, Paul DAWKINS, Keith D FELDMAN, Robert L POPMA, Jeffrey J MAGORIEN, Raymond WHITBOURN, Robert DAUBER, Ira M RABINOWITZ, Abram C BALL, Michael W BERTOLET, Barry |
| description | The aim of this study was to evaluate the safety and efficacy of the novel platinum chromium TAXUS Element paclitaxel-eluting stent (PES) compared with the TAXUS Express PES (Boston Scientific, Natick, Massachusetts) in treating coronary artery stenoses.
The TAXUS Element is a novel thin-strut (81 microm), platinum chromium alloy PES designed to improve radial strength, radiopacity, and deliverability, while safely providing comparable restenosis benefit compared with a previous-generation PES.
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) Workhorse (WH) trial is a prospective, randomized (3:1), controlled, multicenter study of the TAXUS Element (vs. TAXUS Express) PES for the treatment of de novo coronary atherosclerotic lesionsor=2.75 to |
| doi_str_mv | 10.1016/j.jacc.2010.04.011 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_proquest_miscellaneous_733998331</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>733998331</sourcerecordid><originalsourceid>FETCH-LOGICAL-p268t-8336ff76ff33ec0e5a4f08838c255abcc738f20ca49e393765ffed4f983236443</originalsourceid><addsrcrecordid>eNpdklurEzEUhUdRPPXoH_BBAiLqw9TMZDIX30odL3DwlF7Qt5KT7rQpmaQmmWL99e5eDqIPISH59tprhZ0kLzI6zGhWvt8Ot0LKYU7xghZDmmUPk0HGeZ0y3lSPkgGtGE8z2lRXydMQtpTSss6aJ8lVTouGlZwNHtRjo62WwhBhV2Rk19qtvdhttCS3fZSug0BGKoIncw8idmAjcYp8BPLN7R0ZO--s8Acyi2BdQPi7jhsijq9gyMSIqG3fkfHGu07jYb7RNp1F38dTSfxAJl53R4UphN7EcFSPGyCTdjprFzPyduJd2IGMeg-k3QvTo6SzRFvsMkXTqPsbVmhPY4hL8UwoiIdTpFYpjCcP90-LAPfH-egHNmgNnFJNhDQ6il9g0tb0aHv9bzo0fAgRunfnVs-Sx0qYAM8v-3Wy-NTOx1_Sm9vPX8ejm3SXl3VMa8ZKpSpcjIGkwEWhaF2zWuacizspK1arnEpRNMAaVpVcKVgVqqlZzsqiYNfJm7PuzrufPYS47HSQYIyw4PqwrBhrEGYZkq_-I7eu9xbNLTNOy7zKKedIvbxQ_V0Hq-Xu_P3L-5FA4PUFEAHnQnlhpQ5_OUZ5gyT7A2Y0yeg</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1506272055</pqid></control><display><type>article</type><title>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</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals Complete</source><source>EZB-FREE-00999 freely available EZB journals</source><source>Alma/SFX Local Collection</source><creator>KEREIAKES, Dean J ; CANNON, Louis A ; KABOUR, Ameer ; FOSTER, Michael C ; WANG, John C ; UNDERWOOD, Paul ; DAWKINS, Keith D ; FELDMAN, Robert L ; POPMA, Jeffrey J ; MAGORIEN, Raymond ; WHITBOURN, Robert ; DAUBER, Ira M ; RABINOWITZ, Abram C ; BALL, Michael W ; BERTOLET, Barry</creator><creatorcontrib>KEREIAKES, Dean J ; CANNON, Louis A ; KABOUR, Ameer ; FOSTER, Michael C ; WANG, John C ; UNDERWOOD, Paul ; DAWKINS, Keith D ; FELDMAN, Robert L ; POPMA, Jeffrey J ; MAGORIEN, Raymond ; WHITBOURN, Robert ; DAUBER, Ira M ; RABINOWITZ, Abram C ; BALL, Michael W ; BERTOLET, Barry</creatorcontrib><description>The aim of this study was to evaluate the safety and efficacy of the novel platinum chromium TAXUS Element paclitaxel-eluting stent (PES) compared with the TAXUS Express PES (Boston Scientific, Natick, Massachusetts) in treating coronary artery stenoses.
The TAXUS Element is a novel thin-strut (81 microm), platinum chromium alloy PES designed to improve radial strength, radiopacity, and deliverability, while safely providing comparable restenosis benefit compared with a previous-generation PES.
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) Workhorse (WH) trial is a prospective, randomized (3:1), controlled, multicenter study of the TAXUS Element (vs. TAXUS Express) PES for the treatment of de novo coronary atherosclerotic lesions<or=28 mm in length in reference vessels>or=2.75 to <or=4.0 mm in diameter. The primary end point was the 12-month rate of target lesion failure, and the secondary end point was 9-month angiographic in-segment percentage diameter stenosis. The study was powered to demonstrate noninferiority to TAXUS Express for both end points.
The intent-to-treat analysis included 1,262 patients (320 TAXUS Express, 942 TAXUS Element). The TAXUS Element was noninferior to TAXUS Express with respect to both the incidence of target lesion failure (5.57% vs. 6.14%, respectively; difference: 0.57%; 95% credible interval: 1.85%; Bayesian posterior probability of noninferiority=0.9996) and percentage diameter stenosis (ln[%DS] 3.09 vs. 3.12, respectively; difference: 0.03; 95% credible interval: 0.11; Bayesian posterior probability of noninferiority=0.9970). No differences in clinical outcomes to 12 months were observed between stent treatments, and stent thrombosis was infrequent (0.3% Express, 0.4% Element).
At 1 year, the TAXUS Element is comparable in efficacy to the TAXUS Express PES. Furthermore, no safety concerns related to the novel platinum chromium alloy or stent design were observed. (A Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions; NCT00484315).</description><identifier>ISSN: 0735-1097</identifier><identifier>EISSN: 1558-3597</identifier><identifier>DOI: 10.1016/j.jacc.2010.04.011</identifier><identifier>PMID: 20493653</identifier><identifier>CODEN: JACCDI</identifier><language>eng</language><publisher>New York, NY: Elsevier</publisher><subject>Aged ; Angioplasty ; Biological and medical sciences ; Cardiology ; Cardiology. Vascular system ; Cardiovascular system ; Chromium - administration & dosage ; Chromium - adverse effects ; Chromium Alloys - administration & dosage ; Chromium Alloys - adverse effects ; Coronary Angiography - standards ; Coronary heart disease ; Coronary Stenosis - diagnostic imaging ; Coronary Stenosis - drug therapy ; Drug therapy ; Drug-Eluting Stents - adverse effects ; Drug-Eluting Stents - standards ; Female ; Follow-Up Studies ; Heart ; Heart attacks ; Humans ; Investigative techniques, diagnostic techniques (general aspects) ; Male ; Medical sciences ; Middle Aged ; Paclitaxel - administration & dosage ; Paclitaxel - adverse effects ; Platinum - administration & dosage ; Platinum - adverse effects ; Prospective Studies ; Radiodiagnosis. Nmr imagery. Nmr spectrometry ; Single-Blind Method ; Stainless steel ; Stents ; Treatment Outcome</subject><ispartof>Journal of the American College of Cardiology, 2010-07, Vol.56 (4), p.264-271</ispartof><rights>2015 INIST-CNRS</rights><rights>Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.</rights><rights>Copyright Elsevier Limited Jul 20, 2010</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23059936$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20493653$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>KEREIAKES, Dean J</creatorcontrib><creatorcontrib>CANNON, Louis A</creatorcontrib><creatorcontrib>KABOUR, Ameer</creatorcontrib><creatorcontrib>FOSTER, Michael C</creatorcontrib><creatorcontrib>WANG, John C</creatorcontrib><creatorcontrib>UNDERWOOD, Paul</creatorcontrib><creatorcontrib>DAWKINS, Keith D</creatorcontrib><creatorcontrib>FELDMAN, Robert L</creatorcontrib><creatorcontrib>POPMA, Jeffrey J</creatorcontrib><creatorcontrib>MAGORIEN, Raymond</creatorcontrib><creatorcontrib>WHITBOURN, Robert</creatorcontrib><creatorcontrib>DAUBER, Ira M</creatorcontrib><creatorcontrib>RABINOWITZ, Abram C</creatorcontrib><creatorcontrib>BALL, Michael W</creatorcontrib><creatorcontrib>BERTOLET, Barry</creatorcontrib><title>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</title><title>Journal of the American College of Cardiology</title><addtitle>J Am Coll Cardiol</addtitle><description>The aim of this study was to evaluate the safety and efficacy of the novel platinum chromium TAXUS Element paclitaxel-eluting stent (PES) compared with the TAXUS Express PES (Boston Scientific, Natick, Massachusetts) in treating coronary artery stenoses.
The TAXUS Element is a novel thin-strut (81 microm), platinum chromium alloy PES designed to improve radial strength, radiopacity, and deliverability, while safely providing comparable restenosis benefit compared with a previous-generation PES.
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) Workhorse (WH) trial is a prospective, randomized (3:1), controlled, multicenter study of the TAXUS Element (vs. TAXUS Express) PES for the treatment of de novo coronary atherosclerotic lesions<or=28 mm in length in reference vessels>or=2.75 to <or=4.0 mm in diameter. The primary end point was the 12-month rate of target lesion failure, and the secondary end point was 9-month angiographic in-segment percentage diameter stenosis. The study was powered to demonstrate noninferiority to TAXUS Express for both end points.
The intent-to-treat analysis included 1,262 patients (320 TAXUS Express, 942 TAXUS Element). The TAXUS Element was noninferior to TAXUS Express with respect to both the incidence of target lesion failure (5.57% vs. 6.14%, respectively; difference: 0.57%; 95% credible interval: 1.85%; Bayesian posterior probability of noninferiority=0.9996) and percentage diameter stenosis (ln[%DS] 3.09 vs. 3.12, respectively; difference: 0.03; 95% credible interval: 0.11; Bayesian posterior probability of noninferiority=0.9970). No differences in clinical outcomes to 12 months were observed between stent treatments, and stent thrombosis was infrequent (0.3% Express, 0.4% Element).
At 1 year, the TAXUS Element is comparable in efficacy to the TAXUS Express PES. Furthermore, no safety concerns related to the novel platinum chromium alloy or stent design were observed. (A Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions; NCT00484315).</description><subject>Aged</subject><subject>Angioplasty</subject><subject>Biological and medical sciences</subject><subject>Cardiology</subject><subject>Cardiology. Vascular system</subject><subject>Cardiovascular system</subject><subject>Chromium - administration & dosage</subject><subject>Chromium - adverse effects</subject><subject>Chromium Alloys - administration & dosage</subject><subject>Chromium Alloys - adverse effects</subject><subject>Coronary Angiography - standards</subject><subject>Coronary heart disease</subject><subject>Coronary Stenosis - diagnostic imaging</subject><subject>Coronary Stenosis - drug therapy</subject><subject>Drug therapy</subject><subject>Drug-Eluting Stents - adverse effects</subject><subject>Drug-Eluting Stents - standards</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Heart</subject><subject>Heart attacks</subject><subject>Humans</subject><subject>Investigative techniques, diagnostic techniques (general aspects)</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Paclitaxel - administration & dosage</subject><subject>Paclitaxel - adverse effects</subject><subject>Platinum - administration & dosage</subject><subject>Platinum - adverse effects</subject><subject>Prospective Studies</subject><subject>Radiodiagnosis. Nmr imagery. Nmr spectrometry</subject><subject>Single-Blind Method</subject><subject>Stainless steel</subject><subject>Stents</subject><subject>Treatment Outcome</subject><issn>0735-1097</issn><issn>1558-3597</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdklurEzEUhUdRPPXoH_BBAiLqw9TMZDIX30odL3DwlF7Qt5KT7rQpmaQmmWL99e5eDqIPISH59tprhZ0kLzI6zGhWvt8Ot0LKYU7xghZDmmUPk0HGeZ0y3lSPkgGtGE8z2lRXydMQtpTSss6aJ8lVTouGlZwNHtRjo62WwhBhV2Rk19qtvdhttCS3fZSug0BGKoIncw8idmAjcYp8BPLN7R0ZO--s8Acyi2BdQPi7jhsijq9gyMSIqG3fkfHGu07jYb7RNp1F38dTSfxAJl53R4UphN7EcFSPGyCTdjprFzPyduJd2IGMeg-k3QvTo6SzRFvsMkXTqPsbVmhPY4hL8UwoiIdTpFYpjCcP90-LAPfH-egHNmgNnFJNhDQ6il9g0tb0aHv9bzo0fAgRunfnVs-Sx0qYAM8v-3Wy-NTOx1_Sm9vPX8ejm3SXl3VMa8ZKpSpcjIGkwEWhaF2zWuacizspK1arnEpRNMAaVpVcKVgVqqlZzsqiYNfJm7PuzrufPYS47HSQYIyw4PqwrBhrEGYZkq_-I7eu9xbNLTNOy7zKKedIvbxQ_V0Hq-Xu_P3L-5FA4PUFEAHnQnlhpQ5_OUZ5gyT7A2Y0yeg</recordid><startdate>20100720</startdate><enddate>20100720</enddate><creator>KEREIAKES, Dean J</creator><creator>CANNON, Louis A</creator><creator>KABOUR, Ameer</creator><creator>FOSTER, Michael C</creator><creator>WANG, John C</creator><creator>UNDERWOOD, Paul</creator><creator>DAWKINS, Keith D</creator><creator>FELDMAN, Robert L</creator><creator>POPMA, Jeffrey J</creator><creator>MAGORIEN, Raymond</creator><creator>WHITBOURN, Robert</creator><creator>DAUBER, Ira M</creator><creator>RABINOWITZ, Abram C</creator><creator>BALL, Michael W</creator><creator>BERTOLET, Barry</creator><general>Elsevier</general><general>Elsevier Limited</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7T5</scope><scope>7TK</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope></search><sort><creationdate>20100720</creationdate><title>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</title><author>KEREIAKES, Dean J ; CANNON, Louis A ; KABOUR, Ameer ; FOSTER, Michael C ; WANG, John C ; UNDERWOOD, Paul ; DAWKINS, Keith D ; FELDMAN, Robert L ; POPMA, Jeffrey J ; MAGORIEN, Raymond ; WHITBOURN, Robert ; DAUBER, Ira M ; RABINOWITZ, Abram C ; BALL, Michael W ; BERTOLET, Barry</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p268t-8336ff76ff33ec0e5a4f08838c255abcc738f20ca49e393765ffed4f983236443</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Aged</topic><topic>Angioplasty</topic><topic>Biological and medical sciences</topic><topic>Cardiology</topic><topic>Cardiology. Vascular system</topic><topic>Cardiovascular system</topic><topic>Chromium - administration & dosage</topic><topic>Chromium - adverse effects</topic><topic>Chromium Alloys - administration & dosage</topic><topic>Chromium Alloys - adverse effects</topic><topic>Coronary Angiography - standards</topic><topic>Coronary heart disease</topic><topic>Coronary Stenosis - diagnostic imaging</topic><topic>Coronary Stenosis - drug therapy</topic><topic>Drug therapy</topic><topic>Drug-Eluting Stents - adverse effects</topic><topic>Drug-Eluting Stents - standards</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Heart</topic><topic>Heart attacks</topic><topic>Humans</topic><topic>Investigative techniques, diagnostic techniques (general aspects)</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Paclitaxel - administration & dosage</topic><topic>Paclitaxel - adverse effects</topic><topic>Platinum - administration & dosage</topic><topic>Platinum - adverse effects</topic><topic>Prospective Studies</topic><topic>Radiodiagnosis. Nmr imagery. Nmr spectrometry</topic><topic>Single-Blind Method</topic><topic>Stainless steel</topic><topic>Stents</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>KEREIAKES, Dean J</creatorcontrib><creatorcontrib>CANNON, Louis A</creatorcontrib><creatorcontrib>KABOUR, Ameer</creatorcontrib><creatorcontrib>FOSTER, Michael C</creatorcontrib><creatorcontrib>WANG, John C</creatorcontrib><creatorcontrib>UNDERWOOD, Paul</creatorcontrib><creatorcontrib>DAWKINS, Keith D</creatorcontrib><creatorcontrib>FELDMAN, Robert L</creatorcontrib><creatorcontrib>POPMA, Jeffrey J</creatorcontrib><creatorcontrib>MAGORIEN, Raymond</creatorcontrib><creatorcontrib>WHITBOURN, Robert</creatorcontrib><creatorcontrib>DAUBER, Ira M</creatorcontrib><creatorcontrib>RABINOWITZ, Abram C</creatorcontrib><creatorcontrib>BALL, Michael W</creatorcontrib><creatorcontrib>BERTOLET, Barry</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of the American College of Cardiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>KEREIAKES, Dean J</au><au>CANNON, Louis A</au><au>KABOUR, Ameer</au><au>FOSTER, Michael C</au><au>WANG, John C</au><au>UNDERWOOD, Paul</au><au>DAWKINS, Keith D</au><au>FELDMAN, Robert L</au><au>POPMA, Jeffrey J</au><au>MAGORIEN, Raymond</au><au>WHITBOURN, Robert</au><au>DAUBER, Ira M</au><au>RABINOWITZ, Abram C</au><au>BALL, Michael W</au><au>BERTOLET, Barry</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>Journal of the American College of Cardiology</jtitle><addtitle>J Am Coll Cardiol</addtitle><date>2010-07-20</date><risdate>2010</risdate><volume>56</volume><issue>4</issue><spage>264</spage><epage>271</epage><pages>264-271</pages><issn>0735-1097</issn><eissn>1558-3597</eissn><coden>JACCDI</coden><abstract>The aim of this study was to evaluate the safety and efficacy of the novel platinum chromium TAXUS Element paclitaxel-eluting stent (PES) compared with the TAXUS Express PES (Boston Scientific, Natick, Massachusetts) in treating coronary artery stenoses.
The TAXUS Element is a novel thin-strut (81 microm), platinum chromium alloy PES designed to improve radial strength, radiopacity, and deliverability, while safely providing comparable restenosis benefit compared with a previous-generation PES.
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) Workhorse (WH) trial is a prospective, randomized (3:1), controlled, multicenter study of the TAXUS Element (vs. TAXUS Express) PES for the treatment of de novo coronary atherosclerotic lesions<or=28 mm in length in reference vessels>or=2.75 to <or=4.0 mm in diameter. The primary end point was the 12-month rate of target lesion failure, and the secondary end point was 9-month angiographic in-segment percentage diameter stenosis. The study was powered to demonstrate noninferiority to TAXUS Express for both end points.
The intent-to-treat analysis included 1,262 patients (320 TAXUS Express, 942 TAXUS Element). The TAXUS Element was noninferior to TAXUS Express with respect to both the incidence of target lesion failure (5.57% vs. 6.14%, respectively; difference: 0.57%; 95% credible interval: 1.85%; Bayesian posterior probability of noninferiority=0.9996) and percentage diameter stenosis (ln[%DS] 3.09 vs. 3.12, respectively; difference: 0.03; 95% credible interval: 0.11; Bayesian posterior probability of noninferiority=0.9970). No differences in clinical outcomes to 12 months were observed between stent treatments, and stent thrombosis was infrequent (0.3% Express, 0.4% Element).
At 1 year, the TAXUS Element is comparable in efficacy to the TAXUS Express PES. Furthermore, no safety concerns related to the novel platinum chromium alloy or stent design were observed. (A Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions; NCT00484315).</abstract><cop>New York, NY</cop><pub>Elsevier</pub><pmid>20493653</pmid><doi>10.1016/j.jacc.2010.04.011</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0735-1097 |
| ispartof | Journal of the American College of Cardiology, 2010-07, Vol.56 (4), p.264-271 |
| issn | 0735-1097 1558-3597 |
| language | eng |
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| source | MEDLINE; Elsevier ScienceDirect Journals Complete; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection |
| subjects | Aged Angioplasty Biological and medical sciences Cardiology Cardiology. Vascular system Cardiovascular system Chromium - administration & dosage Chromium - adverse effects Chromium Alloys - administration & dosage Chromium Alloys - adverse effects Coronary Angiography - standards Coronary heart disease Coronary Stenosis - diagnostic imaging Coronary Stenosis - drug therapy Drug therapy Drug-Eluting Stents - adverse effects Drug-Eluting Stents - standards Female Follow-Up Studies Heart Heart attacks Humans Investigative techniques, diagnostic techniques (general aspects) Male Medical sciences Middle Aged Paclitaxel - administration & dosage Paclitaxel - adverse effects Platinum - administration & dosage Platinum - adverse effects Prospective Studies Radiodiagnosis. Nmr imagery. Nmr spectrometry Single-Blind Method Stainless steel Stents Treatment Outcome |
| title | 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 |
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