Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions
Early clinical studies demonstrated the feasibility of local paclitaxel delivery in reducing restenosis after treatment of de novo coronary lesions in small patient populations. We conducted a randomized, double-blind trial of 536 patients at 38 medical centers evaluating slow-release (SR) and moder...
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| Veröffentlicht in: | Circulation (New York, N.Y.) N.Y.), 2003-08, Vol.108 (7), p.788-794 |
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| creator | Colombo, Antonio Drzewiecki, Janusz Banning, Adrian Grube, Eberhard Hauptmann, Karl Silber, Sigmund Dudek, Dariusz Fort, Stephen Schiele, Francois Zmudka, Krysztof Guagliumi, Giulio Russell, Mary E |
| description | Early clinical studies demonstrated the feasibility of local paclitaxel delivery in reducing restenosis after treatment of de novo coronary lesions in small patient populations.
We conducted a randomized, double-blind trial of 536 patients at 38 medical centers evaluating slow-release (SR) and moderate-release (MR) formulations of a polymer-based paclitaxel-eluting stent (TAXUS) for revascularization of single, primary lesions in native coronary arteries. Cohort I compared TAXUS-SR with control stents, and Cohort II compared TAXUS-MR with a second control group. The primary end point was 6-month percent in-stent net volume obstruction measured by intravascular ultrasound. Secondary end points were 6-month angiographic restenosis and 6- and 12-month incidence of major adverse cardiac events, a composite of cardiac death, myocardial infarction, and repeat revascularization. At 6 months, percent net volume obstruction within the stent was significantly lower for TAXUS stents (7.9% SR and 7.8% MR) than for respective controls (23.2% and 20.5%; P |
| doi_str_mv | 10.1161/01.cir.0000086926.62288.a6 |
| format | Article |
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We conducted a randomized, double-blind trial of 536 patients at 38 medical centers evaluating slow-release (SR) and moderate-release (MR) formulations of a polymer-based paclitaxel-eluting stent (TAXUS) for revascularization of single, primary lesions in native coronary arteries. Cohort I compared TAXUS-SR with control stents, and Cohort II compared TAXUS-MR with a second control group. The primary end point was 6-month percent in-stent net volume obstruction measured by intravascular ultrasound. Secondary end points were 6-month angiographic restenosis and 6- and 12-month incidence of major adverse cardiac events, a composite of cardiac death, myocardial infarction, and repeat revascularization. At 6 months, percent net volume obstruction within the stent was significantly lower for TAXUS stents (7.9% SR and 7.8% MR) than for respective controls (23.2% and 20.5%; P<0.0001 for both). This corresponded with a reduction in angiographic restenosis from 17.9% to 2.3% in the SR cohort (P<0.0001) and from 20.2% to 4.7% in the MR cohort (P=0.0002). The incidence of major adverse cardiac events at 12 months was significantly lower (P=0.0192) in the TAXUS-SR (10.9%) and TAXUS-MR (9.9%) groups than in controls (22.0% and 21.4%, respectively), predominantly because of a significant reduction in repeat revascularization of the target lesion in TAXUS-treated patients.
Compared with a bare metal stent, paclitaxel-eluting stents reduced in-stent neointimal formation and restenosis and improved 12-month clinical outcome of patients with single de novo coronary lesions.</description><identifier>ISSN: 0009-7322</identifier><identifier>EISSN: 1524-4539</identifier><identifier>DOI: 10.1161/01.cir.0000086926.62288.a6</identifier><identifier>PMID: 12900339</identifier><identifier>CODEN: CIRCAZ</identifier><language>eng</language><publisher>United States: American Heart Association, Inc</publisher><subject>Coated Materials, Biocompatible - administration & dosage ; Cohort Studies ; Coronary Angiography ; Coronary Artery Disease - surgery ; Delayed-Action Preparations - administration & dosage ; Delayed-Action Preparations - adverse effects ; Disease-Free Survival ; Drug Implants - administration & dosage ; Drug Implants - adverse effects ; Female ; Follow-Up Studies ; Hemorrhage - etiology ; Humans ; Male ; Middle Aged ; Postoperative Complications - etiology ; Stents - adverse effects ; Stents - standards ; Thrombosis - etiology ; Treatment Outcome ; Ultrasonography, Interventional</subject><ispartof>Circulation (New York, N.Y.), 2003-08, Vol.108 (7), p.788-794</ispartof><rights>Copyright American Heart Association, Inc. Aug 19 2003</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c501t-5801ef789ada34dc654b9526c96fa6a28332980faf82ac9cb505919ef3e5c3523</citedby><cites>FETCH-LOGICAL-c501t-5801ef789ada34dc654b9526c96fa6a28332980faf82ac9cb505919ef3e5c3523</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,3674,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12900339$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Colombo, Antonio</creatorcontrib><creatorcontrib>Drzewiecki, Janusz</creatorcontrib><creatorcontrib>Banning, Adrian</creatorcontrib><creatorcontrib>Grube, Eberhard</creatorcontrib><creatorcontrib>Hauptmann, Karl</creatorcontrib><creatorcontrib>Silber, Sigmund</creatorcontrib><creatorcontrib>Dudek, Dariusz</creatorcontrib><creatorcontrib>Fort, Stephen</creatorcontrib><creatorcontrib>Schiele, Francois</creatorcontrib><creatorcontrib>Zmudka, Krysztof</creatorcontrib><creatorcontrib>Guagliumi, Giulio</creatorcontrib><creatorcontrib>Russell, Mary E</creatorcontrib><creatorcontrib>TAXUS II Study Group</creatorcontrib><title>Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions</title><title>Circulation (New York, N.Y.)</title><addtitle>Circulation</addtitle><description>Early clinical studies demonstrated the feasibility of local paclitaxel delivery in reducing restenosis after treatment of de novo coronary lesions in small patient populations.
We conducted a randomized, double-blind trial of 536 patients at 38 medical centers evaluating slow-release (SR) and moderate-release (MR) formulations of a polymer-based paclitaxel-eluting stent (TAXUS) for revascularization of single, primary lesions in native coronary arteries. Cohort I compared TAXUS-SR with control stents, and Cohort II compared TAXUS-MR with a second control group. The primary end point was 6-month percent in-stent net volume obstruction measured by intravascular ultrasound. Secondary end points were 6-month angiographic restenosis and 6- and 12-month incidence of major adverse cardiac events, a composite of cardiac death, myocardial infarction, and repeat revascularization. At 6 months, percent net volume obstruction within the stent was significantly lower for TAXUS stents (7.9% SR and 7.8% MR) than for respective controls (23.2% and 20.5%; P<0.0001 for both). This corresponded with a reduction in angiographic restenosis from 17.9% to 2.3% in the SR cohort (P<0.0001) and from 20.2% to 4.7% in the MR cohort (P=0.0002). The incidence of major adverse cardiac events at 12 months was significantly lower (P=0.0192) in the TAXUS-SR (10.9%) and TAXUS-MR (9.9%) groups than in controls (22.0% and 21.4%, respectively), predominantly because of a significant reduction in repeat revascularization of the target lesion in TAXUS-treated patients.
Compared with a bare metal stent, paclitaxel-eluting stents reduced in-stent neointimal formation and restenosis and improved 12-month clinical outcome of patients with single de novo coronary lesions.</description><subject>Coated Materials, Biocompatible - administration & dosage</subject><subject>Cohort Studies</subject><subject>Coronary Angiography</subject><subject>Coronary Artery Disease - surgery</subject><subject>Delayed-Action Preparations - administration & dosage</subject><subject>Delayed-Action Preparations - adverse effects</subject><subject>Disease-Free Survival</subject><subject>Drug Implants - administration & dosage</subject><subject>Drug Implants - adverse effects</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Hemorrhage - etiology</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Postoperative Complications - etiology</subject><subject>Stents - adverse effects</subject><subject>Stents - standards</subject><subject>Thrombosis - etiology</subject><subject>Treatment Outcome</subject><subject>Ultrasonography, Interventional</subject><issn>0009-7322</issn><issn>1524-4539</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFUdtKAzEQDaJovfyCBN-z5tKkG9-keIOCIPoc0uxEV3Y3Ncmq9SP8ZlMtOC-HuZw5wxyEzhitGFPsnLLKtbGim6iV5qpSnNd1ZdUOmjDJp2Qqhd5Fk9LXZCY4P0CHKb2WVImZ3EcHjGtKhdAT9P1ghyb07Rc0OOWxWeMcsE0JUsL5BTB4Dy637zBsKsHj1IUPggsJ96GBaDOQCB3YBHgVunUPkSxL0uCVdV2b7Sd0BLoxt8NzEYAhJ-xDxC7EMNi4xjZmKNBBasOQjtGet12Cky0eoafrq8f5LVnc39zNLxfEScoykTVl4Ge1to0V08YpOV1qyZXTyltleS0E1zX11tfcOu2WkkrNNHgB0gnJxRE6-9u7iuFthJTNaxjjUCQNZ1zNioAqQxd_Qy6GlCJ4s4ptX442jJqNE4YyM797MP9OmF8nzOWGfLpVGJc9NP_U7evFD3v1iK0</recordid><startdate>20030819</startdate><enddate>20030819</enddate><creator>Colombo, Antonio</creator><creator>Drzewiecki, Janusz</creator><creator>Banning, Adrian</creator><creator>Grube, Eberhard</creator><creator>Hauptmann, Karl</creator><creator>Silber, Sigmund</creator><creator>Dudek, Dariusz</creator><creator>Fort, Stephen</creator><creator>Schiele, Francois</creator><creator>Zmudka, Krysztof</creator><creator>Guagliumi, Giulio</creator><creator>Russell, Mary E</creator><general>American Heart Association, Inc</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>NAPCQ</scope><scope>U9A</scope></search><sort><creationdate>20030819</creationdate><title>Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions</title><author>Colombo, Antonio ; Drzewiecki, Janusz ; Banning, Adrian ; Grube, Eberhard ; Hauptmann, Karl ; Silber, Sigmund ; Dudek, Dariusz ; Fort, Stephen ; Schiele, Francois ; Zmudka, Krysztof ; Guagliumi, Giulio ; Russell, Mary E</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c501t-5801ef789ada34dc654b9526c96fa6a28332980faf82ac9cb505919ef3e5c3523</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2003</creationdate><topic>Coated Materials, Biocompatible - administration & dosage</topic><topic>Cohort Studies</topic><topic>Coronary Angiography</topic><topic>Coronary Artery Disease - surgery</topic><topic>Delayed-Action Preparations - administration & dosage</topic><topic>Delayed-Action Preparations - adverse effects</topic><topic>Disease-Free Survival</topic><topic>Drug Implants - administration & dosage</topic><topic>Drug Implants - adverse effects</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Hemorrhage - etiology</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Postoperative Complications - etiology</topic><topic>Stents - adverse effects</topic><topic>Stents - standards</topic><topic>Thrombosis - etiology</topic><topic>Treatment Outcome</topic><topic>Ultrasonography, Interventional</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Colombo, Antonio</creatorcontrib><creatorcontrib>Drzewiecki, Janusz</creatorcontrib><creatorcontrib>Banning, Adrian</creatorcontrib><creatorcontrib>Grube, Eberhard</creatorcontrib><creatorcontrib>Hauptmann, Karl</creatorcontrib><creatorcontrib>Silber, Sigmund</creatorcontrib><creatorcontrib>Dudek, Dariusz</creatorcontrib><creatorcontrib>Fort, Stephen</creatorcontrib><creatorcontrib>Schiele, Francois</creatorcontrib><creatorcontrib>Zmudka, Krysztof</creatorcontrib><creatorcontrib>Guagliumi, Giulio</creatorcontrib><creatorcontrib>Russell, Mary E</creatorcontrib><creatorcontrib>TAXUS II Study Group</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>Nursing & Allied Health Premium</collection><jtitle>Circulation (New York, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Colombo, Antonio</au><au>Drzewiecki, Janusz</au><au>Banning, Adrian</au><au>Grube, Eberhard</au><au>Hauptmann, Karl</au><au>Silber, Sigmund</au><au>Dudek, Dariusz</au><au>Fort, Stephen</au><au>Schiele, Francois</au><au>Zmudka, Krysztof</au><au>Guagliumi, Giulio</au><au>Russell, Mary E</au><aucorp>TAXUS II Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions</atitle><jtitle>Circulation (New York, N.Y.)</jtitle><addtitle>Circulation</addtitle><date>2003-08-19</date><risdate>2003</risdate><volume>108</volume><issue>7</issue><spage>788</spage><epage>794</epage><pages>788-794</pages><issn>0009-7322</issn><eissn>1524-4539</eissn><coden>CIRCAZ</coden><abstract>Early clinical studies demonstrated the feasibility of local paclitaxel delivery in reducing restenosis after treatment of de novo coronary lesions in small patient populations.
We conducted a randomized, double-blind trial of 536 patients at 38 medical centers evaluating slow-release (SR) and moderate-release (MR) formulations of a polymer-based paclitaxel-eluting stent (TAXUS) for revascularization of single, primary lesions in native coronary arteries. Cohort I compared TAXUS-SR with control stents, and Cohort II compared TAXUS-MR with a second control group. The primary end point was 6-month percent in-stent net volume obstruction measured by intravascular ultrasound. Secondary end points were 6-month angiographic restenosis and 6- and 12-month incidence of major adverse cardiac events, a composite of cardiac death, myocardial infarction, and repeat revascularization. At 6 months, percent net volume obstruction within the stent was significantly lower for TAXUS stents (7.9% SR and 7.8% MR) than for respective controls (23.2% and 20.5%; P<0.0001 for both). This corresponded with a reduction in angiographic restenosis from 17.9% to 2.3% in the SR cohort (P<0.0001) and from 20.2% to 4.7% in the MR cohort (P=0.0002). The incidence of major adverse cardiac events at 12 months was significantly lower (P=0.0192) in the TAXUS-SR (10.9%) and TAXUS-MR (9.9%) groups than in controls (22.0% and 21.4%, respectively), predominantly because of a significant reduction in repeat revascularization of the target lesion in TAXUS-treated patients.
Compared with a bare metal stent, paclitaxel-eluting stents reduced in-stent neointimal formation and restenosis and improved 12-month clinical outcome of patients with single de novo coronary lesions.</abstract><cop>United States</cop><pub>American Heart Association, Inc</pub><pmid>12900339</pmid><doi>10.1161/01.cir.0000086926.62288.a6</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0009-7322 |
| ispartof | Circulation (New York, N.Y.), 2003-08, Vol.108 (7), p.788-794 |
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| source | MEDLINE; American Heart Association Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Journals@Ovid Complete |
| subjects | Coated Materials, Biocompatible - administration & dosage Cohort Studies Coronary Angiography Coronary Artery Disease - surgery Delayed-Action Preparations - administration & dosage Delayed-Action Preparations - adverse effects Disease-Free Survival Drug Implants - administration & dosage Drug Implants - adverse effects Female Follow-Up Studies Hemorrhage - etiology Humans Male Middle Aged Postoperative Complications - etiology Stents - adverse effects Stents - standards Thrombosis - etiology Treatment Outcome Ultrasonography, Interventional |
| title | Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions |
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