Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents
The long-term effects of treatment with sirolimus-eluting stents, as compared with bare-metal stents, have not been established. We performed an analysis of individual data on 4958 patients enrolled in 14 randomized trials comparing sirolimus-eluting stents with bare-metal stents (mean follow-up int...
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| Veröffentlicht in: | The New England journal of medicine 2007-03, Vol.356 (10), p.1030-1039 |
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| creator | KASTRATI, Adnan MEHILLI, Julinda SEYFARTH, Melchior PFISTERER, Matthias E SCHÖMIG, Albert PACHE, Jürgen KAISER, Christoph VALGIMIGLI, Marco KELBK, Henning MENICHELLI, Maurizio SABATE, Manel SUTTORP, Maarten J BAUMGART, Dietrich |
| description | The long-term effects of treatment with sirolimus-eluting stents, as compared with bare-metal stents, have not been established.
We performed an analysis of individual data on 4958 patients enrolled in 14 randomized trials comparing sirolimus-eluting stents with bare-metal stents (mean follow-up interval, 12.1 to 58.9 months). The primary end point was death from any cause. Other outcomes were stent thrombosis, the composite end point of death or myocardial infarction, and the composite of death, myocardial infarction, or reintervention.
The overall risk of death (hazard ratio, 1.03; 95% confidence interval [CI], 0.80 to 1.30) and the combined risk of death or myocardial infarction (hazard ratio, 0.97; 95% CI, 0.81 to 1.16) were not significantly different for patients receiving sirolimus-eluting stents versus bare-metal stents. There was a significant reduction in the combined risk of death, myocardial infarction, or reintervention (hazard ratio, 0.43; 95% CI, 0.34 to 0.54) associated with the use of sirolimus-eluting stents. There was no significant difference in the overall risk of stent thrombosis with sirolimus-eluting stents versus bare-metal stents (hazard ratio, 1.09; 95% CI, 0.64 to 1.86). However, there was evidence of a slight increase in the risk of stent thrombosis associated with sirolimus-eluting stents after the first year.
The use of sirolimus-eluting stents does not have a significant effect on overall long-term survival and survival free of myocardial infarction, as compared with bare-metal stents. There is a sustained reduction in the need for reintervention after the use of sirolimus-eluting stents. The risk of stent thrombosis is at least as great as that seen with bare-metal stents. |
| doi_str_mv | 10.1056/NEJMoa067484 |
| format | Article |
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We performed an analysis of individual data on 4958 patients enrolled in 14 randomized trials comparing sirolimus-eluting stents with bare-metal stents (mean follow-up interval, 12.1 to 58.9 months). The primary end point was death from any cause. Other outcomes were stent thrombosis, the composite end point of death or myocardial infarction, and the composite of death, myocardial infarction, or reintervention.
The overall risk of death (hazard ratio, 1.03; 95% confidence interval [CI], 0.80 to 1.30) and the combined risk of death or myocardial infarction (hazard ratio, 0.97; 95% CI, 0.81 to 1.16) were not significantly different for patients receiving sirolimus-eluting stents versus bare-metal stents. There was a significant reduction in the combined risk of death, myocardial infarction, or reintervention (hazard ratio, 0.43; 95% CI, 0.34 to 0.54) associated with the use of sirolimus-eluting stents. There was no significant difference in the overall risk of stent thrombosis with sirolimus-eluting stents versus bare-metal stents (hazard ratio, 1.09; 95% CI, 0.64 to 1.86). However, there was evidence of a slight increase in the risk of stent thrombosis associated with sirolimus-eluting stents after the first year.
The use of sirolimus-eluting stents does not have a significant effect on overall long-term survival and survival free of myocardial infarction, as compared with bare-metal stents. There is a sustained reduction in the need for reintervention after the use of sirolimus-eluting stents. The risk of stent thrombosis is at least as great as that seen with bare-metal stents.</description><identifier>ISSN: 0028-4793</identifier><identifier>EISSN: 1533-4406</identifier><identifier>DOI: 10.1056/NEJMoa067484</identifier><identifier>PMID: 17296823</identifier><identifier>CODEN: NEJMAG</identifier><language>eng</language><publisher>Boston, MA: Massachusetts Medical Society</publisher><subject>Angioplasty, Balloon, Coronary ; Biological and medical sciences ; Cardiovascular disease ; Clinical trials ; Coronary Disease - mortality ; Coronary Disease - therapy ; Coronary Restenosis - epidemiology ; Coronary Restenosis - therapy ; Coronary Thrombosis - epidemiology ; Coronary Thrombosis - etiology ; Drug Delivery Systems ; Follow-Up Studies ; General aspects ; Heart attacks ; Humans ; Immunosuppressive Agents - administration & dosage ; Medical sciences ; Myocardial Infarction - epidemiology ; Myocardial Infarction - etiology ; Prosthesis Design ; Prosthesis Failure ; Randomized Controlled Trials as Topic ; Regression Analysis ; Risk ; Sirolimus - administration & dosage ; Stents ; Stents - adverse effects ; Survival Analysis</subject><ispartof>The New England journal of medicine, 2007-03, Vol.356 (10), p.1030-1039</ispartof><rights>2007 INIST-CNRS</rights><rights>Copyright 2007 Massachusetts Medical Society.</rights><rights>Copyright © 2007 Massachusetts Medical Society. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c475t-fb6238e3a0048dae61d0c2723b6655c856c1fb2ad43c6eed7fdadf0fa4118cf83</citedby><cites>FETCH-LOGICAL-c475t-fb6238e3a0048dae61d0c2723b6655c856c1fb2ad43c6eed7fdadf0fa4118cf83</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,2746,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=18598202$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17296823$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>KASTRATI, Adnan</creatorcontrib><creatorcontrib>MEHILLI, Julinda</creatorcontrib><creatorcontrib>SEYFARTH, Melchior</creatorcontrib><creatorcontrib>PFISTERER, Matthias E</creatorcontrib><creatorcontrib>SCHÖMIG, Albert</creatorcontrib><creatorcontrib>PACHE, Jürgen</creatorcontrib><creatorcontrib>KAISER, Christoph</creatorcontrib><creatorcontrib>VALGIMIGLI, Marco</creatorcontrib><creatorcontrib>KELBK, Henning</creatorcontrib><creatorcontrib>MENICHELLI, Maurizio</creatorcontrib><creatorcontrib>SABATE, Manel</creatorcontrib><creatorcontrib>SUTTORP, Maarten J</creatorcontrib><creatorcontrib>BAUMGART, Dietrich</creatorcontrib><title>Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents</title><title>The New England journal of medicine</title><addtitle>N Engl J Med</addtitle><description>The long-term effects of treatment with sirolimus-eluting stents, as compared with bare-metal stents, have not been established.
We performed an analysis of individual data on 4958 patients enrolled in 14 randomized trials comparing sirolimus-eluting stents with bare-metal stents (mean follow-up interval, 12.1 to 58.9 months). The primary end point was death from any cause. Other outcomes were stent thrombosis, the composite end point of death or myocardial infarction, and the composite of death, myocardial infarction, or reintervention.
The overall risk of death (hazard ratio, 1.03; 95% confidence interval [CI], 0.80 to 1.30) and the combined risk of death or myocardial infarction (hazard ratio, 0.97; 95% CI, 0.81 to 1.16) were not significantly different for patients receiving sirolimus-eluting stents versus bare-metal stents. There was a significant reduction in the combined risk of death, myocardial infarction, or reintervention (hazard ratio, 0.43; 95% CI, 0.34 to 0.54) associated with the use of sirolimus-eluting stents. There was no significant difference in the overall risk of stent thrombosis with sirolimus-eluting stents versus bare-metal stents (hazard ratio, 1.09; 95% CI, 0.64 to 1.86). However, there was evidence of a slight increase in the risk of stent thrombosis associated with sirolimus-eluting stents after the first year.
The use of sirolimus-eluting stents does not have a significant effect on overall long-term survival and survival free of myocardial infarction, as compared with bare-metal stents. There is a sustained reduction in the need for reintervention after the use of sirolimus-eluting stents. The risk of stent thrombosis is at least as great as that seen with bare-metal stents.</description><subject>Angioplasty, Balloon, Coronary</subject><subject>Biological and medical sciences</subject><subject>Cardiovascular disease</subject><subject>Clinical trials</subject><subject>Coronary Disease - mortality</subject><subject>Coronary Disease - therapy</subject><subject>Coronary Restenosis - epidemiology</subject><subject>Coronary Restenosis - therapy</subject><subject>Coronary Thrombosis - epidemiology</subject><subject>Coronary Thrombosis - etiology</subject><subject>Drug Delivery Systems</subject><subject>Follow-Up Studies</subject><subject>General aspects</subject><subject>Heart attacks</subject><subject>Humans</subject><subject>Immunosuppressive Agents - administration & dosage</subject><subject>Medical sciences</subject><subject>Myocardial Infarction - epidemiology</subject><subject>Myocardial Infarction - etiology</subject><subject>Prosthesis Design</subject><subject>Prosthesis Failure</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Regression Analysis</subject><subject>Risk</subject><subject>Sirolimus - 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Academic</collection><jtitle>The New England journal of medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>KASTRATI, Adnan</au><au>MEHILLI, Julinda</au><au>SEYFARTH, Melchior</au><au>PFISTERER, Matthias E</au><au>SCHÖMIG, Albert</au><au>PACHE, Jürgen</au><au>KAISER, Christoph</au><au>VALGIMIGLI, Marco</au><au>KELBK, Henning</au><au>MENICHELLI, Maurizio</au><au>SABATE, Manel</au><au>SUTTORP, Maarten J</au><au>BAUMGART, Dietrich</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents</atitle><jtitle>The New England journal of medicine</jtitle><addtitle>N Engl J Med</addtitle><date>2007-03-08</date><risdate>2007</risdate><volume>356</volume><issue>10</issue><spage>1030</spage><epage>1039</epage><pages>1030-1039</pages><issn>0028-4793</issn><eissn>1533-4406</eissn><coden>NEJMAG</coden><abstract>The long-term effects of treatment with sirolimus-eluting stents, as compared with bare-metal stents, have not been established.
We performed an analysis of individual data on 4958 patients enrolled in 14 randomized trials comparing sirolimus-eluting stents with bare-metal stents (mean follow-up interval, 12.1 to 58.9 months). The primary end point was death from any cause. Other outcomes were stent thrombosis, the composite end point of death or myocardial infarction, and the composite of death, myocardial infarction, or reintervention.
The overall risk of death (hazard ratio, 1.03; 95% confidence interval [CI], 0.80 to 1.30) and the combined risk of death or myocardial infarction (hazard ratio, 0.97; 95% CI, 0.81 to 1.16) were not significantly different for patients receiving sirolimus-eluting stents versus bare-metal stents. There was a significant reduction in the combined risk of death, myocardial infarction, or reintervention (hazard ratio, 0.43; 95% CI, 0.34 to 0.54) associated with the use of sirolimus-eluting stents. There was no significant difference in the overall risk of stent thrombosis with sirolimus-eluting stents versus bare-metal stents (hazard ratio, 1.09; 95% CI, 0.64 to 1.86). However, there was evidence of a slight increase in the risk of stent thrombosis associated with sirolimus-eluting stents after the first year.
The use of sirolimus-eluting stents does not have a significant effect on overall long-term survival and survival free of myocardial infarction, as compared with bare-metal stents. There is a sustained reduction in the need for reintervention after the use of sirolimus-eluting stents. The risk of stent thrombosis is at least as great as that seen with bare-metal stents.</abstract><cop>Boston, MA</cop><pub>Massachusetts Medical Society</pub><pmid>17296823</pmid><doi>10.1056/NEJMoa067484</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0028-4793 |
| ispartof | The New England journal of medicine, 2007-03, Vol.356 (10), p.1030-1039 |
| issn | 0028-4793 1533-4406 |
| language | eng |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; New England Journal of Medicine |
| subjects | Angioplasty, Balloon, Coronary Biological and medical sciences Cardiovascular disease Clinical trials Coronary Disease - mortality Coronary Disease - therapy Coronary Restenosis - epidemiology Coronary Restenosis - therapy Coronary Thrombosis - epidemiology Coronary Thrombosis - etiology Drug Delivery Systems Follow-Up Studies General aspects Heart attacks Humans Immunosuppressive Agents - administration & dosage Medical sciences Myocardial Infarction - epidemiology Myocardial Infarction - etiology Prosthesis Design Prosthesis Failure Randomized Controlled Trials as Topic Regression Analysis Risk Sirolimus - administration & dosage Stents Stents - adverse effects Survival Analysis |
| title | Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents |
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