| Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction. | |
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MedLine Citation:
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PMID: 19420364 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: There is no consensus regarding the safety and efficacy of drug-eluting stents, as compared with bare-metal stents, in patients with ST-segment elevation myocardial infarction who are undergoing primary percutaneous coronary intervention (PCI). METHODS: We randomly assigned, in a 3:1 ratio, 3006 patients presenting with ST-segment elevation myocardial infarction to receive paclitaxel-eluting stents (2257 patients) or otherwise identical bare-metal stents (749 patients). The two primary end points of the study were the 12-month rates of target-lesion revascularization for ischemia (analysis powered for superiority) and a composite safety outcome measure of death, reinfarction, stroke, or stent thrombosis (powered for noninferiority with a 3.0% margin). The major secondary end point was angiographic evidence of restenosis at 13 months. RESULTS: Patients who received paclitaxel-eluting stents, as compared with those who received bare-metal stents, had significantly lower 12-month rates of ischemia-driven target-lesion revascularization (4.5% vs. 7.5%; hazard ratio, 0.59; 95% confidence interval [CI], 0.43 to 0.83; P=0.002) and target-vessel revascularization (5.8% vs. 8.7%; hazard ratio, 0.65; 95% CI, 0.48 to 0.89; P=0.006), with noninferior rates of the composite safety end point (8.1% vs. 8.0%; hazard ratio, 1.02; 95% CI, 0.76 to 1.36; absolute difference, 0.1 percentage point; 95% CI, -2.1 to 2.4; P=0.01 for noninferiority; P=0.92 for superiority). Patients treated with paclitaxel-eluting stents and those treated with bare-metal stents had similar 12-month rates of death (3.5% and 3.5%, respectively; P=0.98) and stent thrombosis (3.2% and 3.4%, respectively; P=0.77). The 13-month rate of binary restenosis was significantly lower with paclitaxel-eluting stents than with bare-metal stents (10.0% vs. 22.9%; hazard ratio, 0.44; 95% CI, 0.33 to 0.57; P<0.001). CONCLUSIONS: In patients with ST-segment elevation myocardial infarction who were undergoing primary PCI, implantation of paclitaxel-eluting stents, as compared with bare-metal stents, significantly reduced angiographic evidence of restenosis and recurrent ischemia necessitating repeat revascularization procedures. No safety concerns were apparent at 1 year. (ClinicalTrials.gov number, NCT00433966.) |
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Authors:
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Gregg W Stone; Alexandra J Lansky; Stuart J Pocock; Bernard J Gersh; George Dangas; S Chiu Wong; Bernhard Witzenbichler; Giulio Guagliumi; Jan Z Peruga; Bruce R Brodie; Dariusz Dudek; Martin Möckel; Andrzej Ochala; Alison Kellock; Helen Parise; Roxana Mehran; |
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Publication Detail:
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Type: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The New England journal of medicine Volume: 360 ISSN: 1533-4406 ISO Abbreviation: N. Engl. J. Med. Publication Date: 2009 May |
Date Detail:
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Created Date: 2009-05-07 Completed Date: 2009-05-22 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0255562 Medline TA: N Engl J Med Country: United States |
Other Details:
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Languages: eng Pagination: 1946-59 Citation Subset: AIM; IM |
Copyright Information:
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2009 Massachusetts Medical Society |
Affiliation:
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Columbia University Medical Center and New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY 10022, USA. gs2184@columbia.edu |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00433966 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Aged, 80 and over Angioplasty, Transluminal, Percutaneous Coronary Combined Modality Therapy Coronary Angiography Coronary Restenosis / epidemiology, prevention & control Coronary Stenosis / therapy Drug-Eluting Stents* / adverse effects Female Fibrinolytic Agents / therapeutic use Follow-Up Studies Humans Kaplan-Meiers Estimate Male Middle Aged Myocardial Infarction / drug therapy, mortality, therapy* Paclitaxel / administration & dosage* Recurrence Retreatment / statistics & numerical data Risk Stents* / adverse effects Sweden |
| Chemical | |
Reg. No./Substance:
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0/Fibrinolytic Agents; 33069-62-4/Paclitaxel |
| Investigator | |
Investigator/Affiliation:
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G W Stone / ; B R Brodie / ; D A Cox / ; C L Grines / ; B D Rutherford / ; D Bhatt / ; G Dangas / ; F Feit / ; M Ohman / ; H Bonnier / ; A Colombo / ; E Garcia / ; E Grube / ; G Guagliumi / ; A Kastrati / ; P Serruys / ; H Suryapranata / ; H Bonnier / ; H Suryapranata / ; A Colombo / ; G Guagliumi / ; E Garcia / ; E Grube / ; A Kastrati / ; Y Almagor / ; A Banning / ; J Belardi / ; L Grinfeld / ; D Dudek / ; K Huber / ; D Nilsen / ; G Olivecrona / ; L Rasmussen / ; S C Wong / ; M Farkouh / ; M Attubato / ; G Dangas / ; F Feit / ; R Mehran / ; D Winsted / ; R Mehran / ; L Gambone / ; I Bihl / ; H Parise / ; B J Gersh / ; D Faxon / ; S King / ; S J Pocock / ; D O Williams / ; A J Lansky / ; E Cristea / ; J Reiffel / ; G Mintz / ; Oscar A Mendiz / ; Jose Amadeo Alvarez / ; Jose Alvarez / ; Diego David Grinfeld / ; Miguel Angel Riccitelli / ; Daniel Berrocal / ; Jorge Belardi / ; Anibal Agustin Damonte / ; Guillermo Cugat / ; A Rodriguez / ; Ernesto M Torresani / ; Hugo F Londero / ; Dietmar Glogar / ; Kurt Huber / ; George Gaul / ; Johann Altenberger / ; Othmar Pachinger / ; Hans-Georg Olbrich / ; Bernhard Witzenbichler / ; Martin Moeckel / ; Wolfgang Rutsch / ; Eberhard Grube / ; Gert Richardt / ; Klaus Pethig / ; Martin Desaga / ; Gerald Werner / ; Johannes Brachmann / ; Helmut Kuecherer / ; Rainer Hoffmann / ; Franz Hartmann / ; Stefan Willems / ; Jochen Wöhrle / ; Adnan Kastrati / ; Ricardo Krakover / ; Uri Rosenschein / ; Basil S Lewis / ; Morris Mosseri / ; Ran Petach-Tikva Kornowski / ; Luis Gruberg / ; Yaron Almagor / ; Victor Guetta / ; Ariel Finkelstein / ; Yoseph Rozenman / ; Giulio Guagliumi / ; Antonio Colombo / ; Hans Bonnier / ; Harry Suryapranata / ; Peter Smits / ; Jan Erik Nordrehaug / ; Dennis Nilsen / ; Witold Ruzyllo / ; Adam Witkowski / ; Dariusz Dudek / ; Andrzej Rynkiewicz / ; Jan Z Peruga / ; Andrzej Ochala / ; Krzysztof Zmudka / ; Robert Gil / ; Pascual Bordes / ; Adrian Banning / ; Daniel Blackman / ; Magdi El-Omar / ; Adam De Belder / ; Ever Grech / ; Bernard Prendergast / ; Sarah Johnson / ; Brent McLaurin / ; Tommy Lee / ; Duane S Pinto / ; Joe Choo / ; Ronald Karlsberg / ; Louis A Cannon / ; Trilok Sharma / ; James Ritter / ; Leroy Rabbani / ; Pierre P Leimgruber / ; Ofsman Quintana / ; Joseph McGarvey / ; Oscar Aguilar / ; Henry Liberman / ; Jim Blankenship / ; Ali Razavi / ; Rajesh Dave / ; John Rashid / ; Joseph F Stella / ; Edmund Finkinski / ; Matthew Bach / ; Bruce Brodie / ; Mirle A Kellett / ; Ofsman Quintana / ; Ron Waksman / ; Robert Iwaoka / ; Gregory M Eaton / ; Keith Atassi / ; Michael Attubato / ; Raj Chandwaney / ; Bradley Evans / ; Oscar Aguilar / ; Henry Lui / ; David Rizik / ; David Rizik / ; John Griffin / ; Jason O Hall / ; Michael C Foster / ; Jorge A Hernandez / ; Noel Camba / ; Thomas LaLonde / ; Mahesh Bikkina / ; Barry Rutherford / ; Vibhuti Singh / ; John McPherson / ; Richard B Zelman / ; James B Hermiller / ; Kenneth S Korr / ; Christopher Metzger / ; Paul Gordon / ; Cary Hirsch / ; Venkatraman Srinivasan / ; Kalim Habet / ; Mark A Turco / ; Douglas Ebersole / ; Cindy L Grines / |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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