NDLI: Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Brodie, Bruce R. Peruga, Jan Z. Parise, Helen Stone, Gregg W. Möckel, Martin Witzenbichler, Bernhard Dudek, Dariusz Kellock, Alison Ochala, Andrzej Guagliumi, Giulio Lansky, Alexandra J. Pocock, Stuart J. Gersh, Bernard J. Dangas, George Wong, S. Chiu Mehran, Roxana
Spatial Coverage	Sweden
Description	Author Affiliation: Stone GW ( Columbia University Medical Center and New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY 10022, USA. gs2184@columbia.edu)
Abstract	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.)
ISSN	00284793
Issue Number	19
Volume Number	360
e-ISSN	15334406
Journal	New England Journal of Medicine
Language	English
Publisher	Massachusetts Medical Society (United States)
Publisher Date	2009-05-07
Publisher Place	United States
Access Restriction	Subscribed
Subject Keyword	Drug-Eluting Stents Myocardial Infarction Therapy Paclitaxel Administration & Dosage Stents Adult Aged Aged, 80 And Over Angioplasty, Balloon, Coronary Combined Modality Therapy Coronary Angiography Coronary Restenosis Epidemiology Prevention & Control Coronary Stenosis Adverse Effects Female Fibrinolytic Agents Therapeutic Use Follow-Up Studies Humans Kaplan-Meier Estimate Male Middle Aged Drug Therapy Mortality Recurrence Retreatment Statistics & Numerical Data Risk Sweden Comparative Study Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't Medicine
Content Type	Text
Resource Type	Article
Subject	Medicine

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