Document Detail


Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease.
MedLine Citation:
PMID:  20445180     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Previous studies have established the superiority of coronary everolimus-eluting stents over paclitaxel-eluting stents with respect to angiographic findings. However, these trials were not powered for superiority in clinical end points. METHODS: We randomly assigned 3687 patients at 66 U.S. sites to receive everolimus-eluting stents or paclitaxel-eluting stents without routine follow-up angiography. The primary end point was the 1-year composite rate of target-lesion failure (defined as cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization). RESULTS: Everolimus-eluting stents were superior to paclitaxel-eluting stents with respect to the primary end point of target-lesion failure (4.2% vs. 6.8%; relative risk, 0.62; 95% confidence interval, 0.46 to 0.82; P=0.001). Everolimus-eluting stents were also superior with respect to the major secondary end point of the 1-year rate of ischemia-driven target-lesion revascularization (P=0.001) and were noninferior with respect to the major secondary end point of the 1-year composite rate of cardiac death or target-vessel myocardial infarction (P<0.001 for noninferiority; P=0.09 for superiority). The 1-year rates of myocardial infarction and stent thrombosis were also lower with everolimus-eluting stents than with paclitaxel-eluting stents (1.9% vs. 3.1%, P=0.02 for myocardial infarction; 0.17% vs. 0.85%, P=0.004 for stent thrombosis). Target-lesion failure was consistently reduced with everolimus-eluting stents as compared with paclitaxel-eluting stents in 12 prespecified subgroups, except in the subgroup of patients with diabetes (6.4% vs. 6.9%, P=0.80). CONCLUSIONS: Everolimus-eluting stents, as compared with paclitaxel-eluting stents, resulted in reduced rates of target-lesion failure at 1 year, results that were consistent in all patients except those with diabetes, in whom the results were nonsignificantly different. (ClinicalTrials.gov number, NCT00307047.)
Authors:
Gregg W Stone; Ali Rizvi; William Newman; Kourosh Mastali; John C Wang; Ronald Caputo; Julie Doostzadeh; Sherry Cao; Charles A Simonton; Krishnankutty Sudhir; Alexandra J Lansky; Donald E Cutlip; Dean J Kereiakes;
Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The New England journal of medicine     Volume:  362     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2010 May 
Date Detail:
Created Date:  2010-05-06     Completed Date:  2010-05-13     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1663-74     Citation Subset:  AIM; IM    
Copyright Information:
2010 Massachusetts Medical Society
Affiliation:
Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY 10022, USA. gs2184@columbia.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00307047
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MeSH Terms
Descriptor/Qualifier:
Aged
Angioplasty, Transluminal, Percutaneous Coronary
Coronary Artery Disease / mortality,  therapy*
Drug-Eluting Stents* / adverse effects
Female
Humans
Logistic Models
Male
Middle Aged
Myocardial Infarction / epidemiology
Paclitaxel / administration & dosage*
Platelet Glycoprotein GPIIb-IIIa Complex / antagonists & inhibitors
Retreatment / statistics & numerical data
Single-Blind Method
Sirolimus / administration & dosage,  analogs & derivatives*
Thrombosis / epidemiology,  prevention & control
Treatment Failure
Chemical
Reg. No./Substance:
0/Platelet Glycoprotein GPIIb-IIIa Complex; 159351-69-6/everolimus; 33069-62-4/Paclitaxel; 53123-88-9/Sirolimus
Investigator
Investigator/Affiliation:
G W Stone / ; A J Lansky / ; D E Cutlip / ; G Johnson / ; S Fink / ; G W Stone / ; K Sudhir / ; T Engels / ; W Pierson / ; J Doostzadeh / ; L Jonnvithula / ; J Coe / ; B Nishimoto / ; M Harvill / ; T Lucente / ; P Patel / ; M Plaunt / ; M Mirgoli / ; X Su / ; D E Cutlip / ; A J Lansky / ; E Cristea / ; R Piana / ; D Rizik / ; J Saczyinski / ; D Mego / ; M Ashcraft / ; M Buchbinder / ; J Logan / ; R Fortuna / ; S Weaver / ; D Shavelle / ; C Mayoralago / ; M Chang / ; S Bordash / ; P Coleman / ; J Willson / ; J Greenberg / ; S West / ; A Doing / ; S Kaczkowski / ; L Satler / ; D Sawyer / ; F Fleischhauer / ; J Lehman / ; S Culp / ; J Kelley / ; J Hermiller / ; A Rizvi / ; L Burkert / ; S Gallagher / ; S Shaikh / ; D Richardson / ; M Tannenbaum / ; C Noyes / ; M Wiley / ; C Jones / ; J McClaymont / ; W Skinner / ; J Hamilton / ; N Xenopoulos / ; P Adkisson / ; M Kellett / ; J Burgess / ; J Resar / ; K Citro / ; J Wang / ; J Raqueno / ; S Hearne / ; K Fiddler / ; M Turco / ; K Gray / ; K Mastali / ; E Shlian / ; L Mauri / ; A Connors / ; E Ramsaran / ; P Siegel / ; D Fisher / ; S Ball / ; W Felten / ; D Lee / ; V Blitzer / ; S Dabbous / ; J Gugudis / ; D Wohns / ; K Postema / ; T Fischell / ; S Wilson / ; C D'Haem / ; T Zambon / ; L Cannon / ; J LaLonde / ; E Hockstad / ; P Wyman / ; J Grantham / ; R Gans / ; J Maddux / ; B Krininger / ; D Netz / ; C Godfrey / ; A Kaplan / ; L Martel / ; C Hirsch / ; C Kunz / ; A Masud / ; L Delzoppo / ; R Caputo / ; J Riley / ; M Collins / ; A Hill-Boyd / ; M Kamanda-Kosseh / ; S Wong / ; D Reynolds / ; L Gruberg / ; J Kidd / ; J Williams / ; B Carroll / ; A Maganares / ; W Tan / ; D Bembridge / ; J Harris / ; W Newman / ; S Darden / ; J Patterson / ; B Coleman / ; R Applegate / ; T Young / ; D Kereiakes / ; D White / ; S Yakubov / ; G Robb / ; T Terry / ; N Farhat / ; A Giunta / ; T Caulfield / ; E Johnson / ; K Skelding / ; A Temple / ; A Smith / ; L Baxendell / ; P Gordon / ; L DeSimone / ; D Williams / ; J Muratori / ; C Nielsen / ; C Vaughn / ; P Hall / ; T Gonter / ; J Sheriod-Scott / ; J Cebe / ; S Harrelson / ; J McPherson / ; L Blair-Anton / ; L Walder / ; S Williams / ; B Raybuck / ; M Dang / ; D Eich / ; C Zulick / ; H Dauerman / ; F Straight / ; P Bernstein / ; S Oxborough /
Comments/Corrections
Comment In:
N Engl J Med. 2010 May 6;362(18):1728-30   [PMID:  20445185 ]

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