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Prasugrel versus clopidogrel for acute coronary syndromes without revascularization

Authors
Roe M.T.Armstrong P.W.Fox K.A.A.White H.D.Prabhakaran D.Goodman S.G.Cornel J.H.Bhatt D.L.Clemmensen P.Martinez F.Ardissino D.Nicolau J.C.Boden W.E.Gurbel P.A.Ruzyllo W.Dalby A.J.McGuire D.K.Leiva-Pons J.L.Parkhomenko A.Gottlieb S.Topacio G.O.Hamm C.Pavlides G.Goudev A.R.Oto A.Tseng C.-D.Merkely B.Gasparovic V.Corbalan R.Cintezǎ M.McLendon R.C.Winters K.J.Brown E.B.Lokhnygina Y.Aylward P.E.Huber K.Hochman J.S.Ohman E.M.Ohman E.Bassand J.P.Castillo V.R.Chua T.Cinteza M.Erlinge D.Foley D.P.Fridrich V.Ge J.Goodman S.Goudev A.Gratsiansky N.Hamm C.W.Jeong M.H.Jun-Ren Z.Lopez-Sendon J.Luscher T.Mogrovejo W.E.Nicolau J.Petrauskiene B.Providencia L.Roe M.Sritara P.Syvänne M.Topacio G.Verheugt F.Widimsky P.Wiviott S.D.Zambahari R.Van de Werf F.Budaj A.Gersh B.J.Montalescot G.Pocock S.J.Wilcox R.G.Williams D.O.Wilson M.Mehta R.H.Alexander J.H.Kong D.F.Lopes R.Mahaffey K.W.Melloni C.Newby L.Shah B.R.Tricoci P.George D.J.Beaven A.W.Blackwell K.L.Morse M.A.Onken J.E.Ready N.E.Strickler J.H.Zafar S.Hafley G.Pieper K.Stevens S.Schibler T.Chan M.Chin C.T.Gharacholou S.Subherwal S.McLendon R.Marshall D.Macias W.Lenarz L.Petijean H.Plat F.van Kranen R.Zamoryakhin D.Albisu J.Alvarez C.Amuchastegui M.Astesiano A.L.Beloscar J.Bergallo J.Bono J.Bordonava A.Botta C.E.Budassi N.Caccavo A.Cartasegna L.Colombo H.Costello R.Covelli G.De Valais F.Dran R.Duronto E.Forte E.H.Garcia D.F.Garcia Escudero A.Hominal M.Hrabar A.D.Ibañez J.O.Jure H.Leon de la Fuente R.Lobo Marquez L.Luciardi H.Luquez H.Marino J.Martingano R.Moises Azize G.Nul D.Patocchi C.Piombo A.Prado A.Rodriguez M.Romero Acuña A.Scaro G.B.Sosa Liprandi A.Varini S.D.Vigo S.J.Aroney G.Arstall M.Blenkhorn A.Carroll P.Chew D.Collins N.Hammett C.Lee A.Marrinan M.Roberts-Thomson P.Waites J.Benzer W.Lang I.Podczeck-Schweighofer A.Baetslé P.Beauloye C.De Tollenaere M.Lancellotti P.Marechal P.Van Dorpe A.Albuquerque D.Andrade Lotufo P.Ardnt M.Arminio G.Alves da Cost F.A.Baracioli L.M.Bertolim Precoma D.Carvalho Neuenschwander F.Damiao Gomes Seabra M.De Souza J.Duda N.T.Dutra O.P.Feitosa A.Filho H.Finimundi H.C.Gomes M.Gubolino L.Guimarães A.E.Hernandes M.Jardim C.A.Kunz Sebba Barroso de Souza W.Leaes P.E.Maia L.N.Manenti E.Marin Neto J.A.Marino R.Michalaros Y.Mora Junior R.Moraes Junior J.B.Nogueira Liberato de Sousa L.Pimentel Filho P.Polanczyk C.Rabelo Alves A.Jr.Ramos R.Reis G.Rocha Faria Neto J.Rossi Dos Santos F.Saporito W.Saraiva J.F.Sartori P.C.Scholz Issa J.Silva Junior D.Sousa A.Teixeira M.Zimmermann S.L.Lazov P.Tokmakova M.Penchev K.Petrov I.Baldjiev E.Georgiev P.Hergeldjieva V.Manolova A.Dimov B.Mihov A.Pencheva G.Raev D.Ramshev K.Tumbev H.Tzekova M.Boichev B.Kadiiski A.Devedzhiev T.Bakbak A.Berlingieri J.Burstein J.Déry J.P.Heath J.Huynh T.Kassam S.Kostuk W.Labonte R.Maccallum C.Nawaz S.Quraishi A.U.Senaratne M.Syan G.Syan R.Vizel S.Castro P.Florenzano F.Lamich R.Manriquez L.Potthoff S.Stockins B.Bugueño C.Cobos J.Sepulveda P.Opazo M.Montecinos H.Ke Y.Chen Y.D.Chen J.Wang J.Li W.Xu B.Ma G.Li Z.Sun Y.Tang 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Issue Date
Oct-2012
Publisher
Massachussetts Medical Society
Citation
New England Journal of Medicine, v.367, no.14, pp 1297 - 1309
Pages
13
Indexed
SCI
SCIE
SCOPUS
Journal Title
New England Journal of Medicine
Volume
367
Number
14
Start Page
1297
End Page
1309
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/12831
DOI
10.1056/NEJMoa1205512
ISSN
0028-4793
1533-4406
Abstract
BACKGROUND: The effect of intensified platelet inhibition for patients with unstable angina or myocardial infarction without ST-segment elevation who do not undergo revascularization has not been delineated. METHODS: In this double-blind, randomized trial, in a primary analysis involving 7243 patients under the age of 75 years receiving aspirin, we evaluated up to 30 months of treatment with prasugrel (10 mg daily) versus clopidogrel (75 mg daily). In a secondary analysis involving 2083 patients 75 years of age or older, we evaluated 5 mg of prasugrel versus 75 mg of clopidogrel. RESULTS: At a median follow-up of 17 months, the primary end point of death from cardiovascular causes, myocardial infarction, or stroke among patients under the age of 75 years occurred in 13.9% of the prasugrel group and 16.0% of the clopidogrel group (hazard ratio in the prasugrel group, 0.91; 95% confidence interval [CI], 0.79 to 1.05; P = 0.21). Similar results were observed in the overall population. The prespecified analysis of multiple recurrent ischemic events (all components of the primary end point) suggested a lower risk for prasugrel among patients under the age of 75 years (hazard ratio, 0.85; 95% CI, 0.72 to 1.00; P = 0.04). Rates of severe and intracranial bleeding were similar in the two groups in all age groups. There was no significant between-group difference in the frequency of nonhemorrhagic serious adverse events, except for a higher frequency of heart failure in the clopidogrel group. CONCLUSIONS: Among patients with unstable angina or myocardial infarction without ST-segment elevation, prasugrel did not significantly reduce the frequency of the primary end point, as compared with clopidogrel, and similar risks of bleeding were observed. (Funded by Eli Lilly and Daiichi Sankyo; TRILOGY ACS ClinicalTrials.gov number, NCT00699998.) Copyright © 2012 Massachusetts Medical Society.
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