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N Engl J Med. 2011 Sep 15;365(11):981-92. doi: 10.1056/NEJMoa1107039. Epub 2011 Aug 27.

Apixaban versus warfarin in patients with atrial fibrillation.

Collaborators (1151)

Granger CB, Wallentin L, Alexander JH, Ansell J, Diaz R, Easton JD, Gersh BJ, Hanna M, Horowitz J, Hylek EM, McMurray JJ, Mohan P, Verheugt FW, Diaz R, Bahit MC, Aylward P, Amerena J, Huber K, Bartunek J, Avezum A, Ezekowitz JA, Dorian P, Lanas F, Lisheng L, Zhu J, Isaza D, Jansky P, Husted S, Harjola VP, Steg PG, Hohnloser SH, Keltai M, Pais P, Xavier D, Lewis BS, De Caterina R, Goto S, Hermosillo AG, Alings AM, Atar D, Segura L, Ruzyllo W, Vinereanu D, Varshavsky S, Golitsyn S, Oh BH, Commerford P, Lopez-Sendon JL, Rosenquist M, Erol C, McMurray JJ, Parkhomenko A, Flaker G, Garcia D, Pfeffer MA, Diener HC, Maggioni A, Pocock S, Rouleau JL, Wyse G, Hatch L, Banks M, Handler A, Yang H, Garg J, Griffith K, Burr A, Dremsizov T, Vidal J, Hinton S, Rossi L, Fiedorek F, Nepal S, Croop R, Delvaux A, Mullin S, Arotsky N, Nemeth E, Bastien A, Wolf R, Jackson N, Braceras R, Alexander JH, Al-Khatib S, Lopes RD, Held C, Hylek EM, Bushnell C, Terent A, Leonardi S, Subherwal S, Eapen Z, Vavalle J, Zomorodi A, Kolls B, Berger J, Vergara J, Parikh D, Zia S, Stashenko G, Lombardi C, Matthews R, Hagstrom E, Akerblom A, Varenhorst C, Berntsson SG, Stenborg A, Lundstrom E, Guimaraes H, Flato U, Nacif S, Barros P, Echenique L, Rodrigues P, Armaganijan L, Lopes AC, Albrecht A, Vico M, Mackinnon I, Vogel D, Vico M, Gabito A, Cassettari A, Zaidman C, Montaña O, Hrabar A, Jure H, Lastiri H, Poy C, Caccavo A, Cuneo C, Colombo H, Rolandi F, Hershson A, Garrido M, Sanchez A, Bruno ML, Piskorz D, Cuadrado J, Hasbani E, Serra J, Cartasegna L, Schygiel P, Muratore C, Marino J, Sosa Liprandi MI, Guerrero RA, Ramos H, Mercado D, Guzman L, Beneitez C, Estepo J, Torrijos R, Retyk E, Vita N, Luciardi H, Casey M, Orlando S, Labarta MB, Santos D, Amerena J, Purnell P, Horowitz J, Salem H, Liu A, Zimmet L, Roger S, de Looze F, de Looze F, Lehman R, de Looze F, Jackson B, Ashby D, Heddle W, Rogers J, Brieger D, Martin P, Cross D, Walters D, Waites J, Counsell J, Lowy A, de Looze F, Huber K, Stockenhuber F, Pieske B, Striekwold H, Wollaert B, Nachtergaele H, Vijgen J, El Allaf D, Mairesse G, Boxho G, De Deyn PP, Vanderheyden M, Semeraro O, Desfontaines P, Leroy J, Provenier F, Bruneel B, Vrolix M, Peeters A, Deceuninck O, Saraiva JF, Reis G, Rossi P, Zimmermann S, Jaber J, Botelho R, Manenti E, Jorge J, Maia L, Leães P, Guimaraes Filho FV, Fichino M, De Paola A, do Brasil CK, Albuquerque D, Bodanese L, Matsubara L, Rocha RM, Genta P, Meneghelo Z, Oliveira L, Lorga Filho A, Garbelini B Jr, Oliveira G, Teixeira M, Precoma D, Pelloso E, Muniz A, Braile MC, Ueda R, Alves AR Jr, Pimentel Filho P, Zimerman L, Coutinho M, Silveira J, Reis H, Moreira D, Paiva M, Aziz JL, Gois J, Dutra O, Yao L, Syan G, Coutu B, Chehayeb R, Sabe-Affaki G, Fortin C, Borts D, Bhargava R, Fell D, Cha J, Pandey A, Boucher P, Sabbah E, Ma P, Talbot P, Spence D, Wade A, Green M, Berlingieri J, Vizel S, Chan YK, Blostein M, Talajic M, Sterns L, Grondin F, Hruczkowski T, Labonte R, O'Mahony M, Rupka D, Mangat I, Dowell A, Kelly A, St Maurice F, Henein S, Saunders K, Lasko B, Sami M, MacKinnon R, Rizvi Q, O'Keefe D, Ricci J, Gervais B, Hart R, Bose S, Nawaz S, Connors S, Winkler L, Boileau M, Healey J, Collette R, Rebane T, Ramjattan B, Senior R, Therrien R, Wells P, Raffo C, Cobos J, Potthoff S, Stockins B, Pincetti C, Corbalan R, Vejar M, Potthoff S, Li W, Zhao S, Chen X, Wu S, Tan H, Wu S, Qu P, Jiang X, Wei M, Yang X, Li J, Ma S, Gu S, Dai QY, Li L, Yu B, Yin Y, Wang N, Gao L, Zhou SX, Wang JA, Li ZQ, Bai F, Zhang F, Lu G, Chen Y, Zhang Y, Jiang D, Zonggui W, Li H, Cao K, Lu Q, Li L, Hu T, Li H, Wang X, Botero R, Reyes A, Jaramillo N, Urina M, Velez S, Gomez E, Pava L, Isaza D, Dunaj M, Hudcovic M, Jerabek O, Brat R, Spinar J, Dedek V, Zidkova E, Podpera I, Cech M, Gorican K, Micko M, Stribrna M, Frost L, Torp-Pedersen C, Larsen CT, Tuxen C, May O, Pedersen KE, Jensen G, Nielsen T, Nyvad O, Husted S, Hansen MG, Egstrup K, Lomholdt J, Skagen K, Jakobsen TJ, Olsen M, Grande P, Melin J, Tynni M, Harjola VP, Strand J, Parikka H, Jääskeläinen T, Corbelli JL, Gosse P, Mirode A, Mansourati J, Lavabre G, Defaye P, Steg PG, Kahrmann G, Horacek T, Bauer A, Spitzer S, Schlegl M, Winkelmann B, Vöhringer HF, Stenzel G, Haverkamp W, Harenberg J, Schumacher M, Wunderlich J, Natour M, Rieker W, Gass S, Brachmann J, Jung J, Poppert H, Häge R, Lickfett L, Schoeller R, Goedel-Meinen L, Utech A, Buerke M, Maschke M, Haberl R, von Hodenberg E, Griewing B, Schlachetzki F, Hamer H, Hoch T, Zabel M, Jordan R, Stögbauer F, Hetzel A, Weimar C, Schauerte P, Fischer D, Mügge A, Bittersohl A, Mügge A, Lee K, Yu C, Lakatos F, Vértes A, Kovács A, Takács J, Pálinkás A, Bakai J, Papp A, Illés Á, Tomcsányi J, Szakál I, László Z, Katona A, Jobbágy L, Keltai K, Dézsi C, Lupkovics G, Cziraki A, Mohácsi A, Simon K, Gupta S, Agarwal D, Fulwani M, Naik A, Nambiar A, Chidambaram N, Srinivasasastry B, Joseph J, Padinhare M, Khanna P, Grant P, Arneja J, Gadkari M, Garg N, Pothineni RB, Sathe S, Ramesh S, Malipeddi B, Bharani A, Gowdappa HB, Prakash VS, Dharmadhikari A, Bhandari S, Desai N, Banerjee S, Ghaisas N, Ramagiri B, Sinha S, Gojanur G, Duggal J, Jain V, Dani S, Singh P, Srikanthan V, Puri VK, Gopal R, Viskin S, Shochat M, Hayek T, Reisin L, Rosenheck S, Lewis B, Zimlichman R, Weiss A, Marmor A, Turgeman Y, Klainman E, Francis A, Lahav M, Omary M, Morris M, Olivieri C, Santonastaso M, Fenici R, Mos L, Ghirarduzzi A, De Caterina R, Novo S, Richiardi E, Testa S, Pini M, D'Angelo A, Barsotti A, Donati M, Chiariello M, Galli M, Casolo G, Moretti L, Atsushi Y, Yamamoto K, Goto S, Kihara H, Akihiko T, Saito T, Yoshii H, Sasaki T, Suwa M, Adachi S, Usada K, Nakamura Y, Hayashida K, Yamada T, Iwasawa T, Kawase Y, Sugi K, Murakami T, Satake K, Iwao T, Maemura K, Koretsune Y, Tsubokou Y, Yamashita M, Sato Y, Kouichi F, Yura S, Matsushima A, Iwade K, Kamakura S, Tanaka S, Murata H, Yamamoto S, Kobayashi Y, Higashi Y, Shinozaki T, Ikeda H, Hisaoka T, Node K, Takagi H, Ong TK, Abidin IZ, Yusof Z, Yusoff K, Maskon O, De los Rios Ibarra M, Alcocer Gamba M, Lopez Rosas E, Calvo Vargas C, Fajardo Campos P, Cordero-Cabra JA, JerJes-Sanchez C, Hernandez Santamaria I, Molina L, Olvera Ruiz R, Arean Martinez C, Gonzalez Guerra J, Morales Gonzalez I, Cervantes-Escarcega J, Chuquiure-Valenzuela EJ, Riojas C, Gonzalez Hermosillo J, Galicia A, Nierop P, Verheugt F, Daniels M, Lok D, Alings A, Scholten M, Plomp J, Derksen R, Bredero A, Zwart P, Schaap A, Michels H, Van der Zwaan C, Hysing J, Elle S, Omland T, Rønnevik P, Øie B, Otterstad JE, Bogale N, Kjærnli T, Halvorsen S, Bryhni B, Vikenes K, Cabrera W, Rodriguez A, Chavez C, Gamboa R, Segura L, Araoz O, Azanero R, Toce L, Medina F, Bustamante G, Rios Vasquez C, Zubiate M, Collado F, Morales-Palomares E, Sy R, Morales D, Rogelio G, Abola MT, Ramos E, Yamamoto M, Collado F, De Leon F, Abelardo N, Kania G, Szpajer M, Rajzer M, Janion M, Bronisz M, Ruzyllo W, Piepiorka M, Wendland M, Czerski T, Korzeniak R, Budaj A, Wawrzynska L, Ogorek M, Miekus P, Tracz W, Ocicka-Kozakiewicz A, Stepinska J, Kiedrowicz Z, Pasierski T, Kasprzak J, Galewicz M, Podogrodzka B, Krauze-Wielicka M, Chmielinski A, Boruczkowska-Kaszkowiak A, Piotrowski W, Vinereanu D, Stamate S, Cinteza M, Tanaseanu CM, Dan GA, Benedek I, Ionescu RM, Lighezan D, Salajan A, Carasca E, Capalneanu R, Pop C, Fierbinteanu-Braticevici CG, Zdrenghea DT, Gaita D, Manitiu I, Nanea T, Georgescu CA, Chizhov P, Kastanayan A, Oleynikov V, Treshkur T, Govorin A, Zhelninova T, Barbarash O, Novikova T, Reshetko O, Sivkova E, Obrezan A, Panchenko E, Popov S, Ivleva A, Zotov D, Gordienko A, Kamalov G, Chernichka I, Levin A, Zrazhevsky K, Golitsyn S, Shilkina N, Golovach A, Filonenko G, Bondarev S, Orlov V, Bragina A, Koziolova N, Svistov A, Shustov S, Libov I, Kisliak O, Privalova E, Aleksandrov O, Mazur E, Karpov Y, Belenky D, Kostenko V, Shubik Y, Ruda M, Arutyunov G, Eltishcheva V, Sidorenko B, Oseshnyuk R, Boyarkin M, Pozdnyakov Y, Staxhinskiy N, Sinopalnikov A, Yakushin S, Koniakhin A, Yarohno N, Sizova Z, Zadionchenko V, Klimov I, Duplyakov D, Kanorsky S, Mareev V, Terekhov V, Arkhipov V, Sotnikova T, Yakusevich V, Lesnov V, Gordeev I, Gratsiansky N, Shalaev S, Sulimov V, Talibov O, Zemtsovsky E, Azarin O, Tan RS, Thorne J, De Jong D, Basson M, van Zyl L, Commerford P, Weich H, van Nieuwenhuizen E, Roos J, Kelbe D, Viljoen J, Hong TJ, Oh BH, Park KS, Jeong MH, Rhim CY, Choi DJ, Sung JH, Kim YN, Bae JH, Tahk SJ, Ryu KH, Kwon SU, Rho TH, Cha TJ, Shin DG, Álvarez García P, Vida M, Galve E, Bruguera J, Roquer J, Olías de la Cruz F, Paz Bermejo MA, Segura T, Gómez Gómez JH, Ugarriza A, Plaza Pérez I, Villacastin J, Bertomeu V, Vargas R, Serena Leal J, Egido Herrero J, Bethencourt González A, Albert X, Gonzalez Juanatey C, Medrano V, Vivancos J, Andersson T, Lindholm CJ, Al-Khalili F, Höglund C, Rosenqvist M, Bergström O, Herlitz J, Rasmanis G, Johansson L, Christersson C, Fredholm O, Al-Khalili F, Callander M, Po H, Pan JP, Tseng CD, Shyu KG, Chu SH, Kultursay H, Gorenek B, Erol C, Lip G, Albazzaz M, Kadr H, Cohen A, Cooke J, Agarwal A, Brack M, Pye M, Anderson M, Dunn F, Wong YK, Glen S, Ford G, Alwail A, Yousef Z, Blagden M, Murdoch D, McInnes G, Camm J, Smith WR, McMurray JJ, Senior R, Webster J, Dutka D, McClements B, Yousef Z, Levy T, Yogasundram S, Moriarty A, McCullagh M, Flather J, Gumbley M, Findlay I, Davies J, Cooke A, Ahsan A, Cannon J, Bakhai A, Jacob A, Trouton T, Ajala A, Bartkowiak A, Humiston D, Kufs W, Klancke K, Jetty P, Gupta D, Nadar V, Yousuf K, Sosa-Suarez G, Gill S, Wukelic M, Mayer N, Colan D, Haskel E, Grena P, Haught W, Walsh R, Carr K, Tahirkheli N, Jardula M, Cebe J, Bloom S, Bilazarian S, Gilmore R, Jaffrani N, Goldscher D, Lebowitz A, Friedlander I, Stein M, Promisloff S, Magnano A, Dean J, Gerber J, Perloff D, Cohen Y, Meholick A, Tobin T, Acheatel R, Levanovich P, Ip J, Porterfield J, Seshadri N, McKenzie M, Alfieri A, Gazmuri R, Beanblossom B, Van Hamersveld D, McCriskin J, Gelernt M, Bowden W, Sotolongo C, Lang J, Kaatz S, Agnone F, Hassman D, Flores E, Albrecht F, Hassel C, Quartner J, LaFata J, Bedwell N, Herzog W, Amin J, Usedom J, Brockmyre A, Abadier R, Corder C, Marple R, Lovell C, Henry W 3rd, Chhabra A, Baker S, Bedoya R, Sandoval R, Nathan M, Garcia D, Vora K, Sloan S, Kosinski E, Foster R, Salacata A, Weachter R, Bredlau C, Mehta P, Russo C, Swint R Sr, Rosenthal S, Bybee K, Peart B, Chaudhuri P, Iteld B, Staab M, Rhodes D, Kappler J, Mandviwala M, Niedermaier O, Sofley C, Heiman M, Gips S, Harris R, East C, Nguyen V, Huling R, Thadani U, Travis D, Maislos F, West M, Castello R, Cohen K, Karlsberg R, Schmedtje J Jr, Gottlieb D, MacKinnon A, Noble G, O'Neill P, Roth J, Kobayashi J, Honan M, Hanovich G, Ehrlich S, Wilson W, Warner A, Rubin A, Rivera E, Leu S, Smith L, Agaiby J, Jan M, Gould R, Weiner S, Fleming J, Hemphill J, Parr K, Stoddard M, Curran P, Kurrelmeyer K, Desai V, Kereiakes D, Schwarz E, Lillestol M, Vazquez-Tanus J, Vicari R, White J, Shroff R, Fierer R, Vijay N, Hamad A, Kozinn M, Young D, Fenton S, Ouyang P, Wellford A, Zwerner P, Meyer P, Foley J, Boyle A, Dotani M, Skolnick A, Rodriguez-Fierro C, Hattler B, Rubin M, Hartley P, Tami L, Ball E, McPherson C, Eisenberg S, Niazi I, Orlov M, Bachhuber B, Massey C, Phillips W, Mouhayar E, Griffin J, Blumberg E, Slabic S, Danisa K, Samal A, Rohrbeck S, McCullough P, Dohan D, Aycock G, Jones A, Anderson J, Silverman R, Smith W, Mishkel D, Patterson N, Moore H, Kabour A, Muttreja M, Jaffrani W, Vidic T, Kent S, Platt B, Goldberg R, Kulback S, Patel R, Bazzi A, Goldman S, Roman A, Levin C, Lachterman B, Chandrashekhar Y, Aisiku I, Powers C, Engeron E, Bernstein R, Shah S, Strobel J, Punatar H, Garcia R, Linden D, Al-Mudamgha A, Quick A, Kramer J, Feldman G, Stapleton D, Davis M, Graff J, Galizia J, Wassmer P, Chiu D, Ison R, Curry K, Finneran M, Solomon A, Schifferdecker B, Seger J, Alexander A, Yates S, Ashley R Jr, Cordero-Sepulveda J, Cowen P, Ayres T, Kowalski B, Anton S, Phillips J, Donovan D, Patel A, Smith R, Updegrove J, Buxton A, Clark D, Margolis J, Brooks G, Pernenkil R, Walters J, Richards M, Maccaro P, Pieniek M, Pulido JG, Lee CW, Ilvento J, Riff D, Blue B, Welker J, Karunaratne H, Santucci P, Vatutin M, Kraiz I, Mostovoy Y, Karpenko O, Tseluyko V, Kononenko L, Volkov V, Parkhomenko A, Popik G, Chopey I, Burmak Y, Pavlyk S, Vizir V, Barna O, Sychov O, Vykhovanyuk I, Tashchuk V, Khomazjuk I, Andrievskaya S, Telyatnikova Z, Bondarchuk O, Netiazhenko V, Seredyuk N, Koval O, Kovalsky I, Bazylevych A, Lysenko G, Borschivsky M, Yagensky A, Dzyak G, Bereznyakov I, Rudenko L, Ignatenko G, Amosova K, Voloshyna O, Ivanova L, Tykhonova S, Suprun E.

Abstract

BACKGROUND:

Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with aspirin.

METHODS:

In this randomized, double-blind trial, we compared apixaban (at a dose of 5 mg twice daily) with warfarin (target international normalized ratio, 2.0 to 3.0) in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke. The primary outcome was ischemic or hemorrhagic stroke or systemic embolism. The trial was designed to test for noninferiority, with key secondary objectives of testing for superiority with respect to the primary outcome and to the rates of major bleeding and death from any cause.

RESULTS:

The median duration of follow-up was 1.8 years. The rate of the primary outcome was 1.27% per year in the apixaban group, as compared with 1.60% per year in the warfarin group (hazard ratio with apixaban, 0.79; 95% confidence interval [CI], 0.66 to 0.95; P<0.001 for noninferiority; P=0.01 for superiority). The rate of major bleeding was 2.13% per year in the apixaban group, as compared with 3.09% per year in the warfarin group (hazard ratio, 0.69; 95% CI, 0.60 to 0.80; P<0.001), and the rates of death from any cause were 3.52% and 3.94%, respectively (hazard ratio, 0.89; 95% CI, 0.80 to 0.99; P=0.047). The rate of hemorrhagic stroke was 0.24% per year in the apixaban group, as compared with 0.47% per year in the warfarin group (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P<0.001), and the rate of ischemic or uncertain type of stroke was 0.97% per year in the apixaban group and 1.05% per year in the warfarin group (hazard ratio, 0.92; 95% CI, 0.74 to 1.13; P=0.42).

CONCLUSIONS:

In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality. (Funded by Bristol-Myers Squibb and Pfizer; ARISTOTLE ClinicalTrials.gov number, NCT00412984.).

PMID:
21870978
DOI:
10.1056/NEJMoa1107039
[Indexed for MEDLINE]
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