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N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19.

Edoxaban versus warfarin in patients with atrial fibrillation.

Collaborators (2908)

Braunwald E, Antman EM, Giugliano RP, Ruff CT, Morin SE, Hoffman EB, Murphy SA, Deenadayalu N, Grip L, Mercuri M, Lanz H, Patel I, Curt V, Duggal A, Hanyok J, Davé J, Morgan D, Choi Y, Shi M, Jin J, Xie J, Crerand W, Kappelhof J, Maxwell W, Skinner M, Patel S, Betcher J, Selicato G, Otto C Jr, Reissner C, Smith K, Ostroske J, Ron A, Braunwald E, Antman EM, Giugliano R, Mercuri M, Connolly S, Camm J, Ezekowitz M, Halperin J, Waldo A, Paolasso E, Aylward P, Heidbuchel H, Nicolau JC, Goudev A, Roy D, Weitz J, Corbalán R, Yang Y, Botero R, Bergovec M, Ŝpinar J, Grande P, Hassager C, Voitk J, Huikuri H, Nieminen M, Blanc JJ, LeHeuzey JY, Mitrovic V, Alexopoulos D, Sotomora G, Kiss R, SomaRaju B, Lewis B, Merlini P, Metra M, Koretsune Y, Yamashita T, García-Castillo A, Ophuis T, White H, Atar D, Horna M, Babilonia N, Ruzyllo W, Morais J, Dorobantu M, Ruda M, Ostojic M, Duris T, Dalby A, Chung N, Zamorano JL, Juul-Möller S, Moccetti T, Chen SA, Sritara P, Oto A, Parkhomenko A, Senior R, Verheugt F, Skene A, Anderson J, Bauer K, Easton JD, Goto S, Wiviott S, Lowe C, Awtry E, Berger CJ, Croce K, Desai A, Gelfand E, Goessling W, Greenberger NJ, Ho C, Leeman DE, Link MS, Norden AD, Pande A, Rost N, Ruberg F, Silverman S, Singhal A, Vita JA, Vogelmann O, Gonzalez C, Ahuad Guerrero R, Rodriguez M, Albisu J, Rosales E, Allall O, Reguero M, Alvarez C, Garcia M, Ameriso S, Ameriso P, Amuchastegui M, Caceres M, Beloscar J, Petrucci J, Berli M, Berli M, Budassi N, Valle M, Bustamante Labarta G, Saravia M, Caccavo A, Fracaro V, Cartasegna L, Novas V, Caruso O, Zarandon RS, Colombo H, Morandini M, Cuello J, Rosell M, Cuneo C, Bocanera M, D'Amico A, Cendali G, Dran R, Moreno V, Estol C, Davolos M, Facello A, Facello M, Falu E, Iriarte M, Femenia F, Arrieta M, Fuselli J, Zanotti A, Gant Lopez J, Meiller F, Garcia Duran R, Perlo D, Garrido M, Ceirano C, Giacomi G, Eden M, Giannaula R, Huerta M, Goicoechea R, von Wulffen M, Hominal M, Bianchini M, Jure H, Jure D, Kevorkian R, Monaco F, Lanternier G, Belcuore M, Liniado G, Iglesias M, Litvak B, Nigro A, Llanos J, Vignau S, Lorente C, Shatsky K, Lotti J, Raimondi G, Mackinnon I, Carne M, Manuale O, Calderon M, Marino J, Funes I, Muntaner J, Gandur H, Nul D, Verdini E, Piskorz D, Tommasi A, Povedano G, Casares E, Pozzer D, Fernandez E, Prado A, Venturini C, Ramos H, Navarrete S, Rodriguez M, Alvarez M, Sanchez A, Bowen L, Sanjurjo M, Codutti O, Saravia Toledo S, Formoso I, Schmidberg J, Goloboulicz A, Schygiel P, Buzzetti C, Severino P, Morara P, Sosa Liprandi M, Teves M, Vico M, Morell Y, Anderson C, Paraskevaidis T, Arstall M, Hoffmann B, Colquhoun D, Price-Smith S, Crimmins D, Slattery A, Dart A, Kay S, Davis S, Silver G, Flecknoe-Brown S, Roberts J, Gates P, Jones S, Lehman R, Morrison H, McKeirnan M, Li J, Paul V, Batta C, Purnell P, Perrett L, Szto G, O'Shea V, Capiau L, Banaeian F, De Bleecker J, de Koning K, De Tollenaere M, De Bruyne L, Desfontaines P, Tincani G, Heidbuchel H, Meeusen K, Herzet J, Malmendier D, Mairesse G, Raepers M, Parqué J, Clinckemaille N, Scavée C, Huyberechts D, Stockman D, Jacobs C, Vandekerckhove Y, Derycker K, Vanwelden J, van Welden J, Vervoort G, Mestdagh I, Vrolix M, Beerts C, Wollaert B, Denie D, Amato Vincenzo de Paola A, Coutinho E, Andrade Lotufo P, de Melo RF, Atie J, Motta C, Augusto Alves da Costa F, Ferraz RF, Bertolim Precoma D, Sehnem E, Botelho R, Cunha S, Brondani R, Fleck N, Chaves Junior H, Silva J, Costantini C, Barroso D, De Patta M, Pereira V, Duda N, Laimer R, Dutra O, Morgado S, Faustino Saporito W, Seroqui M, Ferreira L, Araújo E, Finimundi H, Daitz C, Gagliardi R, Pereira G, Gomes M, Gomes A, Guimarães A, Ninho L, Jaeger C, Pereira L, Jorge J, Cury C, Kaiser S, Almeida A, Kalil C, Radaelli G, Kunz Sebba Barroso de Souza W, Morales K, Leaes P, Luiz RO, Pimenta Almeida J, Gozalo A, Reis G, Avellar K, Reis Katz Weiand L, Leipelt J, Rocha J, Barros R, Rodrigues L, Rocha MR, Rodrigues A, Rodrigues D, Rossi dos Santos F, Pagnan LG, Sampaio R, do Val R, Saraiva J, Vicente C, Simoes M, Carraro A, Sobral Filho D, Lustosa E, Villas Boas F, Almeida M, Zimmermann S, Zimmermann EB, Chompalova B, Parishev G, Denchev S, Milcheva N, Donova T, Gergova V, Georgiev B, Kostova E, Goudev A, Kinova E, Hergeldjieva V, Kamenova P, Manolova A, Vasilev I, Mihov A, Miteva B, Mincheva V, Stoyanovski V, Nikolov F, Vasilev D, Pencheva G, Kostov K, Petranov S, Milusheva T, Popov A, Vasilev I, Staneva A, Momchilova-Lozeva D, Todorov G, Nyagina M, Tumbev H, Tumbeva D, Tzekova M, Kitova M, Manoylov E, Archibald J, Antle S, Bhargava R, Stafford C, Bose S, Hundseth M, Cha J, Otis J, Chehayeb R, Lepage C, Chilvers M, Vansickle L, Cleveland D, Valley S, Constance C, Gauthier M, Costi P, Masson C, Coutu B, Denis I, du Preez M, Kubanska A, Dufresne M, Krider J, Eikelboom J, Zondag M, Fortin C, Viau C, Green M, Houbraken D, Hatheway R, Mabee J, Heath J, Scott L, Ho K, Ho V, Hoag G, Standring R, Huynh T, Perkins L, Kouz S, Roy M, Labonte R, Dewar C, Lainesse A, St-Germain L, Lam S, Lam H, Lichtenstein T, Roberts P, Luton R, Douglas S, Ma P, Seib M, MacCallum C, Matthews J, Malette P, Vaillancourt T, Maranda C, Studenikow E, Mawji A, Morely A, Morrison D, Roth M, Mucha M, Krider J, Najarali A, Lamoureux U, Nicholson R, Morely A, O'Hara G, Banville P, O'Mahony W, Bolton R, Parkash R, Carroll L, Pesant Y, Sardin V, Polasek P, Turri L, Qureshi A, Nethercott C, Ricci J, Bozek B, Rupka D, Marchand C, Shu D, Silverio G, St-Hilaire R, Morissette A, Sussman J, Kailey P, Syan G, Bobbie C, Talajic M, David D, Talbot P, Tremblay M, Teitelbaum I, Teitelbaum J, Velthuysen G, Giesbrecht L, Wahby R, Morley A, Wharton S, Caterini T, Woodford T, Mabee J, Balboa W, Matus LR, Bugueño C, Mondaca PM, Cobos J, Obreque C, Corbalan R, Parada A, Florenzano F, Diaz PA, Lopetegui M, Rebolledo C, Manriquez L, Silva LM, Martinez D, Llamas RR, Opazo M, Pérez MC, Pincetti C, Carrasco GT, Potthoff S, Staub JZ, Rodriguez M, Campisto Y, Stockins B, Lara CL, Yovaniniz P, Azua MG, Bai F, Xu GL, Chen JZ, Xie XD, Chen XP, Zhang X, Dong YG, Feng C, Fu GS, Zhang P, Hong K, You ZG, Hong L, Qiu Y, Jiang XJ, Qu Z, Li L, Liu H, Li TF, Kong YQ, Li WM, Liu B, Li ZQ, Liu Y, Liao DN, Gu XJ, Liu L, Lu ZH, Ma SM, Yang ZY, Wang DM, Qi SY, Wang GP, Shi XJ, Wei M, Huang D, Wu SL, Li YE, Xu JH, Gu JY, Xu YM, Liang YZ, Yang K, Li AY, Yang YJ, Zheng X, Zheng Y, Gao M, Yin YH, Xu YP, Yu B, Li LL, Yuan ZY, Qiang H, Zhang HQ, Lin YN, Zhang Z, Kang H, Zhao RP, Han RJ, Zhao XL, Wang JQ, Zheng ZQ, Li BG, Zhou SX, Zhang YL, Accini J, Accini M, Cano N, Pineda LL, Delgado Restrepo J, Arroyave C, Fernández Ruiz R, Diaz IA, Hernandez H, Delgado P, Jaramillo Muñoz C, Builes A, Manzur F, Rodriguez ER, Moncada Corredor M, Giraldo DL, Orozco Linares L, Fonseca J, Quintero A, Gonzales C, Sanchez Vallejo G, Mejia IP, Bagatin J, Carevic V, Car S, Jeric M, Ciglenecki N, Tusek S, Ferri Certic J, Romic I, Francetic I, Ausperger KM, Jelic V, Jurinjak SJ, Knezevic A, Buksa B, Samardzic P, Lukenda KC, Steiner R, Kirner D, Sutalo K, Bakliza Z, Vrazic H, Bergovec M, Lucijanic T, Bar M, Brodova P, Berka L, Kunkelova V, Brtko M, Brtko M, Burianova H, Burianova H, Cermak O, Cermak O, Elbl L, Elbl L, Ferkl R, Ferkl R, Florian J, Florian J, Francek L, Francek L, Golan L, Golan L, Gregor P, Gregor P, Honkova M, Honkova M, Hubac J, Hubac J, Jandik J, Jandik J, Jarkovsky P, Jarkovsky P, Jelinek Z, Jelinek Z, Jerabek O, Jerabek O, Jirmar R, Jirmar R, Kobza R, Kobza R, Kochrt M, Kostkova G, Kosek Z, Kosek Z, Kovar P, Kovar P, Kuchar R, Kuchar R, Kvasnicka J, Kvasnicka J, Ludka O, Ludka O, Machova V, Krocova E, Melichar M, Melichar M, Nechanicky R, Nechanicky R, Olsr J, Olsr J, Peterka K, Peterka K, Petrova I, Havlova I, Pisova J, Pisova J, Podrazil P, Jirsova E, Reichert P, Reichert P, Slaby J, Slaby J, Spacek R, Spacek R, Spinar J, Labrova R, Vodnansky P, Samkova D, Zidkova E, Zidkova E, Dodt K, Christensen H, Christensen L, Hassager C, Loof A, Ibsen H, Madsen H, Iversen H, Veng-Olsen T, Nielsen H, Olsen R, Overgaard K, Petrovic V, Raymond I, Raae D, Sand N, Svenningsen A, Torp-Pedersen C, Jakobsen U, Wiggers H, Serup-Hansen K, Kaik J, Stern A, Kolk R, Kolk R, Laane E, Rivis L, Paumets M, Voitk J, Laheäär M, Rosenthal A, Rajasalu R, Vahula V, Ratnik E, Huikuri H, Kaarleenkaski S, Hussi E, Valpas S, Jäkälä P, Lappalainen T, Mäenpää A, Viitaniemi J, Nyman K, Sankari T, Rasi H, Salminen O, Virtanen V, Nappila H, Le Heuzey J, Agraou B, El Jarroudi F, Amarenco P, Boursin P, Babuty D, Boyer M, Belhassane A, El Jarroudi F, Berbari H, Berbari H, Blanc J, Dias P, Coisne D, Berger N, Decoulx E, El Jarroudi M, Dinanian S, Arfaoui M, Hermida J, Deruche E, Kacet S, Corbut S, Poulard J, Leparree S, Roudaut R, Duprat C, Al-Zoebi A, Wurow A, Bernhardt P, Dichristin U, Berrouschot J, Vierbeck S, Beyer-Westendorf J, Sehr B, Bouzo M, Schnelzer P, Braun R, Ladenburger K, Buhr M, Weihrauch D, Contzen C, Kara M, Daut W, Ayasse D, Degtyareva E, Kranz P, Drescher T, Herfurth B, Faghih M, Faghih M, Forck-Boedeker K, Schneider K, Fuchs R, Manuela W, Grigat C, Otto A, Hartmann A, Peitz M, Heuer H, Dieckheuer U, Hoffmann U, Dorn S, Hoffmann S, Schuppe M, Horacek T, Fink P, Junggeburth J, Schmid S, Jungmair W, Schoen B, Kleinecke-Pohl U, Meusel P, Koenig H, Bauch F, Koenig H, Bauch F, Lohrbaecher-Kozak I, Grosse B, Lueders S, Venneklaas U, Luttermann M, Wulf M, Maus O, Hoefer K, Meissner G, Braemer U, Meyer-Pannwitt U, Frahm E, Mitrovic V, Vogt S, Muegge A, Barbera S, Mueller-Glamann M, Raddatz K, Piechatzek R, Lewinsky D, Pohl W, Pohl W, Proskynitopoulos N, Kuhlmann M, Rack K, Pilipenko H, Rinke A, Kühlenborg A, Schaefer A, Szymanowski N, Schellong S, Frommhold R, Schenkenberger I, Finsterbusch T, Dreykluft K, Schiewe C, Schiewe C, Schmidt A, Schmidt M, Schreckenberg A, Hellmers J, Seibert H, Gold G, Sohn H, Baylacher M, Spitzer S, Bonin K, Stoehring R, Stoehring R, Taggeselle J, Zarpentin C, Veltkamp R, Ludwig I, Voehringer, Buchholz M, Weyland K, Winkelmann B, Buelow-Johansen B, Wolde C, Winter K, Alexopoulos D, Mavronasiou E, Bourlios P, Tziortziotis A, Karamitsos C, Exarchou E, Kifnidis K, Daskalaki A, Moschos N, Dimitra K, Olympios C, Kartsagkoulis E, Pyrgakis V, Korantanis K, Ayau Milla O, Ramirez Vde L, Guzman Melgar I, Jimenez T, Ovando Lavagnino A, Guevara S, Rodas Estrada M, Jimenez T, Sanchez M, Pozuelos JM, Sanchez Samayoa C, Guerra L, Velasquez Camas L, Almaraz SP, Dioszeghy P, Muskoczki E, Edes I, Szatmari J, Fiok J, Varga A, Kanakaridisz N, Kosztyu M, Kis E, Feil JF, Kiss R, Jakal A, Koczka M, Koczka M, Kovacs I, Baranyai M, Kovacs Z, Kovacs Z, Lupkovics G, Karakai HH, Matoltsy A, Kiss T, Medvegy M, Kiss K, Merkely B, Kolumban E, Nagy A, Nagy A, Palinkas A, Toth SR, Sayour A, Bognar A, Simor T, Ruzsa D, Sipos T, Sipos T, Szakal I, Szakal I, Tomcsanyi J, Marosi A, Vertes A, Kincses M, Malhan S, Abdullakutty J, Agarwal D, Ranka R, Arneja J, Memon A, Arora V, Shree R, Avvaru G, Shaikh A, Babu P, Rao B, Babu R, Reddy J, Banker D, Sheth T, Benjarge P, Surushe S, Bharani A, Solanki R, Bhargava V, Rathi A, Biniwale A, Bhuti M, Calambur N, Somaraju B, Karnwal N, Chopda M, Mali N, Goyal N, Saini A, Gupta J, Singh P, Hadan S, Savanth P, Hardas S, Thakor G, Hiremath J, Ghume A, Jain R, Pahuja M, Joseph S, Oommen D, Joseph J, Thomas R, Joshi H, Iby, Kale V, Raut N, Kandekar B, Kandekar S, Kishore R, Krishnan H, Kotiwale V, Kulkarni R, Deokar M, Kulkarni G, Lawande A, Kumar P, Karpuram M, Kumar A, Francis J, Kumbla M, Anthony A, Lavhe P, Kale M, Mardikar H, Bhaskarwar P, Mathur A, Sharma P, Menon J, Francis V, Namjoshi D, Shelke S, Narendra J, Natarajan S, Francis V, Oomaan A, Gurusamy P, Angel J, Purayil MP, Shams S, Pandurangi U, Sababathi R, Parekh P, Jasani B, Patki N, Babbar A, Pinto B, Kharalkar H, Premchand R, Jambula H, Rao M, Vuriya A, Ravi Shankar A, Reddy R, Bekal S, Roy D, Barai A, Saha D, Gadepalli R, Sant H, Jadhav D, Sarna M, Arora T, Sawhney J, Singh R, Sethi K, Bansal N, Sethia A, Sethia S, Shetty G, Sudheer R, Singh G, Gupta R, Srinivas A, Thankaraj L, Varma S, Kaur A, Vinod MV, Thakur B, Zanwar I, Dharmarao A, Atar S, Lasri E, Dicker D, Marcoviciu D, Elias M, Ron GA, Francis A, Ghantous R, Goldhaber A, Goldhaber M, Gottlieb S, Rouwaida S, Grossman E, Dagan T, Hasin Y, Roshrosh M, Hayek T, Majdoub A, Klainman E, Genin I, Lahav M, Gilat T, Lewis B, Ben Ari M, Lishner M, Karny M, Ouzan E, Givoni H, Rozenman Y, Logvinenko S, Schiff E, Sterlin J, Shochat M, Aloni I, Swissa M, Belatsky V, Tsalihin D, Kisos D, Zeltser D, Platner N, Berni A, Giovannelli F, Boriani G, Cervi E, Comi G, Peruzzotti L, Cuccia C, Forgione C, De Caterina R, De Pace D, De Servi S, Mariani M, Di Lenarda A, Mazzone C, Di Pasquale G, Di Niro M, Fattore L, Bosco B, Grassia V, Murena E, Laffi, Gaggioli G, Lo Pinto G, Raggi F, Marino P, Francalacci G, Merlini P, Babbolin M, Metra M, Bulgari M, Penco M, Lioy E, Perrone Filardi P, Marciano C, Pirelli S, Paradiso G, Piseddu G, Fenu L, Raisaro A, Granzow K, Rasura M, Cannoni S, Severi S, Breschi M, Toschi V, Gagliano M, Zacà V, Furiozzi F, Hirahara T, Akihisa U, Masaki W, Ajioka M, Matsushita C, Anzai T, Mino K, Arakawa S, Tsukimine A, Endo H, Fujiwara M, Fujii K, Kozeni S, Fujii E, Kotera M, Fujimoto S, Omae K, Fujimoto K, Ichishita Y, Fujita T, Ito Y, Fukamizu S, Harada J, Fukuda N, Fujimoto C, Funazaki T, Yamaguchi A, Furukawa Y, Kamitake C, Hagiwara N, Naganuma M, Hara S, Kumagai S, Harada K, Fuki Y, Haruna T, Nakahara Y, Hashimoto Y, Shimazu Y, Hiasa Y, Oga Y, Higashikata T, Nakagawa Y, Hirayama A, Kawaguchi A, Iesaka Y, Miyamoto C, Iijima T, Higuchi K, Ino H, Noguchi H, Inomata T, Nakamura K, Ishibashi Y, Nozaki T, Ishii Y, Tomita H, Ishimaru S, Ise M, Itamoto K, Ito T, Ito Y, Onishi M, Iwade K, Sakuma Y, Iwasaki T, Nagatome H, Kakinoki S, Adachi C, Kamakura S, Nakahara F, Kamijo M, Iida S, Kamiyama K, Fujii R, Kato K, Ishida A, Kazatani Y, Ichikawa Y, Kitazawa H, Igarashi C, Kobayashi Y, Kikuchi R, Kohno M, Tamura S, Koretsune Y, Yumoto I, Kurabayashi M, Koya E, Masuyama T, Kaneno Y, Matsuda K, Ebina E, Meno H, Satake M, Mita T, Takeda M, Miyamoto N, Kimizu T, Miyauchi Y, Sakamoto S, Munemasa M, Murata J, Nagai Y, Sakata Y, Naito S, Oyama H, Nishi Y, Nagase T, Ochiai J, Junko H, Ogawa T, Sugeno M, Oguro H, Tanabe M, Okada K, Moriyama Y, Okajima K, Nakashima M, Okazaki O, Wada H, Okishige K, Kitani S, Okumura K, Narita Y, Onaka H, Moriyama H, Ozaki Y, Tanikawa I, Sakagami S, Nakano A, Sakuragi S, Hayashi N, Sakurai S, Ooki H, Sasaki T, Oosawa N, Satoh A, Fujimoto E, Seino Y, Narumi M, Shirai T, Shigenari M, Shoji Y, Ueda J, Sugi K, Miyazaki E, Sumii K, Asakura H, Takagi M, Mohri S, Takahashi W, Yoshida K, Takahashi A, Kishi N, Takahashi T, Sakurai Y, Takeda K, Yahata A, Takenaka T, Yamagishi K, Takeuchi S, Watanabe E, Tanaka K, Uchida M, Tanouchi J, Nishiya Y, Tsuboi H, Yoshida K, Tsuboi N, Terakura K, Uematsu M, Yasumoto S, Ueyama Y, Onishi M, Usuda K, Sakai Y, Yagi M, Sato A, Yagi H, Kuroda T, Yamabe H, Sakamoto Y, Yamada T, Yamano R, Yamagishi T, Sasaki S, Yamamoto Y, Ito Y, Yamashina A, Takiguchi M, Yamashita T, Matsuda K, Yonehara T, Tanaka K, Yoshino H, Nomura H, Yoshioka K, Fujiwara Y, Bayram Llamas E, Hurtado A, Calvo Vargas C, Limon MC, Cardona Muñoz E, Hernandez S, Carrillo J, Delgadillo T, Cásares Ramirez M, Valles JF, Garcia N, Colin MA, Garcia-Castillo A, Jaramillo A, Leiva-Pons J, de la Mora S, Llamas Esperón G, Grajales A, Mendez-Machado G, Avila H, Ruiz LN, Magallanes G, Sánchez Díaz C, Ortiz A, Sánchez RV, Velazquez EM, Alhakim M, van Welsen I, Bruning T, Jones A, Buiks C, Buiks C, de Groot J, Radder I, de Vos R, de Vos R, Hazeleger R, Daniels R, Kietselaer B, Muijs L, Mannaerts H, Kooiman E, Mevissen H, Mevissen H, van der Heijden D, Hofmeyer H, Anscombe R, O'Meeghan T, Kjentjes M, Benatar J, White H, Borthwick L, Doughty R, Copley M, Fisher R, Monkley R, Green B, Scott D, Hamer A, Tomlinson J, Hart H, Turner A, Scott D, Cammell R, Troughton R, Skelton L, Young C, Kennett K, Atar 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Abstract

BACKGROUND:

Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects. The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known.

METHODS:

We conducted a randomized, double-blind, double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in 21,105 patients with moderate-to-high-risk atrial fibrillation (median follow-up, 2.8 years). The primary efficacy end point was stroke or systemic embolism. Each edoxaban regimen was tested for noninferiority to warfarin during the treatment period. The principal safety end point was major bleeding.

RESULTS:

The annualized rate of the primary end point during treatment was 1.50% with warfarin (median time in the therapeutic range, 68.4%), as compared with 1.18% with high-dose edoxaban (hazard ratio, 0.79; 97.5% confidence interval [CI], 0.63 to 0.99; P<0.001 for noninferiority) and 1.61% with low-dose edoxaban (hazard ratio, 1.07; 97.5% CI, 0.87 to 1.31; P=0.005 for noninferiority). In the intention-to-treat analysis, there was a trend favoring high-dose edoxaban versus warfarin (hazard ratio, 0.87; 97.5% CI, 0.73 to 1.04; P=0.08) and an unfavorable trend with low-dose edoxaban versus warfarin (hazard ratio, 1.13; 97.5% CI, 0.96 to 1.34; P=0.10). The annualized rate of major bleeding was 3.43% with warfarin versus 2.75% with high-dose edoxaban (hazard ratio, 0.80; 95% CI, 0.71 to 0.91; P<0.001) and 1.61% with low-dose edoxaban (hazard ratio, 0.47; 95% CI, 0.41 to 0.55; P<0.001). The corresponding annualized rates of death from cardiovascular causes were 3.17% versus 2.74% (hazard ratio, 0.86; 95% CI, 0.77 to 0.97; P=0.01), and 2.71% (hazard ratio, 0.85; 95% CI, 0.76 to 0.96; P=0.008), and the corresponding rates of the key secondary end point (a composite of stroke, systemic embolism, or death from cardiovascular causes) were 4.43% versus 3.85% (hazard ratio, 0.87; 95% CI, 0.78 to 0.96; P=0.005), and 4.23% (hazard ratio, 0.95; 95% CI, 0.86 to 1.05; P=0.32).

CONCLUSIONS:

Both once-daily regimens of edoxaban were noninferior to warfarin with respect to the prevention of stroke or systemic embolism and were associated with significantly lower rates of bleeding and death from cardiovascular causes. (Funded by Daiichi Sankyo Pharma Development; ENGAGE AF-TIMI 48 ClinicalTrials.gov number, NCT00781391.).

PMID:
24251359
DOI:
10.1056/NEJMoa1310907
[Indexed for MEDLINE]
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