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N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10.

Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.

Collaborators (1236)

Becker RC, Paolini J, Breithardt G, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Singer DE, Califf RM, Fox KA, Ardissino D, Avezum A, Aylward P, Biedermann B, Breithardt G, Bode C, Carolei A, Corbalán R, Csiba L, Dalby A, Diaz R, Diener HC, Donnan G, Goodman S, Heidbüchel H, Hu DY, Huber K, Jensen G, Keltai M, Lewis B, López-Sendón J, MacInnes G, Mas JL, Massaro A, Norrving B, Penicka M, Prabhakaran D, Roine R, Sirnes PA, Skvortsova V, Steg PG, Tan RS, White H, Wong L, Alpert J, Boysen G, Eikelboom J, Rothwell P, Skene A, Hannan K, Schwabe K, Mohanty S, Oppenheimer L, Zhang Z, Pan G, Garg J, Sapp SK, Anderson J, Bedwell N, Bilsker M, Bruce G, Agah R, DeSantis M, Eisenberg S, Flores A, Herzog W, Klein S, Snyder H, Krueger S, Almaguer E, Lavie E, Lee C, Mallis G, Modi M, Woodworth G, Niazi I, Peart B, Sundaram S, Snoddy B, Sotolongo R, Moloney J, Vijayaraghavan K, Whittier F, Yellen L, Banerjee S, Lustgarten D, Suresh D, Gelernt M, Levinson L, Ghanekar R, Niazi I, Kneller G, Hall C, Fadl Y, Suresh D, Pirwitz M, French W, Mayer N, Pugeda J, Steel K, Mody F, Malik A, Chandna H, Go A, Emlein G, Bowden W, Moscoso R, Hodson R, Berk M, Pan D, Pappas J, Orchard R, Lynchard G, Vijay N, Khan W, El Khadra M, Antonishen M, Cucher F, Staab M, Zebrack J, Borromeo S 3rd, Heilman J, Chaturvedi S, Makam S, Turk S, Hyers T, Williams G, Labroo A, Gill S, Myears D, Weinstein J, Shanes J, Chandrashekhar Y, Shah S, Reiter W, Logemann T, Almquist A, Bhagwat R, Tak T, Shen-Ling J, Patel P, Artis A, Arouni A, Lauer M, Kinney K, Elsen J, Roan P, Villafria R, Sumpter M, Ip J, Welka S, Schifferdecker B, Sandoval R, Speirs S, Jones A, Haldis T, Kazmierski J, Sutherland J, Dietrich D, Telfer E, Berry J, McElveen A, Russell J, Sackett M, Antonios N, Smith D, Vora K, Kirby A, Lui H, Mego D, Ziada K, Navas J, Taussig A, Koren M, Vogel C, Saba F, Parrott C, Schneider R, Shirwany A, Rubin M, Treasure C 2nd, Bertolet B, Chang M, Langberg J, Becker R, Cohen Y, McGrew F, White J, Arzola F, Zelenka J, Tannenbaum A, Fernandes V, Jamnadas P, Agamasu J, Collins B, Jauch W, Sasseen B, Hotchkiss D, Abadier R, Osunkoya A, Schlau A, Chappel C, Foster M, Braun E, Mostel E, Capo J, Ashchi M, Howard V, Albirini A, Burger A, Rolston D, Staniloae C, Bacon J, Wiseman A, McGarvey J Jr, Sonel A, Hamroff G, Chang D, Daboul N, Broderick G, Meholick A, Corbelli J, Silverman R, Raffetto J, Fishberg R, Georgeson S, Held J, Seidner M, Saint-Jacques H, Heitner J, Kutalek S, Friedlander I, Hutchinson B, Walia J, Kondo N, Smiley N, Blitz L, Dale H, Sulman S, Szulawski I, Modares F, Martin R, Nahhas A, Renzi M, Akyea-Djamson A, Alfieri A, Sandhu J, Voyce S, Amaram S, Meyerrose G, Shoukfeh M, Lee F, Villegas B, Idowu O, Khera A, Sam C, Vo A, Lieber I, Smith T, Awan N, Tsai C, Ganim R, Alzaghrini G, Pitt W, Shepherd A, Tang S, Go A, Stoltz S, Nelson W, Cox S, Meymandi S, Melucci M, Thomas G, Gogia H, Machell C, Chandrasekaran S, Brown C, Jetty P, Miller G, Dykstra G, Jaffrani N, Zakhary B, Caruso A, Zolty R, Fox D, Jacobs G, Lebenthal M, Mukherjee S, Zimetbaum P, Kingsley J, Jones R, Robinson V, Kenton D, Usedom J, Williams S, Snipes C, Wilson V, Hasty R, Shoemaker J, Robinson V, Donahue M, Al-Saghir Y, Thomsen E, Yarows S, Chastain S, McLaughlin P, Wakham M, Shrestha D, Simmons J, Fisher D, Seymour Z, Frandsen B, First B, Sharpe C, Popeil L, Guthrie R, Hunter J, Alvarado O, Sandberg J, Gutman N, Belber A, Arkhipov M, Ballyzek M, Baranov A, Barbarash O, Barbarich V, Belenky D, Berkovich O, Bokarev I, Boyarkin M, Vaniev S, Volkova E, Gratsiansky N, Demin A, Zadionchenko V, Zateyshchikov D, Zrazhevsky K, Mazaev V, Martynov A, Mikhailov S, Mkrtchian V, Novozhenov V, Raskina T, Rebrov A, Sanina N, Simanekov V, Sitnikova M, Smolenskaya O, Stryuk R, Storozhakov G, Tankhilevich B, Tereschenko S, Khokhlov A, Khrustalev O, Chernov S, Shvarts Y, Shubik Y, Shulman V, Yakushin S, Bugrova O, Ivleva A, Libis R, Khozyainova N, Maslov S, Baranova E, Sherenkov A, Libov I, Lusov V, Chumakova G, Kuznetsov V, Ryamzina I, Reshetko O, Boldueva S, Alekseeva N, Novikova T, Dvornikov V, Idrisova E, Shostak N, Yarokhno N, Tebloev K, Treshkur T, Mazurov V, Loktin E, Sedavnyh I, Alexeeva O, Yakhontova P, Repin A, Izmozherova N, Kostenko V, Fokin A, Ketova G, Kouz S, Leader R, Ayala-Paredes F, Luton R, Ma P, Pandey S, Pesant Y, Senior R, Vertes G, Bell A, Crowley D, Vizel S, Lasko B, Landry D, Berger L, Heath J, Bessoudo R, Ling M, Tellier G, Berlingieri J, Kafka H, Hill L, Mazza G, O'Mahony W, Chilvers M, O'Mahony M, Newman D, Newman D, Newman D, Silagy S, Heffernan M, Bennett M, Bhesania T, Rockman G, Ng K, Kalra B, Meneses G, Liang W, Cheung M, Kozak J, Pugen G, Vavougios J, Kates M, Nunes-Vaz C, Jaffer S, Orfi J, Faiers A, Chung C, Felsen S, Bergman S, Bernstein I, Brownscombe L, Stockdill J, Silver E, Ezekiel D, Jagan N, Khurana M, Reisler H, Goldman H, Maung T, Wong F, Gillis G, Vexler R, Goldberg B, Luterman M, Gould D, Coutu B, Ouellet A, MacDonald P, Jones M, Collette R, Chong P, Fargher T, St-Maurice F, Fortin C, Chehayeb R, Proulx G, Roy R, Liutkus J, Syan G, Rupka D, Lichtenstein T, Kooy J, Papastergiou D, Lubelsky B, Doyle W, Rajakumar A, Cha J, Choudhry A, Bhamjee H, Mawji A, Durfresne M, Constance C, Mutrie J, Najarali A, Warren R, Mucha M, Borts D, Nord P, Carrier S, Dawood M, Sabe-Affaki G, Archibald J, Abram N, Teitelbaum E, Ebrahim I, Siebert R, van Zyl L, Theron H, Lloyd E, Sommers R, Podgorski G, Steingo L, Dalby A, Bayat J, Herbst L, Bester F, Corbett C, Bennett J, Roodt A, Roux J, Abelson M, Mohamed Z, Nortje H, Da Silva A, Nikolaides K, Liagkas K, Papasteriadis E, Achimastos A, Koliopoulos N, Trikas A, Manolis A, Ruiter J, Basart D, Crijns H, Withagen A, Janssen M, Van Langeveld R, van Gelder I, Hamer B, Van der Heijden R, Hertzeberger D, Van Hessen M, Pieterse M, Groutars R, Kuijper A, De Ruiter G, van Boven A, Hoogslag P, Kragten H, Thijssen H, Veldkamp R, Scavee C, Heidbuchel H, Debruyne P, Deruyter B, El Ali H, Goethals M, Cytryn R, Striekwold H, De Wolf L, Goethals P, Provenier F, Hellemans S, Galinier M, Coisne D, Koenig A, Galley D, Destrac L, Leduc J, Rifai A, Citron B, Ellie E, Fournier P, Steg G, Landel R, Robinson A, Ziegler F, Boulliat J, Zuber M, Vida M, Galve Basilio E, Lopez M, Íñiguez C, Iglesias Alonso L, Cavero Gibanel M, Olivan Martinez J, Calvo Iglesias F, Marco Vera P, Bruguera Cortada J, Jaber Houbani A, Merino J, Olaz Preciado F, Balaguer J, de la Hera Galarza J, Martinez Rubio A, Fontcuberta J, Sotillo Marti J, Gonzalez Juanatey J, Del Campo R, Vivanco G, Alvarez Garcia P, Pelayo M, Lippai J, Zamolyi K, Károly T, Vertes A, Nagy A, Kosa I, Janosi A, Lupkovics G, Kalo E, Forster T, Kis E, Tenczer J, Bereczki D, Komoly S, Csanyi A, Kiss R, Valikovics A, Dioszeghy P, Masini F, Terrosu P, Cirrincione V, Marabotti C, Cosmi F, Salvioni A, Binetti G, Piovaccari G, Nassiacos D, Boriani G, Calvi V, De Caterina R, Pengo V, Parati G, Carolei A, D'Angelo A, Di Biase M, Fattore L, Agnelli G, Merlini P, Furlan M, Rasura M, Gandolfo C, Ageno W, Piovella F, Micieli G, Cinteza M, Fierbinteanu C, Natase-Melicovic D, Ionescu D, Macarie C, Nanea I, Radoi M, Tatu-Chitoiu G, Dragulescu S, Tudose A, Militaru C, Bengus C, Ungureanu G, Tau A, Popa V, Pirvu O, Bojinca M, Sipciu D, Popescu M, Chiru M, Vinereanu D, Tudoran M, Cojocaru T, Vintila M, Aron G, Petrascu O, Bolohan F, Baumgartner R, Sekoranja L, Vojacek J, Lacnak B, Kellnerova I, Dunaj M, Cihalik C, Janota T, Janousek J, Bouchal P, Spacek R, Choi Siruckova J, Heinc P, Vojtisek P, Pirchala M, Malecha J, Padour F, Linhart A, Mandysova E, Jandik J, Zidkova E, Sipula D, Ostadal P, Polasek R, Stransky V, Marcinek G, Rysava D, Osmancik P, Huber K, Drexel H, Brainin M, Eichinger-Hasenauer S, Lang W, Pilger E, Moriarty A, Hudson I, Tang K, Cleland J, MacWalter R, Cooke J, McInnes G, Durairaj R, MacLeod M, Murdoch D, Kadr H, Lip G, Andrews R, Hunt B, Jackson P, MacLeod M, Roffe C, Syed H, Bath P, Coyle J, Kelly D, Stender S, Torp-Pedersen C, Tuxen C, Jensen G, Melchior T, Klarlund K, Dahlstrom C, Nielsen T, Nielsen E, Bronnum-Schou J, Sykulski R, Blomstrom P, Lindholm C, Wallen T, Nilsson C, Bertholds E, Carlsater J, Sirnes P, Elle S, Risberg K, Furuseth K, Skag A, Hoivik H, Landmark N, Kjaernli T, Berg-Johansen J, Gradek G, Drzewiecki A, Pluta W, Szwed H, Trusz-Gluza M, Ogorek M, Loboz-Grudzien K, Ruszkowski P, Sciborski R, Kopaczewski J, Jaworska K, Kubica J, Opolski G, Hoffman A, Krzciuk M, Sinkiewicz W, Piotrowski W, Kolodziej P, Goszczynska M, Rynkiewicz A, Chojnowska L, Lewczuk J, Biedrzycka M, Piepiorka M, Kowal J, Karczmarczyk A, Pruszczyk P, Tendera M, Gaciong Z, Krzeminska-Pakula M, Kornacewicz-Jach Z, Kania G, Brachmann J, Lawall H, Guelker H, Spitzer S, Moebius-Winkler S, Dempfle C, Bode C, Darius H, Genth-Zotz S, Sommer S, Roehnisch J, Strasser R, Daenschel W, Schwencke C, vom Dahl J, Meuser M, Behrens-Spandau S, Behrens-Humbold S, Muegge A, Schoen N, Grooterhorst P, Ebert H, Kraemer A, Kohler B, Taggeselle J, Claus G, Sarnighausen H, Al-Zoebi A, Schroeder T, Weissbrodt M, Lange R, Gabelmann M, Kaeaeb S, Doerr M, Boscher D, Bosch R, Sonntag F, Bauknecht C, Omran H, Leicht M, Veltkamp R, Hohensee H, Dieckmann H, Winkelmann B, Bernhardt P, Schnabel A, Kadel C, Proskynitopoulos N, Seidl K, Schellong S, Rios C, Guevara C, Coloma R, Torrejon H, Parra Galvan J, Drago Silva J, Gallegos J, Mendoza A, Negron S, Watanabe L, Medina F, Virgen Carrilo L, Alvarez Lopez H, Rodriguez I, Leiva-Pons J, Baños Velasco A, Villarreal-Careaga J, De los Rios M, Alcocer Gamba M, Llamas Esperon G, Villeda E, Ahuad Guerrero A, Alvariqueta A, Amuchastegui M, Bluguermann J, Caime G, Cuneo C, Gabito A, Garcia Brasca D, Hominal M, Jure H, Luquez H, Montana O, Piskorz D, Listorti S, Serra J, Sessa H, Varini S, Vita N, Aiub J, MacKinnon I, Chekherdemian S, Castagnino J, Cimbaro Canella J, Sgammini H, Escudero A, Albina G, Rapallo C, Balparda C, Chahin M, Fuentealba V, Riccitelli M, Casabe J, Lobo Marquez L, Kevorkian R, Cuadrado J, Dran R, Muntaner J, Gonzalez M, Cartasegna L, Hasbani E, Hrabar A, Sanchez A, Vogel D, Hershson A, Avezum A, Jaber J, Leaes PE, Bozza A, Lorga Filho A, Pimentel Filho P, Jorge JM, Maia L, Manenti E, Mora RD Jr, de Souza Neto J, Precoma D, Rabelo A, Rocha J, Rossi P, Saraiva JK, Zimerman L, Bodanese L, Figueiredo E, de Souza WS, Braga J, Alessi S, Gomes M, Silva R, Teixeira M, Costa F, Motta M, Sobral Filho D, Reis G, Garbelini B Jr, Zimmermann S, Pereira Barretto A, Dohmann H, Barreto Filho J, Ghorayeb N, Borelli F, dos Santos FR, Prudente ML, Vejar M, Lanas F, Del Pino R, Potthoff S, Charme G, Aguirre A, Saldana A, Garces E, Bunster L, Figueroa H, Olivares C, Raffo C, Vergara E, Sepulveda P, Jano G, Morales Alvarado J, Suarez R, Urina M, Perez G, Quintero A, Pava L, Botero Lopez R, Luengas C, Hernandez E, Sanchez D, Poveda C, Coronel J, Beltran R, Jaramillo C, Pardo J, Ponte Negretti C, Isea J, Vergara G, Morr I, Sim K, Ahmad WW, Yusof Z, Rosman A, Basri H, Thompson P, Jeffery I, Purnell P, Roberts-Thomson P, Heddle W, Waites J, Walters D, Amerena J, Challa P, Karrasch J, Lowy A, Fitzpatrick D, Parsons M, Phan T, Karrasch J, Karrasch J, Bladin C, Donnan G, Aroney G, Gerraty R, Anderson C, Blombery P, Martin P, Wijeratne KT, Cross D, Crimmins D, Packham D, Jackson D, Chua W, Merino R, Magno M, Tirador L, Batalla E, Manalo C, Uy N, Ebo G, Reyes E, Bernan A, Richards M, Hart H, Mann S, Fisher R, Stewart R, Wilkins G, Barber A, Tan R, Ong H, Singh R, Sukonthasarn A, Tanomsup S, Krittayaphong R, Piamsomboon C, Piyayotai D, Sunsaneewitayakul B, Baek S, Seo H, Rim S, Kim C, Kim K, Ryu K, Jo S, Tahk S, Lee H, Kim C, Kim Y, Shin D, Choi Y, Chung N, Namgung J, Kim C, Hong T, Shin W, Jin S, Yan X, Fu G, Lu G, Yang K, Xu D, Chen J, Liu J, Wu S, Song J, Liao Y, Xu B, Li Z, Ma S, Yin Y, Zhao Y, Hu D, Ma C, Ma J, Sun J, Li H, Hong X, Yu B, Lu Q, Yang J, Wu Z, Li Y, Huang Y, Wang Y, Liu M, Cheng Y, Yang T, Chen K, Wang H, Yuan Z, Wang J, Zeng Z, Chen Y, Yavuzgil O, Kozan O, Etemoglu M, Diker E, Belgi A, Ceyhan C, Cin V, Yilmaz O, Ata N, Altunkeser B, Agir AA, Karadede A, Topsakal R, Gulati R, Madhavan A, Jain S, Oomman A, Janorkar S, Kumar P, Naik AM, Thacker H, Rajasekhar V, Reddy R, Keshavamurthy C, Jain P, Gowdappa B, Gadkari M, Abhyankar A, Babu BR, Vydianathan P, Sinha S, Garg N, Rao S, Gautam P, Chockalingam K, Kumbla M, Panwar R, Banker D, Kaste M, Jäkälä P, Roine R, Mihov A, Raev D, Yordanova V, Dimitrova S, Benov H, Tsanova V, Kyolean M, Marchev S, Stoikov A, Zdravkov N, Ramshev K, Krastev A, Stamenova P, Angelova I, Pencheva G, Grigorova V, Petrauskiene B, Skripkauskiene I, Raugaliene R, Norkiene S, Mazutavicius R, Kavoliuniene A, Aidietiene S, Aganauskiene J, Dailydkiene A, Marcinkeviciene J, Grigoniene L, Anusauskiene J, Kavaliauskiene R, Lizogub V, Rudenko L, Tseluyko V, Voronkov L, Sychov O, Svyshchenko Y, Sirenko Y, Serkova V, Seredyuk N, Pertseva T, Netyazhenko V, Lishnevska V, Kupchynska O, Koval O, Koshukova G, Karpenko O, Grishyna O, Faynyk A, Dzyak G, Dyadyk O, Yena L, Volkov V, Rudyk I, Kopytsya M, Kononenko L, Amosova K, Zhurba S, Kazimirko V, Iuzkiv I, Shershnyova O, Khomazyuk T, Batushkin V, Vykhovanyuk I, Popik G, Skrebkov V, Skurtov A, Mishchenko T, Lytvynenko N, Sokolova L, Vatutin M, Shved M, Rebrov B, Kadina L, Vajda M, Ursol G, Zheleznyy V, Vysochanska T, Gozhenko A, Fan K, Ho D, Tse H, Yu C, Wong L, Yeh H, Pai P, Hsieh I, Huang C, Hsieh Y, Yin W, Tsai L, Huang T, Chen C, Chiang F, Ueng K, Charng M, Yeh H, Marmor A, Katz A, Butnaru A, Lewis B, Eldar M, Rosenhack S, Elias N, Koifman B, Shochat M, Swissa M, Zimlichman R, Bental T, Weiss A, Ganam R, Elias M, Nseir W, Oliven A, Brenner B, Dayan M.

Author information

  • 1Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27705, USA. manesh.patel@duke.edu

Abstract

BACKGROUND:

The use of warfarin reduces the rate of ischemic stroke in patients with atrial fibrillation but requires frequent monitoring and dose adjustment. Rivaroxaban, an oral factor Xa inhibitor, may provide more consistent and predictable anticoagulation than warfarin.

METHODS:

In a double-blind trial, we randomly assigned 14,264 patients with nonvalvular atrial fibrillation who were at increased risk for stroke to receive either rivaroxaban (at a daily dose of 20 mg) or dose-adjusted warfarin. The per-protocol, as-treated primary analysis was designed to determine whether rivaroxaban was noninferior to warfarin for the primary end point of stroke or systemic embolism.

RESULTS:

In the primary analysis, the primary end point occurred in 188 patients in the rivaroxaban group (1.7% per year) and in 241 in the warfarin group (2.2% per year) (hazard ratio in the rivaroxaban group, 0.79; 95% confidence interval [CI], 0.66 to 0.96; P<0.001 for noninferiority). In the intention-to-treat analysis, the primary end point occurred in 269 patients in the rivaroxaban group (2.1% per year) and in 306 patients in the warfarin group (2.4% per year) (hazard ratio, 0.88; 95% CI, 0.74 to 1.03; P<0.001 for noninferiority; P=0.12 for superiority). Major and nonmajor clinically relevant bleeding occurred in 1475 patients in the rivaroxaban group (14.9% per year) and in 1449 in the warfarin group (14.5% per year) (hazard ratio, 1.03; 95% CI, 0.96 to 1.11; P=0.44), with significant reductions in intracranial hemorrhage (0.5% vs. 0.7%, P=0.02) and fatal bleeding (0.2% vs. 0.5%, P=0.003) in the rivaroxaban group.

CONCLUSIONS:

In patients with atrial fibrillation, rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism. There was no significant between-group difference in the risk of major bleeding, although intracranial and fatal bleeding occurred less frequently in the rivaroxaban group. (Funded by Johnson & Johnson and Bayer; ROCKET AF ClinicalTrials.gov number, NCT00403767.).

Comment in

PMID:
21830957
[PubMed - indexed for MEDLINE]
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