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N Engl J Med. 2011 Mar 3;364(9):806-17. doi: 10.1056/NEJMoa1007432. Epub 2011 Feb 10.

Apixaban in patients with atrial fibrillation.

Collaborators (993)

Connolly SJ, Eikelboom J, Yusuf S, O'Donnell M, Diener HC, Hart R, Joyner CD, Lawrence J, Pogue J, Synhorst D, Adalet K, Atar D, Avezum A, Budaj A, Commerford PJ, Dans AL, De Caterina R, Diaz R, Flaker GC, Franzosi MG, Golitsyn SP, Gonzalez Hermosillo JA, Halon D, Hohnloser SH, Husted S, Jansky P, Kaatz S, Karatzas N, Kim JH, Lanas-Zanetti F, Lau CP, Lewis BS, Lip GY, Liu LS, Lopez Pareja M, Munawar M, Pais PS, Paolasso E, Parkhomenko AN, Piegas LS, Sim KH, Steg G, Swedberg K, Talajic M, Tan RS, Toivonen L, Valentin V, Van Mieghem W, Varigos J, Wang CC, Xavier D, Zhu J, Diener HC, Joyner CD, Hart R, Albers G, Diehl A, Diener HC, Hankey G, O'Donnell M, Cairns J, Camm AJ, Crowther M, Friedman L, Roberts R, Sacco R, Atra M, Avezum A, Beghi E, Bornstein N, Boysen G, Brouwers PJ, Chen WH, Cheung R, Djojoatmodjo S, Duray GZ, Dvorakova H, Goshev EG, Guimaraes HP, Gulkevych O, Haberl RL, Halon D, Hartikainen J, Husted S, Iliesiu AM, Irkin O, Jacobsson F, Jansky P, Jaxa-Chamiec T, Kim JH, Kristensen KS, Lee KL, Lewis BS, Lutay YM, Lyseggen E, Norrving B, Pasco PM, Peeters A, Perovic V, Piegas LS, Pizzolato G, Rafti F, Russell D, Simmers TA, Šrámek M, Strozynska E, Tanne D, Thijs VN, Van Mieghem W, Vanhooren G, Wong L, Zaborska B, Zaborski J, Zimlichman R, Bollini S, Davis K, Geraldes M, Hall R, Rossi L, Synhorst D, Thoma J, Wang L, Afzal R, Ampas D, Christmas L, Lewis G, Maystrenko N, Nevills S, Smith J, Weatherhead K, Yang S, Alebuena A, Alzogaray MF, Amuchastegui LM, Bonato RR, Bordoni PD, Bustamante Labarta G, Caccavo A, Cartasegna L, Casali WP, Colombo HR, Contreras A, Costa GA, Covelli G, Cuadrado JA, Cuello JL, Cuneo CA, Cusimano SV, Dellatorre MA, Elizari MV, Garrido MA, Guerlloy FP, Gutierrez NC, Hasbani EG, Hominal MA, Jure HO, Kuschnir E, Lobo Marquez LL, Mackinnon IJ, Manzolillo HS, Marigo MS, Marino JC, Montaña OR, Paolasso HC, Parody ML, Piskorz DL, Pozzer DL, Prado AD, Ramos JL, Ravetti NS, Resk JH, Risso Patron F, Rodriguez CA, Saravia A, Schiavi L, Schygiel P, Sernia VL, Siegel MR, Sokn F, Velasco DN, Vico ML, Vogel DR, Zaidman CJ, Aliprandi-Costa B, Amerena JV, Armstrong CG, Brieger DB, Cahill PD, Colquhoun DM, Coulshed DS, Cross DB, Fatehee N, Fitzpatrick MA, Garrahy P, Gibling RL, Hall CL, Karrasch J, Karrasch JA, Mackay DI, Purnell PW, Roger SD, Rogers J, Scott S, Shanahan TK, Waites JH, Wilsmore B, Woods JL, Danmayr F, Eckhardt G, Fazekas F, Gruber F, Haring HP, Heinzel FR, Matzinger M, Pieske BM, Schrotter G, Stockenhuber F, Topakian R, Vosko MR, Cools FJ, Develter I, Goethals MP, Hollanders G, Jottrand M, Lemoine IF, Lesseliers H, Maamar R, Marechal P, Schoors DF, Simenon I, Simons N, Stammen F, Thoeng J, Van Mieghem W, Albuquerque DC, Angioleto C, Barretto AP, Braga JC, Braga braile MV, Coutinho M, Garbelini LD, De Moraes ER, De Paola AA, Debetio MG, Del Monaco MI, Dias C, Filho PP, Francischetti A, Furtado MV, Garbelini B Jr, Guimaraes Filho FV, Indio do Brasil CK, Jorge JM, Kruse ML, Lameira AO, Lima GG, Lima WL, Lorga AM, Lorga Filho AM, Maia LN, Manenti ER, Mansur AJ, Marques de Oliveira O, Mattos AC, Migliorini Mustafá E, Minicucci MF, Momiy I, Mora RD Jr, Mouco OC, Moura MV, Mourilhe-Rocha R, Okoshi MP, Oliveira GB, Oliveira LF, Pelloso EA, Péricles Esteves J, Polanczyk CA, Précoma DB, Rabelo A Jr, Reis G, Reis HL, Rossi PR, Ruschel KB, Santos LB, Saraiva JF, Scarano Avellar K, Sguizzatto GT, Silva MC, Teixeira M, Thirone AC, Treptow V, Vicente CC, Zimmermann SL, Zucchetti C, Bakbak A, Berlingieri JC, Bhargava RK, Bose S, Chappell M, Chehayeb R, Coutu B, David D, Denis I, Dewar C, Dorian P, Eikel L, Faul J, Fortin C, Fox BA, Green MS, Harvey N, Healey JS, Henderson RJ, Hill LL, Houbraken D, Joyner CD, Lam AS, Lepage C, Malcolm VM, Maranda C, Mariano ZM, Masson C, Nawaz S, Nisker WA, O'Mahony MF, Pandey AS, Pesant Y, Poulin F, Richert L, Saunders KK, Savard D, Schulman S, Singh JK, Sloane D, St Hilaire R, Studenikow E, Swailes L, Syan G, Talajic M, Talbot P, Tytus RH, Viau C, Vizel S, Yao J, Yao L, Benavides ME, Cobos L, Corbalan R, Escobar E, Garcés EE, Lanas F, Potthoff SH, Raffo CA, Reyes T, Rodriguez L, Saavedra J, Soto A, Varleta P, Verdejo H, Chen XP, Feng YQ, Gao LJ, Gao MM, Guo YF, Hu TH, Jiang B, Jiang H, Jiang XJ, Ke YN, Li H, Li JX, Li L, Liang Y, Liao XW, Liu GN, Liu JQ, Lu GP, Qi GX, Qi SY, Song JP, Sun ZJ, Wan LY, Wang F, Wu SL, Wu XS, Yang YM, Yang TS, Yang XC, Yao Y, Zhang F, Zhang HL, Zhou BL, Zhu BP, Botero R, Florez ML, Lopez M, Nieto T, Pava LF, Perafan PE, Quiroz FR, Urina MA, Velasquez C, Ballek L, Cermak O, Cisarova J, Dedek V, Hejny J, Hemzsky L, Hohnova J, Hudcovic M, Jansky P, Marcinek G, Paulyskova P, Pederzoliova E, Plachy M, Simon J, Sipula J, Spac J, Stepanovova R, Stipal R, Sucha L, Velimsky T, Vencour D, Wasserburger B, Egstrup M, Hummelshøj J, Husted SE, Nielsen T, Tuxen C, Hämäläinen S, Jarvenpaa J, Mänttäri M, Melin JH, Nikkilä M, Peuhkurinen KJ, Toivonen L, Tuomainen PO, Attias D, Carlioz R, Defaye P, Farnoud R, Gacem K, Galley DL, Ghodbane L, Jacon P, Laurent P, Leparree S, Martelet M, Mouallem J, Poulard JE, Pollock BW, Appel KF, Boldt LH, Boy S, Buerke M, Dempfle CE, Dormann A, Drexler M, Ebert HH, Ehrlich J, Fink A, Fink P, Frank B, Genth-Zotz S, Grönefeld GC, Harenberg J, Haverkamp W, Heider J, Henzgen R, Hoffmann U, Horacek T, Illies G, Jantke HJ, Kahrmann G, Katus HA, Kaufmann K, Kuckuck H, Licka MB, Löbe M, Morgil M, Natour M, Niethammer M, Omran H, Paitazoglou C, Pluemer-Schmidt M, Reinecke N, Schaefer I, Schlachetzki F, Schlichthärle T, Schlitt A, Schmidt H, Schulze U, Sperling K, Stangl V, Stenzel G, Volmar J, Vukojevic Y, Weimar C, Weissbrodt M, Wunderlich J, Appana PM, Georgakopoylos N, Karatzas N, Skoumbourdis EA, Chan E, Lee KL, Leung TW, Li SK, Tse TS, Wong KS, Agarwal DK, Agre AH, Bharani A, Byrapaneni RB, Choudhari V, Dharmadhikari AV, Gaddam K, Garani NB, Gautam N, Gupta JB, Gupta SK, Hiremath RS, Iyengar SS, Jain AS, Jain M, Joseph J, Kesarwani N, Kuruvila P, Lakshminarasimhan R, Lavhe PV, Naik AM, Oomman A, Panwar RB, Parikh KH, Patil CB, Ramesh SS, Raskar JA, Sabu C, Shrimanker RJ, Singh P, Srikanth KV, Srikanthan VS, Thacker HP, Vadagenalli PS, Akbar MR, Dharmadjati BB, Hakim L, Hanafy DE, Mumpuni H, Munawar M, Nadha B, Nangoi P, Putranto JN, Santoso A, Setianto BY, Tedjasukmana P, Yahya AF, Yamin M, Ben Aharon J, Brenner BB, Francis A, Genin I, Katz A, Khader N, Klainman E, Kogan-Nilsen NG, Lahav M, Levin I, Marmor AT, Omary MZ, Peres D, Plaev T, Rogowski O, Steinvil A, Turgeman Y, Tzoran I, Uziel-Iunger K, Zimlichman R, Arteni F, Balbi M, Bezante GP, Carità P, Casolo G, Chioccioli M, De Caterina R, Glorioso N, Moretti L, Mos L, Novo S, Olivieri C, Pisano M, Renda G, Santilli A, Terrosu P, Testa M, Troffa C, Bae JH, Cha TJ, Chae SC, Choi EK, Jang SW, Kim CH, Kim HJ, Kim JH, Kim KI, Kim SK, Lee JU, Lee JW, Oh S, Ok JS, Park HS, Chee KH, Chong WP, Chua SK, Fong AY, Ismail O, Jeyaindran S, Lee CY, Liew CK, Ma SK, Maskon O, Ross NT, Saidin N, Acosta JM, Alcocer-Gamba MA, Alvarado-Ruiz R, Arenas JL, Ayala V, Bayram EA, Briseño D, Carrillo J, Carrillo MA, de los Rios-Ibarra MO, Espinoza-Lopez OE, Gomez JF, Juárez MC, Leiva-Pons JL, Lopez Rosas E, Martínez CA, Matadamas N, Molina L, Olvera R, Pacheco N, Padilla LJ, Perez Jaime S, Ramirez Isunza JM, Reyes Cisneros FA, Reyes-Sanchez R, Rivera JJ, Robles Torres FJ, Rodriguez-Briones I, Rodriguez-Briones R, Ruiz CR, Ruiz ED, Solis Morales L, Teran F, Velasco RG, Villezca DL, Yong R, Andersen AM, Atar D, Berland K, Buchmann E, Dalima AD, Meen H, Meen Ø, Nakling AE, Abias AV, Brillantes AC, Co HU, Corpuz FC, De Chavez A, De Leon FA, Debalucos AL, Edmilao ME, Loyola AB, Palomares EM, Rey NR, Sevilla RC, Timonera MR, Turla VY, Vasquez SO, Bacior B, Boruczkowska-Kaszkowiak AB, Bronisz M, Czarnul B, Czerski T, Derezinski TL, Derlaga B, Janion M, Jarski P, Jaxa-Chamiec T, Kalarus Z, Kawecka-Jaszcz K, Kawka-Urbanek T, Kokoszka M, Konieczny M, Krauze-Wielicka M, Laskowska-Derlaga E, Makuch M, Mickiewicz-Pawlowska M, Miękus P, Monies F, Ogorek M, Ogorek M, Oleskowska L, Pielok AP, Piotrowski W, Polewczyk A, Przywoska-Para B, Reszka Z, Wasikowska BM, Więckowski M, Akatova EV, Artamoshina N, Barabanova NG, Barbarich VB, Bart B, Belousov YB, Berngardt ER, Bessonova NA, Biserova IN, Bochkareva EV, Butina EK, Chernichka II, Duplyakov D, Dymova DM, Ermasova S, Fokina EG, Freydlin MS, Furman N, Gordeev IG, Grachev VG, Kalugina OA, Kamalov GM, Khasanov NR, Khrustalev AO, Khrustalev OA, Kokorin IA, Koziolova NA, Laguta PS, Larina V, Libov I, Malkina TA, Mezhin VY, Moiseeva Y, Nikolin OP, Nosova NN, Obrezan AG, Panchenko EP, Pavlova YR, Petrik ES, Pevzner AV, Philippov E, Pisklakov VP, Popov V, Reshetko O, Shalaev SV, Sherenkov A, Sheyanov SV, Shvarts Y, Sivkova E, Sokolovskaya GI, Surovtseva MV, Suvorov AV, Tatarsky BA, Treshkur TV, Tsvetkova SI, Tuckbatova A, Upnitsky AA, Vaniev SB, Vorontsova SA, Yakushin S, Zalevsky GI, Aung TH, Ching CK, Foo DC, Ling LF, Ong HY, Tan VH, Tong KL, Ellis T, Engelbrecht JM, Gibson GJ, Kapp CE, Okreglicki AM, Theron HD, Theron JP, Van Niekerk WA, van Zyl L, Venter TP, Abizanda P, Anguera I, Manzano-Espinosa L, Monte R, Rabuñal R, Sabate X, Sanchez E, Sánchez-Jurado PM, Vidan MT, Yebra-Yebra M, Blomström Lundqvist C, Eklind Cervenka M, Fahlen KL, Hoglund C, Jacobsson FT, Klintberg L, Ortgren L, Ostrowska B, Rangman B, Rasmanis G, Rosenqvist M, Ulvenstam G, Welin-Berger B, Ai-Hsien L, Chen JY, Lai WT, Lee SC, Lee TH, Lin LJ, Lin TH, Shu-Hsun C, Shyu KG, Ueng KC, Wang CC, Adalet K, Bilge AK, Ebinç H, Erdogan D, Ozaydin M, Tulmaç M, Prykhodko VY, Amosova KM, Bagriy AE, Bezuglova S, Dykun IY, Fedtchouk LN, Grishyna OI, Gunayeva O, Karapetyan KG, Karpenko O, Kraiz I, Kuryata OV, Liepieieva OA, Parkhomenko AN, Prokhorov OV, Prudkyi IV, Rudenko LV, Skarzhevsky OA, Stadniuk LA, Suliman YV, Tseluyko V, Yakovleva L, Aggarwal RK, Albazzaz MK, Alwail A, Andrews A, Brack MJ, Cooke CJ, Davey P, Dougal K, Findlay IN, Gamble K, Glen SK, Haynes R, Helliwell LK, Hill SL, Kadr HH, Lane DA, Mackin A, McInnes GT, Moore S, Moriarty AJ, Muir SW, Murdoch DL, O'Callaghan J, Savelieva I, Sutton D, Thomas SH, Wade T, Wass HL, Wong Y, Alford S, Anderson J, Andresen TA, Atieh MK, Ayres TM, Baia KD, Baliga R, Ball EM, Barr M, Bayer MW, Bedwell NW, Benton RE, Ben-Yehuda O, Bilazarian SD, Black RA, Brew TP, Brown AM, Bryan SH, Budzinski SL, Burton E, Chen J, Chua KG, Doman AL, Domingo D, El Shahawy M, Ellsworth S, Entcheva M, Ewing BL, Fields RH, Flaker GC, Fletcher MH, Friedlander IR, Garbarino JA, Genovely H, Gerber JR, Ghannadian B, Gikas H, Gill SK, Gillespie E, Gogia HS, Graff JC, Grena PG, Hamroff G, Heiman M, Henry WJ, Hermany P, Hilton T, Hollenweger L, Hunter JJ, Jan MA, Jardula MF, Jarmukli NF, Johnson MA, Keane-Richmond P, Keavey S, Kingsley JK, Klancke KA, Kufs WM, Kutscher AH, Lafata JA, Lang DT, Leeper CJ, Lelevier JA, Lesser MF, Levanovich P, Magnano AR, Maletz L, Margiotti RA, Mcgough MF, Mckinley LJ, Naito RW, Nsah EN, Nunamaker JL, Ochalek TB, O'Malley AK, Oza SR, Paliwal YK, Parr KL, Perez L, Phillips RT, Presant LA, Price DT, Promisloff SD, Ravipudi SD, Roach KL, Salacata A, Sanders BA, Sanders DO, Saxman KA, Schmedtje JF, Schneider RM, Shah P, Shayani SS, Simpson PJ, Smith RH, Springer LK, Stephens JL, Stindt SC, Stone B, Surber JG, Tahirkheli NK, Taylor M, Vasile F, Vidaillet HM, Waidner LW, Walsh RL, Weachter RJ, Williams J, Wilson V, Wolfe CM, Zwerner P.

Abstract

BACKGROUND:

Vitamin K antagonists have been shown to prevent stroke in patients with atrial fibrillation. However, many patients are not suitable candidates for or are unwilling to receive vitamin K antagonist therapy, and these patients have a high risk of stroke. Apixaban, a novel factor Xa inhibitor, may be an alternative treatment for such patients.

METHODS:

In a double-blind study, we randomly assigned 5599 patients with atrial fibrillation who were at increased risk for stroke and for whom vitamin K antagonist therapy was unsuitable to receive apixaban (at a dose of 5 mg twice daily) or aspirin (81 to 324 mg per day), to determine whether apixaban was superior. The mean follow up period was 1.1 years. The primary outcome was the occurrence of stroke or systemic embolism.

RESULTS:

Before enrollment, 40% of the patients had used a vitamin K antagonist. The data and safety monitoring board recommended early termination of the study because of a clear benefit in favor of apixaban. There were 51 primary outcome events (1.6% per year) among patients assigned to apixaban and 113 (3.7% per year) among those assigned to aspirin (hazard ratio with apixaban, 0.45; 95% confidence interval [CI], 0.32 to 0.62; P<0.001). The rates of death were 3.5% per year in the apixaban group and 4.4% per year in the aspirin group (hazard ratio, 0.79; 95% CI, 0.62 to 1.02; P=0.07). There were 44 cases of major bleeding (1.4% per year) in the apixaban group and 39 (1.2% per year) in the aspirin group (hazard ratio with apixaban, 1.13; 95% CI, 0.74 to 1.75; P=0.57); there were 11 cases of intracranial bleeding with apixaban and 13 with aspirin. The risk of a first hospitalization for cardiovascular causes was reduced with apixaban as compared with aspirin (12.6% per year vs. 15.9% per year, P<0.001). The treatment effects were consistent among important subgroups.

CONCLUSIONS:

In patients with atrial fibrillation for whom vitamin K antagonist therapy was unsuitable, apixaban reduced the risk of stroke or systemic embolism without significantly increasing the risk of major bleeding or intracranial hemorrhage. (Funded by Bristol-Myers Squibb and Pfizer; ClinicalTrials.gov number, NCT00496769.).

PMID:
21309657
DOI:
10.1056/NEJMoa1007432
[Indexed for MEDLINE]
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