Edoxaban versus Warfarin in Patients with Atrial Fibrillation

Giugliano, Robert P; Ruff, Christian T; Braunwald, Eugene; Murphy, Sabina A; Wiviott, Stephen D; Halperin, Jonathan L; Waldo, Albert L; Ezekowitz, Michael D; Weitz, Jeffrey I; Spinar, Jindrich; Ruzyllo, Witold; Ruda, Mikhail; Koretsune, Yukihiro; Betcher, Joshua; Shi, Minggao; Grip, Laura T; Patel, Shirali P; Patel, Indravadan; Hanyok, James J; Mercuri, Michele; 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; Budassi, N; Valle, M; Bustamante Labarta, G; Saravia, M; Caccavo, A; Fracaro, V; Cartasegna, L; Novas, V; Caruso, O; Saa Zarandon, R; 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; 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doi:10.1056/NEJMoa1310907

Edoxaban versus Warfarin in Patients with Atrial Fibrillation

Author:

Giugliano, Robert P

Ruff, Christian T ; Braunwald, Eugene ; Murphy, Sabina A ; Wiviott, Stephen D ; Halperin, Jonathan L ; Waldo, Albert L ; Ezekowitz, Michael D ; Weitz, Jeffrey I ; Spinar, Jindrich ; Ruzyllo, Witold ; Ruda, Mikhail ; Koretsune, Yukihiro ; Betcher, Joshua ; Shi, Minggao ; Grip, Laura T ; Patel, Shirali P ; Patel, Indravadan ; Hanyok, James J ; Mercuri, Michele ; 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 ; Budassi, N ; Valle, M ; Bustamante Labarta, G ; Saravia, M ; Caccavo, A ; Fracaro, V ; Cartasegna, L ; Novas, V ; Caruso, O ; Saa Zarandon, R ; 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 ; 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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 ; Filardi, P Perrone ; 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 ; Zaca, 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 ; Cedano Limon, M ; Cardona Munoz, E ; Hernandez, S ; Carrillo, J ; Delgadillo, T ; Casares Ramirez, M ; Franco Valles, J ; Garcia, N ; Alcantara Colin, M ; Garcia-Castillo, A ; Jaramillo, A ; Leiva-Pons, J ; de la Mora, S ; Llamas Esperon, G ; Grajales, A ; Mendez-Machado, G ; Avila, H ; Nevarez Ruiz, L ; Magallanes, G ; Sanchez Diaz, C ; Ortiz, A ; Velasco Sanchez, R ; Moran Velazquez, E ; Alhakim, M ; van Welsen, I ; Bruning, T ; Jones, A ; Buiks, C ; de Groot, J ; Radder, I ; de Vos, R ; Hazeleger, R ; Daniels, R ; Kietselaer, B ; Muijs, L ; Mannaerts, H ; Kooiman, E ; 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, D ; Claussen, H ; Hofsoy, K ; Melbue, R ; Sandvik, J ; Thunhaug, H ; Tveit, A ; Enger, S ; Bustamante, G ; Tejada Guillen, M ; Cabrera, J ; Esteves Mendoza, R ; Chavez, C ; Luna, C ; Lema, J ; Carrion, A ; Llerena, N ; Araoz Bedregal, S ; Medina Palomino, F ; Rodriguez, J ; Minchola, J ; Bautista, C ; Negron Miguel, S ; Honores Armas, B ; Rodriguez, A ; Romero, N ; Torres, P ; Fernandez Rodriguez, K ; Yanac Chavez, P ; Horna, M ; Delgado, S ; Babilonia, N ; Sambaz, CM ; Barcinas, R ; Zapanta, M ; Coching, R ; Vallenas, M ; Matiga, G ; Enad, C ; Rogelio, G ; Joaquin, F ; Roxas, A ; Gilo, L ; To, R ; Aquino, M ; Villamor, L ; Nario, K ; Adamus, J ; Korzeniowska-Adamus, J ; Baszak, J ; Bronisz, M ; Cieslak, B ; Busz-Papiez, B ; Krzystolik, A ; Cymerman, K ; Dabrowska, M ; Ptak, A ; Derlaga, B ; Laskowska-Derlaga, E ; Domanska, E ; Guziewicz, M ; Gieroba, A ; Zajac, E ; Gniot, J ; Mroczkowski, P ; Januszewicz, A ; Makowiecka-Ciesla, M ; Jazwinska-Tarnawska, E ; Ciezak, P ; Jurowiecki, J ; Kaczmarek, B ; Pacholska, A ; Kaminski, L ; Kania, G ; Tymendorf, K ; Karczmarczyk, A ; Kaliszczak, R ; Konieczny, M ; Benicka, E ; Korzeniak, R ; Borowski, W ; Krzyzanowski, W ; Muzyk-Osikowicz, M ; Sklodowskiej-Curie, M ; Kus, W ; Lesnik, J ; Wierzykowski, T ; Lewczuk, J ; Stopyra-Poczatek, M ; Lubinski, A ; Szymanska, K ; Lysek, R ; Jaguszewska, G ; Matyszczak-Toniak, L ; Sznajder, R ; Wnetrzak-Michalska, R ; Kosmaczewska, A ; Mazur, S ; Chmielowski, A ; Miekus, P ; Kosmalska, K ; Mosiewicz, J ; Myslinski, W ; Napora, P ; Biniek, D ; Nessler, J ; Nessler, B ; Niezgoda, K ; Nej, A ; Nowak, J ; Olszewski, M ; Podjacka, D ; Janczewska, D ; Pogorzelska, H ; Polaszewska-Pulkownik, V ; Bojanowska, E ; Raczak, G ; Zienciuk-Krajka, A ; Rewinska, H ; Rozmyslowicz-Szerminska, W ; Ronkowski, R ; Ruzyllo, W ; Norwa-Otto, B ; Sendrowski, D ; Spyra, J ; Szolkiewicz, M ; Malanska, A ; Turbak, R ; Wrobel, W ; Muzalewski, P ; Wysokinski, A ; Kudlicki, J ; Zarebinski, M ; Krauze, R ; Zielinski, M ; Nawrot, M ; Matias, F ; Correia, J ; Gil, V ; Lopes, S ; Madeira, J ; Maymone, D ; Martins, D ; Neves, E ; Monteiro, P ; Oliveira, D ; Leitao Marques, A ; Salgado, A ; Goncalves, A ; Santos, O ; Veiga Pais Nunes, L ; Santos, J ; Soares, D ; Albulescu, P ; Ciortea, M ; Apetrei, E ; Matei, C ; Bartos, D ; Badila, E ; Bengus, C ; Ochean, V ; Bobescu, E ; Doka, B ; Bolohan, F ; Ciobotaru, G ; Andor, M ; Coman, I ; Ghionea, M ; Constantinescu, M ; Creteanu, M ; Parasteac, M ; Cristea, M ; Anciu, M ; Crisu, D ; Jemna, D ; Dobre, I ; Voicu, O ; Dobreanu, D ; Sirbu, I ; Dragomir, D ; Jurca, S ; Iosipescu, L ; Costache, L ; Minescu, B ; Serban, D ; Pop, C ; Cozma, M ; Popescu, M ; Ardelean, A ; Sipciu, D ; Plosca, P ; Stamate, S ; Spinu, C ; Topolnitchi, L ; Tudoran, M ; Tudoran, C ; Zhukova, N ; Arutyunov, G ; Chernyavskaya, T ; Ballyuzek, M ; Alexandrova, L ; Barbarash, O ; Bashkireva, A ; Bart, B ; Larina, V ; Belenky, D ; Kosolapov, Y ; Berns, S ; Yukhno, E ; Bokarev, I ; Khlevchuk, T ; Chumakova, G ; Pokutneva, O ; Demko, A ; Masin, A ; Dovgalevsky, P ; Puchinyan, N ; Drapkina, O ; Zyatenkova, E ; Egorova, L ; Esip, V ; Kirichek, N ; Filatov, A ; Soin, I ; Gilinskaya, O ; Valuyshkih, E ; Glezer, M ; Valovyeva, S ; Golitsyn, S ; Kratskina, T ; Goloshchekin, B ; Laptev, I ; Gratsiansky, N ; Mazovets, O ; Karpov, Y ; Buza, V ; Kosenko, B ; Khirmanov, V ; Kireenkov, I ; Khokhlov, A ; Sinitsina, O ; Khokhlov, R ; Tsareva, E ; Khrustalev, O ; Khrustalev, A ; Kostenko, V ; Karabalieva, S ; Koziolova, N ; Polyanskaya, E ; Kozyrev, O ; Kostenko, O ; Kuznetsov, V ; Rychkov, A ; Lavrova, O ; Tereschenko, L ; Levashov, S ; Volkova, E ; Libis, R ; Maslova, A ; Libov, I ; Moiseeva, Y ; Lila, A ; Belousova, L ; Lukyanov, Y ; Lamden, D ; Nikolaev, K ; Nikolaev, A ; Nikolskaya, I ; Khromova, O ; Novikova, N ; Patrusheva, S ; Panchenko, E ; Laguta, P ; Panov, A ; Nilk, R ; Polkanova, E ; Matveeva, I ; Poluyanova, N ; Pikalova, N ; Raskina, T ; Letaeva, M ; Rebrov, A ; Karoli, N ; Repin, M ; Rodina, N ; Shaposhnik, I ; Lebedev, E ; Shogenov, Z ; Agirov, M ; Sidorenko, B ; Vorontsova, S ; Sinitsina, I ; Orlov, V ; Sizova, Z ; Lapidus, N ; Sobolev, K ; Erofeeva, S ; Suprun, E ; Dronov, D ; Tarasov, N ; Isakov, L ; Tereshenko, S ; Kositsyna, I ; Tikhonova, E ; Solovyev, A ; Timofeev, A ; Bulygin, S ; Ustyugov, S ; Rossovskaya, M ; Vishnevsky, A ; Kirgizova, A ; Volkov, D ; Rodina, N ; Yakusevich, V ; Petrochenko, A ; Yakushin, S ; Nikulina, N ; Zateyshchikov, D ; Zotova, I ; Zateyshchikova, A ; Mankhaeva, B ; Zenin, S ; Kononenko, O ; Zubeeva, G ; Motylev, I ; Apostolovic, S ; Djordjevic-Radojkovic, D ; Celic, V ; Majstorovic, A ; Adjic, N Cemerlic ; Bjelobrk, M ; Despotovic, N ; Erceg, P ; Ilic, S ; Ilic, B ; Krotin, M ; Djokovic, A ; Miloradovic, V ; Djokic, I ; Otasevic, P ; Tasic, N ; Potpara, T ; Polovina, M ; Putnikovic, B ; Kalezic, T ; Seferovic, P ; Milinkovic, I ; Tavciovski, D ; Davicevic, Z ; Vasiljevic-Pokrajcic, Z ; Mitrovic, P ; Tesic, B Vujisic ; Ostojic, M ; Castro, C ; Topolnitchi, O ; Ruda, M ; Golshmid, M ; Tesic, M ; Ambrovicova, V ; Ambrovic, I ; Banikova, A ; Dukat, A ; Kosmalova, V ; Dulkova, K ; Dulka, T ; Duris, T ; Vankova, L ; Dzupina, A ; Dzupinova, M ; Hatalova, K ; Hatala, R ; Hranai, M ; Hofmanova, J ; Kasperova, V ; Reptova, A ; Mazur, J ; Pella, D ; Fedacko, J ; Ruffini, L ; Morsky, J ; Slanina, M ; Kmec, J ; Zachar, A ; Kokles, M ; Zareczky, P ; Bollova, D ; Badenhorst, J ; Erasmus, L ; Basson, M ; Poynton, M ; Dalby, A ; Allman, J ; Ellis, G ; Botha, L ; Engelbrecht, J ; Mostert, M ; Essop, M ; Nunkoo, T ; Gani, M ; Wilson, L ; Kelfkens, Y ; Mitha, I ; Taljaard, J ; Naidoo, D ; Duki, Y ; Snyders, F ; Munnik, M ; Soma, P ; Johnston, H ; Van Der Merwe, N ; Goosen, Y ; Van Zyl, L ; Le Roux, M ; Venter, T ; Wessels, L ; Bae, HJ ; Han, MG ; Cha, JK ; Kim, DH ; Cho, BR ; Ryu, DR ; Choi, HH ; Hong, KS ; Chung, WS ; Oh, YS ; Han, SH ; Lee, KH ; Hong, TJ ; Lee, HW ; Hyon, MS ; Jung, JW ; Jeon, HK ; Lee, JM ; Kang, DH ; Choi, KJ ; Kim, CJ ; Jin, ES ; Kim, DS ; Seo, JS ; Kim, HS ; Cha, MJ ; Kim, JT ; Park, MS ; Kim, JH ; Park, JH ; Kim, JS ; Park, SJ ; Kim, SH ; Seo, JB ; Kim, YJ ; Chun, MY ; Lee, MH ; Joung, BY ; Lee, SH ; Shin, DG ; Namgung, J ; Kwak, JJ ; Rha, SW ; Na, JO ; Rim, SJ ; Kim, JY ; Arcocha Torres, M ; Manzanal Rey, A ; Blanco Coronado, J ; Puertas, I ; Bruguera Cortada, J ; Cabero, P ; Calvo, C ; Calvo, G ; De Arce Borda, A ; Asensio, A ; Diez Tejedor, E ; Perez Guevara, M ; Gonzalez Juanatey, J ; Moure, M ; Hernandez Madrid, A ; Delgado, A ; Lopez Garcia-Aranda, V ; Barquero, R ; Manzano, L ; Blanco Abril, S ; Merino, J ; Diaz-Pintado, M ; Arias, J ; Fernandez, M ; Fernandez Alvarez, R ; Terns, M ; Dachs Delgado, M ; Villuendas, R ; Astier, L ; Appelros, P ; Akerberg, A ; Blom, K Berndtsson ; Andersson, R ; Blomstrom, P ; Persson, L ; Carlsson, T ; Bengtsson, A Stener ; Dettmann, S ; Ostberg, S ; Engdahl, J ; Karlsson, L ; Herlitz, J ; Winberg, L ; Juul-Moller, S ; Jernhed, H ; Koskinen, P ; Hakansson, E ; Kozak, P ; Edlund, M ; Malmqvist, L ; Eriksson, G ; Randers, F ; Moodh, J ; Rautio, A ; Johansson, M ; Ronn, F ; Sundholm, C ; Stenberg, A ; Gunnarsson, A ; Thulin, J ; Broberg, M ; Moccetti, T ; Slater, I Petrova ; Cheng, CC ; Wu, WS ; Chiang, CE ; Yu, WC ; Chiang, FT ; Wu, YW ; Chiou, CW ; Yeh, TC ; Hsia, CH ; Chen, YP ; Huang, JL ; Chen, YF ; Kuo, CT ; Wang, CL ; Lai, WT ; Lin, TH ; Lee, JT ; Pai, PY ; Lin, KH ; Shyu, KG ; Chiu, CZ ; Tseng, WK ; Pan, YF ; Ueng, KC ; Lee, SC ; Wang, JH ; Tsai, WC ; Yeh, HI ; Kuo, JY ; Jirasirirojanakorn, K ; Pornchaiyasit, K ; Kaewsuwanna, P ; Sinthusopa, W ; Kiatchoosakun, S ; Sriprasert, S ; Laothavorn, P ; Bamrungpong, P ; Piyayotai, D ; Sripracha, A ; Sritara, P ; Panpunuan, P ; Sukonthasarn, A ; Mekara, W ; Vorasettakarnkij, Y ; Puripun, E ; Acikel, M ; Akilli, H ; Demir, H ; Ata, N ; Bayata, S ; Cakmak, N ; Calik, A ; Cayli, M ; Ceyhan, C ; Erdogan, D ; Ermis, C ; Kabul, K ; Kanadasi, M ; Oto, A ; Turgut, O ; Tandogan, I ; Yalcin, R ; Yigit, F ; Yigit, Z ; Zoghi, M ; Batushkin, V ; Azhdari, M ; Bazylevych, A ; Vlasyuk, Z ; Bereznyakov, I ; Lebedynskaya, M ; Dotsenko, S ; Kulynych, R ; Dzyak, G ; Vasilyeva, L ; Faynyk, A ; Sorokivskyy, M ; Gavrysyuk, V ; Dzublik, Y ; Horbach, L ; Husyev, V ; Godlevska, O ; Samburg, Y ; Karpenko, O ; Nevolina, I ; Karpenko, Y ; Blihar, O ; Kaydashev, I ; Gerasimenko, N ; Kolomyyits, S ; Vasylets, V ; Kopytsya, M ; Petyunina, O ; Kotseruba, V ; Dvoieglazova, M ; Koval, V ; Ohirko, O ; Koval', O ; Kaplan, P ; Kraiz, I ; Usan, N ; Kraydashenko, O ; Stets, R ; Kupnovytska, I ; Kyyak, Y ; Lizogub, V ; Gorna, O ; Malynovsky, Y ; Fedotov, S ; Ostrovska, L ; Ushakova-Sokolova, L ; Parkhomenko, A ; Dovgan, N ; Potapenko, P ; Nekrasa, A ; Prokhorov, O ; Leonidova, V ; Rebrov, B ; Gamachek, O ; Rishko, M ; Chendey, T ; Rudyk, I ; Shatilo, V ; Ishchuk, V ; Shcherbak, V ; Goncharova, I ; Shvetz, N ; Zamlynskyy, M ; Sirenko, Y ; Stanislavchuk, M ; Perebetiuk, L ; Sychov, O ; Lyzohub, S ; Tseluyko, V ; Kuznetsov, I ; Tykhonova, S ; Vakaliuk, I ; Drapchak, I ; Vatutin, M ; Sklyanna, O ; Vizir, V ; Goncharov, O ; Volkov, V ; Serik, S ; Yagensky, A ; Nahrebetskyy, V ; Yena, L ; Mudruk, I ; Zharinov, O ; Logvinov, Y ; Zhurba, S ; Shandra, T ; Aggarwal, R ; Smith, S ; Beeton, I ; Dunn, S ; Blagden, M ; Price, R ; Camm, J ; Dougal, K ; Chapman, O ; Davies, D ; Choy, A ; Duff, J ; Cohen, A ; Wilmott, R ; D'Costa, D ; Green, M ; Douglas, H ; Dickinson, D ; Lie, F ; Ramasamy, V ; Lindsay, S ; Atkinson, C ; Linker, N ; Finlayson, M ; Lip, G ; Brown, R ; MacCallum, P ; Ebano, P ; MacLeod, M ; McGhee, C ; Marazzi, P ; Jones, D ; Maxwell, T ; Isted, C ; More, R ; Helliwell, L ; Moriarty, A ; Mackin, A ; Murdoch, D ; Andrews, A ; Newby, D ; Flint, L ; Pye, M ; Wright, L ; Roberts, J ; Avery, D ; Senior, R ; Young, G ; Sopher, M ; Kennard, S ; Storey, R ; Bridge, C ; Turner, W ; Walker, M ; Venkataraman, A ; Gilchrist, M ; Watkin, R ; Chung, A ; Wright, A ; Wright, J ; Abi-Mansour, P ; Panella, M ; Adams, K ; Lohman, J ; Adler, J ; Barash, B ; Adler, P ; Reiling, S ; Aggarwal, R ; Beck, P ; Ahmad, A ; Hussain, A ; Ahmadpour, H ; Lim, G ; Akhter, F ; Brubaker, S ; Alexander, J ; Genova-Peeva, E ; Aliyar, P ; Godsey, W ; Allison, J ; Biscardi, R ; Almquist, A ; MacDonald, H ; Alsheikh, T ; Lane, B ; Amin, K ; Khetarpal, S ; Amin, M ; Persechino, F ; Anderson, J ; York, T ; Arnold, T ; Shoaf, R ; Arouni, A ; Rasmussen, L ; Attanti, S ; Strickland, S ; Aude, Y ; Cobos, D ; Awasty, V ; Baldwin, E ; Ayesu, K ; Thompson, B ; Baine, S ; Batista, M ; Baman, R ; Campbell, G ; Barber, M ; Altonen, D ; Barker, T ; Faircloth, C ; Barrington, P ; Gordon, L ; Bartkowiak, A ; Benton, J ; Beasley, R ; Hoffman, T ; Bedoya, R ; Luis-Valdes, M ; Bedwell, N ; Craig, M ; Beinart, S ; Swaim, D ; Bensimhon, D ; Garman, V ; Berk, M ; Ibarra, M ; Bernard, J ; Eldred, R ; Bilal, B ; Preston, S ; Bilazarian, S ; Langone, L ; Bingham, S ; Antonino, M ; Block, T ; Talbot-Lawson, C ; Blonder, R ; Ensminger, E ; Bloomberg, R ; Bloomberg, K ; Blue, B ; Vernon, M ; Borsheim, M ; Hickenbotham, D ; Bouchard, A ; Wade, W ; Bowden, W ; Ziegler, K ; Bradley, A ; Terry, P ; Brilakis, E ; Frey, W ; Brown, H ; Triano, A ; Bybee, K ; Al-Maliky, T ; Cader, C ; Morton, S ; Canaday, D ; Dickinson, D ; Canosa, R ; Hartranft, E ; Caplan, J ; Jameson, L ; Carr, K ; Phan, D ; Chang, M ; Hatfield, G ; Charlat, M ; Tamayo, M ; Chaturvedi, S ; Sawaya, K ; Ciaramita, J ; Bagby, J ; Clapp, T ; Clay, A ; McClelland, M ; Cohen, A ; Dutka, C ; Cohen, R ; Bossaers, J ; Colan, D ; Salpas, S ; Cole, J ; Fisher, M ; Concha, M ; Martinez, E ; Corbett, B ; Svadbik, L ; Cossu, S ; Mullinax, K ; Cottiero, R ; Masson, E ; Cowan, L ; Nelson, L ; Curtis, B ; Sarpola, N ; Dang, N ; 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Keywords:

Science & Technology, Life Sciences & Biomedicine, Medicine, General & Internal, General & Internal Medicine, FACTOR XA INHIBITOR, ORAL ANTICOAGULANTS, STROKE, PHARMACOKINETICS, METAANALYSIS, GENERATION, PREVENTION, SAFETY, Adult, Aged, Anticoagulants, Atrial Fibrillation, Cardiovascular Diseases, Double-Blind Method, Embolism, Female, Follow-Up Studies, Hemorrhage, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Pyridines, Stroke, Thiazoles, Warfarin, ENGAGE AF-TIMI 48 Investigators, 11 Medical and Health Sciences, 32 Biomedical and clinical sciences, 42 Health sciences

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.).