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N Engl J Med. 2012 Jan 5;366(1):9-19. doi: 10.1056/NEJMoa1112277. Epub 2011 Nov 13.

Rivaroxaban in patients with a recent acute coronary syndrome.

Collaborators (860)

Braunwald E, Gibson CM, Mega JL, Morin SE, Murphy SA, Contant C, Mohanavelu S, Deenadayalu N, McHale S, Burton P, Brennan V, DeCaprio L, DiBattiste P, Gambale J, Kojak C, Lee M, Notani R, Plotnikov A, Sun X, Tian H, Cook-Bruns N, Misselwitz F, Berkowitz S, Bassand JP, Bhatt DL, Bode C, Cohen M, Fox K, Goto S, Schneider D, Verheugt F, Amuchastegui M, Ardissino D, Aylward P, Bergovec M, Betriu A, Botero R, Chopra V, Corbalan R, Dellborg M, Duris T, Erglis A, Gao R, Giannitsis E, Katus H, Gibson CM, Gotcheva N, Haouala H, Jensen SE, Kiss R, LeMay M, Theroux P, Llamas Esperon G, Meisel S, Montalescot G, Morais J, Nicolau JC, Oude Ophuis T, van Hessen M, Parkhomenko A, Petrauskiene B, Ruda M, Seung KB, Sim KH, Squire I, Sritara P, Tendera M, Van de Werf F, Vasiljevic Z, Vinereanu D, White H, Widimsky P, Yigit Z, Weaver D, Skene A, Anderson J, Daida H, Hamm C, Hochman J, Giugliano R, Ruff C, Scirica B, Wiviott S, Awtry E, Berger C, Desai A, Gelfand E, Ho C, Leeman D, Link M, Pande A, Ruberg F, Vita J, Sabatine MS, Markov V, Boyarkin M, Yakushin S, Lipchenko A, Duda A, Gruzdev A, Motylev I, Tarasov N, Sayganov S, Gordeev I, Suprun E, Kobalava Z, Freidlin M, Shulman V, Bokarev I, Zateischikov D, Bartosh L, Gratsiansky N, Barbarash O, Tankhilevich B, Mirolyubova O, Boldueva S, Karpov Y, Palatkina T, Nikolskaya I, Filatov A, Libis R, Zrazhevsky K, Arkhipov M, Simanenkov V, Kuzmenko A, Romanchuk S, Shalaev S, Vasilyeva E, Strongin L, Dembitskaya A, Kuimov A, Bessonova N, Ballyuzek M, Suvorov A, Panov A, Ragozina N, Chernov S, Shaposhnik I, Ruda MY, Khokhlov A, Kuchinsky A, Dvornikov V, Gorokhovskaya G, Shylko J, Vasyuk Y, Stryuk R, Kuzin A, Mkrtchan V, Solovyev O, Egorova L, Lesnov V, Sokolova M, Lapin O, Syrkin A, Zemtsovsky E, Kulibaba E, Shapovalova J, Kosmachova E, Efremov D, Ginzburg M, Storozhakov G, Sarana A, Chernyatina M, Alexandrov O, Bisne V, Kumbla M, Chandra N, Abhyankar AD, Gupta SK, Panchangam SK, Khan A, Mehta V, Sharma K, Chopra VK, Vijan V, Aggarwal RK, Prabhavathi, Ramayya P, Parikh K, Dani S, Jeswani DR, Thakkar B, Sharma V, Sawhney JP, Parikh N, Pothineni RB, Banker D, Subramaniam Bhuvaneswaran J, Joshi A, Oomman A, Rathnavel S, Reddy NC, Singh P, Sathe SP, Panja M, Subramanyam K, Chockalingam K, Abdullakutty J, Dugal JS, Gadkari MA, Rao AC, Patki N, Bali HK, Srinivas A, Kumar N, Grant P, Prasad GN, Mohanan PP, Madappa N, Menon J, Krishnankutty Nair K, Jaiswal S, Naik S, Joshi H, Banerjee S, Chacko KA, Thanvi S, Kopaczewski J, Tendera M, Drzewiecki A, Kusnierz B, Musial W, Dabrowski M, Klecha A, Witkowski A, Trusz-Gluza M, Szpajer M, Ponikowski P, Jaworska K, Busz-Papiez B, Kornacewicz-Jach Z, Hamankiewicz M, Biedrzycka M, Pluta W, Dobrzycki S, Peruga J, Wendland M, Lesnik J, Buszman P, Krauze-Wielicka M, Gil R, Wysocki H, Kawecka-Jaszcz K, Wojciechowski D, Stachaczyk L, Kubica J, Miekus P, Kochman J, Szwed H, Kleinrok A, Drozdz J, Zinka E, Szczuka K, Hochul M, Gasior Z, Rzezniczak J, Zheng X, Zhang S, Wu S, Yang K, Li L, Wang J, Xu B, Ma S, Yang X, Yuan Z, Li H, Sun Y, Wang H, Zhu J, Chen Y, He B, Li H, Ma C, Wei M, Ke Y, Li Z, Lu Q, Li W, Liu S, Zhao S, Shen W, Huo Y, Li G, Yang Y, Xian S, Fu G, Sun Y, Lazov P, Grigorov M, Mollov M, Raev D, Petrov I, Tzekova M, Milanova M, Bohzidar D, Gruev T, Hergeldjieva V, Mihov A, Nikolov F, Benov H, Chompalova B, Goudev A, Jorgova J, Todorova M, Gotcheva N, Parvanova Z, Petranov S, Ramshev K, Tumbev H, Manolova A, Rogers WJ Jr, Sonn A, Gogia H, Angirekula MR, Smith C, Rivera E, Larrain G, Harjai K, Hamroff GS, Angiolillo D, Guidera SA, Roth DL, Gill SK, Zebrack JS, DeFehr SP, Quealy K, Bloom S, Kotlaba D, Singh V, Shah RR, Crowley ST, Staab ME, Cannon LA, Hardy WD, Gollapudi R, Schifferdecker B, Gogo P, Prashad R, Lang DT, Bertolet B, Leimgruber PP, Tolerico P, Anderson JL, Artis AK, Henderson D, Gupta V, Longo JA, Markus TD, Lloret RL, Molk BL, Kondo NI, Jeremias A, Harris J, Vlastaris AG, Whitaker J, Kereiakes DJ, Amirani H, Wohns DH, Hermiller JB, Shaikh SR, Simmons JF, Schmedtje JF Jr, Corbelli JC, Lim MJ, Schwartz DJ, Kazmierski JF, Scirica B, Smith CR Jr, McGrew F, Vogel C, Wassmer P, Atassi K, Zhurba SV, Karpenko OI, Kraiz IG, Rudenko LV, Amosova K, Serkova VK, Shershneva O, Parkhomenko AN, Netiazhenko VZ, Shved MI, Zavgorodniy A, Batushkin VV, Yagensky AV, Koval OA, Klantsa AI, Vatutin MT, Kovalsky IP, Tseluyko VI, Potapenko P, Yarema NI, Mostovoy YM, Kopytsya NP, Zheleznyy VP, Perepelytsya OY, Bagriy AE, Horbach LO, Rishko MV, Katerenchuk IP, Seredyuk NM, Giraldez RR, Pimentel Filho P, dos Santos ES, Reis G, Sobral Filho DC, Rossi PR, Dutra OP, Vilas Boas F, dos Santos FR, Bodanese LC, Maia LN, Michalaros YL, Neuenschwander F, Lopes AC, Saraiva JF, Moura Jorge J, Marin Neto J, Précoma DB, Leães PE, de Moraes AF, Hammett C, Singh B, Jayasinghe R, Walters D, Van Gaal W, Whelan A, Shetty S, Colquhoun D, Collins N, Thompson P, Garrahy P, Yadav R, Sinhal A, Lefkovits J, Horrigan M, Waites J, Tousek P, Monhart Z, Bělohlávek J, Kala P, Pleva L, Slabý J, Jandík J, Reichert P, Vojáček J, Mayer O, Dunaj M, Paďour F, Marcínek G, Jelínek P, Otava M, Černohous M, Červinka P, Sychra M, Florián J, Merkely B, Vértes A, Tomcsányi J, Kiss GR, Dézsi A, Apró D, Czuriga I, Stefán J, Lupkovics G, Nagy L, Herczeg B, Jánosi A, Zámolyi K, Alvarisqueta A, Hominal M, Codutti O, Cartasegna L, Guzman L, Poy CA, Ramos HR, Aiub JR, Jure H, Nul D, Macín SM, Sarjanovich JR, García Brasca D, Schmidberg JM, Rodriguez M, Fernandez A, Hasbani E, Bonato R, Berli MA, Diez FA, Amuchastegui M, Snitman M, Vita NA, Navarro JL, Albisu JP, Caime G, Luquez H, Lobo Marquez LL, Sokn F, Cuneo C, Montaña O, Dran DR, Sessa HA, Hiasa Y, Komura Y, Noda T, Endoh S, Sakamoto T, Hirayama A, Yamamoto H, Shimomura H, Inoko M, Ohyanagi M, Kato K, Nakamura Y, Muramatsu T, Sakurai S, Fujino S, Itoh A, Shimizu M, Okishige K, Usuda K, Himi T, Hirayama H, Iwade K, Morikami Y, Noike H, Fujii K, Shimizu M, Takahashi A, Sakai R, Higa T, Maemura K, Ujihira T, Kuramoti T, Kazatani Y, Namiki A, Ikefuji H, Sasaki T, Hanada M, Sata M, Umehara E, Tange S, Imamura T, Sano H, Miura T, Takebayashi H, Iuchi T, Hokimoto S, Minagoe S, Hosokawa J, Soneda J, Van Hessen M, Milhous JG, Herrman JP, Ronner E, Willems F, Oude Ophuis T, Van Vlies B, Werner H, Ten Berg J, Van Daele M, Robles de Medina R, Post JC, Pos B, Van Beek E, Wardeh A, Meisel RS, Elias M, Marmor TA, Klutstein WM, Atar S, Hasin Y, Roth A, Pollak A, Kracoff HO, Oliven A, Fuchs S, Schellong S, Möbius-Winkler S, Kreuzer J, Buerke M, Giannitsis E, Werner N, Dengler T, Stangl V, Möhlenkamp S, Kadel C, Schunkert H, Felix S, Moser M, Fischer D, Leschke M, Hoffmann U, Wachter R, Braun-Dullaeus R, Bergmann M, Rauch U, Vöhringer HF, Naber C, Horacek T, Vinereanu D, Rosu D, Stanciulescu G, Benedek IS, Ionescu DD, Bengus CM, Sinescu CJ, Aron G, Stamate SC, Popescu MI, Sanchez Vallejo G, Delgado JA, Fernandez RR, Jaramillo CF, Botero R, Saaibi J, Molina DI, Atehortua LH, Vélez S, Jaramillo CF, Poveda CM, Gómez JE, Accini MJ, Urina MA, De los Rios M, Alcocer M, Martinez C, Uruchurtu E, Baños A, Leiva JL, Llamas G, Guerrero F, Muñoz L, Sanchez CJ, Virgen L, Benavides MA, Velasco R, Vidal G, Trevelyan J, Brack M, Squire I, Glover J, Moriarty A, De Belder M, Spurrell P, Cooke J, Townend J, Alamgir F, Neyses L, Qureshi N, Lip G, Andrews R, Lewis P, Beeton I, Sulke N, Ardissino D, Fattore L, Morocutti G, Capuano V, Baldin MG, Perna G, Tamburino C, Merlini P, Fiscella A, Terrosu G, Olivari Z, Ghezzi F, Patrizi G, Lioy E, Murena E, Mos L, Nassiacos D, Zanini R, Tarsi G, Bordes P, Ariza A, Iglesias L, Sanmartín M, Hernandez F, Latour J, Rincón A, Heras M, Jimenez M, Bruguera J, Goicolea J, Alonso JJ, Macaya C, Camprubi M, Diaz J, Berrazueta JR, Balaguer J, Casares G, Lopez V, Paz MA, Pabón P, De Mora M, Elbaz M, Schiele F, Montalescot G, Elhadad S, Cattan S, Range G, Coisne D, Zemour G, Charbonnier B, De Poli F, Cottin Y, Albornoz F, León L, Yovaniniz P, Araneda G, Cobos J, Lanas F, Florenzano F, Balboa W, Eggers G, Castro P, Potthoff S, Escobar J, Opazo M, Nguyen M, Kostuk W, Kouz S, Kokis A, Nawaz S, LeMay MR, Potvin JM, Tsui W, St Hillaire R, MacCallum CG, Welsh R, Brossoit R, Zadra R, Khurana MC, Rodes-Cabau J, Bhargava R, Boutros G, Hricak V, Duris T, Stevlik J, Spisak V, Mechmeche R, Haouala H, Boujnah MR, Boughezala E, Kammoun S, Belhani A, Petrauskiene B, Baksyte G, Grigoniene L, Raugaliene R, Norkiene S, Dambrauskaite A, Jodziuniene L, Beauloye C, Striekwold H, Vrolix M, Vankelecom B, Marechal P, De Wolf A, Van de Werf F, Marenne F, Mowafy A, Reda AA, Hassanein M, Sobhi B, el Hawary A, Reda AA, Jeong MH, Chae IH, Lee SH, Seong IW, Tahk SJ, Park SW, Seung KB, Skogward P, Calais F, Wallén H, Wodlin P, Hansen O, Ottander P, Mooe T, Jovinge S, Dellborg M, Piamsomboon C, Piyayotai D, Sritara P, Sunsaneewitayakul B, Sukonthasarn A, Yigit Z, Oguzhan A, Tukek T, Sahin M, Guneri S, Erol MK, Arı H, Tandogan I, Zoghi M, Cayli M, Mutlu B, Yalcin R, Ceyhan C, Degertekin M, Tasic N, Pavlovic M, Obrenovic-Kircanski B, Ilic S, Dincic D, Vasiljevic Z, Neskovic A, Miloradovic V, Mota P, Morais J, Cardoso P, Ferreira ML, Santos W, Gonçalo L, Ribeiro V, Carvalho H, Diogo NA, Basto L, Dormidontova G, Libins A, Erglis A, Kalnins A, Verbovenko J, Eggert Jensen S, Friis E, Nyvad O, Grande P, Dodt Kaae K, Fredenhardt B, Thayssen P, Ternouth IF, Devlin GP, Edwards CC, Hamer AW, White HD, O'Meeghan TJ, Lee CY, Wan Ahmad WA, Ong TK, Maskon O, Yusof Z, Anastasiou-Nana M, Moschos N, Triposkiadis F, Pyrgakis V, Mavric Z, Bergovec M, Samardzic P, Khatoouri A, Hamani A, Nazzi M, Tirador LS, Babilonia NA, Rogelio GG, Manalo CJ, Habaluyas RS.

Abstract

BACKGROUND:

Acute coronary syndromes arise from coronary atherosclerosis with superimposed thrombosis. Since factor Xa plays a central role in thrombosis, the inhibition of factor Xa with low-dose rivaroxaban might improve cardiovascular outcomes in patients with a recent acute coronary syndrome.

METHODS:

In this double-blind, placebo-controlled trial, we randomly assigned 15,526 patients with a recent acute coronary syndrome to receive twice-daily doses of either 2.5 mg or 5 mg of rivaroxaban or placebo for a mean of 13 months and up to 31 months. The primary efficacy end point was a composite of death from cardiovascular causes, myocardial infarction, or stroke.

RESULTS:

Rivaroxaban significantly reduced the primary efficacy end point, as compared with placebo, with respective rates of 8.9% and 10.7% (hazard ratio in the rivaroxaban group, 0.84; 95% confidence interval [CI], 0.74 to 0.96; P=0.008), with significant improvement for both the twice-daily 2.5-mg dose (9.1% vs. 10.7%, P=0.02) and the twice-daily 5-mg dose (8.8% vs. 10.7%, P=0.03). The twice-daily 2.5-mg dose of rivaroxaban reduced the rates of death from cardiovascular causes (2.7% vs. 4.1%, P=0.002) and from any cause (2.9% vs. 4.5%, P=0.002), a survival benefit that was not seen with the twice-daily 5-mg dose. As compared with placebo, rivaroxaban increased the rates of major bleeding not related to coronary-artery bypass grafting (2.1% vs. 0.6%, P<0.001) and intracranial hemorrhage (0.6% vs. 0.2%, P=0.009), without a significant increase in fatal bleeding (0.3% vs. 0.2%, P=0.66) or other adverse events. The twice-daily 2.5-mg dose resulted in fewer fatal bleeding events than the twice-daily 5-mg dose (0.1% vs. 0.4%, P=0.04).

CONCLUSIONS:

PMID:
22077192
[PubMed - indexed for MEDLINE]
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