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N Engl J Med. 2013 Feb 7;368(6):513-23. doi: 10.1056/NEJMoa1111096.

Rivaroxaban for thromboprophylaxis in acutely ill medical patients.

Collaborators (596)

Büller H, Cohen AT, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Spiro T, Spyropoulos A, Tapson V, Francis C, Kobayashi S, Leizorovicz A, Lowe G, Roberts R, Brandges D, Kolbach D, Limburg ML, Mac Gillavry MR, Otten HM, Peters RG, Prins M, Robben S, Voorend M, Spiro T, Hemmrich M, Li L, Meng I, Mühlhofer E, Beckmann H, Desanctis Y, Duszczyszyn A, Fielding L, Twomey T, Müller K, Byra W, Haskell L, Nessel C, Atkinson S, Bottaro FJ, Caberlotto O, Grand B, Hendler H, Hojman M, Mykietiuk A, Salerno R, Baker R, Carroll P, Chong B, Colquhoun D, Gan E, Hall S, Jackson D, Leyden M, Salem H, Serisier D, Balcke P, Bauer B, Bauer NC, Erlacher L, Fortunat W, Grafl E, Keil F, Kirchmair P, Pilger E, Schönherr HR, Siostrzonek P, Weidinger F, Weltermann A, Wenisch C, Blockmans D, Delobbe A, Hendrickx K, Jacquy C, Soupart A, Striekwold H, van Hoof ME, Vanden Abeele A, van Roey G, van Zandweghe L, Bizzacchi JM, Cavalheiro C, Chamone D, Fiss E, Garicochea B, Lopes AC, Rocha Moreira RC, van Bellen B, Dimov D, Ivanov Y, Lyubenov L, Milanov S, Mincheva V, Nenkova S, Popov D, Taseva M, Bergeron C, Boulanger JM, Buck B, Daneault N, Desai H, Dube F, Kutsogiannis DJ, Miron MJ, Moddel G, Shuaib A, Silver F, Stotts G, Verreault S, Bugedo G, Torres H, Chen KN, Chen P, Chen RC, Chen Y, Gai L, Gao Q, Guo S, Hu D, Hu T, Hua Q, Li H, Li J, Li W, Li YS, Liu C, Liu J, Liu Y, Qi G, Qin X, Shen C, Sun S, Sun Y, Wan Q, Wang C, Wang H, Wang Y, Wang Y, Wu C, Wu J, Wu S, Xian S, Xiu Q, Xu B, Yan X, Yang K, Yang L, Yang Y, Zhang DP, Zhang J, Zhang S, Zhao Y, Zhao Z, Zhou Y, Botero R, Cedano JE, Fajardo D, Gómez LF, Jaramillo CF, Rada R, Uribe LG, Velásquez JC, Bergovec M, Hajnsek S, Knezevic A, Samarzija M, Steiner R, Zupancic-Salek S, Fiksa J, Gorican K, Linhart A, Macel I, Mayer O, Prochazka V, Sedlacek J, Avnstrøm S, Nielsen H, Nielsen T, Østergaard OV, Tuxen C, Kolbassova O, Lember M, Marandi T, Uuetoa T, Karmakoski J, Lassila R, Aquilanti S, Bergmann JF, Brisot D, Debourdeau P, Duchemin A, Farge-Bancel D, Fournier C, Galinier M, Lacroix P, Lambert M, Le Jeunne C, Lorcerie B, Mahe I, Marquette CH, Mismetti P, Mottier D, Proust A, Quere I, Rihani R, Schmidt J, Stephan D, Vital-Durand D, Barth J, Beyer-Westendorf J, Borst M, Dormann A, Drouven FM, Espinola-Klein C, Heintges T, Hindahl H, Klotz T, Lawall H, Leschke M, Milstrey HR, Möbius-Winkler S, Mühlbauer B, Niederau C, Petermann W, Pohl C, Ringe JD, Sanner B, Scharrer I, Schellong S, Schmidt-Lucke JA, Schöffauer I, Stoelben E, Theelen W, Veltkamp R, vom Dahl J, Apsokardos S, Babalis D, Bassaris H, Karafoulidou A, Katsivas A, Panoutsopoulos G, Patsilinakos S, Skoutelis A, Toubis M, Vlastos F, Wong LK, Wong RS, Frankfurter Z, Nagy F, Jakab G, Kondakor I, Nikl J, Nyirati G, Szakacs Z, Szegedi N, Avvaru G, Bhairappa S, Cheviri AN, Gadkari M, Grant P, Kuchimanchi K, Kumar KP, Mahajan A, Naik A, Oomman A, Raghu C, Ramanathan RM, Talwar D, Whig J, Kalim H, Machfoed MH, Tambunan KL, Elias M, Elias N, Hayek T, Lishner M, Oren S, Osamah H, Sthoeger Z, Telman G, Zeltser D, Zimlichman R, Ageno W, Agnelli G, Berrettini M, Bondi M, Buzzoni R, Castaman G, De Blasio A, De Gaudenzi E, Falanga A, Fontanella A, Giorgi Pierfranceschi M, Landolfi R, Lodigiani C, Morra E, Parise P, Pini M, Pizzini A, Poggio R, Quintavalla R, Siragusa S, Violi F, Ando S, Fujimoto K, Fukui K, Funada J, Hataji O, Ibata H, Ichinose T, Ikefuji H, Imai S, Ito K, Kani H, Kato M, Momiyama Y, Nishi S, Mekaru S, Mio T, Nagaoka M, Nakagawa H, Nakamura Y, Okazaki O, Oshiro K, Ozawa T, Saito T, Sakagami S, Shimizu A, Shiohira Y, Tanaka E, Uchiyama T, Utsugisawa K, Tsuji T, Wada A, Yamada N, Bang SM, Chung CS, Kang DW, Kim YK, Lee YS, YeunOh D, Yoon BW, Aizsilniece I, Krievins D, Kupcs U, Pontaga N, Rozitis V, Stukena I, Alekniene B, Bagdonas A, Basijokiene V, Butkiene Z, Griskeviciene V, Gumbrevicius G, Norviliene R, Petrauskiene R, Stonkus S, Vitkauskas A, Muller P, Rauh S, Chin SP, Sim KH, Wan Azman BW, Cardoza Amador JI, Gallegos Martínez J, Gómez Lara M, González Garza J, Hernández Gaeta DE, Herver Cabrera MJ, Nares Ochoa F, Perea Sánchez RA, Romero López C, Tanaka Chávez A, Vázquez López MÁ, Velasco Rodríguez VM, Dees A, de Kreuk AM, Fijnheer R, ten Cate H, Jackson S, Ockelford P, Simpson D, Ghanima WK, Schjesvold FH, Stokstad I, Torp R, Aziz Z, Rizvi N, Tayyab GN, Arrieta Días F, Castillo Leon R, Cotrina R, Moncada Vilela Z, Salas Pérez M, Salazar Candiotti OC, Ulloa Pérez VR, Biedrzycka M, Bojarska-Los M, Goch A, Gorska M, Gutowska-Jablonska M, Jahnz-Rozyk K, Krysiak W, Mirek-Bryniarska E, Ogorek M, Sydor A, Szczeklik A, Walasek L, Wrzesinski K, Zechowicz T, Bettencourt P, Ducla Soares J, Ferreira A, Ferreira F, Gomes F, Martins A, Mello e Silva A, Providência L, Rodrigues T, Santos F, Aroutynov G, Ershova O, Fedorova T, Glezer MG, Khatkova S, Moiseev V, Shilkina N, Sotnikov A, Chua G, Gan HW, Ng AW, Ong TH, Tan RS, Tang OT, Gaspar L, Kovar F, Spisak V, Stevlik J, Szentivanyi M, Flezar M, Gorjup V, Jereb M, Sok M, Tratar G, Zvan B, Adler D, Bloy B, Dreosti LM, Engelbrecht JM, Janse van Rensburg H, Koegelenberg CF, Nortje H, Quinton S, Rabie WJ, Rapoport BL, Roodt A, Smith C, Steenkamp FW, van Nieuwenhuizen E, van Zyl L, Bisbe J, Castro A, Cereto Castro F, Conget F, Guil M, Monreal M, Nieto Rodríguez JA, Tirado Miranda R, Tolosa C, Trujillo Santos J, Villalta J, Bertholds E, Cwikiel M, Laska AC, Östergren J, Själander A, Svensson P, Timberg I, Torstensson I, Wiklund PG, Banyai M, Baumgartner I, Imhof A, Jeanneret C, Nussbaumer P, Schifferli JA, Chuang KY, Guo BF, Lee JT, Lin YH, Shyu KG, Permpikul C, Pothirat C, Wattanathum A, Goker E, Ilerigelen B, Kucukoglu S, Nalbantgil S, Sirin H, Yilmaz U, Genyk S, Goncharova Y, Karpenko O, Korzh O, Koval V, Legkonogov O, Perepeliuk M, Polyakov A, Ryabichenko T, Skrebkov V, Sorkin V, Svyshchenko Y, Tseluyko V, Vakaliuk I, Vatutin M, Voronkov L, Cohen A, Durairaj R, Elliott M, Kesteven P, Luckit JK, Rafferty P, Scully M, Albrecht CR 3rd, Anderson S, Benninghoff M, Bidair M, Birch TA, Brensilver J, Chastain S, Chen D, Comerota AJ, Concha M, Conrad SA, Cox MJ, Daboul NY, Dexter J, Dietrich DW, Fei RH, Fontes ML, French WJ, Gonzales E, Hazelrigg MR, Heller BN, Heyder AM, Hill GT Jr, Jaffer AK, Jetty P, Johnson G, Kaatz S, Kazimir M, Lavender RC, Lawton CB, Lerner R, Light RW, Ling TG, Mahal S, Manos P, Masson J, Maynor K, McLafferty RB, Mehra P, Merli GJ, Minkowitz HS, Murray RM, Nadar V, Nathanson A, Patton WF, Peberdy M, Plautz M, Pokharel P, Quintana OE, Rajamani K, Rastogi P, Reiter WM, Reyes JA, Schuller D, Seibert A, Sharma A, Simmons J, Soff GA, Stein RW, Stoltz S, Suen J, Thurm C, Toe W, Updegrove JD, Ward JA, Waxman K, Welker J, Whittier FC, Wright PE Jr, Wun T, Yusen RD, Ziedalski TM.

Author information

  • 1Department of Vascular Surgery, King's College Hospital, London SE5 9RS, United Kingdom. alexander.cohen@kcl.ac.uk

Abstract

BACKGROUND:

The clinically appropriate duration of thromboprophylaxis in hospitalized patients with acute medical illnesses is unknown. In this multicenter, randomized, double-blind trial, we evaluated the efficacy and safety of oral rivaroxaban administered for an extended period, as compared with subcutaneous enoxaparin administered for a standard period, followed by placebo.

METHODS:

We randomly assigned patients 40 years of age or older who were hospitalized for an acute medical illness to receive subcutaneous enoxaparin, 40 mg once daily, for 10±4 days and oral placebo for 35±4 days or to receive subcutaneous placebo for 10±4 days and oral rivaroxaban, 10 mg once daily, for 35±4 days. The primary efficacy outcomes were the composite of asymptomatic proximal or symptomatic venous thromboembolism up to day 10 (noninferiority test) and up to day 35 (superiority test). The principal safety outcome was the composite of major or clinically relevant nonmajor bleeding.

RESULTS:

A total of 8101 patients underwent randomization. A primary efficacy outcome event occurred in 78 of 2938 patients (2.7%) receiving rivaroxaban and 82 of 2993 patients (2.7%) receiving enoxaparin at day 10 (relative risk with rivaroxaban, 0.97; 95% confidence interval [CI], 0.71 to 1.31; P=0.003 for noninferiority) and in 131 of 2967 patients (4.4%) who received rivaroxaban and 175 of 3057 patients (5.7%) who received enoxaparin followed by placebo at day 35 (relative risk, 0.77; 95% CI, 0.62 to 0.96; P=0.02). A principal safety outcome event occurred in 111 of 3997 patients (2.8%) in the rivaroxaban group and 49 of 4001 patients (1.2%) in the enoxaparin group at day 10 (P<0.001) and in 164 patients (4.1%) and 67 patients (1.7%) in the respective groups at day 35 (P<0.001).

CONCLUSIONS:

In acutely ill medical patients, rivaroxaban was noninferior to enoxaparin for standard-duration thromboprophylaxis. Extended-duration rivaroxaban reduced the risk of venous thromboembolism. Rivaroxaban was associated with an increased risk of bleeding. (Funded by Bayer HealthCare Pharmaceuticals and Janssen Research and Development; MAGELLAN ClinicalTrials.gov number, NCT00571649.).

Comment in

PMID:
23388003
[PubMed - indexed for MEDLINE]
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