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N Engl J Med. 2018 Sep 20;379(12):1118-1127. doi: 10.1056/NEJMoa1805090. Epub 2018 Aug 26.

Rivaroxaban for Thromboprophylaxis after Hospitalization for Medical Illness.

Collaborators (697)

Douketis J, Turpie AG, Schulman S, Kearon C, Linkins LA, Schellong S, Bauer K, Geerts W, Roberts R, Casais P, Gallus A, Karrasch J, Eichinger-Hasenauer S, Krivenchuk V, Hadzovic-Dzuvo A, Trbojevic S, Lopes R, Mincheva V, Carrier M, Dennis R, Tudoric N, Spinar J, Nielsen H, Marandi T, Shaburishvili T, Beyer-Westendorf J, Vardas P, Boda Z, Brenner B, Piovella F, Krievins D, Petrauskiene B, Dejanova-Ilijevska V, Virgen Carrillo LR, Middeldorp S, Castillo Leon RP, Torbicki A, Saraiva de Sousa M, Dorobantu M, Militaru C, Yavelov I, Vuckovic B, Reuter H, Basson M, Monreal M, Kucukoglu S, Parkhomenko A, Alikhan R, Rosenberg D, Yusen R, Khorana A, Tapson V, Pollack C, Hazelrigg M, Jure H, Alvarisqueta A, Cartasegna L, Hominal M, Cursack G, Alzogaray M, Maillo M, Parody M, Caccavo A, Dran RD, Muntaner JA, Casas M, Schmidberg J, Sarjanovich R, Gabito A, Garrido M, Amuchastegui M, Fernandez A, Loureyro J, Giumelli C, Heazlewood V, Colquhoun D, White H, Sabet A, Bowler S, Carroll P, Khalafallah A, Baker R, Hedger S, Simpson FG, Jackson D, Chong B, Siostrzonek P, Gary T, Hoppe U, Dosta N, Prystrom A, Gorokhovsky S, Yanushko V, Skrahin A, Kulik A, Maslianski B, Yakubtsevich R, Timkin I, Moguchaya O, Tanaskovic N, Miljkovic S, Stojkovic S, Kovacevic-Preradovic T, Jovic D, Basagic E, Radjen M, Mutapcic M, Rizvanovic-Vojic E, Galic K, Terzic I, Pojskic B, Stevanovic D, Cehajic M, Rech R, Annichino-Bizzacchi J, Stelmach R, Blanco D, Castro I, Backes LM, Saraiva JF, Ramacciotti E, de Barros e Silva PGM, Reis G, Moreira Vieira E, Leães P, Zimmermann S, Van Bellen B, Precoma D, Luiz Silvestrini T, Hernandes ME, Kyoleyan M, Kalinova T, Tiholov R, Petrov I, Mihov A, Chompalova B, Velikov C, Pencheva G, Atanasov P, Raev D, Kinova E, Peltegov V, Marchev S, Siulemezova S, Ayryanova ID, Grigorov M, Naydenova I, Koteva N, Dimov B, Runev N, Getov D, Metev H, Donchev K, Taseva M, Hadzhieva A, Benov H, Stoyanov M, Tisheva-Gospodinova S, Mihaylova N, Abadzhiev S, Atzev B, Georgiev R, Mollov M, Stoikov A, Mazhdrakov G, Karastanev K, Dube F, Roth S, Mansour S, Wu C, Dolan S, Pesant Y, Pietrangelo M, Dresser G, Kahn S, Kruisselbrink R, Cadena Bonfanti A, Botero R, Quintero Ossa A, Poveda CM, Cedano J, Gómez Isaza L, Villaquiran Torres C, Gomez Mesa J, Vargas Alonso R, Espinosa D, Rodriguez JM, Sanchez G, Accini Mendoza JL, Gómez Flórez CC, Cuervo Millan F, Pesek K, Horvat D, Fuckar K, Ruzic A, Ostricki B, Knezevic A, Breitenfeld T, Laganovic M, Samodol A, Sikic J, Starcevic B, Babic Z, Samarzija M, Milas K, Votocek S, Kvapil M, Kolman P, Bindas P, Simon V, Adamek T, Svobodova J, Gergely L, Lastuvka J, Macel I, Navratil K, Gregor P, Lacnak B, Janousek J, Kellnerova I, Hulinsky V, Matusek Z, Prucek L, Dunaj M, Pirchala M, Vencour D, Pavolko M, Gorican K, Fiksa J, Tuxen C, Meyer C, Suppli Ulrik C, Uuetoa T, Otarishvili N, Khintibidze I, Emukhvari N, Kipiani Z, Gochitashvili D, Mamatsashvili M, Megreladze I, Paposhvili K, Agladze R, Eradze Z, Chelidze K, Lominadze S, Chukhrukidze A, Chumburidze V, Metreveli S, Danelia V, Orjonikidze S, Kobulia B, Nikolaishvili G, Gvenetadze R, Melia A, Tsinamdzgvrishvili B, Sekhniashvili M, Sikharulidze I, Meuser M, Licka M, Rauch-Kroehnert U, Graf K, Brachmann J, Akin I, Toumbis M, Vassilikos V, Konstantinides S, Steiropoulos P, Gogos C, Andrikopoulos G, Parthenakis F, Karydi P, Tsivgoulis G, Mertzanos G, Olympios C, Karapanayiotides T, Paraskevopoulou E, Kifnidis K, Hahalis G, Skoutelis A, Vadikolias K, Nyirati G, Nagy L, Matoltsy A, Komoly S, Lippai J, Kiss K, Tóth K, Pozsegovits K, Király C, Bereczki D, Zolyomi S, Boda Z, Szakal I, Pall D, Fűtő L, Forster T, Lovasz O, Papp A, Kiraly Z, Pozsonyi Z, Hajkó E, Kristóf P, Lakatos F, Plés Z, Kirschner R, Lupkovics G, Tímár G, Pintér I, Kristof T, Kis E, Kovacs A, Jakab G, Palinkas A, Müller G, Túri T, Horváth C, Kondakor I, Csanyi A, Frankfurter Z, Gurzo M, Gafter-Gvili A, Kuchuk M, Azzam Z, Elis A, Halabi M, Hussein O, Blum A, Tsoran-Rosenthal I, Lishner M, Hochberg-Klein S, Caraco Y, Atar S, Elias N, Gavish D, Butnaru A, Cosmi F, Garbelotto R, Giorgi Pierfranceschi M, Simioni L, Gronda E, Pesci A, D'Angelo A, Fedele F, Ghirarduzzi A, Piovaccari G, Lembo G, Ria L, Monaco GL, Brunelli C, Tosetto A, Capucci A, Zanatta N, Pistolesi M, Mazzi V, Testa S, Scherillo M, Di Biase M, Antonicelli R, Lodigiani C, Nassiacos D, Viksne I, Lapkovska Z, Rancane G, Sime I, Pontaga N, Eglite R, Puzule S, Smolova R, Butkiene Z, Bagdonas A, Raugaliene R, Norkiene S, Norviliene R, Basijokiene V, Stonkus S, Griskeviciene V, Miskiniene A, Norvaisiene R, Skripkauskiene I, Jovkovska-Kaeva B, Kochovska-Kamchevska N, Antovski A, Nechevska L, Celeska V, Ilievska-Poposka B, Kostojchinoska M, Donchovska S, Kedev S, Kuzmanovski I, Bushletikj O, Stojchev S, Bakrachevski N, Kuzmanovska B, Angusheva T, Llamas Esperón G, Valdez López H, Medina Pech C, Cortés Hernandez M, Virgen Carrillo L, Gans S, Smulders S, Swart H, Boersma W, Goosens M, Hovens M, Semplonius G, Söhne M, Lema Osores J, Salas Pérez MD, Rodriguez A, Rios Oliva C, Cotrina R, Berrospi Argandoña P, Toce Yañez L, Chavez Ayala C, Mirek-Bryniarska E, Goch A, Skucha W, Skorski M, Miekus P, Szyszka A, Piotrowski G, Gniot J, Czerski T, Debich P, Zaluska R, Bebenek W, Wozakowska-Kaplon B, Sciborski R, Ilkowski J, Wojnowski P, Uscinska E, Gaciong Z, Bonek R, Sobkowicz B, Berkowski P, Bejgier K, Polonski L, Kosior D, Lata S, Kolodziej P, Gessek J, Kachel T, Talalaj M, Musial J, Lewczuk J, Krysiak W, Kucharski L, Wysokinski A, Minc P, Martinez J, Gregório T, Almeida F, Monteiro P, Stanciulescu G, Mercea CD, Iosipescu LC, Ciobotaru V, Crisu D, Burca M, Tudoran M, Savu A, Negrean V, Cojocaru C, Minescu B, Popa V, Blajan D, Nastase-Melicovici D, Fruntelata A, Barbulescu S, Lukinyh L, Akhunova S, Vishneva E, Semenova I, Nikolaev K, Shaydyuk O, Nilk R, Shalnev V, Apartsin K, Goloshchekin BM, Shpagina L, Khlevchuk T, Arkhipov M, Malygin A, Shvarts Y, Khaisheva L, Popov D, Kobalava Z, Lipchenko A, Shapovalova Y, Zrazhevsky K, Greshnova I, Maslova N, Karabenenko A, Shogenov Z, Budankova E, Barbarash O, Uspenskiy Y, Kosmacheva E, Berns S, Kostenko V, Zateyshchikov D, Vishnevsky A, Boldueva S, Podzolkov V, Sergeeva E, Grinshtein Y, Khrustalev O, Bugrova O, Repin A, Andreev D, Petrovic P, Boskovic Matic T, Apostolovic S, Lazic Z, Stankovic D, Stankovic A, Mitov V, Sofronic D, Kopitovic I, Zdravkovic V, Joksimovic Z, Lazovic N, Petrovic-Stanojevic N, Ilic A, Vujadinovic O, Pencic-Popovic B, Andjelkovic N, Sekularac N, Hinic S, Radjen G, Zivkovic A, Putnikovic B, Ivanov I, Babic R, Van Zyl L, Hobson B, Engelbrecht J, Mitha I, Siebert H, Jacobson B, Breedt J, Prozesky H, Ntsekhe M, Bayat J, Ellis G, Tarr G, Adler D, Van Dyk C, Ismail SM, Spargo CE, Abdool-Gaffar M, Saaiman J, Venter K, Lorente Aroca ML, Fernández Portales F, Pedrajas Navas J, Rodríguez Botaro A, Santa Cruz Siminiani A, López Reyes R, Bisbe i Company J, Piedecausa Selfa M, Velasco Garrido J, Sobrino-Martinez J, Muñoz Delgado G, Sala Llinas E, Blanco Coronado J, Almenar Bonet L, Vida Gutiérrez M, Sánchez Lora F, Sánchez Martínez R, Calderón EJ, Villalta Blanch J, De la Hera Galarza JM, Bustamante Ruiz A, García-Fuster MJ, Ripoll Vera T, Álvarez-Sala Walter L, Todolí Parra JA, Díaz Fernández J, Bosa Ojeda F, Pellicer-Ciscar C, Jara Palomares L, Quiles Granado J, Trigo Bautista A, Ruiz Bustillo S, Ordi Ros J, Tolosa-Vilella C, Marín Ortuño F, García Sánchez F, Barba Martín R, Segovia Cubero J, Cuervas-Mons Martínez V, Galán Montejano M, López Meseguer M, Sener Comert S, Koksal N, Tertemiz K, Ernam D, Dursun AB, Yildiz O, Rudenko L, Abrahamovych O, Goloborodko A, Holovchenko N, Kulyk A, Yagensky A, Batushkin V, Zolotaikina V, Kozyolkin O, Faynyk A, Maslovskyy V, Petrovskyy R, Koshlia V, Chopey I, Burmak I, Malynovsky Y, Voronkov L, Karpenko O, Dziublyk O, Godlevska O, Borovyk V, Bezrodna L, Serik S, Ovsyannikova N, Vynnychenko L, Kopytsya M, Rudkovskiy V, Grishyna O, Vyshnyvetskyy I, Prystupa L, Tseluyko V, Perepeliuk M, Koval O, Sychov O, Church A, Goudie A, Elliott M, Ferguson C, Welker J, Kao CK, Bhagwat R, Serota H, Bozorgchami H, Nambiar R, Spilseth S, Bhagwath G, Syed F, Morrow L, Updegrove J, Bercz P, Kambo V, Henderson D, Wright P, Dang N, Nadar V, Jaffrani N, El-Shahawy M, Grossman CH, Pearle J, Weinstein D, Galanis TP, Gazmuri R, Kastelic R, Martinez R, Laman D Jr, Macchiavelli A, Kmetzo J, Thurm C, Kayembe T, Chandrashekhar Y, Bassetti D, Jaoude P, Williams H, Dewhurst R, Naqvi S, Burr J, Rodriguez-Cintron W, Jeanfreau R, Kosinski E, Ndukwu IM, Sotolongo C, Daboul N, Wilmer C, Simon P, Tak T, Rees C, Gupta N, Lerner R, Graffagnino C, Reed RM, Alford CM, Mody F, Wellmon B, Hamroff G, Rajan R, Kaatz S.

Abstract

BACKGROUND:

Patients who are hospitalized for medical illness remain at risk for venous thromboembolism after discharge, but the role of extended thromboprophylaxis in the treatment of such patients is a subject of controversy.

METHODS:

In this randomized, double-blind trial, medically ill patients who were at increased risk for venous thromboembolism on the basis of a modified International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) score of 4 or higher (scores range from 0 to 10, with higher scores indicating a higher risk of venous thromboembolism) or a score of 2 or 3 plus a plasma d-dimer level of more than twice the upper limit of the normal range (defined according to local laboratory criteria) were assigned at hospital discharge to either once-daily rivaroxaban at a dose of 10 mg (with the dose adjusted for renal insufficiency) or placebo for 45 days. The primary efficacy outcome was a composite of symptomatic venous thromboembolism or death due to venous thromboembolism. The principal safety outcome was major bleeding.

RESULTS:

Of the 12,024 patients who underwent randomization, 12,019 were included in the intention-to-treat analysis. The primary efficacy outcome occurred in 50 of 6007 patients (0.83%) who were given rivaroxaban and in 66 of 6012 patients (1.10%) who were given placebo (hazard ratio, 0.76; 95% confidence interval [CI], 0.52 to 1.09; P=0.14). The prespecified secondary outcome of symptomatic nonfatal venous thromboembolism occurred in 0.18% of patients in the rivaroxaban group and 0.42% of patients in the placebo group (hazard ratio, 0.44; 95% CI, 0.22 to 0.89). Major bleeding occurred in 17 of 5982 patients (0.28%) in the rivaroxaban group and in 9 of 5980 patients (0.15%) in the placebo group (hazard ratio, 1.88; 95% CI, 0.84 to 4.23).

CONCLUSIONS:

Rivaroxaban, given to medical patients for 45 days after hospital discharge, was not associated with a significantly lower risk of symptomatic venous thromboembolism and death due to venous thromboembolism than placebo. The incidence of major bleeding was low. (Funded by Janssen Research and Development; MARINER ClinicalTrials.gov number, NCT02111564 .).

PMID:
30145946
DOI:
10.1056/NEJMoa1805090
[Indexed for MEDLINE]
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