Scientific Publications Database

Article Title: Rivaroxaban for Thromboprophylaxis after Hospitalization for Medical Illness
Authors: Spyropoulos, Alex C.; Ageno, Walter; Albers, Gregory W.; Elliott, C. Gregory; Halperin, Jonathan L.; Hiatt, William R.; Maynard, Gregory A.; Steg, P. Gabriel; Weitz, Jeffrey I.; Suh, Eunyoung; Spiro, Theodore E.; Barnathan, Elliot S.; Raskob, Gary E.; Jure, Horacio; Alvarisqueta, Andres; Cartasegna, Luis; Hominal, Miguel; Cursack, Guillermo; Alzogaray, Maria; Maillo, Martin; Parody, Maria; Caccavo, Alberto; Dran, R. Dario; Muntaner, Juan Antonio; Casas, Marcelo; Schmidberg, Jorge; Sarjanovich, Rodolfo; Gabito, Andrea; Garrido, Marcelo; Amuchastegui, Marcos; Fernandez, Alberto; Loureyro, Juan; Giumelli, Carla; Heazlewood, Vernon; Karrasch, Jeff; Colquhoun, David; White, Hayden; Sabet, Arman; Bowler, Simon; Carroll, Patrick; Khalafallah, Alhossain; Baker, Ross; Hedger, Stephen; Simpson, Frederick Graham; Jackson, David; Chong Beng; Eichinger-Hasenauer, Sabine; Siostrzonek, Peter; Gary, Thomas; Hoppe, Uta; Dosta, Nikolay; Krivenchuk, Vitaly; Prystrom, Andrei; Gorokhovsky, Sergey; Yanushko, Viachaslav; Skrahin, Aliaksandr; Kulik, Anatoly; Maslianski, Boris; Yakubtsevich, Ruslan; Timkin, Ivan; Moguchaya, Olga; Tanaskovic, Natasa; Miljkovic, Sinisa; Stojkovic, Sanja; Kovacevic-Preradovic, Tamara; Jovic, Darko; Basagic, Edin; Radjen, Mirjana; Mutapcic, Meliha; Rizvanovic-Vojic, Etida; Galic, Kristina; Terzic, Ibrahim; Pojskic, Belma; Stevanovic, Dragan; Cehajic, Mili; Trbojevic, Stevan; Rech, Rafael; Annichino-Bizzacchi, Joyce; Stelmach, Rafael; Blanco, Daniela; Castro, Iran; Backes, Luciano Marcelo; Saraiva, Jose Francisco; Ramacciotti, Eduardo; de Barros e Silva, Pedro Gabriel Melo; Reis, Gilmar; Vieira, Moreira Eduardo; Leaes, Paulo; Zimmermann, Sergio; Van Bellen, Bonno; Precoma, Dalton; Silvestrini, Luiz Tiago; Hernandes, Mauro Esteves; Kyoleyan, Michael; Kalinova, Tanya; Tiholov, Rumen; Petrov, Iliyan; Mihov, Atanas; Chompalova, Boryana; Velikov, Chavdar; Pencheva, Galina; Atanasov, Peter; Raev, Dimitar; Kinova, Elena; Peltegov, Valentin; Marchev, Sotir; Mincheva, Valentina; Siulemezova, Silvia; Ayryanova, Ivaneta Dimitrova; Grigorov, Mladen; Naydenova, Iveta; Koteva, Nadya; Dimov, Bojidar; Runev, Nikolay; Getov, Dimitar; Metev, Hristo; Donchev, Krasimir; Taseva, Margarita; Hadzhieva, Antoaneta; Benov, Haralambi; Stoyanov, Miroslav; Tisheva-Gospodinova, Snezhanka; Mihaylova, Nadya; Abadzhiev, Stefan; Atzev, Borislav; Georgiev, Rosen; Mollov, Mihail; Stoikov, Anastas; Mazhdrakov, Georgi; Karastanev, Krassimir; Dube, Francois; Roth, Sherryn; Mansour, Samer; Carrier, Marc; Wu, Cynthia; Dolan, Sean; Pesant, Yves; Pietrangelo, Maria; Dresser, George; Kahn, Susan; Kruisselbrink, Rebecca; Cadena Bonfanti, Andres; Botero, Rodrigo; Quintero Ossa, Alvaro; Poveda, Claudia Marcela; Cedano, Jorge; Gomez Isaza, Luis; Villaquiran Torres, Claudio; Gomez Mesa, Juan; Vargas Alonso, Ruben; Espinosa, David; Maria Rodriguez, Jose; Sanchez, Gregorio; Accini Mendoza, Jose Luis; Gomez Florez, Carmen Cecilia; Cuervo Millan, Francisco; Pesek, Ksenija; Horvat, Davor; Fuckar, Krunoslav; Tudoric, Neven; Ruzic, Alen; Ostricki, Branko; Knezevic, Aleksandar; Breitenfeld, Tomislav; Laganovic, Mario; Samodol, Ante; Sikic, Jozica; Starcevic, Boris; Babic, Zdravko; Samarzija, Miroslav; Milas, Kresimir; Votocek, Stepan; Kvapil, Milan; Spinar, Jindrich; Kolman, Petr; Bindas, Pavol; Simon, Vladimir; Adamek, Tomas; Svobodova, Jaromira; Gergely, Ladislav; Lastuvka, Jiri; Macel, Igor; Navratil, Karel; Gregor, Pavel; Lacnak, Borek; Janousek, Jiri; Kellnerova, Ivana; Hulinsky, Vaclav; Matusek, Zdenek; Prucek, Lukas; Dunaj, Milan; Pirchala, Marian; Vencour, David; Pavolko, Martin; Gorican, Karel; Fiksa, Jan; Tuxen, Christian; Meyer, Christian; Ulrik, Suppli; Marandi, Toomas; Uuetoa, Tiina; Shaburishvili, Tamaz; Otarishvili, Nino; Khintibidze, Irakli; Emukhvari, Nodar; Kipiani, Zviad; Gochitashvili, David; Mamatsashvili, Merab; Megreladze, Irakli; Paposhvili, Kakhi; Agladze, Rusudan; Eradze, Zviad; Chelidze, Kakhaber; Lominadze, Sulkhan; Chukhrukidze, Archil; Chumburidze, Vakhtang; Metreveli, Shorena; Danelia, Vakhtang; Orjonikidze, Sergo; Kobulia, Bondo; Nikolaishvili, Giorgi; Gvenetadze, Rusudan; Melia, Anzor; Tsinamdzgvrishvili, Bezhan; Sekhniashvili, Marika; Sikharulidze, Ioseb; Meuser, Mario; Licka, Manuela; Beyer-Westendorf, Jan; Rauch-Kroehnert, Ursula; Graf, Kristof; Brachmann, Johannes; Akin, Ibrahim; Toumbis, Michalis; Vassilikos, Vassilios; Konstantinides, Stavros; Steiropoulos, Paschalis; Gogos, Charalambos; Andrikopoulos, Giorgos; Parthenakis, Fragkiskos; Karydi, Panagiota; Tsivgoulis, Georgios; Mertzanos, Georgios; Olympios, Christopher; Karapanayiotides, Theodoros; Paraskevopoulou, Efrosyni; Kifnidis, Konstantinos; Hahalis, George; Skoutelis, Athanasios; Vadikolias, Konstantinos; Nyirati, Gabor; Nagy, Laszlo; Matoltsy, Andras; Komoly, Samuel; Lippai, Jozsef; Kiss, Krisztian; Kalman, Toth; Pozsegovits, Krisztian; Csaba, Kiraly; Bereczki, Daniel; Zolyomi, Szilard; Boda, Zoltan; Szakal, Imre; Pall, Denes; Futo, Laszlo; Forster, Tamas; Lovasz, Orsolya; Papp, Aniko; Kiraly, Zsolt; Pozsonyi, Zoltan; Erik, Hajko; Kristof, Piroska; Lakatos, Ferenc; Zsolt, Ples; Kirschner, Robert; Lupkovics, Geza; Timar, Gyula; Pinter, Istvan; Kristof, Tunde; Kis, Erno; Kovacs, Aranka; Jakab, Gabor; Palinkas, Attila; Mueller, Gabor; Turi, Tibor; Horvath, Csaba; Kondakor, Istvan; Csanyi, Attila; Frankfurter, Zsuzsanna; Gurzo, Mihaly; Gafter-Gvili, Anat; Kuchuk, Michael; Azzam, Zaher; Elis, Avishay; Halabi, Majdi; Hussein, Osamah; Blum, Arnon; Tsoran-Rosenthal, Inna; Lishner, Michael; Hochberg-Klein, Sarit; Caraco, Yoseph; Atar, Shaul; Elias, Nizar; Gavish, Dov; Butnaru, Adi; Cosmi, Franco; Garbelotto, Raffaella; Pierfranceschi, Giorgi; Simioni, Livio; Gronda, Edoardo; Pesci, Alberto; D'Angelo, Armando; Fedele, Francesco; Ghirarduzzi, Angelo; Piovaccari, Giancarlo; Lembo, Giuseppe; Ria, Luigi; Monaco, Giuseppe; Brunelli, Claudio; Tosetto, Alberto; Capucci, Alessandro; Zanatta, Nello; Pistolesi, Massimo; Mazzi, Valeria; Testa, Sophie; Scherillo, Marino; Di Biase, Matteo; Antonicelli, Roberto; Lodigiani, Corrado; Nassiacos, Daniele; Krievins, Dainis; Viksne, Inese; Lapkovska, Zinaida; Rancane, Gita; Sime, Iveta; Pontaga, Natalija; Eglite, Ruta; Puzule, Sarmite; Smolova, Rita; Butkiene, Zita; Bagdonas, Alfredas; Raugaliene, Rasa; Norkiene, Sigute; Norviliene, Rita; Petrauskiene, Birute; Basijokiene, Vida; Stonkus, Sigitas; Griskeviciene, Violeta; Miskiniene, Ausra; Norvaisiene, Rima; Skripkauskiene, Irena; Jovkovska-Kaeva, Biserka; Kochovska-Kamchevska, Nade; Antovski, Antonio; Nechevska, Liljana; Celeska, Violeta; Ilievska-Poposka, Biljana; Kostojchinoska, Mira; Donchovska, Snezhana; Kedev, Sashko; Kuzmanovski, Igor; Bushletikj, Oliver; Stojchev, Sasho; Bakrachevski, Nikola; Kuzmanovska, Biljana; Angusheva, Tanja; Llamas Esperon, Guillermo; Valdez Lopez, Hector; Medina Pech, Carlos; Cortes Hernandez, Miguel; Virgen Carrillo, Luis; Gans, Stephanus; Smulders, Sietske; Swart, Henk; Middeldorp, Saskia; Boersma, Willem; Goosens, Martijn; Hovens, Marcel; Semplonius, Geesje; Sohne, M.; Osores, Lema; Salas Perez, Marcia; Rodriguez, Aldo; Rios Oliva, Carlos; Cotrina, Rosa; Berrospi Argandona, Percy; Toce Yanez, Luis; Chavez Ayala, Carlos; Mirek-Bryniarska, Ewa; Goch, Aleksander; Skucha, Wojciech; Skorski, Marcin; Miekus, Pawel; Szyszka, Andrzej; Piotrowski, Grzegorz; Gniot, Jacek; Czerski, Tomasz; Debich, Piotr; Zaluska, Roman; Bebenek, Waldemar; Wozakowska-Kaplon, Beata; Sciborski, Ryszard; Ilkowski, Jan; Wojnowski, Piotr; Uscinska, Ewa; Gaciong, Zbigniew; Bonek, Robert; Sobkowicz, Bozena; Berkowski, Piotr; Bejgier, Katarzyna; Polonski, Lech; Kosior, Dariusz; Lata, Stanislaw; Kolodziej, Piotr; Gessek, Jacek; Kachel, Tomasz; Talalaj, Marek; Musial, Jacek; Lewczuk, Jerzy; Krysiak, Waldemar; Kucharski, Lech; Wysokinski, Andrzej; Minc, Piotr; Martinez, Jorge; Gregorio, Tiago; Almeida, Filipa; Monteiro, Pedro; Stanciulescu, Gabriela; Mercea, Corina; Iosipescu, Laura; Militaru, Constantin; Ciobotaru, Valentina; Crisu, Daniela; Burca, Mitel; Tudoran, Mariana; Savu, Angelica; Negrean, Vasile; Cojocaru, Cristian; Minescu, Bogdan; Popa, Virgil; Blajan, Daniel; Nastase-Melicovici, Dorel; Fruntelata, Ana; Barbulescu, Sanziana; Lukinyh, Liya; Akhunova, Svetlana; Vishneva, Elena; Semenova, Irina; Nikolaev, Konstantin; Shaydyuk, Oxana; Nilk, Rostislav; Shalnev, Vladimir; Apartsin, Konstantin; Goloshchekin, Boris; Shpagina, Liubov; Khlevchuk, Tatiana; Arkhipov, Mikhail; Malygin, Alexander; Shvarts, Yury; Khaisheva, Larisa; Popov, Dmitry; Kobalava, Zhanna; Lipchenko, Alexander; Shapovalova, Yulia; Zrazhevsky, Konstantin; Greshnova, Irina; Maslova, Natalia; Karabenenko, Alexander; Shogenov, Zaur; Budankova, Ekaterina; Barbarash, Olga; Uspenskiy, Yury; Kosmacheva, Elena; Berns, Svetlana; Kostenko, Victor; Zateyshchikov, Dmitry; Vishnevsky, Alexandr; Boldueva, Svetlana; Podzolkov, Valeriy; Sergeeva, Elena; Grinshtein, Yury; Khrustalev, Oleg; Bugrova, Olga; Repin, Alexey; Andreev, Denis; Petrovic, Predrag; Matic, Tatjana; Apostolovic, Svetlana; Lazic, Zorica; Stankovic, Dusica; Stankovic, Aleksandar; Mitov, Vladimir; Sofronic, Dejan; Kopitovic, Ivan; Zdravkovic, Vladimir; Joksimovic, Zoran; Lazovic, Nada; Petrovic-Stanojevic, Natasa; Ilic, Aleksandra; Vujadinovic, Olivera; Pencic-Popovic, Biljana; Andjelkovic, Nebojsa; Sekularac, Nikola; Hinic, Sasa; Radjen, Goran; Zivkovic, Aleksandar; Putnikovic, Biljana; Vuckovic, Biljana; Ivanov, Igor; Babic, Rade; Van Zyl, Louis; Hobson, Biano; Basson, Matthys; Engelbrecht, Johannes; Mitha, Ismail; Siebert, Heidi; Jacobson, Barry; Breedt, Johannes; Prozesky, Hans; Ntsekhe, Mpiko; Bayat, Junaid; Ellis, Graham; Tarr, Gareth; Adler, David; Van Dyk, Christo; Ismail, S.; Spargo, Catherine; Abdool-Gaffar, Mohamed; Saaiman, Jan; Venter, Karl; Lorente Aroca, Maria; Fernandez Portales, Francisco; Pedrajas Navas, Jose; Rodriguez Botaro, Antonio; Cruz Siminiani, Antonio; Lopez Reyes, Raquel; Bisbe i Company, Josep; Piedecausa Selfa, Mar; Velasco Garrido, Jose; Sobrino-Martinez, Javier; Munoz Delgado, Gregorio; Sala Llinas, Ernest; Blanco Coronado, Jose; Almenar Bonet, Luis; Vida Gutierrez, Manuel; Sanchez Lora, Fernando; Sanchez Martinez, Rosario; Calderon, Enrique; Villalta Blanch, Jaume; De la Hera Galarza, Jesus; Bustamante Ruiz, Ana; Jose Garcia-Fuster, Maria; Ripoll Vera, Tomas; Alvarez-Sala Walter, Luis; Todoli Parra, Jose; Diaz Fernandez, Jose; Bosa Ojeda, Francisco; Pellicer-Ciscar, Concepcion; Jara Palomares, Luis; Quiles Granado, Juan; Trigo Bautista, Alberto; Ruiz Bustillo, Sonia; Ordi Ros, Josep; Tolosa-Vilella, Carles; Marin Ortuno, Francisco; Garcia Sanchez, Florentino; Barba Martin, Raquel; Segovia Cubero, Javier; Cuervas-Mons Martinez, Valentin; Galan Montejano, Miguel; Lopez Meseguer, Manuel; Sener Comert, Sevda; Koksal, Nurhan; Tertemiz, Kemal; Ernam, Dilek; Dursun, Adile; Yildiz, Oznur; Rudenko, Leonid; Abrahamovych, Orest; Goloborodko, Alla; Holovchenko, Nataliia; Kulyk, Anna; Yagensky, Andriy; Batushkin, Valerii; Zolotaikina, Viktoriia; Kozyolkin, Oleksandr; Faynyk, Andriy; Maslovskyy, Valentyn; Petrovskyy, Roman; Koshlia, Volodymyr; Chopey, Ivan; Burmak, Iurii; Malynovsky, Yaroslav; Voronkov, Leonid; Karpenko, Olexandr; Dziublyk, Oleksandr; Godlevska, Olga; Borovyk, Valentyna; Bezrodna, Larysa; Serik, Sergii; Ovsyannikova, Nataliya; Vynnychenko, Lyudmyla; Kopytsya, Mykola; Rudkovskiy, Volodymyr; Grishyna, Olena; Vyshnyvetskyy, Ivan; Prystupa, Lyudmyla; Tseluyko, Vira; Perepeliuk, Mykola; Koval, Olena; Sychov, Oleg; Church, Alistair; Goudie, Andrew; Elliott, Mark; Ferguson, Craig; Welker, James; Kao, Cheng-Kai; Bhagwat, Ravi; Serota, Harvey; Rosenberg, David; Bozorgchami, Hormozd; Nambiar, Rajesh; Hazelrigg, Monica; Spilseth, Sara; Bhagwath, Gayathri; Syed, Faizullah; Morrow, Lee; Updegrove, John; Bercz, Peter; Kambo, Varinder; Henderson, David; Wright, Patrick; Dang, Nguyen; Nadar, Venkatesh; Jaffrani, Naseem; El-Shahawy, Mohamed; Grossman, Colby; Pearle, James; Weinstein, Debra; Galanis, Taki; Gazmuri, Raul; Kastelic, Richard; Martinez, Rafael; Laman, David; Macchiavelli, Anthony; Kmetzo, James; Thurm, Craig; Kayembe, Tshiswaka; Chandrashekhar, Yellapragada; Bassetti, Dennis; Jaoude, Philippe; Williams, Hayes; Dewhurst, Robert; Naqvi, Syed; Burr, John; Rodriguez-Cintron, William; Jeanfreau, Robert; Kosinski, Edward; Ndukwu, Ikeadi; Sotolongo, Carlos; Daboul, Nizar; Wilmer, Charles; Simon, Peter; Tak, Tahir; Rees, Christopher; Gupta, Nishant; Lerner, Robert; Tapson, Victor; Graffagnino, Carmelo; Reed, Robert; Alford, Chad; Mody, Freny; Wellmon, Baxter; Hamroff, Glenn; Rajan, Raj; Kaatz, Scott
Journal: NEW ENGLAND JOURNAL OF MEDICINE Volume 379 Issue 12
Date of Publication:2018
Abstract:
BACKGROUNDPatients 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.METHODSIn 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 n-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.RESULTSOf 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).CONCLUSIONSRivaroxaban, 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.