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1. Evaluation of the predictive value of the bleeding prediction score VTE‐BLEED for recurrent venous thromboembolism

Author

Klok, Frederikus A., Presles, Emilie, Tromeur, Cecile, Barco, Stefano, Konstantinides, Stavros V., Sanchez, Olivier, Pernod, Gilles, Raj, Leela, Robin, Philippe, Le Roux, Pierre‐Yves, Hoffman, Clément, Mélac, Solen, Bertoletti, Laurent, Girard, Philippe, Laporte, Silvy, Mismetti, Patrick, Meyer, Guy, Leroyer, Christophe, Couturaud, Francis, Jego, P., Duhamel, E., Provost, K., Parent, F., Mottier, D., Guégan, M., Le Hir, A., Lenoir, S., Lamer, C., Bergmann, J.F., Wahl, D., Drouet, L., Chevarier, P., Monte, N., Morvan, F., Kouassi, V., Ibrir, N., El Asri, G., Salaun, P.Y., Bressollette, L., Quéhé, P., Gestin, S., Nonent, M., Bahuon, J., Deloire, L., Planquette, B., Jobic, Y., Etienne, Y., Didier, R., Leven, F., Leroux, L., Galinat, H., Le Maréchal, C., Gourhant, L., Mingant, F., Lacut, K., Lemoigne, E., De Saint Martin, L., Delluc, A., Le Gal, G., Paleiron, N., Le Mao, R., Pison, C., Guéret, P., Décousus, H., Lassagne, C., Pan‐Petesh, B., Bura‐Riviere, A., Delahousse, B., Gruel, Y., Lorut, C., Schmidt, J., and Connault, J.

Published
2019
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3. Predicting the risk of cancer after unprovoked venous thromboembolism: external validation of the RIETE score

Author

Bertoletti, L., Robin, P., Jara‐Palomares, L., Tromeur, C., Pastre, J., Prevot‐Bitot, N., Mouneh, T., Le Gal, G., Salaun, P.‐Y., Armand, A., de Boisjolly, J. M., Bordot, A. S., Dambrine, S., Delori, M., Derrien, B., Guillaume, B., Lavigne, C., Loison, J., Pattier, K., Roy, P. M., Barnier, A., Blanc, J. J., Cornily, J. C., Couturaud, O., Delluc, A., Gut‐Gobert, C., Jaffrelot, M., Lacut, K., Leroyer, C., Le Hénaff, M., Le Moigne, E., Mottier, D., Paleiron, N., Pasquier, E., Pennec, P. Y., Quéré, G., Rogé, C., de Saint Martin, L., Belmont, L., Gosset, M., Meyer, G., Mourin, G., Planquette, B., Roux, A., Sanchez, O., Wermert, D., Accassat, S., Bost, V., Buchmuller, A., Décousus, H., Décousus, M., Merah, A., Rivron‐Guillot, K., Robert, F., Tardy, B., and Torris, P.

Published
2017
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24. Comparison of Fatal or Irreversible Events With Extended-Duration Betrixaban Versus Standard Dose Enoxaparin in Acutely III Medical Patients: An APEX Trial Substudy

Author

Gibson, C. M., Korjian, S., Chi, G., Daaboul, Y., Jain, P., Arbetter, D., Goldhaber, S. Z., Hull, R., Hernandez, A. F., Lopes, R. D., Gold, A., Cohen, A. T., Harrington, R. A., Bello, F., Ferrari, A. E., Jure, H., Macin, S., Oliva, M., Parody, M., Poy, C., Baker, R., Colquhoun, D., Coughlin, P., Finfer, S., Hammerschlag, G., Rubinfeld, A., Huber, K., Konig, J., Mathies, R., Pilger, E., Schoenerr, H., Adzerikho, I., Koryk, V., Mikhailova, E., Mitkovskaya, N., Pimanov, S., Polonetsy, L., Soroka, N., Blockmans, D., Delforge, M., Dive, A., Lienart, F., Motte, S., Annichino Bizzacchi, J., Fiss, E., Freire, A., Manenti, E., Ramacciotti, E., Raymuno, S., Rocha, A., Saraiva, J. F., Dimov, B., Grigorov, M., Kalpachki, R., Kamenova, Z., Kostadinova, M., Milanova, M., Mincheva, V., Pencheva, G., Raev, D., Runev, N., Stoeva, N., Stoyanov, M., Syulemzova, S., Todorov, G., Tokmakova, M., Dhar, A., Douketis, J., Kahn, S., Le Gal, G., Pearce, M., Provencher, S., Verreault, S., Arias Alarcon, M., Olivares Canon, C., Opazo Lazcano, M., Potthoff Cardenas, S., Butkovic-Soldo, S., Car, S., Ciglenecki, N., Francetic, I., Jakopovic, M., Kalinic-Grgorinic, H., Knezevic, A., Malojcic, B., Marusic, S., Sikic Vagic, J., Skerk, V., Cermak, O., Cervinka, P., Chlumsky, J., Chochola, J., Cizek, V., Dunaj, M., Dusek, J., Francek, L., Havelka, J., Herold, M., Holaj, R., Horny, I., Hubac, J., Jajtner, P., Kolman, P., Lang, P., Mayer, O., Mikulova, J., Podpera, I., Reiterer, P., Spacek, R., Vejvoda, J., Vyhnanek, M., Christensen, H., Lassen, M., Storgaard, M., Tuxen, C., Urhammer, S., Lember, M., Marandi, T., Uuetoa, T., Airaksinen, J., Honkaniemi, J., Kaaja, R., Lassila, R., Saarinen, J., Tatlisumak, T., Vikman, S., Agraou, B., Aquilanti, S., Belhassane, A., Brisot, D., De Geeter, G., Debourdeau, P., Decoulx, E., El Kouri, D., Falvo, N., Grange, C., Lacroix, P., Messas, E., Mismetti, P., Montaclair, K., Mottier, D., Paleiron, N., Payot, L., Pernod, G., Pottier, P., Proust, A., Quere, I., Roy, P. -M., Schmidt, J., Simoneau, G., Datikashvili-David, I., Khabeishvili, G., Khintibidze, I., Kobulia, B., Megreladze, I., Pagava, Z., Paposhvili, K., Shaburishvili, T., Amann, B., Berrouschot, J., Beyer-Westendorf, J., Blessing, E., Bott, M., Dengler, T., Diehm, C., Dziewas, R., Genth-Zotz, S., Hamann, F., Horacek, T., Klimpe, S., Kroning, R., Lapp, H., Lawall, H., Licka, M., Rizos, T., Schellong, S., Schmidt-Lucke, J., Singer, C., Tiefenbacher, C., Veltkamp, R., Weimar, C., Zeymer, U., Alkonyi, B., Falukozy, J., Futo, L., Katona, A., Kirschner, R., Kristof, P., Lakatos, F., Laszlo, Z., Lupkovics, G., Merkely, B., Nagy Andras, C., Nemeth, L., Papp, A., Soltesz, P., Sudar, Z., Szabo, G., Szegedi, N., Timar, G., Valco, J., Vertes, A., Efrati, S., Elias, M., Gafter, A., Hayek, T., Hussein, O., Lishner, M., Lugassy, G., Zeltser, D., Ageno, W., Cerveri, I., D'Angelo, A., De Pellegrin, A., Imberti, D., Landolfi, R., Lembo, G., Lodigiani, C., Luisetti, M., Moia, M., Molteni, M., Mumoli, N., Novo, S., Orlandini, F., Parisi, R., Pizzini, A., Pomero, F., Salvi, A., Schenone, A., Visona, A., Krievins, D., Martinova, V., Pontaga, N., Rozitis, V., Stukena, I., Alekniene, B., Bagdonas, A., Basijokiene, V., Butkiene, Z., Griskeviciene, V., Naudziunas, A., Norvaisiene, R., Norviliene, R., Petrauskiene, R., Poskiene, R., Susinskiene, D., Valavicius, A., Castillo Leon, R., Cotrina Pereyra, R., Farjardo Karlo, L., Horna, M., Lema Osores, J., Salas, M., Toche Yanez, L., Fryze, W., Gaciong, Z., Gniot, J., Gorecka, D., Gruenpeter, P., Grzelakowski, P., Jastrzebski, D., Kucharski, L., Mirek-Bryniarska, E., Pulkowski, G., Sobkowicz, B., Sulik, P., Tomkowski, W., Walasek, L., Waldemar, K., Wrzesinski, K., Balogh, Z. E., Bojinca, M., Marin, I., Mot, S., Musetescu, R., Podoleanu, C., Popescu, M., Stamate, S., Stanciulescu, G., Vida-Simiti, L., Abashev, A., Andreev, D., Apartsin, K., Arkhipov, M., Averkov, O., Barbarash, O., Belskaya, G., Bogdanov, E., Boldueva, S., Chefranova, Z., Dovgalevskiy, Y., Ershova, O., Goloshchekin, B., Khachatryan, N., Khurs, E., Klein, G., Kobalava, Z., Kosmacheva, E., Kostenko, V., Malygin, A., Martynenko, T., Martynenko, V., Maslova, N., Mordovin, V., Nikolaev, K., Nilk, R., Panchenko, E., Popov, D., Privalova, E., Reshetko, O., Sergeeva, E., Shapovalova, Y., Shpagina, L., Shvarts, Y., Simanenkov, V., Solovyov, O., Vishneva, E., Vishnevskiy, A., Apostolovic, S., Celic, V., Ilic, S., Kovacevic-Kuzmanovic, A., Miloradovic, V., Tan, R. S., Bodikova, S., Cervenakova, A., Dvorak, M., Gaspar, L., Herman, O., Hrubon, A., Kokles, M., Krastev, G., Payer, J., Prokop, D., Spisakova, M., Adler, D., Basson, M., Breedt, J., Engelbrecht, J., Jacobson, B., Mitha, I., Van Dyk, C., Alvarez Sala, L. A., Barbagelata Lopez, C., Bisbe, J., Castro Guardiola, A., Cepeda, J. M., Cereto, F., Diaz Santos, E., Ferrer, R., Gomez Cerezo, J., Gonzales-Porras, J. R., Grandes, J., Jimenez, D., Martin Loeches, I., Mellibovsky, L., Richart, C., Riera, A., Trujillo, J., Vargas Nunez, J. A., Villalta, J., Akgul, O., Guneri, S., Kilichesmez, K., Kirma, C., Kutluk, H., Nazliel, B., Okumus, G., Ongen, G., Tigen, K., Topcuoglu, M., Tuncay, E., Abrahamovych, O., Batushkin, V., Brozhyk, J., Burmak, I., Godlevska, O., Goloborodko, A., Goloborodko, B., Goncharova, Y., Gryb, V., Karpenko, O., Kopytsya, M., Koshlia, V., Krakhmalova, O., Kyrychenko, I., Legkonogov, O., Malynovsky, Y., Maslovaskyi, V., Nikonov, V., Parkhomenko, O., Perepeliuk, M., Reshotko, D., Rudenko, L., Ryabichenko, T., Svyridova, I., Svyshchenko, Y., Tseluyko, V., Ursol, G., Vakaliuk, I., Vishnivestsky, I., Voronkov, L., Yagensky, A., Body, R., Chandra, D., Davis, M., Kesteven, P., Maccallum, P., Mccollum, C., Natarajan, I., Almasri, E., Amin, M., Anderson, C., Baker, S., Barney, J., Bastani, B. B. A., Bercz, P., Bidair, M., Carman, T., Chang, H., Clark, C., Concha, M., Cornell, J., Dhingra, R., Doshi, A., Ebrahimi, R., Farley, B., Fermann, G., Foster, G., Fraiz, J., Fulmer, J., Gaggin, H., Goytia-Leos, D., Hahn, B., Haidar, A., Hamad, A., Hazelrigg, M., Ioachimescu, O., Johnson, B., Kabler, H., Kao, C. -K., Kazimir, M., Kouras, F., Kung, M., Lerner, R., Lopez, J., Macchiavelli, A., Mahal, S., Margolis, B., Mclaren, G., Milling, T., Mittal, M., Nadar, V., Ohaju, V., Ortel, T., Overcash, J., Parthiban, K., Pearl, R., Pineda, L., Pratt, R., Pullman, J., Quintana, O., Rajan, R., Rastogi, P., Rees, C., Rodriguez, W., Saba, F., Shammas, N., Sharma, S., Sokol, S., Stoltz, S., Subich, D., Tuck, M., Updegrove, J., Warner, A., Welch, M., Welker, J., Whitman, B., Wichman, T., Yousef, K., Yusen, R., and Zakai, N.

Subjects
Male, pulmonary embolism, Time Factors, Pyridines, Intracranial hemorrhage, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, law.invention, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, Risk Factors, Clinical Studies, Medicine, 030212 general & internal medicine, Myocardial infarction, Original Research, Ischemic stroke, Hazard ratio, Absolute risk reduction, Venous Thromboembolism, Middle Aged, Interventional Cardiology, Pulmonary embolism, Death, myocardial infarction, Treatment Outcome, Cardiovascular Diseases, Anesthesia, Acute Disease, Benzamides, Number needed to treat, Female, Cardiology and Cardiovascular Medicine, Intracranial Hemorrhages, Adult, venous thromboembolism, Hemorrhage, 03 medical and health sciences, Double-Blind Method, death, ischemic stroke, Humans, Enoxaparin, Aged, Proportional Hazards Models, Inpatients, Venous thromboembolism, business.industry, Settore MED/09 - MEDICINA INTERNA, Anticoagulants, Thrombosis, medicine.disease, Clinical trial, chemistry, Betrixaban, business, Acute Coronary Syndromes, intracranial hemorrhage, Factor Xa Inhibitors
Abstract

Background Extended‐duration betrixaban showed a significant reduction in venous thromboembolism in the APEX trial (Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study). Given the variable clinical impact of different efficacy and safety events, one approach to assess net clinical outcomes is to include only those events that are either fatal or cause irreversible harm. Methods and Results This was a post hoc analysis of the APEX trial—a multicenter, double‐blind, randomized controlled trial comparing extended‐duration betrixaban versus standard‐of‐care enoxaparin. A composite of all fatal or irreversible safety (fatal bleeding or intracranial hemorrhage) and efficacy events (cardiopulmonary death, myocardial infarction, pulmonary embolism, and ischemic stroke) was evaluated in a time‐to‐first event analysis. In patients with positive D‐dimer results, betrixaban reduced fatal or irreversible events at 35 to 42 days (4.80% versus 3.54%; hazard ratio, 0.73; absolute risk reduction, 1.26%; number needed to treat, 79 [ P =0.033]) and at study end at 77 days (6.27% versus 4.36%; hazard ratio, 0.70; absolute risk reduction, 1.91%; number needed to treat, 52 [ P =0.005]) versus enoxaparin. In all patients, betrixaban reduced fatal or irreversible events at 35 to 42 days (4.08% versus 2.90%; hazard ratio, 0.71; absolute risk reduction, 1.18%; number needed to treat, 86 [ P =0.006]) and 77 days (5.17% versus 3.64%; hazard ratio, 0.70; absolute risk reduction, 1.53%; number needed to treat, 65 [ P =0.002]). Conclusions Among hospitalized medically ill patients, extended‐duration betrixaban demonstrated an ≈30% reduction in fatal or irreversible ischemic or bleeding events compared with standard‐duration enoxaparin. A total of 65 patients would require treatment with betrixaban to prevent 1 fatal or irreversible event versus enoxaparin. Clinical Trial Registration URL : http://www.ClinicalTrials.gov . Unique identifier: NCT 01583218.

Published
2017

27. Mediterranean Symposium of rheumatology: Naples, 14–15 June, 1984

Author

Schiavetti, L., Galeazzi, M., Purpura, M., Pras, M., Zemer, D., Cabili, S., Ciocci, A., Colombo, B., Tosi, S., Govoni, E., Genacchi, G., Carcassi, U., Mela, Q., Bonomo, L., Aiuti, F., D'Amelio, R., Puigdollers-Colas, J. M., Roca-Rossellini, N., Permanyer-Barrier, J., Rovellat, M. A. Puigdollers, Georgiadis, A. E., Yazici, H., Tuzun, Y., Yurdakul, S., Pazarli, H., Ozyazgan, Y., Ozdogan, H., Serdarogu, S., Ersanli, M., Ulku, B., Muftuoglu, A., Dilsen, N., Konice, M., Aral, O., Giordano, M., Cotticelli, L., Migliaresi, S., Picillo, U., Tirri, G., Hamza, M., Ciompi, M. L., Fosella, P. V., Ammannati, P., Gremignal, G., Olivieri, I., Tassoni, S., Pecori, F., Gamici, M., Porciatt, A., Fantini, F., Valenti, F., Marin, F., Mercuriali, F., Figueirinhas, J., Silva, V., Tanakol, R., Pecar, J., Daneo, V., Modena, V., Maiocco, I., Bosio, C., De Filipi, P. G., Drosos, A. A., Moutsopoulos, H. M., Oriente, P., Scarpa, R., Pucino, A., Biondi-Oriente, C., Jacquot, P., Blanc, M., Giordano, D., Pennec, Y., Youinou, P., Mottier, D., Jouquan, J., Gentric, A., Ferec, C., Le Menn, G., Ambamelli, U., Kontomerkos, A., Karagiannidis, N., Georgiadis, A., Dantis, P., Dilsen, G., Rovetta, G., Cervini, C., Hadidi, T., Valentini, G., Chianese, U., Gualdieri, L., Maniera, A., Tirri, R., La Palombara, F., Mavridis, A. K., Serratrice, G., Schiano, A., Desnuelles, C., Pouget, J., Zoppini, A., Taccari, E., Teddori, S., Roux, H., Antipoff, G. M., Paris, D., Thivolet, J., Hermier, C., Fabiano, F., Bevilacqua, M., Ramonda, R., Lazzarin, P., Ostuni, P. A., Todesco, S., Contantopoulos, S. H., Capelli, L., Vatti, M., Fichera, G., Sany, J., Combes, B., Cosso, B., Bonneaux, M., Andary, M., Clot, J., Consoli, G., Di Mattteo, L., Wirth, W., Lonauer, G., Demptroeder, F., Sinigaglia, L., Guidi, G., Ranza, R., Marchesoni, A., Abdelkafi, M. M., Medeb, T., Kassab, M. T., Cammoun, M., Jaafoura, H., Hamza, R., Ben Lamine, B., Traballi, G., Aletti, A., Imbimbo, B., Canesi, B. A., Cutolo, M., Accardo, S., Castellani, P., Borsi, L., Cimmino, M., Zardi, L., Scagliusi, P., Fasiello, V., De Lucia, M., Loizzi, P., Pipitone, V., Ribatti, D., Contino, R., Di Pietro, F., Scarano, R., Tursi, A., Le Goff, P., Coutois, B., Lydyard, P. M., Le Poivre, B., Brousse, A., Rossi, A., Bini, M., Arcidiacono, R., Canesi, B., Casadei, G., Barberis, M., Buffrini, G. Rovetta, Nicolini, F., Zakraoui, L., Daly, L., Daouissi, N., Haddad, S., La Montagna, G., Gallo, M., Squame, G., Giordano, A., Quattrocchi, G., Molica, A., Grasso, E., Lagana, A., Sirna, R., Olivieri, J., Rizzo, G., Porciatti, A., Italia, A., Capone, M., Zorbin, L., Cherie-Ligniere, G., Marconi, A., Colombo, B., Coche, P., Riccio, A., De Marco, F., Farinaro, C., Prantera, T., Ferri, S., Villeco, A. S., Giacovazzo, M., Romiti, A., Martelletti, P., Gallo, M. F., Casale, R., Sessarego, P., Kokodoko, A., Dato, G., Cimmino, M. A., Bianchi, G., Mancinelli, S., Marazzi, M. C., Palombi, L., Concerva, P., Fiore, L., Biaccarini, V., Pana, A., Venegoni, C., Chevallard, M., Carrabba, M., Paresce, E., Anelini, M., Viara, M., Galcagno, L., Mercier, P., Fasciolo, D., Maglio, M. L., Carrara, P., Seriolo, B., Ferretti, A., Giglio, A., Vinci, M., Raciti, T., Gatto, A., DiStefano, F., Carcassi, A., Boschi, S., Campagna, S., Quattrohi, G., Musolino, C., Aliquo, E., Di Stefano, F., Crovato, F., Nazzari, G., Herne, J. P., Cledes, J., Guillodo, M. P., Le Guy, P., Bourbigot, B., Riccio, R., Farinaro, L., Scognamiglio, A., Lanteri, L., Percivalle, A., Maccagolo, P., Soave, G., Samanta, E., Zorzin, L., and Biagiotti, T.

Published
1985
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28. Oral Apixaban for the Treatment of Acute Venous Thromboembolism

Author

Agnelli, G, Buller, H, Cohen, A, Gallus, A, Raskob, G, Weitz, J, Prins, M, Brandjes, D, Kolbach, D, Limburg, M, Mac Gillavry, M, Otten, Jm, Peters, R, Roos, Y, Segers, A, Slagboom, T, Bounameaux, H, Hirsh, J, Samama, Mm, Wedel, H, Curto, M, Johnson, M, Masiukiewicz, U, Pak, R, Porcari, A, Sanders, P, Sisson, M, Sullivan, B, Thompson, J, Auerbach, J, Cesario, L, Crawford, J, Gordon, M, Noble, M, Pennington, A, Reinhold, P, Simmons, M, Urwin, K, Ceresetto, J, Mcrae, S, Pabinger, I, Pereira, Ah, Spencer, F, Wang, C, Zhang, J, Gorican, K, Husted, Se, Mottier, D, Harenberg, J, Vértes, A, Pinjala, R, Zeltser, D, Prandoni, Paolo, Sandset, M, Torbicki, A, Fijalkowska, A, Alvares, Jp, Kirienko, A, Shvarts, Y, Sala, La, Jacobson, B, Gudz, I, Ortel, T, Spyropoulos, A, Beyer Westendorf, J, Sipos, G, Bredikhin, R, Della Siega, A, Klinke, W, Lawall, H, Zwettler, U, Prasol, V, Cannon, K, Vasylyuk, S, Jin, B, Prandoni, P, Desai, S, Zaichuk, A, Katelnitskiy, I, De Pellegrin, A, Santonastaso, M, Skupyy, O, Pesant, Y, Shvalb, P, Spacek, R, Visonà, A, Alvarez Sala, L, Borja, V, Noori, E, Sereg, M, Braester, A, Falvo, N, Vöhringer, H, Laperna, L, Oliven, A, Skalicka, L, Bolster, D, Haidar, A, Schellong, S, Smith, S, Sergeev, O, Pullman, J, Torp Pedersen, C, Zimlichman, R, Elias, M, Fourie, N, Pernod, G, Panchenko, E, Pendleton, R, van Nieuwenhuizen, E, Vinereanu, D, Becattini, C, Manina, G, Leduc, J, Dunaj, M, Frost, L, Gavish, D, Jakobsen, T, Lishner, M, Morales, L, Chochola, J, Gubka, O, Holaj, R, Hussein, O, Katona, A, Sergeeva, E, Bova, C, Cepeda, J, Cohen, K, Sobkowicz, B, Grzelakowski, P, Husted, S, Lupkovics, G, Dedek, V, Liu, C, Puskas, A, Ritchie, B, Ambrosio, G, Parisi, R, Heuer, H, Livneh, A, Podpera, I, Stanbro, M, Caraco, Y, Fulmer, J, Ghirarduzzi, A, Schmidt Lucke, J, Bergmann, J, Cizek, V, Leyden, M, Stein, R, Abramov, I, Chong, B, Colan, D, Jindal, R, Liu, S, Pereira, A, Porreca, E, Salem, H, Welker, J, Yusen, R, Dhar, A, Podczeck Schweighofer, A, Shtutin, O, Vital Durand, D, Balaji, V, Correa, J, Kline, J, Runyon, M, Laszlo, Z, Martelet, M, Parakh, R, Sandset, Pm, Schmidt, J, Yeo, E, Bhagavan, N, Bura Riviere, A, Ferrer, J, Lacroix, P, Lewczuk, J, Pilger, E, Sokurenko, G, Yu, H, Nikulnikov, P, Pabinger Fasching, I, Sanchez Diaz, C, Schuller, D, Suresh, K, Lobo, S, Lyons, R, Marschang, P, Palla, A, Schulman, S, Spyropoulous, A, Fraiz, J, Gerasymov, V, Lerner, R, Llamas Esperón, G, Manenti, E, Masson, J, Moreira, R, Poy, C, Rodoman, G, Bruckner, I, Gurghean, A, Carrier, M, Freire, A, Gan, E, Gibson, K, Herold, M, Hudcovic, M, Kamath, G, Koslow, A, Meneveau, N, Roos, J, Zahn, R, Balanda, J, Bratsch, H, Dolan, S, Gould, T, Hirschl, M, Hoffmann, U, Kaatz, S, Shah, V, Kadapatti, K, Kræmmer Nielsen, H, Lahav, M, Natarajan, S, Tuxen, C, Tveit, A, Alves, C, Formiga, A, Brudevold, R, Cardozo, M, Lorch, D, Marais, H, Mismetti, P, Panico, M, Pop, C, Quist Paulsen, P, Stevens, D, Tarleton, G, Yoshida, W, Cox, M, Crispin, P, Czekalski, P, Ebrahim, I, Game, M, Ghanima, W, Harrington, D, Jackson, D, Lee, A, Matoska, P, Meade, A, Camargo, Ac, Nishinari, K, Sanchez Llamas, F, Tosetto, A, Vejby Christensen, H, Basson, M, Blombery, P, Fu, G, Jha, V, Keltai, K, Le Jeunne, C, Lodigiani, C, Ma, Y, Nagy, A, Neumeister, A, Shotan, A, Wong, T, Ying, K, Anderson, S, Brenner, B, Carnovali, M, Cerana, S, Cunha, C, Diaz Castañon, J, Graham, M, Kirenko, A, Palareti, G, Rodriguez Cintron, W, Nathanson, A, Rosenthal, S, Sanders, D, Scheinberg, P, Schjesvold, F, Torp, R, van Zyl, L, Venher, I, Xia, G, Brockmyre, A, Chen, Z, Hakki, S, Hanefield, C, Mügge, A, Janczak, D, Karpovych, D, Lancaster, G, Lavigne, C, Lugassy, G, Melaniuk, M, Moran, J, Oliver, M, Schattner, A, Staroverov, I, Timi, J, Vöhringer, F, von Bilderling, P, Warr, T, White, R, Wronski, J, Wu, C, Almeida, C, Blum, A, Bono, J, Durán, M, Erzinger, F, Fu, W, Jagadesan, R, Jurecka, W, Korban, E, Nguyen, D, Raval, M, Willms, D, Zevin, S, Zhu, H, Abdullah, I, Achkar, A, Albuquerque, L, Ali, M, Bai, C, Bloomfield, D, Chen, J, Fajardo Campos, P, Garcia Bragado, F, Kobza, I, Lindhoff Last, E, Lourenço, A, Marchena Yglesias, P, Marshall, P, Siegel, M, Mikhailova, O, Oliva, M, Pottier, P, Pruszczyk, P, Sauer, M, Baloira, A, Cromer, M, D'Angelo, A, Faucher, J, Gutowski, P, Hong, S, Lissauer, M, Lopes, A, Lopes, R, Maholtz, M, Mesquita, E, Miekus, P, Mohan, B, Ng, H, Peterson, M, Piovella, F, Siragusa, S, Srinivas, R, Tiberio, G, Van Bellen, B, Arutyunov, G, Assi, N, Baker, R, Blanc, F, Curnow, J, Fu, C, Gonzalez Porras, J, Guijarro Merino, R, Gunasingam, S, Gupta, P, Laule, M, Liu, Z, Luber, J, Serifilippi, G, Paulson, R, Shevela, A, Simonneau, G, Siu, D, Sosa Liprandi, M, Takács, J, Tay, J, Vora, K, Witkiewicz, W, Zhao, L, Aquilanti, S, Dabbagh, O, Dellas, C, Denaro, C, Doshi, A, Flippo, G, Giumelli, C, Gomez Cerezo, J, Han, D, Harris, L, Hofmann L., Jr, Kamerkar, D, Kaminski, L, Kazimir, M, Kloczko, J, Ko, Y, Koura, F, Lavender, R, Maly, J, Margolis, B, Mos, L, Sanchez Escalante, L, Solvang, A, Soroka, V, Szopinski, P, Thawani, H, Vickars, L, Yip, G, Zangroniz, P., Internal and Cardiovascular Medicine - Stroke Unit (PERUGIA - ICM-SU), Università degli Studi di Perugia (UNIPG), Department of Vascular Medicine (DVM - AMC), Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA)-University of Amsterdam [Amsterdam] (UvA), King's College Hospital (KCH), Department of Haematology (ADELAIDE - Dep Haemato), Flinders Medical Centre-Flinders University, Health Sciences Center (OKLAHOMA - HSC), University of Oklahoma (OU), Thrombosis and Atherosclerosis Research Institute (TARI), McMaster University [Hamilton, Ontario], Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), ACS - Amsterdam Cardiovascular Sciences, Vascular Medicine, APH - Amsterdam Public Health, Cardiology, ANS - Amsterdam Neuroscience, Neurology, and Other departments

Subjects
Male, MESH: Factor Xa, [SDV]Life Sciences [q-bio], Administration, Oral, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, THERAPY, MESH: Venous Thromboembolism, chemistry.chemical_compound, 0302 clinical medicine, Edoxaban, MESH: Double-Blind Method, 030212 general & internal medicine, MESH: Warfarin, MESH: Treatment Outcome, MESH: Aged, RISK, MESH: Middle Aged, General Medicine, MESH: Follow-Up Studies, Venous Thromboembolism, Middle Aged, 3. Good health, Pulmonary embolism, Treatment Outcome, MESH: Administration, Oral, Acute Disease, MESH: Acute Disease, Apixaban, Female, MESH: Hemorrhage, medicine.drug, Andexanet alfa, Adult, medicine.medical_specialty, MESH: Enoxaparin, Pyridones, PULMONARY-EMBOLISM, Hemorrhage, MESH: Anticoagulants, 03 medical and health sciences, Double-Blind Method, BINOMIAL TRIALS, Internal medicine, MESH: Pyridones, medicine, Humans, Enoxaparin, MESH: Kaplan-Meier Estimate, RIVAROXABAN, Aged, Rivaroxaban, MESH: Humans, business.industry, Warfarin, Anticoagulants, MESH: Adult, medicine.disease, Confidence interval, MESH: Male, Surgery, chemistry, Relative risk, Pyrazoles, business, MESH: Female, MESH: Pyrazoles, Factor Xa Inhibitors, Follow-Up Studies
Abstract

International audience; BACKGROUND: Apixaban, an oral factor Xa inhibitor administered in fixed doses, may simplify the treatment of venous thromboembolism. METHODS: In this randomized, double-blind study, we compared apixaban (at a dose of 10 mg twice daily for 7 days, followed by 5 mg twice daily for 6 months) with conventional therapy (subcutaneous enoxaparin, followed by warfarin) in 5395 patients with acute venous thromboembolism. The primary efficacy outcome was recurrent symptomatic venous thromboembolism or death related to venous thromboembolism. The principal safety outcomes were major bleeding alone and major bleeding plus clinically relevant nonmajor bleeding. RESULTS: The primary efficacy outcome occurred in 59 of 2609 patients (2.3%) in the apixaban group, as compared with 71 of 2635 (2.7%) in the conventional-therapy group (relative risk, 0.84; 95% confidence interval [CI], 0.60 to 1.18; difference in risk [apixaban minus conventional therapy], -0.4 percentage points; 95% CI, -1.3 to 0.4). Apixaban was noninferior to conventional therapy (P

Published
2013
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29. Apixaban for extended treatment of venous thromboembolism

Author

Agnelli, G, Buller, H, Cohen, A, Gallus, A, Raskob, G, Weitz, J, Prins, M, Brandjes, D, Kolbach, D, Limburg, M, Mac Gillavry, M, Otten, Jm, Peters, R, Roos, Y, Segers, A, Slagboom, T, Bounameaux, H, Hirsh, J, Samama, Mm, Wedel, H, Curto, M, Johnson, M, Masiukiewicz, U, Pak, R, Porcari, A, Sanders, P, Sisson, M, Sullivan, B, Thompson, J, Auerbach, J, Cesario, L, Gamero, M, Gordon, M, Griffiths, A, Noble, M, Ott, J, Pennington, A, Peffer, A, Reinhold, P, Simmons, M, Urwin, K, Ceresetto, J, Mcrae, S, Pabinger, I, Pereira, Ah, Spencer, F, Gorican, K, Husted, Se, Mottier, D, Harenberg, J, Pinjala, R, Zeltser, D, Imberti, D, Sandset, M, Torbicki, A, Fijalkowska, A, Albino, Jp, Kirienko, A, Shvarts, Y, Monreal, M, Jacobson, B, Dolan, G, Gudz, I, Ortel, T, Spyropoulos, A, Skupyy, O, Beryer Westendorf, J, De Pellegrin, A, Prasol, V, Schellong, S, Falvo, N, Abramov, I, Cizek, V, Husted, S, Desai, S, Barillari, G, Sergeev, O, Chetter, I, Inbal, A, Mccollum, C, Shvalb, P, Torp Pedersen, C, Vasylyuk, S, Kraemmer Nielsen, H, Pernod, G, Schmidt, J, Bova, C, Gerasymov, V, Pabinger Fasching, I, Skalicka, L, Zaichuk, A, Achkar, A, Bremmelgaard, A, Chochola, J, Gould, T, Khalafallah, A, Jakobsen, T, Rose, P, Zhukov, B, Dedek, V, Mirete Ferrer, J, Pesant, Y, Repin, A, Salem, H, Solis Morales, L, Spacek, R, Cannon, K, Grzelakowski, P, Jindal, R, Pereira, A, Zidkova, E, Ambrosio, G, Cardozo, M, Dunaj, M, Gavish, D, Ghanima, W, Leduc, Jj, Mismetti, P, Panico, M, Porreca, E, Riera, A, Bareford, D, Chong, B, Dvoryashina, I, Gómez Cerezo, J, Kobza, I, Nielsen, T, Pendleton, R, Pullman, J, Schiffman, G, Stanbro, M, Zwettler, U, Aquilanti, S, Bratsch, H, Cohen, K, Elias, D, Gan, E, Holaj, R, Klinke, W, Liu, Hs, Sandset, Pm, van Nieuwenhuizen, E, Álvarez Sala LA, Basson, M, Braester, A, Bura Riviere, A, Calvo Vargas, C, Correa, J, Elias, M, Frost, L, Landolfi, R, Marschang, P, Moreira, R, Natarajan, S, Pottier, P, Tosetto, A, Tuxen, C, Vöhringer, Hf, Alexander, A, Barbarash, O, Fajardo Campos, P, Graham, M, Gubka, O, Hudcovic, M, Hussein, O, Jackson, D, Katelnitskiy, I, Lawall, H, Palareti, G, Poggio, R, Roos, J, Simonneau, G, Smith, Sw, Szopinski, P, Zimlichman, R, Bridgers, D, Colan, D, Czekalski, P, De Jong, D, Fortinez, Jt, Garcia Bragado, F, Harrington, D, Izbicki, G, Kadr, H, Koslow, A, Loftus, I, Marais, H, Neumeister, A, Oliven, A, Palla, A, Pop, C, Prandoni, Paolo, Puskas, A, Sanchez Llamas, F, Shotan, A, Singh, P, Tveit, A, Baker, R, Borja, V, Brenner, B, Brown, H, Cha, Tj, Cohen, Y, D'Angelo, A, Dhar, A, Friis, E, Hueur, H, Jiménez Rodríguez Madridejos, R, Karl, J, Karrasch, J, Lishner, M, Manenti, E, Meneveau, N, Nguyen, D, Sanchez Escalante, L, Santoscoy Ibarra, J, Sokurenko, G, Staroverov, I, Stein, R, Abdullah, I, Alcocer Gamba, M, Balanda, J, Bruckner, I, Calabuig Alborch, J, Caraco, Y, Comerota, A, Cromer, M, de Araujo Filho, J, De los Rios Ibarra, M, Diaz Castañon, J, Doshi, A, Ebrahim, I, Fessel, Wj, Fletcher, E, Fourie, N, Fu, C, Gutowski, P, Haddad, G, Hoffman, U, Jardula, M, Kvasnicka, T, Lewczuk, J, Leyden, M, Livneh, A, Lodigiani, C, Lovell, C, Miekus, P, Paloma, Mj, Parakh, R, Raval, M, Schmidt Lucke, J, Shtutin, O, Soroka, V, Stevens, D, Sulik, P, Tay, Jc, Vejby Christensen, H, Vinereanu, D, Baghestanian, M, Bono, J, Cerana, S, Freire, A, Gibson, K, Giumelli, C, Iastrebner, C, Karpenko, A, Kelly, A, Lacroix, P, Lafata, J, Lobo, S, Macik, Bg, Marchena Yglesias, P, Nishinari, K, Podczeck Schweighofer, A, Raby, K, Sirpal, S, Solymoss, S, van Zyl, L, Vargas Núñez JA, von Bilderling, P, Warr, T, Wronski, J, Wurster, M, Albino, Ja, Albuquerque, L, Averill, F, Baek, Sh, Bello, F, Bergoeing, M, Blanc, Fx, Bloomberg, R, Bolster, D, Brockmyre, A, Calimano, C, Checketts, D, Cieplinski, W, Chervu, A, Collado, F, Denaro, C, Gaciong, Z, Game, M, Iskander, A, Kaatz, S, Kim, Di, Koura, F, Laguna, F, Lanas Zanetti, F, Lindhoff Last, E, Melaniuk, M, Meade, A, Murphy, T, Ng, Hj, Páramo Fernández JA, Patil, C, Piovella, F, Prisco, D, Pruszczyk, P, Reimers, G, Rivera, E, Rodriguez Cintron, W, Rosenthal, S, Salbach, P, Salvador, D, Schuller, D, Siragusa, S, Staniszewski, R, Torp, R, Vora, K, Yip, G, Alfieri, A, Belaji, V, Bhagavan, N, Carnovali, M, Cobos Segarra, J, Di Todaro, F, Dowell, A, Corder, C, Crispin, P, Cuadrado, J, Flippo, G, Fraiz, J, Guillaumon, A, Gvora, T, Hakki, S, Harris, L, Ison, R, Htun, Pt, Jasani, R, Kates, M, Kaminski, L, Kamerkar, D, Kroger, K, Laperna, L, Leiva, J, Luber, J, Mccann, A, Mckenzie, W, Menna Barreto, S, Moran, J, Nikulnikov, P, Paliwal, Y, Patel, M, Pilger, E, Renwick, W, Shevela, A, Starosiliz, D, Stringam, S, To, R, Updegrove, J, Van Bellen, B, Waintrub, M, White, J, Yeo, E, Zangroniz, P, Zeltser, D., ACS - Amsterdam Cardiovascular Sciences, Vascular Medicine, APH - Amsterdam Public Health, Cardiology, ANS - Amsterdam Neuroscience, Neurology, Department of Vascular Medicine (DVM - AMC), Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA)-University of Amsterdam [Amsterdam] (UvA), Thrombosis and Atherosclerosis Research Institute (TARI), McMaster University [Hamilton, Ontario], Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), and Université de Brest (UBO)-Université de Brest (UBO)

Subjects
Male, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Placebo group, DISEASE, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Recurrence, Fibrinolytic agents, 030212 general & internal medicine, IDRAPARINUX, Administration of drugs, Follow up studies, food and beverages, General Medicine, Venous Thromboembolism, Middle Aged, 3. Good health, Intention to Treat Analysis, Treatment Outcome, Treatment dose, Anesthesia, Creatinine, Factor Xa, Fibrinolítics, Apixaban, Female, Administració de medicaments, Major bleeding, medicine.drug, ARTERIAL CARDIOVASCULAR EVENTS, INTENSITY WARFARIN THERAPY, PULMONARY-EMBOLISM, LONG-TERM, PREVENTION, Adult, Pyridones, Hemorrhage, 03 medical and health sciences, Double-Blind Method, Fibrinolytic Agents, Thromboembolism, medicine, Humans, Tromboembolisme, Aged, Intention-to-treat analysis, business.industry, fungi, Pyrazoles, business, Venous thromboembolism, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Factor Xa Inhibitors, Follow-Up Studies
Abstract

International audience; Background Apixaban, an oral factor Xa inhibitor that can be administered in a simple, fixed-dose regimen, may be an option for the extended treatment of venous thromboembolism. Methods In this randomized, double-blind study, we compared two doses of apixaban (2.5 mg and 5 mg, twice daily) with placebo in patients with venous thromboembolism who had completed 6 to 12 months of anticoagulation therapy and for whom there was clinical equipoise regarding the continuation or cessation of anticoagulation therapy. The study drugs were administered for 12 months. Results A total of 2486 patients underwent randomization, of whom 2482 were included in the intention-to-treat analyses. Symptomatic recurrent venous thromboembolism or death from venous thromboembolism occurred in 73 of the 829 patients (8.8%) who were receiving placebo, as compared with 14 of the 840 patients (1.7%) who were receiving 2.5 mg of apixaban (a difference of 7.2 percentage points; 95% confidence interval [CI], 5.0 to 9.3) and 14 of the 813 patients (1.7%) who were receiving 5 mg of apixaban (a difference of 7.0 percentage points; 95% CI, 4.9 to 9.1) (P

Published
2012
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30. Enoxaparin followed by once-weekly idrabiotaparinux versus enoxaparin plus warfarin for patients with acute symptomatic pulmonary embolism: a randomised, double-blind, double-dummy, non-inferiority trial

Author

Büller, Hr, Gallus, As, Prins, Mh, Raskob, G, Decousus, H, Charbonnier, B, Leizorovicz, A, Laporte, S, Quenet, S, Brandjes, Dp, Middeldorp, S, Blüguermann, J, Amuchastegui, L, Ahuad Guerrero, R, Oberti, P, Alvarez, C, Cassettari, A, Santos, D, Macin, S, Santini, F, Ward, C, Coughlin, P, Salem, H, Gan, E, Leyden, M, Prosser, I, Crispin, P, Carroll, P, Gallus, A, Mcrae, S, Waites, J, Pilger, E, Koppensteiner, R, Kyrle, P, Schinko, H, Mrochek, A, Mitkovskaya, N, Prystrom, A, Motte, S, Ninane, V, Delcroix, M, Hainaut, P, Schneider, E, Saraiva, J, Maia, L, Barreto, S, Fernandes Manenti, E, Araujo, G, Dutra, O, Fiss, E, Moreira, R, Yankov, K, Nenkova, S, Ivanov, Y, Kostov, V, Bhargava, R, Chan, Y, Miron, Mj, Cusson, J, Ugarte, S, Morales, A, Andresen, M, Lanas, F, Arriagada, G, Mendoza, Jj, Zuñiga, C, Sepulveda, P, Wang, C, Liu, Z, Yuan, Y, Ma, Z, Fang, B, Liu, J, Bai, C, Wu, H, Yang, L, Ying, K, Kang, J, Li, Q, Cheng, Z, Zhang, J, Wang, H, Xie, C, Xia, G, Du, Y, Wu, Q, Zhou, X, Chen, L, Yi, Q, Wu, C, Hao, Q, Liu, S, Xiong, S, Jiang, S, Zhao, L, Xiao, Q, Qin, Z, Zhou, J, Dennis, R, Miserque, N, Igueredo, M, Londoño, D, Hildebrando, J, Granados, M, Buitrago, R, Solano, Mh, Pacheco Alvis PM, Botero, R, Saenz, O, Bergovec, M, Padovan, M, Vucic, N, Samarzija, M, Chlumsky, J, Spacek, R, Klimsa, Z, Gregor, P, Povolny, J, Podpera, I, Holm, F, Lang, P, Matoska, P, Sabl, P, Spinar, J, Spac, J, Husted, S, Avnstrom, S, Rasmussen, S, Christensen, A, Guindy, R, Hassanein, M, Paumets, M, Meriste, S, Ferrari, E, Achkar, A, Azarian, R, Meneveau, N, Lorut, C, Mouallem, J, Crestani, B, Proton, A, Salmeron, S, Lerousseau, L, Mottier, D, Wahl, D, Siafakas, N, Papadimitriou, D, Katis, K, Katsaris, G, Gaga, A, Damianos, A, Tipparaju, S, Kalkunte, S, Vidhut, J, Kalashetti, S, Mehta, P, Talwar, D, Ramanathan, R, Mishra, R, Zeltzer, D, Lahav, M, Brenner, B, Caraco, Y, Elias, M, Piovella, F, Barone, M, Poggio, R, Palla, A, Ghirarduzzi, A, Pini, M, Lodigiani, C, Prandoni, Paolo, Agnelli, G, Imberti, D, Scannapieco, G, Salvi, A, Bautista, E, Diaz, J, Mercado, R, Ranero, A, Rodriguez, D, Jerjes, C, Villeda Espinoza, E, Van Der Meer, J, Ijfering, W, Van Marwijk Kooy, M, Boersma, W, Van Leendert, R, Kroon, C, Dullemond Westland, A, Viergever, P, Kuipers, A, Grootenboers, M, Creemers, J, Pieters, W, De Munck, D, Timmer, H, Jackson, S, Sandset, P, Meyer, P, Kristiansen, T, Portugal, J, Paz, E, Salazar, D, Chavez, W, Castillo, L, De Guia, T, Lenora, F, Tomkowski, W, Kloczko, J, Rybak, Z, Gaciong, Z, Sobkowicz, B, Pruszczyk, P, Nizankowski, R, Mirek Bryniarska, E, Kukla, P, Reis, A, França, A, Cortez, M, Sa, J, Santos, F, Marques, Ma, Gordeev, I, Gendlin, G, Yablonsky, P, Sokurenko, G, Soroka, V, Lusov, V, Markov, V, Shvats, Y, Katerlnitskiy, I, Lapin, O, Lyamina, N, Subbotin, Y, Kim, I, Zilber, E, Kchaisheva, L, Poliacik, P, Macek, V, Pretorius, Jp, Abdullah, I, Basson, M, Bollinger, C, Breedt, J, Gani, M, Jansen, J, Le Roux, G, Nortje, H, Van Der Linder, M, Van Zyl, L, Viljoen, J, Bruning, A, Pujol Farriols, R, Raguer, E, Nuffal, D, Sanchez Rodriguez, A, Eriksson, H, Almgren, T, Carlsson, A, Elf, J, Olsson, Cg, Aagesen, J, Savas, I, Sahin, A, Erdogan, Y, Ozhan, M, Ongen, G, Celikel, T, Turker, H, Arseven, O, Tuncay, E, Ozacar, R, Gudz, I, Nykonenko, O, Skupyy, O, Kovalskyy, I, Prasol, V, Cohen, A, Rodriguez Cintron, W, Gurka, D, Bradley, J, Oliver, G, Spyropoulos, A, Lerner, R, Fulmer, J, Lu, Np, Wright, P, Han, D, Servi, R, Nadar, V, Quaranta, A, Gehring, J, Ginsberg, R, Jacobson, A, Colan, D, Vanway, C, Gurza, E, Braslow, B, Shorr, A, Rehm, J, Martin, J, Sellers, M, Concha, M, Gordon, I, Pullman, J, Moran, J, Welker, J, Panzarella, P, Mullins, M, Willms, D, Mcgrew, F, Turki, M, Menajovsky, L., Epidemiologie, MUMC+: KIO Kemta (9), RS: CAPHRI School for Public Health and Primary Care, Amsterdam Cardiovascular Sciences, Vascular Medicine, Department of Vascular Medicine (DVM - AMC), Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA)-University of Amsterdam [Amsterdam] (UvA), SA Pathology at Flinders Medical Center (ASG), Flinders University, Department of Epidemiology (MHP), Maastricht University [Maastricht], College of Public Health (CPH), University of Oklahoma (OU), Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), and Université de Brest (UBO)-Université de Brest (UBO)

Subjects
Male, MESH: Pulmonary Embolism, Oligosaccharides, MESH: Factor X, 030204 cardiovascular system & hematology, MESH: Intention to Treat Analysis, MESH: Aged, 80 and over, 0302 clinical medicine, MESH: Double-Blind Method, 030212 general & internal medicine, MESH: Warfarin, Aged, 80 and over, MESH: Aged, education.field_of_study, Idrabiotaparinux, MESH: Middle Aged, General Medicine, Heparin, Middle Aged, Intention to Treat Analysis, 3. Good health, Pulmonary embolism, Acute Disease, MESH: Acute Disease, Drug Therapy, Combination, Female, medicine.drug, Adult, medicine.medical_specialty, MESH: Enoxaparin, Adolescent, Population, Biotin, MESH: Anticoagulants, Double blind, 03 medical and health sciences, Double-Blind Method, Internal medicine, MESH: Biotin, medicine, Humans, Enoxaparin, education, Aged, MESH: Adolescent, MESH: Humans, Intention-to-treat analysis, business.industry, Warfarin, Anticoagulants, MESH: Adult, Odds ratio, medicine.disease, MESH: Male, Surgery, MESH: Drug Therapy, Combination, Factor X, Pulmonary Embolism, business, MESH: Female, MESH: Oligosaccharides, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

International audience; BACKGROUND: Treatment of pulmonary embolism with low-molecular-weight heparin and vitamin K antagonists, such as warfarin, is not ideal. We aimed to assess non-inferiority of idrabiotaparinux, a reversible longlasting indirect inhibitor of activated factor X, to warfarin in patients with acute symptomatic pulmonary embolism. METHODS: In our randomised, double-blind, double-dummy, non-inferiority trial, we enrolled adults with objectively documented acute symptomatic pulmonary embolism attending 291 centres in 37 countries. We excluded patients who were pregnant, had active bleeding, kidney failure, or malignant hypertension, or were at high risk of death, bleeding, or adverse reactions to study drugs. We randomly allocated patients to receive 5-10 days' enoxaparin 1*0 mg/kg twice daily followed by subcutaneous idrabiotaparinux (starting dose 3*0 mg) or adjusted-dose warfarin (target international normalised ratio 2*0-3*0); regimens lasted 3 months or 6 months dependent on clinical presentation. Block randomisation was done with a central interactive computerised system, stratified by study centre and intended treatment duration. The primary efficacy outcome was recurrent venous thromboembolism at 99 days after randomisation. We estimated the odds ratio and 95% CI with a Mantel-Haenzsel χ(2) analysis (non-inferiority margin 2*0) in the intention-to-treat population. The main safety outcome was clinically relevant bleeding (major or non-major) in all patients at day 99. This study is registered with ClinicalTrials.gov, number NCT00345618. FINDINGS: Between Aug 1, 2006, and Jan 31, 2010, we enrolled 3202 patients aged 18-96 years. 34 (2%) of 1599 patients randomly allocated to receive enoxaparin-idrabiotaparinux and 43 (3%) of 1603 patients randomly allocated to receive enoxaparin-warfarin had recurrent venous thromboembolism (odds ratio 0*79, 95% CI 0*50-1*25; p(non-inferiority)=0*0001). 72 (5%) of 1599 patients in the enoxaparin-idrabiotaparinux group and 106 (7%) of 1603 patients in the enoxaparin-warfarin group had clinically relevant bleeding (0*67, 0*49-0*91; p(superiority)=0*0098). We noted similar differences in outcomes in those patients treated to 6 months. INTERPRETATION: Idrabiotaparinux could provide an attractive alternative to warfarin for the long-term treatment of pulmonary embolism, and seems to be associated with reduced bleeding. FUNDING: Sanofi-Aventis (Paris, France).

Published
2012
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31. Oral Rivaroxaban for the Treatment of Symptomatic Pulmonary Embolism

Author

Agnelli, G, Berkowitz, S, Bounameaux, H, Büller, Hr, Cohen, A, Gallus, A, Lensing, Aw, Misselwitz, F, Haskell, L, Prins, Mh, Raskob, G, Schellong, S, Bauersachs, R, van Bellen, B, Boda, Z, Borris, L, Brenner, B, Brighton, T, Chlumsky, J, Davidson, B, Decousus, H, Eriksson, H, Jacobson, B, Kakkar, A, Kwong, Yl, Lee, Lh, Meijer, K, van der Meer, J, Minar, E, Monreal, M, Piovella, F, Sandset, Pm, Smith, M, Tomkowski, W, Verhamme, P, Wang, Y, Wells, P, Brandjes, D, Mac Gillavry, M, Otten, Hm, Carlsson, A, Laporte, S, Schulman, S, Gent, M, Turpie, A, Martinelli, I, Segers, A, Muhlhofer, E, Tewes, M, Trajanovic, M, Muller, K, Kim, C, Gebel, M, Benson, A, Pap, Af, Godrie, J, Horvat Broecker, A, Spadari, G, Peters Wulf, C, Roig, J, Baker, R, Bianchi, A, Blombery, P, Campbell, P, Carroll, P, Geraghty, R, Chong, B, Ramanathan, S, Archis, C, Coughlin, P, Salem, H, Crispin, P, Dean, M, Soni, R, Denaro, C, Kubler, P, Coghlan, D, Gan, Te, Tran, H, Coleman, C, Jackson, D, Khalafallah, A, Leahy, M, Leyden, M, Leyden, D, Sturtz, C, Mccann, A, Gibbs, H, Mcrae, S, Richards, B, Ward, C, Curnow, J, Baghestanian, M, Erdogmus, B, Samaha, E, Nikoupayan Mofrad, M, Hirschl, M, Sturm, W, Kirchmair, R, Marschang, P, Drexel, H, Mathies, R, Pilger, E, Brodmann, M, Weltermann, A, Buche, M, Demelenne, J, Gustin, M, Hainaut, P, Pothen, L, de Leersnyder, J, Motte, S, Schroë, H, Sprynger, M, Peerlinck, K, Delcroix, M, Vermassen, F, Verstraeten, P, Smet, V, Vossaert, R, Panico, M, Costa, C, Blondal, J, Kovacs, M, Rodger, M, Carrier, M, Wong, T, Bi, J, Chen, Z, Chen, R, Jing, Zc, He, J, Liu, C, Liu, S, Long, S, Ma, Y, Shao, Y, Wang, C, Yang, Yh, Xie, C, Xu, J, Ying, K, Zhihong, L, Hola, D, Jirat, S, Vitovec, M, Kovářová, K, Gilík, J, Dosál, J, Mandakova, E, Matoška, P, Podpera, I, Podperova, M, Spacek, R, Urbanova, R, Tuxen, C, Sukles, K, Pietila, K, Vesanen, M, Achkar, A, Agraou, B, Aquilanti, S, Rifaï, A, Berremili, T, Brisot, D, Brousse, C, Tarodo, P, Bura, A, Amid Lacombe, C, Malloizel, J, Boulon, C, Alavoine, L, Crestani, B, Mismetti, P, Buchmuller, A, Accassat, S, Elias, A, Elias, M, Emmerich, J, Ferrari, E, Guérin, T, Beaka, P, Lacroix, P, Szwebel, Ta, Benhamou, Y, de Maistre, E, Falvo, N, Mahe, I, Meneveau, N, Schiele, F, Meyer, G, Sanchez, O, Planquette, B, Mottier, D, Le Moigne, E, Couturaud, F, Parent, F, Pernod, G, Imbert, B, Elkouri, D, Dary, M, Queguiner, A, Quere, I, Galanaud, Jp, Roy, Pm, de Boisjolly Bonnefoi JM, Schmidt, J, Breuil, N, Heuser, S, Sevestre, Ma, Simoneau, G, Bergmann, Jf, Stephan, D, Trinh Duc, A, Gaillardou, A, Grange, C, Fassier, T, Wahl, D, Baron Von Bilderling, P, Kuhlencordt, P, Beyer Westendorf, J, Halbritter, K, Werth, S, Diehm, C, Lawall, H, Eifrig, B, Espinola Klein, C, Weisser, G, Giannitsis, E, Haering, Hu, Hasslacher, C, Herrmann, T, Hoffmann, U, Czihal, M, Horacek, T, Ibe, M, Bauer, A, Kieback, A, Landgraf, H, Lindhoff Last, E, Malyar, N, Petermann, W, Potratz, J, Ranft, J, Röcken, M, Pomper, L, Frommhold, R, Schwaiblmair, M, Berghaus, T, Taute, B, Lau, Yk, Tse, E, Olah, Z, Farkas, K, Kolossváry, E, Gurzó, M, Kis, E, Kovács, A, Landi, A, Lupkovics, G, Pecsvarady, Z, Riba, M, Sipos, G, Parakh, R, Sembiring, R, Barton, J, Goldstein, L, Gavish, D, Hoffman, R, Hussein, O, Inbal, A, Lishner, M, Elis, A, Lugassy, G, Varon, D, Zeltser, D, Rogowski, O, Steinvil, A, Zisman, D, Ageno, W, Ambrosio, G, Cattaneo, M, D'Angelo, A, Ghirarduzzi, A, Lotti, M, Pierfranceschi, Mg, Lodigiani, C, Palareti, G, Barone, M, Beltrametti, C, Porreca, E, Prandoni, Paolo, Spiezia, L, Quintavalla, R, Cho, Wh, Ha, Jw, Kim, Hs, Park, K, Sime, I, Miliauskas, S, Petrauskiene, R, Sathar, J, Beeker, A, Ten Cate, H, De Groot, M, Kamphuisen, P, Douma, R, Kooy, Mv, Coenen, J, Mäkelburg, A, Knol, M, Tichelaar, V, Harper, P, Knottenbelt, E, Ockelford, P, Young, L, Royle, G, Simpson, D, Chunilal, S, Ghanima, W, Foyn, S, Tveit, A, Abola, Mt, Adamiec, R, Gorski, P, Kloczko, J, Lewczuk, J, Nowak, M, Musial, J, Wronski, J, Ng, Hj, Adler, D, Becker, Jh, Ellis, G, Isaacs, R, Bloy, B, Allie, R, Eckstein, F, van Rensburg JH, Schmidt, S, Siebert, H, Zyl, L, Carrera, M, Del Campo, F, Diego, I, Garcia Bragado, F, Jiménez, D, Sánchez Álvarez, J, Redondo, M, Roman Sanchez, P, Villalta, J, Villegas Scivetti, M, Jonson, T, Tygesen, H, Lapidus, L, Ottosson, E, Själander, A, Asmis, L, Banyai, M, Heidemann, M, Baumgartner, I, Righini, M, Frank, U, Hayoz, D, Periard, D, Chang, Wt, Chiu, K, Wang, Ky, Weng, Zc, Angchaisuksiri, P, Pothirat, C, Rojnuckarin, P, Solis, J, Hunt, B, Luckit, J, Albrecht, C, Banish, D, Feinbloom, D, Botnick, W, Chen, D, Dexter, J, Ettinger, N, Gleeson, J, Jaffer, A, Joseph, S, Kennedy, M, Krell, K, Lavender, R, Lyons, R, Moll, S, Nadar, V, Darrow, K, Hardman, V, Rathbun, S, Rehm, J, Rodriguez Cintron, W, Stevens, K, Wright, P, Ramaswamy, M., ACS - Amsterdam Cardiovascular Sciences, Vascular Medicine, Other departments, Epidemiologie, MUMC+: KIO Kemta (9), RS: CAPHRI School for Public Health and Primary Care, Department of Vascular Medicine (DVM - AMC), Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA)-University of Amsterdam [Amsterdam] (UvA), Department of Epidemiology (MHP), Maastricht University [Maastricht], Groupe de recherche sur la thrombose (GRT (EA 3065)), Université Jean Monnet [Saint-Étienne] (UJM), Service d'angiologie et d'hémostase (MR), Hôpital Universitaire de Genève, Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Centre d'Investigation Clinique (CIC - Brest), and Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
MESH: Pulmonary Embolism, Male, Vitamin K, Administration, Oral, Pulmonary Embolism/drug therapy/mortality, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, chemistry.chemical_compound, 0302 clinical medicine, Rivaroxaban, Edoxaban, Recurrence, Hemorrhage/chemically induced, 030212 general & internal medicine, Vitamin K/antagonists & inhibitors, Enoxaparin/adverse effects/therapeutic use, MESH: Treatment Outcome, MESH: Aged, ddc:616, MESH: Middle Aged, Hazard ratio, General Medicine, MESH: Follow-Up Studies, Vitamin K antagonist, MESH: Thiophenes, Middle Aged, Thrombosis, Morpholines/adverse effects/therapeutic use, 3. Good health, Pulmonary embolism, MESH: International Normalized Ratio, Treatment Outcome, Anesthesia, MESH: Administration, Oral, Administration, Combination, Apixaban, Drug Therapy, Combination, Female, MESH: Hemorrhage, medicine.drug, Oral, MESH: Enoxaparin, medicine.drug_class, Morpholines, Anticoagulants/adverse effects/therapeutic use, MESH: Morpholines, Hemorrhage, Thiophenes, MESH: Anticoagulants, 03 medical and health sciences, Drug Therapy, medicine, Humans, International Normalized Ratio, Enoxaparin, MESH: Kaplan-Meier Estimate, Aged, MESH: Humans, business.industry, MESH: Vitamin K, Anticoagulants, medicine.disease, MESH: Male, MESH: Recurrence, Regimen, MESH: Drug Therapy, Combination, chemistry, Thiophenes/adverse effects/therapeutic use, business, Pulmonary Embolism, MESH: Female, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Follow-Up Studies
Abstract

International audience; BACKGROUND: A fixed-dose regimen of rivaroxaban, an oral factor Xa inhibitor, has been shown to be as effective as standard anticoagulant therapy for the treatment of deep-vein thrombosis, without the need for laboratory monitoring. This approach may also simplify the treatment of pulmonary embolism. METHODS: In a randomized, open-label, event-driven, noninferiority trial involving 4832 patients who had acute symptomatic pulmonary embolism with or without deep-vein thrombosis, we compared rivaroxaban (15 mg twice daily for 3 weeks, followed by 20 mg once daily) with standard therapy with enoxaparin followed by an adjusted-dose vitamin K antagonist for 3, 6, or 12 months. The primary efficacy outcome was symptomatic recurrent venous thromboembolism. The principal safety outcome was major or clinically relevant nonmajor bleeding. RESULTS: Rivaroxaban was noninferior to standard therapy (noninferiority margin, 2.0; P=0.003) for the primary efficacy outcome, with 50 events in the rivaroxaban group (2.1%) versus 44 events in the standard-therapy group (1.8%) (hazard ratio, 1.12; 95% confidence interval [CI], 0.75 to 1.68). The principal safety outcome occurred in 10.3% of patients in the rivaroxaban group and 11.4% of those in the standard-therapy group (hazard ratio, 0.90; 95% CI, 0.76 to 1.07; P=0.23). Major bleeding was observed in 26 patients (1.1%) in the rivaroxaban group and 52 patients (2.2%) in the standard-therapy group (hazard ratio, 0.49; 95% CI, 0.31 to 0.79; P=0.003). Rates of other adverse events were similar in the two groups. CONCLUSIONS: A fixed-dose regimen of rivaroxaban alone was noninferior to standard therapy for the initial and long-term treatment of pulmonary embolism and had a potentially improved benefit-risk profile. (Funded by Bayer HealthCare and Janssen Pharmaceuticals; EINSTEIN-PE ClinicalTrials.gov number, NCT00439777.).

Published
2012
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32. Apixaban versus Enoxaparin for Thromboprophylaxis in Medically Ill Patients

Author

Goldhaber, Sz, Leizorovicz, A, Kakkar, A, Haas, Sk, Merli, G, Weitz, Ji, Ceresetto, Jm, Kyrle, P, Gallus, A, Cools, F, Saraiva, J, Faucher, Jp, Chlumsky, J, Husted, S, Emmerich, J, Bauersachs, R, Zeltser, D, Prandoni, Paolo, Ghiraduzzi, A, Leiva, J, Sparby, Ja, Torbiki, A, Kobalava, Z, Jacobson, B, Suarez, C, Fu, M, Savas, I, Parkhomenko, A, Ansell, J, Landis, Jr, Elliott, Cg, Borris, Lc, Samama, Mm, Pinede, L, Becker, F, Coppere, B, Nony, P, Merah, A, Alves, M, Boulet, H, Loppinet, A, Nicol, C, Ohanessian, L, Roncato, C, Knabb, Rm, Liaw, D, Smith, K, Hess, T, Rossi, L, Chen, D, Doan, C, Doran, J, Matheis, E, Ballard, M, Tsarova, O, Levenstein, S, Tvedegaard, M, Akkal, Z, Jure, H, Mercado, Da, Zangroniz, P, Constantino, M, Bello, F, Giumelli, C, de Sagastizabal, D, Risso Patron, F, Ceresetto, J, Dran, R, Vita, N, Baratta, S, Ahuad Guerrero, R, Penchasky, D, Rubinfeld, A, Layden, M, Karrasch, J, Coughlin, P, Peters, M, Gibbs, H, Ward, Ch, Hahn, U, Pilger, E, Minar, E, El Allaf, D, Marechal, P, Motte, S, Verhamme, P, Wollaert, B, Duck, L, Freire, A, Piegas, L, Jorge, Jm, Guimaraes, H, Oliveira, M, Blacher, C, Leães, P, Toniolo, J, Okoshi, M, Rosa, Dd, Cunha, C, Lobo, S, Leader, R, Dhar, A, Tarabain, O, Miron, M, Brossoit, R, Kahn, S, Kassis, J, Douketis, J, Spencer, F, Faucher, J, Alarcon, Ma, Gutierrez Valenzuela, F, Bisbal Malig, C, Vejar, M, Jaramillo, N, Saaibi, D, Londono, D, Kolman, P, Reiterer, P, Ballek, L, Spacek, R, Soucek, M, Patek, F, Vitovec, M, Kovarova, K, Ceska, R, Podpera, I, Faber, J, Oestergaard, L, Vejby Christensen, H, Frost, L, Rasmussen, Sl, Tuxen, C, Ingerslev, J, Knudsen, T, Torp Pedersen, C, Pedersen, C, Nielsen, H, Mottier, D, Simoneau, G, Leduc, J, Lorcerie, B, Paleiron, N, Proust, A, Conri, C, Pernod, G, Mismetti, P, Achkar, A, Maignan, M, Harenberg, J, Beyer, J, Horacek, T, Lawall, H, Hecker, U, Hammerstingl, C, Weil, J, Fischer, D, Brachmann, J, Klepzig, H, Cheng, G, Soltesz, P, Schnabel, R, Futo, L, Jobbagy, L, Singh, P, Talwar, D, Bhadade, R, Bharani, A, Krishnamurthy, S, Goyal, A, Mehta, P, Samiuddin, M, D'Souza, G, Sinha, S, Sathe, P, Sethuraman, S, Jaganmani, S, Sundaram, P, Saxena, A, Mehta, M, Omar, A, Rajkumar, J, Jog, S, Kumar, S, Hayek, T, Hussein, O, Lahav, M, Efrati, S, Elias, M, Grossman, E, Lugassy, G, Porath, A, Porreca, E, Prandoni, P, Tosetto, A, Imberti, D, Pierfranceschi, G, Ghirarduzzi, A, Scannapieco, G, Testa, S, Ling, P, Yusoff, K, Yusof, Z, Lopez Rosas, E, Hernandez, I, Nanez Terreros, H, Flota, L, Campos, E, Alcocer, M, Viergever, P, Sparby, J, Cotrina, R, Salas, M, Pamo, O, Fajardo, L, Horna, M, Ulloa, V, Toce, L, Moncada, Z, Salazar, O, Habaluyas, R, Collado, F, Edmilao, M, Abola, T, Sevilla, R, Torbicki, A, Tracz, W, Kasprzak, J, Jastrzebski, D, Psuja, P, Hiczkiewicz, J, Piepiorka, M, Pulkowski, G, Tyszkiewicz, I, Kuc, K, Gordeev, I, Boyarkin, M, Privalov, D, Abrosimov, V, Reshetko, O, Goloshchekin, B, Vishnevsky, A, Boldueva, S, Kostenko, V, Mkrtchian, V, Chernichka, I, Belenkov, Y, Rodoman, G, Andreev, D, Shvarts, Y, Aleksandrov, O, Zadionchenko, V, Klochkov, O, Tay, J, Jagadesan, R, Basson, M, Siebert, R, Viljoen, J, Gray, T, Abdool Gaffar, M, Suh, G, In, K, Choi, D, Kim, S, Baek, S, Chung, H, Shin, J, Alvarez Sala, L, Cepeda, J, Ferrer, M, Mallibovsky, L, Garcia Morillo, J, Villalta, J, Gomez Cerezo, J, Capitán, F, Gonzalez Garrido, F, Guijarro, C, Jimenez, D, Richart, C, Elf, J, Ueng, K, Huang, T, Karan, A, Erten, N, Abrahamovych, O, Chopey, I, Gavrysiuk, V, Kraiz, I, Karpenko, A, Volkov, V, Denesyuk, V, Kharchenko, N, Tseluyko, V, Batushkin, V, Sushko, V, Yagensky, A, Ignatenko, G, Dziublyk, O, Cohen, A, Bareford, D, Kesteven, P, Mccollum, P, Das, S, Conrad, S, Botnick, W, Nathanson, A, Hamad, A, Fraiz, J, Goytia Leos, D, Fulmer, J, Mclaren, G, Streiff, M, Hahn, B, Ardolic, B, Klausner, H, Welch, M, Pullman, J, Phillips, D, Felt, J, Mitchell, G, Margolis, B, Pendleton, R, Mahesh, A, Barney, J, Shadan, F, Schuller, D, Joslin, S, Feldman, J, Pearl, R, Welker, J, Hazelrigg, M, Stevens, S, Siegel, M, Meade, A, Bates, J, Tahirkheli, N, Rosenberg, D, Dishman, K, Ikerd, T, Feldman, G, O'Connell, C, Vaince, U, Dabbagh, O, Eyster, E, Weinstein, G, Ginsberg, R, Fine, J, Tillinghast, A, Alabi, F, Nathan, R, Haught, H, Oliver, M., Cardiovascular Division (SZG), Brigham and Women's Hospital [Boston], Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, Thrombosis Research Institute (AKK), University College of London [London] (UCL), Institute for Experimental Oncology and Therapy Research (IEOTR), Technische Universität Munchen - Université Technique de Munich [Munich, Allemagne] (TUM), Jefferson Medical College (JMC), Thomas Jefferson University Hospitals, Thrombosis and Atherosclerosis Research Institute (TARI), McMaster University [Hamilton, Ontario], Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Centre d'Investigation Clinique (CIC - Brest), and Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Male, MESH: Pulmonary Embolism, Placebo-controlled study, MESH: Hospitalization, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, law.invention, MESH: Venous Thromboembolism, chemistry.chemical_compound, 0302 clinical medicine, MESH: Aged, 80 and over, Randomized controlled trial, law, Risk Factors, MESH: Risk Factors, Medicine, MESH: Double-Blind Method, 030212 general & internal medicine, MESH: Treatment Outcome, Aged, 80 and over, MESH: Aged, MESH: Middle Aged, General Medicine, Orvostudományok, Venous Thromboembolism, Middle Aged, 3. Good health, Pulmonary embolism, Hospitalization, Treatment Outcome, Acute Disease, MESH: Acute Disease, Apixaban, Female, Respiratory Insufficiency, MESH: Hemorrhage, medicine.drug, Adult, medicine.medical_specialty, Randomization, MESH: Enoxaparin, Pyridones, Medicina, Hemorrhage, MESH: Anticoagulants, MESH: Drug Administration Schedule, Klinikai orvostudományok, Drug Administration Schedule, 03 medical and health sciences, Double-Blind Method, Internal medicine, MESH: Pyridones, Humans, Risk factor, Enoxaparin, MESH: Kaplan-Meier Estimate, Aged, Heart Failure, MESH: Humans, business.industry, Anticoagulants, MESH: Adult, medicine.disease, MESH: Male, Surgery, chemistry, Relative risk, Betrixaban, MESH: Heart Failure, Pyrazoles, business, Pulmonary Embolism, MESH: Female, MESH: Pyrazoles, MESH: Respiratory Insufficiency, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

The efficacy and safety of prolonging prophylaxis for venous thromboembolism in medically ill patients beyond hospital discharge remain uncertain. We hypothesized that extended prophylaxis with apixaban would be safe and more effective than short-term prophylaxis with enoxaparin. METHODS: In this double-blind, double-dummy, placebo-controlled trial, we randomly assigned acutely ill patients who had congestive heart failure or respiratory failure or other medical disorders and at least one additional risk factor for venous thromboembolism and who were hospitalized with an expected stay of at least 3 days to receive apixaban, administered orally at a dose of 2.5 mg twice daily for 30 days, or enoxaparin, administered subcutaneously at a dose of 40 mg once daily for 6 to 14 days. The primary efficacy outcome was the 30-day composite of death related to venous thromboembolism, pulmonary embolism, symptomatic deep-vein thrombosis, or asymptomatic proximal-leg deep-vein thrombosis, as detected with the use of systematic bilateral compression ultrasonography on day 30. The primary safety outcome was bleeding. All efficacy and safety outcomes were independently adjudicated. RESULTS: A total of 6528 subjects underwent randomization, 4495 of whom could be evaluated for the primary efficacy outcome - 2211 in the apixaban group and 2284 in the enoxaparin group. Among the patients who could be evaluated, 2.71% in the apixaban group (60 patients) and 3.06% in the enoxaparin group (70 patients) met the criteria for the primary efficacy outcome (relative risk with apixaban, 0.87; 95% confidence interval [CI], 0.62 to 1.23; P = 0.44). By day 30, major bleeding had occurred in 0.47% of the patients in the apixaban group (15 of 3184 patients) and in 0.19% of the patients in the enoxaparin group (6 of 3217 patients) (relative risk, 2.58; 95% CI, 1.02 to 7.24; P = 0.04). CONCLUSIONS: In medically ill patients, an extended course of thromboprophylaxis with apixaban was not superior to a shorter course with enoxaparin. Apixaban was associated with significantly more major bleeding events than was enoxaparin, Supported by Bristol-Myers Squibb and Pfizer

Published
2011
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35. 4G MC-CDMA multi antenna system on chip for radio enhancements (4MORE)

Author

Kaiser, S., Durand, Y., Herault, L., Hélard, Jean-François, Mottier, D., Gameiro, Atilio, Arquinero, J., Berens, F., Bauer, F., Rabineau, Rodrigue, Casajus, F.J, Institut d'Électronique et des Technologies du numéRique (IETR), Université de Nantes (UN)-Université de Rennes (UR)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS), Nantes Université (NU)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS), and Université de Nantes (UN)-Université de Rennes 1 (UR1)

Subjects
ComputingMilieux_MISCELLANEOUS
Abstract

International audience

Published
2004

36. The IST project MATRICE on MC-CDMA transmission techniques for future cellular systems

Author

Hérault, Laurent, Des Noes, Mathieu, Berens, F., Chalard, Laurent, Mottier, D., Hélard, Jean-François, Rodriguez, J., Tafazolli, R., Acx, A.G., Gameiro, Atilio, Aguiar, R.-L., Zazo Bello, S., Commissariat à l'énergie atomique et aux énergies alternatives - Laboratoire d'Electronique et de Technologie de l'Information (CEA-LETI), Direction de Recherche Technologique (CEA) (DRT (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Institut d'Électronique et des Technologies du numéRique (IETR), Université de Nantes (UN)-Université de Rennes (UR)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS), Institut de recherches sur la catalyse et l'environnement de Lyon (IRCELYON), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS), Inst. Telec, Univ. Aveiro (IT), Dept. Elect. & Telec., Inst. Telec, Univ. Aveiro, Nantes Université (NU)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS), Université de Nantes (UN)-Université de Rennes 1 (UR1), and Kervella, Katell

Subjects
ComputingMilieux_MISCELLANEOUS
Abstract

International audience

Published
2004

37. High plasma concentration of factor VIII coagulant is also a risk factor for venous thromboembolism in the elderly

Author

Oger, E., Lacut, K., Patrick Van Dreden, Bressollette, L., Abgrall, J. -F, Blouch, M. -T, Scarabin, P. -Y, Mottier, D., Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO)-Université de Brest (UBO), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Service d'hématologie biologique, Centre de recherche en épidémiologie et santé des populations (CESP), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)

Subjects
Aged, 80 and over, Male, Venous Thrombosis, MESH: Age Factors, MESH: Aged, Factor VIII, MESH: Humans, MESH: Middle Aged, Age Factors, Middle Aged, MESH: Factor VIII, MESH: Male, MESH: Aged, 80 and over, Risk Factors, MESH: Risk Factors, MESH: Thromboembolism, Thromboembolism, MESH: Venous Thrombosis, Humans, Female, MESH: Female, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Aged
Abstract

International audience; BACKGROUND AND OBJECTIVES: A high level of coagulant factor VIII is a well known risk factor for venous thromboembolism, but most studies have enrolled patients under 70 years old. This study aimed to test the hypothesis that an association also exists in the elderly. DESIGN AND METHODS: This hospital-based case-referent study took place at the Department of Internal Medicine and Chest Diseases, University Hospital, Brest, France. We enrolled 161 patients with a first episode of venous thrombosis and 239 subjects, referred for a clinical suspicion of venous thromboembolism which was subsequently ruled out. Factor VIII coagulant activity and plasma fibrinogen concentration were measured. RESULTS: High factor VIII coagulant activity was significantly associated with venous thromboembolism, irrespective of the age group. Patients over 70 years with factor VIII coagulant activity above 225% had a 2.4-fold increased risk of venous thromboembolism compared to those patients with levels below 130% (age- and fibrinogen-adjusted odds ratio: 2.6, 95% CI 1.1 to 6.1). INTERPRETATION AND CONCLUSIONS: Our results show that high levels of factor VIII coagulant, a determinant of venous thrombosis in adulthood, is also a risk factor in the elderly.

Published
2003

38. Physical Layer Simulation Chain Description (Reference chain V0)

Author

Brunel, L., Gueguen, A., Mottier, D., Des Noes, Mathieu, Alves, F., Morgado, A., Legouable, R., Zazo, S., Neda, N., Martinelli, P., Tanrikulu, S., Baudais, Jean-Yves, Hemming, H., Mitsubishi Electric ITE-TCL, Commissariat à l'énergie atomique et aux énergies alternatives - Laboratoire d'Electronique et de Technologie de l'Information (CEA-LETI), Direction de Recherche Technologique (CEA) (DRT (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA), France Télécom Recherche & Développement (FT R&D), France Télécom, Institut d'Électronique et des Technologies du numéRique (IETR), Université de Nantes (UN)-Université de Rennes (UR)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS), IST-MATRICE, Nantes Université (NU)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS), and Université de Nantes (UN)-Université de Rennes 1 (UR1)

Subjects
[INFO.INFO-TS]Computer Science [cs]/Signal and Image Processing, [SPI.SIGNAL]Engineering Sciences [physics]/Signal and Image processing, Computer Science::Information Theory
Abstract

This deliverable presents a detailed specification of the signal processing functions involved in the uplink and downlink MC-CDMA physical layer simulation chains that are considered as reference chains (V0) within the MATRICE project. For each reference function, description of algorithms and tests to validate them are proposed. The reference chains will be used for the performance evaluation of advanced transmission techniques that will be investigated during the project life.

Published
2002

39. Optimum and sub-optimum linear MMSE multi-user detection for MC-CDMA transmission system

Author

Mottier, D., Castelain, D., Hélard, Jean-François, Baudais, Jean-Yves, Mitsubishi Electric ITE-TCL, Laboratoire composants et systèmes pour télécommunications (LCST), Institut National des Sciences Appliquées - Rennes (INSA Rennes), and Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)

Subjects
[SPI.OTHER]Engineering Sciences [physics]/Other, [INFO.INFO-TS]Computer Science [cs]/Signal and Image Processing, Data_CODINGANDINFORMATIONTHEORY, [SPI.SIGNAL]Engineering Sciences [physics]/Signal and Image processing
Abstract

International audience; This paper investigates optimum and sub-optimum linear Minimum Mean Square Error (MMSE) Multi-User Detection (MUD) techniques for multi-carrier code division multiple access transmission systems. In a first step, we present two formulations of MMSE MUD techniques that are optimum for any number of users and any power distribution and achieve exactly the same performance with a different computational complexity. In a second step, we present a simplification of optimum MMSE MUD techniques that achieves sub-optimum performance but at a reduced complexity that is similar to single-user detection techniques. Simulation results on indoor channels show that optimum and sub-optimum MMSE MUD techniques outperform the MMSE single-user detection technique, especially for low and medium system loads as well as in case of near-far effect.

Published
2001

41. Self-Adaptive Decision Feedback Equalization. Application to High Order QAM Signals

Author

Mottier, D., Hélard, Maryline, Labbat, J., Institut d'Electronique et de Télécommunications de Rennes (IETR), Centre National de la Recherche Scientifique (CNRS)-Ecole Supérieure d'Electricité - SUPELEC (FRANCE)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES), Sambin, Yolande, Université de Rennes (UR)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), and Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Ecole Supérieure d'Electricité - SUPELEC (FRANCE)-Centre National de la Recherche Scientifique (CNRS)

Subjects
ComputingMilieux_MISCELLANEOUS
Abstract

International audience

Published
1997

42. Influence of tentative decisions provided by a Turbo-Decoder on the carrier synchronization: Application to a 64-QAM

Author

Mottier, D., Hélard, Maryline, Sambin, Yolande, Institut d'Electronique et de Télécommunications de Rennes (IETR), Centre National de la Recherche Scientifique (CNRS)-Ecole Supérieure d'Electricité - SUPELEC (FRANCE)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES), Université de Rennes (UR)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), and Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Ecole Supérieure d'Electricité - SUPELEC (FRANCE)-Centre National de la Recherche Scientifique (CNRS)

Subjects
ComputingMilieux_MISCELLANEOUS
Abstract

International audience

Published
1997

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