Extended thromboprophylaxis with betrixaban in acutely ill medical patients

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

Risultato della ricerca: Contributo in rivistaArticolo in rivista

255 Citazioni (Scopus)

Abstract

BACKGROUND: Patients with acute medical illnesses are at prolonged risk for venous thrombosis. However, the appropriate duration of thromboprophylaxis remains unknown. METHODS: Patients who were hospitalized for acute medical illnesses were randomly assigned to receive subcutaneous enoxaparin (at a dose of 40 mg once daily) for 10±4 days plus oral betrixaban placebo for 35 to 42 days or subcutaneous enoxaparin placebo for 10±4 days plus oral betrixaban (at a dose of 80 mg once daily) for 35 to 42 days. We performed sequential analyses in three prespecified, progressively inclusive cohorts: patients with an elevated D-dimer level (cohort 1), patients with an elevated D-dimer level or an age of at least 75 years (cohort 2), and all the enrolled patients (overall population cohort). The statistical analysis plan specified that if the between-group difference in any analysis in this sequence was not significant, the other analyses would be considered exploratory. The primary efficacy outcome was a composite of asymptomatic proximal deep-vein thrombosis and symptomatic venous thromboembolism. The principal safety outcome was major bleeding. RESULTS: A total of 7513 patients underwent randomization. In cohort 1, the primary efficacy outcome occurred in 6.9% of patients receiving betrixaban and 8.5% receiving enoxaparin (relative risk in the betrixaban group, 0.81; 95% confidence interval [CI], 0.65 to 1.00; P = 0.054). The rates were 5.6% and 7.1%, respectively (relative risk, 0.80; 95% CI, 0.66 to 0.98; P = 0.03) in cohort 2 and 5.3% and 7.0% (relative risk, 0.76; 95% CI, 0.63 to 0.92; P = 0.006) in the overall population. (The last two analyses were considered to be exploratory owing to the result in cohort 1.) In the overall population, major bleeding occurred in 0.7% of the betrixaban group and 0.6% of the enoxaparin group (relative risk, 1.19; 95% CI, 0.67 to 2.12; P = 0.55). CONCLUSIONS: Among acutely ill medical patients with an elevated D-dimer level, there was no significant difference between extended-duration betrixaban and a standard regimen of enoxaparin in the prespecified primary efficacy outcome. However, prespecified exploratory analyses provided evidence suggesting a benefit for betrixaban in the two larger cohorts.
Lingua originaleEnglish
pagine (da-a)534-544
Numero di pagine11
RivistaNew England Journal of Medicine
Volume375
DOI
Stato di pubblicazionePubblicato - 2016

Keywords

  • Acute Disease
  • Adult
  • Aged
  • Benzamides
  • Double-Blind Method
  • Drug Administration Schedule
  • Factor Xa Inhibitors
  • Female
  • Fibrin Fibrinogen Degradation Products
  • Hemorrhage
  • Hospitalization
  • Humans
  • Male
  • Middle Aged
  • Pulmonary Embolism
  • Pyridines
  • Risk Factors
  • Ultrasonography
  • Venous Thromboembolism
  • Venous Thrombosis

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