Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty

Autor: Eriksson, Bi, Borris, Lc, Friedman, Rj, Haas, S, Huisman, Mv, Kakkar, Ak, Bandel, Tj, Beckmann, H, Muehlhofer, E, Misselwitz, F, Geerts, W, COLLABORATORS: Eriksson BI, RECORD1 Study G. r. o. u. p., Levine, M, Eriksson, H, Sandrgen, G, Wallin, J, Bode, C, Bassand, Jp, Lüscher, T, Angeras, U, Falk, A, Prins, M, Leizorovicz, A, Bounameaux, H, Larrey, D, Migge, A, Caviglia, H, Ceresetto, J, Cicchetti, A, D'Onofrio, A, Diaz, A, Mendler, H, Saa, J, Blombery, P, Chong, B, Gallus, A, Leahy, M, Salem, H, Bauer, N, Boehl, N, Freund, N, Hochreiter, J, Jakubek, M, Labek, G, Windhager, R, Zenz, P, Borms, T, Brabants, C, Colinet, J, de Rycke, J, Driesen, R, Gunst, P, Mortele, H, van Loon, L, Vandermeersch, E, Vanlommel, D, Queiroz, Rd, Fridman, M, Penedo, Jm, Schwartsmann, C, Abuzgaya, F, Belzile, E, Dobson, C, Fisher, W, Grosso, P, Mant, M, Pototschnik, R, Solymoss, S, Zalzal, P, Bittelman, S, Cordova, M, Reyes, A, Rocha, C, Toledo, D, Altschul, J, Fousek, J, Koudela, K, Kriz, Z, Lutonsky, M, Pach, M, Sedivy, P, Stehlik, J, Svagr, M, Svec, M, Borgwardt, Oa, Joergensen, P, Lassen, Mr, Lausten, G, Mikkelsen, S, Jokipii, P, Pesola, M, Waris, P, Debue, Jm, Forestier, C, Hennion, G, Lazard, T, Macaire, P, Maire, Jy, Marouan, A, Maschino, X, Matuszczak, Y, Moulinie, Jp, Osman, M, Peron, A, Pinson, Jj, Birkner, W, Buechler, M, Eulert, J, Fritsche, Hm, Guen, Kp, Halder, A, Horacek, T, Kiekenbeck, A, Kleinfeld, F, Krauspe, R, Kurth, A, Labs, K, Mittelme, W, Mouret, P, Muehlbauer, B, Quante, M, Schmelz, H, Wirth, T, Babis, G, Beldekos, A, Soukakos, P, Bucsi, L, Lenart, E, Mike, G, Sarvary, A, Shafiei, F, Szenbeni, A, Szendroi, M, Toth, J, Toth, K, Benkovich, V, Brenner, B, Dekel, S, Halperin, N, Hendel, D, Martinovich, U, Nyska, M, Salai, M, Borghi, B, Bosco, M, Castelli, C, Cherubino, P, Franchin, FRANCESCO MARIA, Fraschini, G, Greco, F, Grossi, P, Gusso, M, Landolfi, R, Leali, T, Lodigiani, C, Marinoni, E, Martorana, U, Massari, L, Melis, G, Miletto, A, Parise, P, Rinaldi, G, Riva, R, Silingardi, M, Porvaneckas, N, Smailys, A, Dijk, Cn, Nolte, Pa, Schuller, Hm, Slappendel, R, van der List JJ, Verheyen, Cc, Vis, Hm, Aarseth, O, Al Dekany, K, Borgen, P, Roenning, Re, Talsnes, O, Bednarek, A, Blacha, J, Deszczyski, J, Dutka, J, Gazdzik, T, Golec, E, Gorecki, A, Gusta, A, Krasicki, M, Kruczyski, J, Kusz, D, Kwiatkowsk, K, Mazurkiewi, S, Niedwiedzki, T, Pozowski, A, Skowronski, J, Swaton, R, Synder, M, Tkaczyk, T, Knapec, L, Lisy, M, Stasko, I, Engelbrecht, J, Myburgh, H, van Zyl, L, Canosa Sevillano, R, Delgado, A, Diaz Almodovar JL, Giros Torres, J, Granero, X, Gomar, F, Lecumberri Villamedi, R, Navarro Quiles, A, Otero Fernandez, R, Paz Jimenez, J, Peidro Garces, L, Pino Minguez, J, Puig Verdier, L, Ruiz Sanchez, A, Salvador, A, Valdes Casas JC, Laestander, H, Liliequist, J, Lind, S, Paulsson, B, Wykman, A, Altintas, F, Esemelli, T, Karatosun, V, Togrul, E, Tozun, R, Allmacher, D, Buettner, C, Colwell C., Jr, Friedman, R, Gimbel, J, Jove, M, King, R, Martin, K, Murray, R, Peters P., Jr, Sledge, S, Swappach, J, Taunton O., Jr, Ward, J.
Přispěvatelé: Eriksson BI, Borris LC., Friedman RJ., Haas S., Huisman MV., Kakkar AK., Bandel TJ., Beckmann H., Muehlhofer E, Misselwitz F., Geerts W., RECORD 1 Study Group, Borghi B.
Jazyk: angličtina
Rok vydání: 2008
Předmět:
Male
medicine.medical_treatment
Arthroplasty
Replacement
Hip

Replacement
Adolescent
Adult
Aged
Aged

80 and over
Anticoagulants

adverse effects/therapeutic use
Arthroplasty

Hip
Double-Blind Method
Enoxaparin

adverse effects/therapeutic use
Factor Xa

antagonists /&/ inhibitors
Female
Humans
Male
Middle Aged
Morpholines

adverse effects/therapeutic use
Pulmonary Embolism

epidemiology/prevention /&/ control
Thiophenes

adverse effects/therapeutic use
Venous Thromboembolism

mortality/prevention /&/ control
Venous Thrombosis

epidemiology/prevention /&/ control
Rivaroxaban
80 and over
antagonists /&/ inhibitors
Aged
80 and over

Venous Thrombosis
medicine.diagnostic_test
RIVAROXABAN
ENOXAPARIN
THROMBOPROFILAXIS
HIP
ARTHROPLASTY
Anticoagulant
General Medicine
Venous Thromboembolism
Middle Aged
mortality/prevention /&/ control
Thrombosis
Pulmonary embolism
adverse effects/therapeutic use
Anesthesia
Factor Xa
Female
Enoxaparin sodium
medicine.drug
Adult
medicine.medical_specialty
Adolescent
medicine.drug_class
thromboprophylaxis
venography
bleeding

Morpholines
Venography
Low molecular weight heparin
Thiophenes
Arthroplasty
Double-Blind Method
medicine
Humans
Enoxaparin
Aged
Hip
business.industry
Anticoagulants
medicine.disease
Surgery
business
Pulmonary Embolism
Factor Xa Inhibitors
Popis: BACKGROUND: This phase 3 trial compared the efficacy and safety of rivaroxaban, an oral direct inhibitor of factor Xa, with those of enoxaparin for extended thromboprophylaxis in patients undergoing total hip arthroplasty. METHODS: In this randomized, double-blind study, we assigned 4541 patients to receive either 10 mg of oral rivaroxaban once daily, beginning after surgery, or 40 mg of enoxaparin subcutaneously once daily, beginning the evening before surgery, plus a placebo tablet or injection. The primary efficacy outcome was the composite of deep-vein thrombosis (either symptomatic or detected by bilateral venography if the patient was asymptomatic), nonfatal pulmonary embolism, or death from any cause at 36 days (range, 30 to 42). The main secondary efficacy outcome was major venous thromboembolism (proximal deep-vein thrombosis, nonfatal pulmonary embolism, or death from venous thromboembolism). The primary safety outcome was major bleeding. RESULTS: A total of 3153 patients were included in the superiority analysis (after 1388 exclusions), and 4433 were included in the safety analysis (after 108 exclusions). The primary efficacy outcome occurred in 18 of 1595 patients (1.1%) in the rivaroxaban group and in 58 of 1558 patients (3.7%) in the enoxaparin group (absolute risk reduction, 2.6%; 95% confidence interval [CI], 1.5 to 3.7; P
Databáze: OpenAIRE