1. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty
- Author
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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., 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, and Borghi B. more...
- Subjects
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 - Abstract
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 more...
- Published
- 2008