Apixaban versus Enoxaparin for Thromboprophylaxis in Medically Ill Patients
| Title: | Apixaban versus Enoxaparin for Thromboprophylaxis in Medically Ill Patients |
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| Authors: | 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; 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.; PRANDONI, PAOLO |
| Contributors: | 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 |
| Publication Year: | 2011 |
| Collection: | Padua Research Archive (IRIS - Università degli Studi di Padova) |
| Description: | BACKGROUND: 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 ... |
| Document Type: | article in journal/newspaper |
| Language: | English |
| Relation: | info:eu-repo/semantics/altIdentifier/pmid/22077144; info:eu-repo/semantics/altIdentifier/wos/WOS:000297731400002; volume:365; issue:23; firstpage:2167; lastpage:2177; numberofpages:11; journal:NEW ENGLAND JOURNAL OF MEDICINE; https://hdl.handle.net/11577/3033808 |
| DOI: | 10.1056/NEJMoa1110899 |
| Availability: | https://hdl.handle.net/11577/3033808; https://doi.org/10.1056/NEJMoa1110899 |
| Accession Number: | edsbas.56CEB50B |
| Database: | BASE |