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1. 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

2. Venous thromboembolism in immobilized patients with dementia. Findings from the RIETE registry

Author

Nuñez, Mj, Villalba, Jc, Cebrián, E, Visoná, A, Lopez Jimenez, L, Núñez, M, Szwebel, Ta, Luque, Jm, Jaras, Mj, Monreal, M, Arcelus, Ji, Barba, R, Barrón, M, Blanco, A, Boix, L, Bosco, J, Calvo, M, Casado, I, Casas, Jm, Cisneros, E, Chavez, E, del Campo, R, del Toro, J, Durán, M, Falgá, C, Fernández Capitán, C, Gabriel, F, Gallego, P, García Bragado, F, Guil, M, Gutiérrez, J, Hernández, L, Hernández Huerta, D, Jiménez Gil, M, Lecumberri, R, Lobo, Jl, López Jiménez, L, Lorenzo, A, Madridano, O, Manzano, V, Maestre, A, Marchena, Pj, Martín Villasclaras JJ, Morales, M, Nauffal, Md, Nieto, Ja, Núñez, Mj, Ogea, Jl, Oribe, M, Otero, R, Pedrajas, Jm, Provenza, M, Rabuñal, R, Riera Mestre, A, Rodríguez, Ma, Roldán, V, Román, B, Román, P, Rosa, V, Royo, C, Rubio, S, Ruíz, C, Ruíz, J, Ruiz Gamietea, A, Ruíz Giménez, N, Sahuquillo, Jc, Samperiz, A, Sánchez, R, Sánchez Muñoz Torrero JF, Soler, S, Soto, Mj, Tiberio, G, Timiraos, J, Tolodí, Ja, Tolosa, C, Trujillo, J, Uresandi, F, Valdés, M, Valdés, V, Valle, R, Vidal, G, Villalta, J, Zorrilla, V, Bura Riviere, A, Debourdeau, P, Durant, C, Farge Bancel, D, Mahe, A, Mismetti, P, Rivron Guillot, K, Szwebel, T, Brenner, B, Barillari, A, Barillari, G, Ciammaichella, M, Di Micco, P, Dalla Valle, F, Duce, R, Pasca, S, Piovella, C, Poggio, R, Prandoni, Paolo, Quintavalla, R, Maida, R, Schenone, A, Tiraferri, E, Tonello, D, Visonà, A, Bosevski, M, and Papadakis, M.

Subjects
Male, medicine.medical_specialty, Deep vein, Hemorrhage, Internal medicine, medicine, Dementia, Humans, Registries, Aged, Aged, 80 and over, business.industry, Incidence (epidemiology), Incidence, Anticoagulants, Hematology, Odds ratio, Venous Thromboembolism, Heparin, Low-Molecular-Weight, Middle Aged, medicine.disease, Thrombosis, Surgery, Pulmonary embolism, Natural history, Clinical trial, medicine.anatomical_structure, Treatment Outcome, Female, business, Pulmonary Embolism
Abstract

Background The natural history of venous thromboembolism (VTE) in patients with dementia has not been thoroughly studied. Methods We used the RIETE Registry data to assess the clinical characteristics, treatment strategies and outcome during the first 3 months after acute VTE in all immobilized patients with dementia. Results As of August 2011, 37988 patients had been enrolled, of whom 1316 (3.5%) had dementia. Most patients in both subgroups were initially treated with low-molecular-weight heparin (LMWH). Then, 48% of patients with dementia and 25% of those without dementia received LMWH as long-term therapy. During the first 3 months of anticoagulant therapy, patients with dementia had a higher incidence of fatal pulmonary embolism (PE): 4.0% vs. 1.2% (odds ratio: 3.3; 95% CI: 2.5-4.4) and fatal bleeding: 1.4% vs. 0.5% (odds ratio: 2.9; 95% CI: 1.8-4.6) than those without dementia. In demented patients initially presenting with PE, the incidence of fatal PE during the first week outweighed that of fatal bleeding (42 vs. 4 deaths), but from Day 8, the incidence of fatal PE was similar to the incidence of fatal bleeding. In patients initially presenting with deep vein thrombosis (DVT), there were 4 fatal PE and 8 fatal bleeding events. Conclusions VTE patients with dementia had a high incidence of fatal PE and fatal bleeding. In those initially presenting with PE, the risk of dying of PE far outweighed that of fatal bleeding. In patients presenting with DVT alone, the risk of fatal PE was lower than that of fatal bleeding.

Published
2012

3. Natural history of patients developing thrombocytopenia while receiving anticoagulant therapy for venous thromboembolism

Author

Di Micco, P, Fontanella, A, Falvo, N, Bonithon Kopp, C, Decousus, H, Riera Mestre, A, Monreal, M, Prandoni, Paolo, Brenner, B, Barba, R, Rivron Guillot, K, Bosevski, M, Alcalde, M, Arcelus, Ji, Barrón, M, Blanco, A, Boix, L, Bosco, J, Bruscas, Mj, Casado, I, Casas, Jm, Chavez, E, del Campo, R, del Molino, F, del Toro, J, Durán, M, Falgá, C, Fernández Capitán, C, Gabriel, F, Gallego, P, García Bragado, F, Guijarro, R, Guil, M, Gutiérrez, J, Gutiérrez, Mr, Hermosa, Mj, Hernández, L, Hernández Juerta, D, Jiménez, M, Jordán, S, Lecumberri, R, Lobo, Jl, López, L, Lorenzo, A, Luque, Jm, Madridano, O, Maestre, A, Marchena, Pj, Martín Villasclaras JJ, Montes, J, Morales, M, Nauffal, Md, Nieto, Ja, Núñez, Mj, Ogea, Jl, Oribe, M, Otero, R, Pedrajas, Jm, Rabuñal, R, Rodríguez, Ma, Roldán, V, Román, P, Rosa, V, Rubio, S, Ruiz Gamietea, A, Ruiz Giménez, N, Sahuquillo, Jc, Samperiz, A, Sánchez, R, Sánchez Muñoz Torrero JF, Soler, S, Soto, Mj, Tiberio, G, Tolodí, Ja, Tolosa, C, Trujillo, J, Uresandi, F, Valdés, M, Valdés, V, Valle, R, Villalta, J, Boccalon, H, Farge Bancel, D, Mahe, I, Szwebel, Ta, Barillari, A, Barillari, G, Ciammaichella, M, Dalla Valle, F, Duce, R, Marconi, M, Pasca, S, Piovaccari, Gc, Piovella, C, Poggio, R, Prandoni, P, Quintavalla, R, Schenone, A, Tiraferri, E, Tonello, D, Visonà, A, Zalunardo, B, and Bosevski, M.

Subjects
Aged, 80 and over, Male, Time Factors, Platelet Count, Anticoagulants, Hemorrhage, Venous Thromboembolism, Middle Aged, Risk Assessment, Thrombocytopenia, Europe, Risk Factors, Disease Progression, Secondary Prevention, Humans, Female, Registries, Aged, Retrospective Studies

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