1. Rivaroxaban for stroke prevention after embolic stroke of undetermined source
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Hart, Robert G, Sharma, Mukul, Mundl, Hardi, Kasner, Scott E, Bangdiwala, Shrikant I, Berkowitz, Scott D, Swaminathan, Balakumar, Lavados, Pablo, Wang, Yongjun, Wang, Yilong, Davalos, Antonio, Shamalov, Nikolay, Mikulik, Robert, Cunha, Luis, Lindgren, Arne, Arauz, Antonio, Lang, Wilfried, Czlonkowska, Anna, Eckstein, Jens, Gagliardi, Rubens J, Amarenco, Pierre, Ameriso, Sebastian F, Tatlisumak, Turgut, Veltkamp, Roland, Hankey, Graeme J, Toni, Danilo, Bereczki, Daniel, Uchiyama, Shinichiro, Ntaios, George, Yoon, Byung-Woo, Brouns, Raf, Endres, Matthias, Muir, Keith W, Bornstein, Natan, Ozturk, Serefnur, O'Donnell, Martin J, De Vries Basson, Matthys M, Pare, Guillaume, Pater, Calin, Kirsch, Bodo, Sheridan, Patrick, Peters, Gary, Weitz, Jeffrey I, Peacock, W Frank, Shoamanesh, Ashkan, Benavente, Oscar R, Joyner, Campbell, Themeles, Ellison, Connolly, Anderson DC, Stuart J., Demets, Dl, Kaste, M, Norrving, B, Wyse, Dg, Alet, M, Allende, G, Beinlich, A, Berrios, W, Bruera, G, Castro, D, Chialvo, L, Claverie, S, Contardo, L, Couto, J, Deganutto, R, Diaz, R, Dossi, D, Esnaola, M, Falco, M, Fernandez Pirrone, P, Ferrari, J, Firstenfeld, A, Galli Giqueauk, E, Gilli, M, Gonzalez, L, Gonzalez Toledo, M, Grecco, M, Halac, B, Hawkes, M, Ioli, P, Jure, L, Klein, F, Lepera, S, Lujan, S, Mackinnon, F, Marroquin, M, Martin, J, Parisi, V, Perez Leguizamon, P, Persi, G, Povedano, P, Povedano, G, Pujol Lereis, V, Radrizzani, L, Reich, E, Repetto, M, Rodriguez Lucci, F, Romano, M, Saredo, G, Schneider, M, Simonsini, C, Sumay, G, Thomson, A, Toledo, W, Torres, C, Vila, A, Abdul Rasheed, N, Anderson, C, Bailey, P, Blacker, D, Carcel, C, Clissold, B, Delcourt, C, Field, D, Gangadharan, S, Ghia, D, Kleinig, T, Leyden, J, Ly, J, Ma, H, Mackey, E, Mishra, S, Moey, A, Musuka, T, Pepper, E, Phan, T, Sabet, A, Saw, J, Singh, B, Tryambake, D, Tu, H, Wijeratne, T, Wong, A, Augustin, S, Esterbauer, M, Garnauf, M, Gasiorek, K, Gasser, S, Gaugg, M, Greisenegger, S, Harrasser, M, Heine, M, Huber, B, Joachim, B, Kapeller, P, Krebs, S, Kreuzpointer, R, Kunzmann, J, Lechner, H, Lohninger, B, Luschin, G, Macher, S, Marko, M, Matosevic, B, Mayr, A, Mismas, A, Mitrovic, N, Mutzenbach, J, Oberndorfer, S, Obmann, S, Raffelsberger, T, Roesler, C, Salletmayr, T, Serles, W, Stadler, K, Tinchon, A, Tolino, M, Verocai, V, Vigl, M, Voglsperger, B, Weber, J, Werner, P, Windt, J, Winkler, A, Wurzinger, H, Zelenka, I, Cras, P, Crols, R, De Keyser, J, De Klippel, N, De Pauw, A, De Smedt, A, Dhollander, I, Hermans, S, Ligot, N, Maqueda, V, Maqueda Maqueda, V, Naeije, G, Seynaeve, L, Soors, P, Van Daele, W, Vanacker, P, Vanderschueren, G, Willems, C, Yperzeele, L, Avelar, W, Bacellar, A, Batista, C, Bazan, R, Braga, G, Cardoso, F, Dagnino, M, Fabio, S, Ferreira Junior, G, Freitas, G, Friedrich, M, Gomes Neto, A, Guarda, S, Katsurayama, M, Machado, M, Martins, S, Meira, F, Minelli, C, Morais, R, Moro, C, Neto, O, Polin, M, Silva, D, Weiss, G, Basile, V, Beaudry, M, Berlingieri, J, Blacquiere, D, 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Skowronska, M, Sliwinska, B, Sobolewski, P, Sobota, A, Stoiński, J, Szczuchniak, W, Szczyrba, S, Szewczyk, Z, Szlufik, S, Tarasiuk, J, Tutaj, A, Uchwat, U, Wach-Klink, A, Winska-Tereszkiewicz, A, Wisniewska, A, Włodek, A, Wojnarowska-Arendt, A, Zalewska, J, Zielinska-Turek, J, Ziomek, M, Zwiernik, J, Abreu, P, E Silva A, Amaral, Azevedo, E, Barroso, C, Calejo, M, Campillo, J, Campos Costa, E, Coelho, J, Correia, M, Correia, C, Gregorio, T, Lopes, D, Machado, C, Mendonca, T, Pereira, L, Pidal, A, Pineiro, S, Pinto, A, Ribeiro, J, Rodrigues, M, Salgado, P, Salgado, A, Santo, G, Sargento, J, Varela, R, Abroskina, M, Badalyan, K, Balueva, T, Barulin, A, Bazhenova, O, Belkin, A, Bogdanov, E, Daineko, A, Druzenko, I, Fedin, A, Fidler, M, Gogoleva, E, Golikov, K, Gonysheva, Y, Greshnova, I, Guryanova, N, Gusev, V, Kashaeva, E, Kaygorodtseva, S, Khairutdinova, D, Kholopov, M, Kirpicheva, S, Koltsov, I, Konkov, I, Kurenkova, N, Kurtenkova, N, Kurushina, O, Kustova, M, Lagutenko, M, Lenskaya, L, 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Clavijo, M, Gil Nunez, A, Giralt, E, Gomez-Choco, M, Gomis, M, Gutiérrez, R, Iglesias Mohedano, A, Lago, A, Lara Lezama, L, Lara Rodriguez, B, Llull, L, Lopez Fernandez, M, Lorenzo, A, Maestre-Moreno, J, Marta Moreno, J, Marti-Fabregas, J, Martínez Sánchez, P, Mauri Cabdevila, G, Mengual Chirifie, J, Molina, C, Molina, J, Moniche, F, Morales, L, Morales, A, Nombela, F, Núñez, F, Pagola, J, Perez, S, Portilla, J, Prats, L, Purroy, F, Quesada Garcia, H, Ramirez Moreno, J, Redondo Robles, L, Renu, A, Riveira Rodriguez, C, Roa, A, Rodriguez Campello, A, Rodriguez Pardo De Donlebun, J, Rodriguez Yanez, M, Rudilosso, S, Ruiz Ares, G, Sànchez Cerón, M, Santamaria Cadavid, M, Sanz Cuesta, B, Serena, J, Silva, Y, Soriano Soriano, C, Tejada Garcia, J, Tejada Meza, H, Tembl, J, Terceno, M, Trillo, S, Urra, X, Usero Ruiz, M, Vazquez, P, Vilar, C, Villanueva Osorio, J, Ximenez-Carrillo, A, Zapata, E, Esbjornsson, M, Karlsson, J, Kremer, C, Kuris, A, Staaf, G, Stiehm, M, Timberg, I, Tossavainen, C, Wester, P, Arnold, M, Baumgartner, P, Beer, J, Bicker, H, Boos, L, Cereda, C, Chaloulos-Iakovidis, P, Christian, L, Engelter, S, Fisch, L, Fischer, U, Frey, S, Frick, M, Hauk, M, Hoffmann, M, Kahles, T, Manno, C, Medlin, F, Mircea, D, Nedeltchev, K, Panos, L, Polymeris, A, Schillinger, N, Stocker, R, Sztajzel, R, Alaydin, H, Batur Caglayan, H, Colakoglu, S, Demirci, N, Duman, T, Eren, F, Gokce, M, Inanc, Y, Nazliel, B, Ongun, G, Ozcekic Demirhan, S, Ozyurt, E, Selcuk, D, Sorgun, M, Tezcan, S, Togay Isikay, C, Tokgoz, O, Ulku Acar, R, Uluduz Ugurlu, D, Abdul-Saheb, M, Ahmad, N, Ali, A, Alwis, L, Balogun, I, Bathula, R, Behnam, Y, Bhandari, M, Bhargavah, M, Black, T, Blank, C, Bruce, D, Burn, M, Canepa, C, Chakrabarti, A, Chandrasena, D, Chembala, J, Cheripelli, B, Clarke, R, Cohen, D, Collas, D, Constantin, C, Dani, K, Del Giudice, A, Dennis, M, Devine, J, Dima, S, Doubal, F, Duodu, Y, Dutta, D, El Ta Wil, S, Elyas, S, Evans, N, Eveson, D, Fotherby, K, France, E, Furnace, J, Grabowski, S, Gunathilagan, G, Gutierrez, R, Guyler, P, Hargroves, D, Harkness, K, Harvey, M, Hayhoe, H, Hicken, L, Hussain, M, Kelly, S, Lam, M, Lindert, R, Louw, S, Luder, R, Macleod, M, Majid, A, Mangion, D, Markova, S, Markus, H, Marsh, R, Mcarthur, K, Menon, N, Metcalf, K, Minhas, J, Minns, M, Mistri, A, Moreton, F, Mpelembue, M, Muddegowda, G, Mudhar, O, Musarrat, K, Myint, M, Natarajan, I, Naylor, D, Ngeh, J, Papavasileiou, V, Perry, R, Piechowski-Jozwiak, B, Pradhan, M, Rani, A, Rashed, K, Robinson, T, Roffe, C, Saksena, R, Sattar, N, Sekaran, L, Selvarajah, J, Shah, S, Sinha, D, Sivakumar, R, Sztriha, L, Walters, D, Webb, T, Werring, D, Whiteley, W, Whiting, R, Abdelhamid, N, Abdul Rahman, D, Amin, H, Androulakis, M, Babikian, V, Baker, M, Barker Trejo, S, Benjamin, A, Birnbaum, L, Burke, J, Chen, S, Clark, W, Coull, B, De Havenon, A, Dearborn, J, Degeorgia, M, Essa, B, Fares, M, Favate, A, Furlan, A, Gebreyohanns, M, Goddeau, R, Green, D, Greer, D, Haralur Sreekantaiah, Y, Hasan, R, Hedna, V, Henninger, N, Holmstedt, C, Ishida, K, Jagolino, A, Johnson, M, Jun-Oconnell, A, Kaur, S, Khanna, A, Kirshner, H, Kittner, S, Kleindorfer, D, Leira, E, Loomis, C, Lord, A, Lowenkopf, T, Lutsep, H, Magadan, A, Majjhoo, A, Maud, A, Mayasi, Y, Mccullough, L, Mckinney, J, Mehta, S, Mehta, D, Mehta, B, Messe, S, Miller, B, Milling, T, Moonis, M, Navaratnam, D, Okpala, M, Patel, N, Pettigrew, L, Phinney, T, Ramos-Estebanez, C, Rasmussen, J, Rodriguez, G, Rybinnik, I, Santiago, P, Sarraj, A, Savitz, S, Sawyer, R, Scandura, T, Schindler, J, Sen, S, Shang, T, Sharrief, A, Sila, C, Simpkins, A, Sundararajan, S, Talahma, M, Tayal, A, Thaler, D, Tirschwell, D, Torres, J, Vora, N, Warnack, W, Waters, M, Wilson, C, Xiong, W, Zweifler, R, Zanferrari, C., St Marys Development Trust, Servicio de Neurologia (SANTIAGO - Neurologie), Universidad del Desarrollo, Department of Neurology (Dep Neuro - BEIJING), Tiantan Hospital, Neurology department, Universidade de Coimbra [Coimbra], Department of Internal Medicine, University Hospital Basel [Basel], Laboratoire de Recherche Vasculaire Translationnelle (LVTS (UMR_S_1148 / U1148)), Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Neurological Sciences, Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome], Department of Neurology, Seoul National University Hospital, Institute of Neurosciences and Psychology [Glasgow], University of Glasgow, Neurology Department, Ichilov Medical Center, CIC Brest, Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital de la Cavale Blanche, Yperzeele, Laetitia, NAVIGATE ESUS Investigators, and Selçuk Üniversitesi
- Subjects
Stroke/etiology ,Male ,[SDV]Life Sciences [q-bio] ,Kaplan-Meier Estimate ,030204 cardiovascular system & hematology ,Brain Ischemia ,Brain ischemia ,0302 clinical medicine ,DESIGN ,Rivaroxaban ,Hemorrhage/chemically induced ,Secondary Prevention ,Medicine ,Factor Xa Inhibitors/adverse effects ,Stroke ,Rivaroxaban/adverse effects ,ComputingMilieux_MISCELLANEOUS ,11 Medical and Health Sciences ,Aspirin ,Atrial fibrillation ,General Medicine ,FORAMEN OVALE CLOSURE ,Middle Aged ,TRIALS ,Intracranial Embolism ,SAFETY ,Aged ,Factor Xa Inhibitors ,Female ,Hemorrhage ,Humans ,Platelet Aggregation Inhibitors ,Medicine (all) ,Cardiology ,Foramen ovale closure ,Platelet aggregation inhibitor ,Settore MED/26 - Neurologia ,Life Sciences & Biomedicine ,medicine.drug ,medicine.medical_specialty ,Platelet Aggregation Inhibitors/adverse effects ,ANTITHROMBOTIC THERAPY ,Aspirin/adverse effects ,WARFARIN ,03 medical and health sciences ,Secondary Prevention/methods ,Medicine, General & Internal ,Internal medicine ,Intracranial Embolism/drug therapy ,General & Internal Medicine ,NAVIGATE ESUS Investigators ,METAANALYSIS ,Science & Technology ,CRYPTOGENIC STROKE ,business.industry ,Warfarin ,medicine.disease ,EFFICACY ,ATRIAL-FIBRILLATION ,Human medicine ,business ,Brain Ischemia/prevention & control ,030217 neurology & neurosurgery ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology - Abstract
WOS: 000434263000007, PubMed: 29766772, BACKGROUND Embolic strokes of undetermined source represent 20% of ischemic strokes and are associated with a high rate of recurrence. Anticoagulant treatment with rivaroxaban, an oral factor Xa inhibitor, may result in a lower risk of recurrent stroke than aspirin. METHODS We compared the efficacy and safety of rivaroxaban (at a daily dose of 15 mg) with aspirin (at a daily dose of 100 mg) for the prevention of recurrent stroke in patients with recent ischemic stroke that was presumed to be from cerebral embolism but without arterial stenosis, lacune, or an identified cardioembolic source. The primary efficacy outcome was the first recurrence of ischemic or hemorrhagic stroke or systemic embolism in a time-to-event analysis; the primary safety outcome was the rate of major bleeding. RESULTS A total of 7213 participants were enrolled at 459 sites; 3609 patients were randomly assigned to receive rivaroxaban and 3604 to receive aspirin. Patients had been followed for a median of 11 months when the trial was terminated early because of a lack of benefit with regard to stroke risk and because of bleeding associated with rivaroxaban. The primary efficacy outcome occurred in 172 patients in the rivaroxaban group (annualized rate, 5.1%) and in 160 in the aspirin group (annualized rate, 4.8%) (hazard ratio, 1.07; 95% confidence interval [CI], 0.87 to 1.33; P=0.52). Recurrent ischemic stroke occurred in 158 patients in the rivaroxaban group (annualized rate, 4.7%) and in 156 in the aspirin group (annualized rate, 4.7%). Major bleeding occurred in 62 patients in the rivaroxaban group (annualized rate, 1.8%) and in 23 in the aspirin group (annualized rate, 0.7%) (hazard ratio, 2.72; 95% CI, 1.68 to 4.39; P, BayerBayer AG; Janssen Research and Development, Supported by Bayer and Janssen Research and Development.
- Published
- 2018