Skip to content
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Rivaroxaban or aspirin for patent foramen ovale and embolic stroke of undetermined source: a prespecified subgroup analysis from the NAVIGATE ESUS trial
The Lancet Neurology, Volume 17, No. 12, Year 2018
Notification
URL copied to clipboard!
Description
Background: Patent foramen ovale (PFO) is a contributor to embolic stroke of undetermined source (ESUS). Subgroup analyses from previous studies suggest that anticoagulation could reduce recurrent stroke compared with antiplatelet therapy. We hypothesised that anticoagulant treatment with rivaroxaban, an oral factor Xa inhibitor, would reduce the risk of recurrent ischaemic stroke compared with aspirin among patients with PFO enrolled in the NAVIGATE ESUS trial. Methods: NAVIGATE ESUS was a double-blinded, randomised, phase 3 trial done at 459 centres in 31 countries that assessed the efficacy and safety of rivaroxaban versus aspirin for secondary stroke prevention in patients with ESUS. For this prespecified subgroup analysis, cohorts with and without PFO were defined on the basis of transthoracic echocardiography (TTE) and transoesophageal echocardiography (TOE). The primary efficacy outcome was time to recurrent ischaemic stroke between treatment groups. The primary safety outcome was major bleeding, according to the criteria of the International Society of Thrombosis and Haemostasis. The primary analyses were based on the intention-to-treat population. Additionally, we did a systematic review and random-effects meta-analysis of studies in which patients with cryptogenic stroke and PFO were randomly assigned to receive anticoagulant or antiplatelet therapy. Findings: Between Dec 23, 2014, and Sept 20, 2017, 7213 participants were enrolled and assigned to receive rivaroxaban (n=3609) or aspirin (n=3604). Patients were followed up for a mean of 11 months because of early trial termination. PFO was reported as present in 534 (7·4%) patients on the basis of either TTE or TOE. Patients with PFO assigned to receive aspirin had a recurrent ischaemic stroke rate of 4·8 events per 100 person-years compared with 2·6 events per 100 person-years in those treated with rivaroxaban. Among patients with known PFO, there was insufficient evidence to support a difference in risk of recurrent ischaemic stroke between rivaroxaban and aspirin (hazard ratio [HR] 0·54; 95% CI 0·22–1·36), and the risk was similar for those without known PFO (1·06; 0·84–1·33; pinteraction=0·18). The risks of major bleeding with rivaroxaban versus aspirin were similar in patients with PFO detected (HR 2·05; 95% CI 0·51–8·18) and in those without PFO detected (HR 2·82; 95% CI 1·69–4·70; pinteraction=0·68). The random-effects meta-analysis combined data from NAVIGATE ESUS with data from two previous trials (PICSS and CLOSE) and yielded a summary odds ratio of 0·48 (95% CI 0·24–0·96; p=0·04) for ischaemic stroke in favour of anticoagulation, without evidence of heterogeneity. Interpretation: Among patients with ESUS who have PFO, anticoagulation might reduce the risk of recurrent stroke by about half, although substantial imprecision remains. Dedicated trials of anticoagulation versus antiplatelet therapy or PFO closure, or both, are warranted. Funding: Bayer and Janssen. © 2018 Elsevier Ltd
Authors & Co-Authors
Kasner, Scott Eric
United States, Philadelphia
University of Pennsylvania
Swaminathan, Balakumar
Canada, Hamilton
Population Health Research Institute, Ontario
Lavados Germain, Pablo M.
Chile, Santiago
Universidad de Chile
Sharma, Mukul K.
Canada, Hamilton
Mcmaster University
Muir, Keith W.
United Kingdom, Glasgow
College of Medical, Veterinary & Life Sciences
Veltkamp, Roland C.
Germany, Essen
Alfried Krupp Krankenhaus
Ameriso, Sebastián Francisco
Argentina, Buenos Aires
Fundacion Para la Lucha Contra Las Enfermedades Neurologicas de la Infancia
Endres, Matthias
Germany, Berlin
Charité – Universitätsmedizin Berlin
Spence, J. David
Canada, London
Western University
Perera, Kanjana Sashi
Canada, Hamilton
Population Health Research Institute, Ontario
Santo, Gustavo Cordeiro
Portugal, Coimbra
Universidade de Coimbra
Olavarria, Veronica V.
Chile, Santiago
Clinica Alemana
Lindgren, Arne G.
Sweden, Lund
Lunds Universitet
Bangdiwala, Shrikant I.
Canada, Hamilton
Mcmaster University
Shoamanesh, Ashkan
Canada, Hamilton
Mcmaster University
Berkowitz, Scott D.
United States, Whippany
Bayer Corporation, Usa
Mundl, Hardi
Germany, Berlin
Bayer Pharma ag
Connolly, Stuart J.
Canada, Hamilton
Mcmaster University
Hart, Robert G.
Canada, Hamilton
Mcmaster University
Abreu, Pedro Miguel Paredes
Unknown Affiliation
Adami, Alessandro
Unknown Affiliation
Amarenco, Pierre
Unknown Affiliation
Amaro, Sergio
Unknown Affiliation
Andersen, Grethe K.
Unknown Affiliation
Anderson, Craig S.
Unknown Affiliation
Androulakis, Xiao Michelle
Unknown Affiliation
Arauz, Antonio
Unknown Affiliation
Arenillas, Juan Francisco
Unknown Affiliation
Arnold, Marcel
Unknown Affiliation
Avelar, Wagner Mauad
Unknown Affiliation
Azevedo, E. Irene
Unknown Affiliation
Bae, Hee-joon
Unknown Affiliation
Bardutzky, Jürgen
Unknown Affiliation
Barroso, Cândida
Unknown Affiliation
Baş, Murat
Unknown Affiliation
Baumgartner, Philipp
Unknown Affiliation
Bejot, Y.
Unknown Affiliation
Benavente, Oscar R.
Unknown Affiliation
Dániel, Bereczki
Unknown Affiliation
Bhandari, Mohit
Unknown Affiliation
Blacquiere, Dylan P.V.
Unknown Affiliation
Bornstein, Natan M.
Unknown Affiliation
Brola, Waldemar
Unknown Affiliation
Brouns, Raf
Unknown Affiliation
H Buck, Brian
Unknown Affiliation
Burn, Mathew
Unknown Affiliation
Cantú-Brito, Carlos Gerardo
Unknown Affiliation
Cappellari, Manuel
Unknown Affiliation
Cardona, Pere
Unknown Affiliation
Cereda, Carlo W.
Unknown Affiliation
Chamorro, Àngel
Unknown Affiliation
Christensen, Hanne Krarup
Unknown Affiliation
Cohen, David Leslie
Unknown Affiliation
Collas, David M.
Unknown Affiliation
Correia, Manuel M.
Unknown Affiliation
Coutts, Shelagh B.
Unknown Affiliation
Cras, Patrick
Unknown Affiliation
Crozier, Sophie
Unknown Affiliation
Cunha, Luís S.
Unknown Affiliation
Członkowska, Anna
Unknown Affiliation
Dàvalos, Antoni E.
Unknown Affiliation
de Vries Basson, Matthys M.
Unknown Affiliation
de Georgia, Michael A.
Unknown Affiliation
DeMets, David L.
Unknown Affiliation
Diószeghy, Péter
Unknown Affiliation
Doubal, Fergus Neil
Unknown Affiliation
Duodu, Yaw
Unknown Affiliation
Dutta, Dipankar
Unknown Affiliation
Eckstein, Jens
Unknown Affiliation
Fazekas, Franz
Unknown Affiliation
Field, Thalia S.
Unknown Affiliation
Fischer, Urs Martin
Unknown Affiliation
Fluri, Felix
Unknown Affiliation
Friedrich, Matthias G.
Unknown Affiliation
Frisullo, Giovanni
Unknown Affiliation
Furlan, Anthony J.
Unknown Affiliation
Gagliardi, Rubens José
Unknown Affiliation
Garnier, Pierre Philippe
Unknown Affiliation
Gebreyohanns, Mehari
Unknown Affiliation
Glabinski, Andrzej R.
Unknown Affiliation
Gladstone ScD, David J.
Unknown Affiliation
Gomis, Meritxell
Unknown Affiliation
Greer, David Matthew
Unknown Affiliation
Guillon, Benoît
Unknown Affiliation
Gunathilagan, Gunaratam
Unknown Affiliation
Guyler, Paul C.
Unknown Affiliation
Hachinski, Vladimir C.I.
Unknown Affiliation
Hankey, Graeme J.
Unknown Affiliation
Li, Hao
Unknown Affiliation
Hargroves, David R.
Unknown Affiliation
Hart, Robert G.
Unknown Affiliation
Hassan, Ahmed M.M.
Unknown Affiliation
Herzig, Roman
Unknown Affiliation
Hill, Michael D.
Unknown Affiliation
Heo, Ji-hoe
Unknown Affiliation
Holmstedt, Christine Anne
Unknown Affiliation
Horev, Anat
Unknown Affiliation
Hussain, Malik
Unknown Affiliation
Iversen, Helle Klingenberg
Unknown Affiliation
Jander, Sebastian
Unknown Affiliation
Joyner, Campbell D.
Unknown Affiliation
Kadlcikova, Jana
Unknown Affiliation
Kása, Krisztián
Unknown Affiliation
Kaste, Markku
Unknown Affiliation
Kelly, Peter J.
Unknown Affiliation
Kittner, Steven J.
Unknown Affiliation
Kleinig, Timothy J.
Unknown Affiliation
Kobayashi, Adam
Unknown Affiliation
Kovács, Krisztina
Unknown Affiliation
Lang, Wielfried
Unknown Affiliation
Lee, Byung-chul
Unknown Affiliation
Leker, Ronen Robert
Unknown Affiliation
Ligot, Noémie
Unknown Affiliation
Llull, Laura
Unknown Affiliation
Lopes, Demetrius Klee
Unknown Affiliation
López-Fernández, María Fernanda
Unknown Affiliation
Mandzia, Jennifer L.
Unknown Affiliation
Markus, Hugh Stephen
Unknown Affiliation
Martí-Fábregas, Joan
Unknown Affiliation
Martinez-Majander, Nicolas
Unknown Affiliation
Maud, Alberto
Unknown Affiliation
Mayasi, Yunis M.
Unknown Affiliation
Medina Pech, Carlos Eduardo
Unknown Affiliation
Mehdiratta, Manu
Unknown Affiliation
Mehta, Shamir R.
Unknown Affiliation
Mehta, Brijesh P.
Unknown Affiliation
Mendonça, Teresa
Unknown Affiliation
Mikulík, Robert
Unknown Affiliation
Minelli, César
Unknown Affiliation
Mishra, Sachin M.
Unknown Affiliation
Mistri, Amit K.
Unknown Affiliation
Molina, Carlos Alberto
Unknown Affiliation
Molnar, Sarah H.
Unknown Affiliation
Monzani, Valter
Unknown Affiliation
Morales Ortíz, Ana M.
Unknown Affiliation
Mowla, Ashkan
Unknown Affiliation
Mueller, Thomas J.
Unknown Affiliation
Murphy, Colleen B.
Unknown Affiliation
Murphy, Séan F.
Unknown Affiliation
Musuka, Tapuwa D.
Unknown Affiliation
Naeije, Gilles
Unknown Affiliation
Nedeltchev, Krassen
Unknown Affiliation
Pontes-Neto, Octavio Marques
Unknown Affiliation
Ng, Kelvin Kuan Huei
Unknown Affiliation
Nikl, János
Unknown Affiliation
Njovane, Xolani W.
Unknown Affiliation
Norrving, Bo
Unknown Affiliation
Ntaios, George C.
Unknown Affiliation
Núñez, Fidel Ãngel
Unknown Affiliation
Obadia, Michaël Alexandre
Unknown Affiliation
O'Donnell, Martin J.
Unknown Affiliation
Öztürk, Şerefnur
Unknown Affiliation
Peacock IV, William Frank
Unknown Affiliation
Pernicka, Manfred
Unknown Affiliation
Peters, Gary R.
Unknown Affiliation
Phan, Thanh G.
Unknown Affiliation
Pico, Fernando
Unknown Affiliation
Piechowski-Jóźwiak, Bartłomiej
Unknown Affiliation
Poppe, Alexandre Y.
Unknown Affiliation
Pretorius, Martha M.
Unknown Affiliation
Purroy García, F. F.
Unknown Affiliation
Reiner, Peggy
Unknown Affiliation
Reková, Petra
Unknown Affiliation
Renú, Arturo
Unknown Affiliation
Robinson, Thompson Gordon
Unknown Affiliation
Roffe, Christine
Unknown Affiliation
Roos, Johan S.
Unknown Affiliation
Rosso, Charlotte
Unknown Affiliation
Rózsa, Csilla S.
Unknown Affiliation
Rudilosso, Salvatore
Unknown Affiliation
Ruíz-Ares, Gerardo
Unknown Affiliation
Rum, Gábor
Unknown Affiliation
Saavedra, Víctor Villarroel
Unknown Affiliation
Sabben, Candice
Unknown Affiliation
Sabet, Arman
Unknown Affiliation
Sagris, Dimitrios
Unknown Affiliation
Sakai, Nobuyuki
Unknown Affiliation
Samson, Yves
Unknown Affiliation
Sarraj, Amrou
Unknown Affiliation
Sas, Attila
Unknown Affiliation
Scandura, Terri A.
Unknown Affiliation
Schindler, Joseph Laurence
Unknown Affiliation
Sekaran, Lakshmanan
Unknown Affiliation
Shamalov, Nikolay A.
Unknown Affiliation
Sharma, Mikul
Unknown Affiliation
Shuaib, Ashfaq
Unknown Affiliation
Sibon, Igor
Unknown Affiliation
Sila, Cathy A.
Unknown Affiliation
Simpkins, Alexis Nétis
Unknown Affiliation
Škoda, Ondřej
Unknown Affiliation
Skowroñska, Marta
Unknown Affiliation
Smyth, Andrew
Unknown Affiliation
Soriano, Cristina Navarro
Unknown Affiliation
Sposato, Luciano A.
Unknown Affiliation
Stotts, Grant
Unknown Affiliation
Sun, Xiang
Unknown Affiliation
Sztajzel, Roman Felix
Unknown Affiliation
Taki, Waro
Unknown Affiliation
Tanne, David
Unknown Affiliation
Tatlisumak, Turgut
Unknown Affiliation
Tayal, Ashis H.
Unknown Affiliation
Teal, Phillip A.
Unknown Affiliation
Tenora, Dusan
Unknown Affiliation
Thouvenot, Éric
Unknown Affiliation
Tiainen, Marjaana
Unknown Affiliation
Timsit, S. G.
Unknown Affiliation
Cundiff, David K.
Unknown Affiliation
Tomppo, Liisa
Unknown Affiliation
Toni, Danilo S.
Unknown Affiliation
Touzé, Emmanuel
Unknown Affiliation
Statistics
Citations: 127
Authors: 210
Affiliations: 16
Identifiers
Doi:
10.1016/S1474-4422(18)30319-3
ISSN:
14744422
Research Areas
Environmental
Genetics And Genomics
Health System And Policy
Noncommunicable Diseases
Study Design
Cross Sectional Study
Cohort Study
Case-Control Study
Study Approach
Systematic review