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Rivaroxaban or aspirin for patent foramen ovale and embolic stroke of undetermined source: a prespecified subgroup analysis from the NAVIGATE ESUS trial
Scott E. Kasner, Balakumar Swaminathan, Pablo M. Lavados, Mukul Sharma, Keith W. Muir, Roland Veltkamp, Sebastián F. Ameriso, Matthias Endres, Helmi L. Lutsep, Steven R. Messé, J. David Spence, Krassen Nedeltechev, Kanjana Perera, Verónica V. Olavarría, Shrikant I. Bangdiwala, Ashkan Shoamanesh, Scott D. Berkowitz, Hardi Mundl, Stuart J. Connolly, Robert G. Hart, Noureldin Abdelhamid, Durdana Rahman, Mudhar Abdul-Saheb, Pedro Abreu, M V Abroskina, Faraz Ahmad, Sandrine Accassat, Monica Acciaresi, Alessandro Adami, Noor-Us-Sabah Ahmad, Farhat Ahmed, M Alberto Hawkes, Fana Alemseged, Asad Ali, Riccardo Altavilla, L Alwis, Pierre Amarenco, Sergio Amaro, LE Amaya Sanchez, A Amelia Pinto, SF Ameriso, Haitham Amin, T. Amino, AK Amjad, E. Anagnostou, Grethe Andersen, Craig S. Anderson, DC Anderson, M Andrea Falco, Frances MacKinnon, David Andreu, Michael Androulakis, Miguel Ángel Gamero-García, G Angel Saredo, Rafael Díaz, M Angels Font, Sabrina Anticoli, Antonio Araúz, AA Arauz Gongora, P. Araya, J. Arenillas Lara, Susana Arias-Rivas, Marcel Arnold, Salvador Augustín, Wagner Mauad Avelar, Elsa Azevedo, Viken L. Babikian, Aroldo Bacellar, K R Badalyan, HJ Bae, Eric A. Martínez, H Bagelmann, Peter Bailey, Zoltán Bak, Mitchell B. Baker, Alejandro B. Balazs, Dobri Baldaranov, Ibrahim Balogun, T V Balueva, Z Bankuti, Michal Bar, Anna Baranowska, Juergen Bardutzky, S Barker Trejo, Jessica Barlinn, Flore Baronnet, C. García Barroso, M Barteys, T Bartolottiova, А. Е. Барулин, M. Baş, Saima Bashir, Vincenzo S. Basile, R. Bathe-Peters, Raj Bathula, César V.F. Batista, Hale Zeynep Batur Çağlayan, Philipp Baumgartner, Rodrigo Bazán, O. K. Bazhenova, Michel Beaudry, Jürg H. Beer, Yousif Behnam, Anne Beinlich, Yannick Béjot, А. А. Белкин, OR Benavente, A. Benjamin, V. Berardi, Dániel Bereczki, Joseph Berlingieri, Waleska Berríos, Jörg Berrouschot, Mohit Bhandari, M Bhargavah, H Bicker, Thomas A. Bicsak, Marta Bilik, Daniela Bindila, Javier A. Birchenall, Lee Birnbaum, Toby Black, David Blacker, Dylan Blacquière, Christelle Blanc-Labarre, C Blank, Stefanie Honegger Bloch, Eric Bodiguel, Э. И. Богданов, Linda Boos, L Borcsik, Natan M. Bornstein, S. Bouly, Geórgia de Carvalho Braga, Irene Bragado, MC Bravi, Ch. Brokalaki, Waldemar Brola, Raf Brouns, David Bruce, J Brzoska-Mizgalska, Brian Buck, James Burke, M Burn, Gabriela Bustamante, L. Cabrejo, Kailin Cai, S. Cajaraville, Margarida Calejo, David Calvet, José A. Campillo, E Campos Costa, Pelayo Camps, Halil Can Alaydın, Elisa Candeloro, Carlo Canepa, CG Cantu Brito, Manuel Cappellari, Cheryl Carcel, Fernando C. Cardoso, M Carek, M. Carletti, J Carlos Portilla, Paola Caruso, Ignacio Casado-Naranjo, Paolo Castellini, David Muñoz Castro, Fidel Meira, Anna Cavallini, N. Cayuela Caudevilla, Sabine Cenciarelli, Carlo W. Cereda, Paolo Cerrone, Anjan Chakrabarti, Panagiotis Chaloulos-Iakovidis, Ángel Chamorro, Denish Chandrasena, D.H. Chang, Chi‐Ming Che, J Chembala, Jun Chen, Zhen Chen, T Chen, Honglin Chen, X Chen, Guanhua Chen, L Chen, Shengyong Chen, Bharath Kumar Cheripelli, Marshall H. Chin, Estefany Angela Flores Anaya, Monika Chorąży, Hanne Christensen, Thomas Christensen, Lisa M. Christian, Francesco Chu, Chung Cs, W. Clark, Robert Clarke, Santiago Claverie, Elio Clemente Agostoni, Benjamin Clissold, José Leonardo Gomes Coelho, David Cohen, Şule Çolakoğlu, David Collas, R Condurso, SJ Connolly, Domenico Consoli, Carmen Constantin, AB Constantino Silva, Luca Contardo, Astrid Corlobé, Manuel Correia, Carlos Correia, E Cortijo Garcia, Bruce M. Coull, Shelagh B. Coutts, Sarah Coveney, Patrick Cras, R Crols, Sophie Crozier, Attila Csányi, László Csiba, Krista Csontos, Réka Csuha, Liying Cui, Luís Cunha, Sami Curtze, Magdalena Agata Czerska, Anna Członkowska, M Czurko, M Czuryszkiewicz, Monica Dagnino, Chengbo Dai, А. С. Дайнеко, Grzegorz Dałek, Dorte Damgaard, Alessandra Danese, Krishna Dani, V Danku, W Dario Toledo, Antoni Dávalos, Adam de Havenon, Jacques De Keyser, Nina De Klippel, Adinda De Pauw, Ann De Smedt, R De Torres, MM De Vries Basson, Jennifer L. Dearborn, Romina Deganutto, Michael DeGeorgia, Ichiro Deguchi, Antonio Del Giudice, Candice Delcourt, Raquel Delgado‐Mederos, Giacomo Della Marca, Benoît Delpont, S. Deltour, DL Demets, Martin Dennis, Jamsheed A. Desai, Joe Devine, I. Dhollander, MT Di Mascio, M. Diaconu, F. Díaz Otero, Josephine Dietzel, Exuperio Díez‐Tejedor, Nik S. Ding, Jie Ding, Marina Diomedi, Péter Diószeghy, Marisa Distefano, Valérie Domigo, E. Dorodnicov, Daiana Dossi, Fergus Doubal, I Druzenko, Ping Du, Juan Du, Taşkın Duman, Y. Duodu, Dipankar Dutta, Łukasz Dylewicz, Jens Eckstein, Eric Ehrensperger, Sven Ehrlich, Guillermo Einer Allende, B Elena Halac, Salim Elyas, JM Engelbrecht, Stefan T. Engelter, Magali Epinat, Fettah Eren, M Esbjörnsson, Begoña M. 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Notice bibliographique
RevueThe Lancet Neurology · 2018
Typearticle
Langueen
DomaineMedicine
ThématiqueCardiovascular and Diving-Related Complications
Établissements canadiensImpactWestern UniversityHamilton Health SciencesMcMaster UniversityPopulation Health Research Institute
Organismes subventionnairesJanssen PharmaceuticalsJanssen Research and DevelopmentCovidienBayer FundBoston Scientific CorporationSanofiGlaxoSmithKlineDaiichi-SankyoBoehringer IngelheimAmgenNational Heart, Lung, and Blood InstitutePfizerBristol-Myers SquibbBayer
Mots-clésMedicineRivaroxabanPatent foramen ovaleAspirinStroke (engine)Subgroup analysisInternal medicinePopulationRandomized controlled trialCardiologySurgeryPediatricsMeta-analysisWarfarinAtrial fibrillationMigraine
Résumé
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: =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.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
score de la tête « metaresearch » (Codex)0,007
score de la tête « metaresearch » (Gemma)0,012
Version: metacan-v3-hybrid-931329e0061cStatut de validation: machine_predicted_unvalidated
Catégories candidatesaucune
Catégories consensuellesaucune
DomaineSignal candidat: aucune · Signal consensuel: aucune
Devis d'étudeSignal candidat: Méta-analyse · Signal consensuel: Méta-analyse
GenreSignal candidat: Empirique · Signal consensuel: aucune
Score de désaccord entre enseignants0,010
Score d'incertitude au seuil0,035
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,007 | 0,012 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,001 |
| Méta-épidémiologie (sens large) | 0,010 | 0,037 |
| Bibliométrie | 0,002 | 0,002 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,002 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,002 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,004 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
Tête enseignante Opus0,106
Tête enseignante GPT0,322
Écart entre enseignants0,216 · la distance entre les deux têtes enseignantes sur ce seul travail
Statut de validation
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Les modèles n’ont appliqué aucune catégorie : rien dans la taxonomie ne correspondait à ce travail.
Devis d'étudeMéta-analyse
Domainenon disponible
GenreEmpirique
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».
En bref
Citations178
Publié2018
Routes d'admission1
Résumé présentoui