Rivaroxaban or aspirin for patent foramen ovale and embolic stroke of undetermined source: a prespecified subgroup analysis from the NAVIGATE ESUS trial

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dc.contributor.authorKasner, Scott
dc.contributor.authorSwaminathan, Balakumar
dc.contributor.authorLavados, Pablo
dc.contributor.authorSharma, Mukul
dc.contributor.authorMuir, Keith
dc.contributor.authorVeltkamp, Roland
dc.contributor.authorAmeriso, Sebastian
dc.contributor.authorEndres, Matthias
dc.contributor.authorLutsep, Helmi
dc.contributor.authorMessé, Steven
dc.contributor.authorSpence, John
dc.contributor.authorNedeltechev, Krassen
dc.contributor.authorPerera, Kanjana
dc.contributor.authorSanto, Gustavo
dc.contributor.authorOlavarria, Veronica
dc.contributor.authorLindgren, Arne
dc.contributor.authorBangdiwala, Shrikant
dc.contributor.authorShoamanesh, Ashkan
dc.contributor.authorBerkowitz, Scott
dc.contributor.authorMundl, Hardi
dc.contributor.authorConnolly, Stuart
dc.contributor.authorHart, Robert
dc.contributor.authorNAVIGATE ESUS Investigators
dc.date.accessioned2022-05-18T14:28:46Z
dc.date.available2022-05-18T14:28:46Z
dc.date.issued2018
dc.description.abstractBackground: 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.es
dc.description.versionVersión publicadaes
dc.identifier.citationKasner SE, Swaminathan B, Lavados P, Sharma M, Muir K, Veltkamp R, Ameriso SF, Endres M, Lutsep H, Messé SR, Spence JD, Nedeltechev K, Perera K, Santo G, Olavarria V, Lindgren A, Bangdiwala S, Shoamanesh A, Berkowitz SD, Mundl H, Connolly SJ, Hart RG; NAVIGATE ESUS Investigators. Rivaroxaban or aspirin for patent foramen ovale and embolic stroke of undetermined source: a prespecified subgroup analysis from the NAVIGATE ESUS trial. Lancet Neurol. 2018 Dec;17(12):1053-1060. doi: 10.1016/S1474-4422(18)30319-3.es
dc.identifier.urihttps://doi.org/10.1016/S1474-4422(18)30319-3es
dc.identifier.urihttp://hdl.handle.net/11447/6098
dc.language.isoenes
dc.subjectFactor Xa Inhibitors / therapeutic usees
dc.subjectAspirin / therapeutic usees
dc.subjectCohort Studieses
dc.subjectFemalees
dc.subjectInternational Cooperationes
dc.subjectPlatelet Aggregation Inhibitors / therapeutic usees
dc.subjectRivaroxaban / therapeutic usees
dc.subjectStatistics, Nonparametrices
dc.subjectStroke / drug therapyes
dc.titleRivaroxaban or aspirin for patent foramen ovale and embolic stroke of undetermined source: a prespecified subgroup analysis from the NAVIGATE ESUS triales
dc.typeArticlees
dcterms.sourceThe Lancet. Neurologyes

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