Kasner, SE; Swaminathan, B; Lavados, P; Sharma, M; Muir, K; Veltkamp, R; Ameriso, SF; ... NAVIGATE ESUS Investigators; + view all Kasner, 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; - view fewer (2018) 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 , 17 (12) pp. 1053-1060. 10.1016/S1474-4422(18)30319-3.

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Abstract

Background: Patent foramen ovale (PFO) is a contributor to embolic stroke of undetermined source (ESUS). Subgroup analyses from prior studies suggest that anticoagulation could reduce recurrent stroke compared with antiplatelet therapy. We hypothesized that anticoagulant treatment with rivaroxaban, an oral factor-Xa inhibitor, would reduce the risk of recurrent stroke compared with aspirin among patients with PFO enrolled in the NAVIGATE-ESUS trial. Methods: The NAVIGATE-ESUS double-blind, randomised trial assessed the efficacy and safety of rivaroxaban 15mg versus aspirin 100mg once daily for secondary stroke prevention in patients with ESUS. For this prespecified subgroup analysis, cohorts with and without PFO were defined based on transthoracic(TTE) and transesophageal echocardiography(TEE). The primary efficacy outcome was time-to-recurrent ischemic stroke between treatment groups. In addition, a systematic review of the literature incorporated prior studies in which patients with cryptogenic stroke and PFO were randomly assigned to anticoagulant or antiplatelet therapy. Findings: 7213 participants were enrolled and followed for a mean of 11 months due to early trial termination. PFO was reported as present in 534 (7.4%) patients based on either TTE or TEE. Aspirinassigned patients with PFO had a recurrent stroke rate of 4.8% per year. Among patients with known PFO, there was insufficient evidence to support a difference in hazards between rivaroxaban and aspirin (HR 0.54; 95%CI:0.22-1.36), while hazards were high similar for those without known PFO (HR 1.06; 95%CI:0.84-1.33); the interaction was not statistically significant (p=0.18). Major bleeding was likely increased with rivaroxaban compared with aspirin (HR 2.05; 95%CI:0.51-8.2) in patients with PFO. Systematic review that included 2 prior trials yielded a summary odds ratio of 0.48 (95%CI:0.24-0.96; p=0.04) in favour of anticoagulation, without evidence of heterogeneity. Interpretation: Among patients with ESUS who have PFO, anticoagulation may reduce the risk of recurrent stroke by about half, though substantial imprecision remains. Dedicated trials of anticoagulation vs. antiplatelet therapy and/or PFO closure are warranted.

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