Rivaroxaban is not inferior to warfarin with regard to safety and efficacy outcomes in patients treated for mild atrial fibrillation (AF)-related acute ischemic stroke, according to results of a retrospective, phase 2 clinical trial published in JAMA Neurology.
Investigators of this trial sought to compare the efficacy and safety outcomes of rivaroxaban and warfarin in patients diagnosed with acute ischemic stroke related to AF. The primary end point was the composite of a new ischemic lesion or intracranial hemorrhage as evidenced by magnetic resonance imaging (MRI) at 4 weeks.
In this study, patients were included in the final primary end point analysis if they presented with electrocardiogram-documented nonvalvular AF and a cardioembolism-induced acute ischemic stroke as evidenced by MRI. In addition, patients suitable for early anticoagulation therapy were also included. A total of 183 patients were included in the final primary end point analysis. Patients received either rivaroxaban (n=95) or warfarin (n=88).
Patients receiving rivaroxaban experienced no difference in the primary end point when compared with the warfarin group (47 [49.5%] vs 48 [54.5%]; relative risk [RR] 0.91; 95% CI, 0.69-1.20; P =.49). In addition, no differences were observed between the 2 groups in terms of the primary end point’s individual components, including a new ischemic lesion (28 [29.5%] vs 31 of 87 [35.6%]; RR 0.83; 95% CI, 0.54-1.26; P =.38) and new intracranial hemorrhage (30 [31.6%] vs 25 of 87 [28.7%]; RR 1.10; 95% CI, 0.70-1.71; P =.68).
Investigators noticed that rivaroxaban was associated with significantly reduced hospital length of stay compared with warfarin (median, 4 days [interquartile range, 2-6 days] vs 6 days [interquartile range, 4-8]; P <.001).
Since this study featured an open-label design, there is a potential risk for reporting bias of clinical events. In addition, the investigators noted that the quality of anticoagulation with warfarin was low, suggesting the study’s findings “might not be applicable to populations with high-quality anticoagulation with warfarin therapy.” The study also examined patients with mild stroke severity, so these findings are not applicable to patients with moderate to severe stroke.
Disclosures: This study was supported by Bayer Korea Ltd and grants HI14C1061 and HI10C2020 from the Korean Health Technology R&D Project, Ministry of Health & Welfare, Republic of Korea.
Hong KS, Kwon SU, Lee SH, et al. Rivaroxaban vs warfarin sodium in the ultra-early period after atrial fibrillation-related mild ischemic stroke: a randomized clinical trial [published online September 11, 2017]. JAMA Neurol. doi:10.1001/jamaneurol.2017.2161