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Rivaroxaban vs warfarin sodium in the ultra-early period after atrial fibrillation-related mild ischemic stroke: A randomized clinical trial

JAMA Neurology Sep 14, 2017

Hong KS, et al. - Researchers aspired to examine whether rivaroxaban or warfarin sodium was safer and more effective for preventing early recurrent stroke in patients with atrial fibrillation (AF)-related acute ischemic stroke. They concluded that rivaroxaban and warfarin had similar safety and efficacy in mild AF-related acute ischemic stroke.

Methods
  • From April 28, 2014, to December 7, 2015, the researchers conducted a randomized, multicenter, open-label, blinded end point evaluation, comparative phase 2 trial, at 14 academic medical centers in South Korea among patients with mild AF-related stroke within the previous 5 days who were deemed suitable for early anticoagulation.
  • They performed the analysis on a modified intent-to-treat basis.
  • They randomized participants 1:1 to receive rivaroxaban, 10 mg/d for 5 days followed by 15 or 20 mg/d, or warfarin with a target international normalized ratio of 2.0-3.0, for 4 weeks.
  • The composite of new ischemic lesion or new intracranial hemorrhage seen on results of magnetic resonance imaging at 4 weeks was the primary end point.
  • They performed primary analysis in patients who received at least 1 dose of study medications and completed follow-up magnetic resonance imaging.
  • Individual components of the primary end point and hospitalization length were the key secondary end points.

Results
  • Magnetic resonance imaging follow-up was completed by 183 individuals (76 women and 107 men; mean [SD] age, 70.4 [10.4] years), among 195 patients randomized and were included in the primary end point analysis.
  • The rivaroxaban group (n = 95) and warfarin group (n = 88) demonstrated no differences in the primary end point (47 [49.5%] vs 48 [54.5%]; relative risk, 0.91; 95% CI, 0.69-1.20; P = .49) or its individual components (new ischemic lesion: 28 [29.5%] vs 31 of 87 [35.6%]; relative risk, 0.83; 95% CI, 0.54-1.26; P = .38; new intracranial hemorrhage: 30 [31.6%] vs 25 of 87 [28.7%]; relative risk, 1.10; 95% CI, 0.70-1.71; P = .68).
  • The researchers observed 1 clinical ischemic stroke in each group, and all new intracranial hemorrhages were asymptomatic hemorrhagic transformations.
  • Compared with warfarin, hospitalization length was reduced with rivaroxaban (median, 4.0 days [interquartile range, 2.0-6.0 days] vs 6.0 days [interquartile range, 4.0-8.0]; P < .001).
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