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Rivaroxaban vs Warfarin Sodium in the Ultra-Early Period After Atrial Fibrillation-Related Mild Ischemic Stroke: A Randomized Clinical Trial

Authors
 Keun-Sik Hong  ;  Sun U Kwon  ;  Sang Hun Lee  ;  Ji Sung Lee  ;  Yong-Jae Kim  ;  Tae-Jin Song  ;  Young Dae Kim  ;  Man-Seok Park  ;  Eung-Gyu Kim  ;  Jae-Kwan Cha  ;  Sang Min Sung  ;  Byung-Woo Yoon  ;  Oh Young Bang  ;  Woo-Keun Seo  ;  Yang-Ha Hwang  ;  Seong Hwan Ahn  ;  Dong-Wha Kang  ;  Hyun Goo Kang  ;  Kyung-Ho Yu 
Citation
 JAMA NEUROLOGY, Vol.74(10) : 1206-1215, 2017-10 
Journal Title
 JAMA NEUROLOGY 
ISSN
 2168-6149 
Issue Date
2017-10
MeSH
Aged ; Aged, 80 and over ; Anticoagulants / therapeutic use* ; Atrial Fibrillation / complications ; Atrial Fibrillation / diagnostic imaging ; Atrial Fibrillation / drug therapy* ; Diffusion Magnetic Resonance Imaging ; Factor Xa Inhibitors / therapeutic use* ; Female ; Follow-Up Studies ; Humans ; Intracranial Hemorrhages / etiology ; Magnetic Resonance Angiography ; Male ; Middle Aged ; Republic of Korea ; Rivaroxaban / therapeutic use* ; Stroke / complications ; Stroke / diagnostic imaging ; Stroke / drug therapy* ; Treatment Outcome ; Warfarin / therapeutic use*
Abstract
Importance: In atrial fibrillation (AF)-related acute ischemic stroke, the optimal oral anticoagulation strategy remains unclear. Objective: To test whether rivaroxaban or warfarin sodium is safer and more effective for preventing early recurrent stroke in patients with AF-related acute ischemic stroke. Design, setting, and participants: A randomized, multicenter, open-label, blinded end point evaluation, comparative phase 2 trial was conducted from April 28, 2014, to December 7, 2015, 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. Analysis was performed on a modified intent-to-treat basis. Interventions: Participants were randomized 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. Main outcomes and measures: The primary end point was the composite of new ischemic lesion or new intracranial hemorrhage seen on results of magnetic resonance imaging at 4 weeks. Primary analysis was performed in patients who received at least 1 dose of study medications and completed follow-up magnetic resonance imaging. Key secondary end points were individual components of the primary end point and hospitalization length. Results: Of 195 patients randomized, 183 individuals (76 women and 107 men; mean [SD] age, 70.4 [10.4] years) completed magnetic resonance imaging follow-up and were included in the primary end point analysis. The rivaroxaban group (n = 95) and warfarin group (n = 88) showed 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). Each group had 1 clinical ischemic stroke, and all new intracranial hemorrhages were asymptomatic hemorrhagic transformations. Hospitalization length was reduced with rivaroxaban compared with warfarin (median, 4.0 days [interquartile range, 2.0-6.0 days] vs 6.0 days [interquartile range, 4.0-8.0]; P < .001). Conclusions and relevance: In mild AF-related acute ischemic stroke, rivaroxaban and warfarin had comparable safety and efficacy. Trial registration: clinicaltrials.gov Identifier: NCT02042534.
Full Text
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5710243/?report=printable
DOI
10.1001/jamaneurol.2017.2161
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Neurology (신경과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Young Dae(김영대) ORCID logo https://orcid.org/0000-0001-5750-2616
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/178329
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