title: Three-month risk-benefit profile of anticoagulation after stroke with atrial fibrillation: The SAMURAI-Nonvalvular Atrial Fibrillation (NVAF) study.
abstract: This study was performed to determine the short-term risk-benefit profiles of patients treated with oral anticoagulation for acute ischemic stroke or transient ischemic attack using a multicenter, prospective registry.
  
  
  
  A total of 1137 patients (645 men, 77 ± 10 years old) with acute ischemic stroke/transient ischemic attack taking warfarin (662 patients) or non-vitamin K antagonist oral anticoagulants (dabigatran in 205, rivaroxaban in 245, apixaban in 25 patients) for nonvalvular atrial fibrillation who completed a three-month follow-up survey were studied. Choice of anticoagulants was not randomized. Primary outcome measures were stroke/systemic embolism and major bleeding.
  
  
  
  Both warfarin and non-vitamin K antagonist oral anticoagulants were initiated within four days after stroke/transient ischemic attack onset in the majority of cases. Non-vitamin K antagonist oral anticoagulant users had lower ischemia- and bleeding-risk indices (CHADS2, CHA2DS2-VASc, HAS-BLED) and milder strokes than warfarin users. The three-month cumulative rate of stroke/systemic embolism was 3.06% (95% CI 1.96%-4.74%) in warfarin users and 2.84% (1.65%-4.83%) in non-vitamin K antagonist oral anticoagulant users (adjusted HR 0.96, 95% CI 0.44-2.04). The rate of major bleeding was 2.61% (1.60%-4.22%) and 1.11% (0.14%-1.08%), respectively (HR 0.63, 0.19-1.78); that for intracranial hemorrhage was marginally significantly lower in non-vitamin K antagonist oral anticoagulant users (HR 0.17, 0.01-1.15). Major bleeding did not occur in non-vitamin K antagonist oral anticoagulant users with a CHADS2 score <4 or those with a discharge modified Rankin Scale score ≤2.
  
  
  
  Stroke or systemic embolism during the initial three-month anticoagulation period after stroke/transient ischemic attack was not frequent as compared to previous findings regardless of warfarin or non-vitamin K antagonist oral anticoagulants were used. Intracranial hemorrhage was relatively uncommon in non-vitamin K antagonist oral anticoagulant users, although treatment assignment was not randomized. Early initiation of non-vitamin K antagonist oral anticoagulants during the acute stage of stroke/transient ischemic attack in real-world clinical settings seems safe in bleeding-susceptible Japanese population.
authors.affiliation: Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.
authors.forename: Shoji
authors.initials: S
authors.lastname: Arihiro
authors.affiliation: Department of Neurology, Kobe City Medical Center General Hospital, Kobe, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Todo
authors.affiliation: Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.
authors.forename: Masatoshi
authors.initials: M
authors.lastname: Koga
authors.affiliation: Department of Stroke Neurology, Kohnan Hospital, Sendai, Japan.
authors.forename: Eisuke
authors.initials: E
authors.lastname: Furui
authors.affiliation: Department of Neurology, National Cerebral and Cardiovascular Center, Suita, Japan.
authors.forename: Naoto
authors.initials: N
authors.lastname: Kinoshita
authors.affiliation: Department of Stroke Medicine, Kawasaki Medical School, Kurashiki, Japan.
authors.forename: Kazumi
authors.initials: K
authors.lastname: Kimura
authors.affiliation: Department of Neurology, National Cerebral and Cardiovascular Center, Suita, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Yamagami
authors.affiliation: Department of Neurology, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan.
authors.forename: Tadashi
authors.initials: T
authors.lastname: Terasaki
authors.affiliation: Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.
authors.forename: Sohei
authors.initials: S
authors.lastname: Yoshimura
authors.affiliation: Departments of Neurosurgery and Stroke Center, Kyorin University School of Medicine, Mitaka, Japan.
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Shiokawa
authors.affiliation: Department of Neurosurgery, Nakamura Memorial Hospital, Sapporo, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Kamiyama
authors.affiliation: Department of Neurology, Tokai University School of Medicine, Isehara, Japan.
authors.forename: Shunya
authors.initials: S
authors.lastname: Takizawa
authors.affiliation: Department of Neurology, NHO Nagoya Medical Center, Nagoya, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Okuda
authors.affiliation: Department of Neurology and Cerebrovascular Medicine, NHO Kyushu Medical Center, Fukuoka, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Okada
authors.affiliation: Department of Neurology, Kyoto Second Red Cross Hospital, Kyoto, Japan.
authors.forename: Yoshinari
authors.initials: Y
authors.lastname: Nagakane
authors.affiliation: Division of Neurology, Jichi Medical University School of Medicine, Shimotsuke, Japan.
authors.forename: Tomoaki
authors.initials: T
authors.lastname: Kameda
authors.affiliation: Department of Neurology, St Marianna University School of Medicine, Kawasaki, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Hasegawa
authors.affiliation: Department of Neurology, South Miyagi Medical Center, Ogawara, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Shibuya
authors.affiliation: Department of Neurology, TOYOTA Memorial Hospital, Toyota, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Ito
authors.affiliation: Department of Cerebrovascular Medicine, NHO Kagoshima Medical Center, Kagoshima, Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Nakashima
authors.affiliation: Department of Neurology, Ohta Memorial Hospital, Fukuyama, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Takamatsu
authors.affiliation: Department of Neurology, Kitasato University School of Medicine, Sagamihara, Japan.
authors.forename: Kazutoshi
authors.initials: K
authors.lastname: Nishiyama
authors.affiliation: Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Matsuki
authors.affiliation: Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.
authors.forename: Kazunari
authors.initials: K
authors.lastname: Homma
authors.affiliation: Department of Neurology, Kobe City Medical Center General Hospital, Kobe, Japan.
authors.forename: Junji
authors.initials: J
authors.lastname: Takasugi
authors.affiliation: Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.
authors.forename: Keisuke
authors.initials: K
authors.lastname: Tokunaga
authors.affiliation: Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.
authors.forename: Shoichiro
authors.initials: S
authors.lastname: Sato
authors.affiliation: Division of Cardiovascular Medicine, Jichi Medical University School of Medicine, Shimotsuke, Japan.
authors.forename: Kazuomi
authors.initials: K
authors.lastname: Kario
authors.affiliation: Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Takanari
authors.initials: T
authors.lastname: Kitazono
authors.affiliation: Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan toyoda@ncvc.go.jp.
authors.forename: Kazunori
authors.initials: K
authors.lastname: Toyoda
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000150:complications* / Q000188:drug therapy; D002545:Brain Ischemia / Q000150:complications* / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006760:Hospitalization; D006801:Humans; D007564:Japan; D008297:Male; D011446:Prospective Studies; D012042:Registries; D018570:Risk Assessment; D020521:Stroke / Q000150:complications* / Q000188:drug therapy*; D016896:Treatment Outcome; D014859:Warfarin / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D000925:Anticoagulants; D014859:Warfarin
keywords: Acute stroke care; anticoagulant; atrial fibrillation; cardioembolism; intracranial hemorrhage; stroke outcome; warfarin