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Int J Stroke. 2016 Jul;11(5):565-74. doi: 10.1177/1747493016632239. Epub 2016 Feb 29.

Three-month risk-benefit profile of anticoagulation after stroke with atrial fibrillation: The SAMURAI-Nonvalvular Atrial Fibrillation (NVAF) study.

Author information

1
Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.
2
Department of Neurology, Kobe City Medical Center General Hospital, Kobe, Japan.
3
Department of Stroke Neurology, Kohnan Hospital, Sendai, Japan.
4
Department of Neurology, National Cerebral and Cardiovascular Center, Suita, Japan.
5
Department of Stroke Medicine, Kawasaki Medical School, Kurashiki, Japan.
6
Department of Neurology, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan.
7
Departments of Neurosurgery and Stroke Center, Kyorin University School of Medicine, Mitaka, Japan.
8
Department of Neurosurgery, Nakamura Memorial Hospital, Sapporo, Japan.
9
Department of Neurology, Tokai University School of Medicine, Isehara, Japan.
10
Department of Neurology, NHO Nagoya Medical Center, Nagoya, Japan.
11
Department of Neurology and Cerebrovascular Medicine, NHO Kyushu Medical Center, Fukuoka, Japan.
12
Department of Neurology, Kyoto Second Red Cross Hospital, Kyoto, Japan.
13
Division of Neurology, Jichi Medical University School of Medicine, Shimotsuke, Japan.
14
Department of Neurology, St Marianna University School of Medicine, Kawasaki, Japan.
15
Department of Neurology, South Miyagi Medical Center, Ogawara, Japan.
16
Department of Neurology, TOYOTA Memorial Hospital, Toyota, Japan.
17
Department of Cerebrovascular Medicine, NHO Kagoshima Medical Center, Kagoshima, Japan.
18
Department of Neurology, Ohta Memorial Hospital, Fukuyama, Japan.
19
Department of Neurology, Kitasato University School of Medicine, Sagamihara, Japan.
20
Division of Cardiovascular Medicine, Jichi Medical University School of Medicine, Shimotsuke, Japan.
21
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
22
Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan toyoda@ncvc.go.jp.

Abstract

AIMS:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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.

KEYWORDS:

Acute stroke care; anticoagulant; atrial fibrillation; cardioembolism; intracranial hemorrhage; stroke outcome; warfarin

PMID:
26927811
DOI:
10.1177/1747493016632239
[Indexed for MEDLINE]

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