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

Shoji Arihiro, Kenichi Todo, Masatoshi Koga, Eisuke Furui, Naoto Kinoshita, Kazumi Kimura, Hiroshi Yamagami, Tadashi Terasaki, Sohei Yoshimura, Yoshiaki Shiokawa, Kenji Kamiyama, Shunya Takizawa, Satoshi Okuda, Yasushi Okada, Yoshinari Nagakane, Tomoaki Kameda, Yasuhiro Hasegawa, Satoshi Shibuya, Yasuhiro Ito, Takahiro NakashimaKazuhiro Takamatsu, Kazutoshi Nishiyama, Takayuki Matsuki, Kazunari Homma, Junji Takasugi, Keisuke Tokunaga, Shoichiro Sato, Kazuomi Kario, Takanari Kitazono, Kazunori Toyoda

Research output: Contribution to journalArticle

29 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)565-574
Number of pages10
JournalInternational Journal of Stroke
Volume11
Issue number5
DOIs
Publication statusPublished - Jan 1 2016

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Anticoagulants
Atrial Fibrillation
Stroke
Transient Ischemic Attack
Warfarin
Hemorrhage
Embolism
Intracranial Hemorrhages
Registries
Ischemia
Outcome Assessment (Health Care)

All Science Journal Classification (ASJC) codes

  • Neurology

Cite this

Three-month risk-benefit profile of anticoagulation after stroke with atrial fibrillation : The SAMURAI-Nonvalvular Atrial Fibrillation (NVAF) study. / Arihiro, Shoji; Todo, Kenichi; Koga, Masatoshi; Furui, Eisuke; Kinoshita, Naoto; Kimura, Kazumi; Yamagami, Hiroshi; Terasaki, Tadashi; Yoshimura, Sohei; Shiokawa, Yoshiaki; Kamiyama, Kenji; Takizawa, Shunya; Okuda, Satoshi; Okada, Yasushi; Nagakane, Yoshinari; Kameda, Tomoaki; Hasegawa, Yasuhiro; Shibuya, Satoshi; Ito, Yasuhiro; Nakashima, Takahiro; Takamatsu, Kazuhiro; Nishiyama, Kazutoshi; Matsuki, Takayuki; Homma, Kazunari; Takasugi, Junji; Tokunaga, Keisuke; Sato, Shoichiro; Kario, Kazuomi; Kitazono, Takanari; Toyoda, Kazunori.

In: International Journal of Stroke, Vol. 11, No. 5, 01.01.2016, p. 565-574.

Research output: Contribution to journalArticle

Arihiro, S, Todo, K, Koga, M, Furui, E, Kinoshita, N, Kimura, K, Yamagami, H, Terasaki, T, Yoshimura, S, Shiokawa, Y, Kamiyama, K, Takizawa, S, Okuda, S, Okada, Y, Nagakane, Y, Kameda, T, Hasegawa, Y, Shibuya, S, Ito, Y, Nakashima, T, Takamatsu, K, Nishiyama, K, Matsuki, T, Homma, K, Takasugi, J, Tokunaga, K, Sato, S, Kario, K, Kitazono, T & Toyoda, K 2016, 'Three-month risk-benefit profile of anticoagulation after stroke with atrial fibrillation: The SAMURAI-Nonvalvular Atrial Fibrillation (NVAF) study', International Journal of Stroke, vol. 11, no. 5, pp. 565-574. https://doi.org/10.1177/1747493016632239
Arihiro, Shoji ; Todo, Kenichi ; Koga, Masatoshi ; Furui, Eisuke ; Kinoshita, Naoto ; Kimura, Kazumi ; Yamagami, Hiroshi ; Terasaki, Tadashi ; Yoshimura, Sohei ; Shiokawa, Yoshiaki ; Kamiyama, Kenji ; Takizawa, Shunya ; Okuda, Satoshi ; Okada, Yasushi ; Nagakane, Yoshinari ; Kameda, Tomoaki ; Hasegawa, Yasuhiro ; Shibuya, Satoshi ; Ito, Yasuhiro ; Nakashima, Takahiro ; Takamatsu, Kazuhiro ; Nishiyama, Kazutoshi ; Matsuki, Takayuki ; Homma, Kazunari ; Takasugi, Junji ; Tokunaga, Keisuke ; Sato, Shoichiro ; Kario, Kazuomi ; Kitazono, Takanari ; Toyoda, Kazunori. / Three-month risk-benefit profile of anticoagulation after stroke with atrial fibrillation : The SAMURAI-Nonvalvular Atrial Fibrillation (NVAF) study. In: International Journal of Stroke. 2016 ; Vol. 11, No. 5. pp. 565-574.
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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.",
author = "Shoji Arihiro and Kenichi Todo and Masatoshi Koga and Eisuke Furui and Naoto Kinoshita and Kazumi Kimura and Hiroshi Yamagami and Tadashi Terasaki and Sohei Yoshimura and Yoshiaki Shiokawa and Kenji Kamiyama and Shunya Takizawa and Satoshi Okuda and Yasushi Okada and Yoshinari Nagakane and Tomoaki Kameda and Yasuhiro Hasegawa and Satoshi Shibuya and Yasuhiro Ito and Takahiro Nakashima and Kazuhiro Takamatsu and Kazutoshi Nishiyama and Takayuki Matsuki and Kazunari Homma and Junji Takasugi and Keisuke Tokunaga and Shoichiro Sato and Kazuomi Kario and Takanari Kitazono and Kazunori Toyoda",
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TY - JOUR

T1 - Three-month risk-benefit profile of anticoagulation after stroke with atrial fibrillation

T2 - The SAMURAI-Nonvalvular Atrial Fibrillation (NVAF) study

AU - Arihiro, Shoji

AU - Todo, Kenichi

AU - Koga, Masatoshi

AU - Furui, Eisuke

AU - Kinoshita, Naoto

AU - Kimura, Kazumi

AU - Yamagami, Hiroshi

AU - Terasaki, Tadashi

AU - Yoshimura, Sohei

AU - Shiokawa, Yoshiaki

AU - Kamiyama, Kenji

AU - Takizawa, Shunya

AU - Okuda, Satoshi

AU - Okada, Yasushi

AU - Nagakane, Yoshinari

AU - Kameda, Tomoaki

AU - Hasegawa, Yasuhiro

AU - Shibuya, Satoshi

AU - Ito, Yasuhiro

AU - Nakashima, Takahiro

AU - Takamatsu, Kazuhiro

AU - Nishiyama, Kazutoshi

AU - Matsuki, Takayuki

AU - Homma, Kazunari

AU - Takasugi, Junji

AU - Tokunaga, Keisuke

AU - Sato, Shoichiro

AU - Kario, Kazuomi

AU - Kitazono, Takanari

AU - Toyoda, Kazunori

PY - 2016/1/1

Y1 - 2016/1/1

N2 - 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.

AB - 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.

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