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January 2, 2017Journal of Arrhythmia97 citationsOpen Access

Current use of direct oral anticoagulants for atrial fibrillation in Japan: Findings from the SAKURA AF Registry

YOYasuo OkumuraKYKatsuaki YokoyamaNMNaoya Matsumoto

Key Result

Direct oral anticoagulant users had a lower baseline risk of stroke (CHADS2 score 0-1 in 46.9% vs 39.4%) compared to warfarin users, and inappropriate low dosing was observed in 19.7-27.6% of DOAC users.

Study Design

Type

Observational (n=3,266)

Multicenter

Yes

Structured PICO

Are there differences in patient characteristics and dosing appropriateness between DOAC and warfarin users in Japanese patients with atrial fibrillation?

P
Population
3,266 Japanese adults with atrial fibrillation receiving stroke prophylaxis with either direct oral anticoagulants or warfarin, evaluated for baseline clinical characteristics and dosing appropriateness.
E
Exposure
Direct oral anticoagulants (DOACs: dabigatran, rivaroxaban, apixaban, or edoxaban) prescribed at investigator discretion.
C
Comparator
Warfarin prescribed at investigator discretion.
O
Outcome
Appropriateness of anticoagulant dosing (under-dosing, appropriate-dosing, over-dosing, inappropriate-low-dosing) and baseline clinical characteristics.

In real-world Japanese practice, DOACs are preferentially prescribed to AF patients with lower stroke risk and better renal function compared to warfarin, but inappropriate low-dosing of DOACs (20-30%) and under-dosing of warfarin (32%) are highly prevalent.

Main Result

Absolute Event Rate: 46.9% vs 39.4%

p-value: p=<0.0001

Limitations

  • Registry incorporated only selected institutions in a limited geographical area (Tokyo area), which may not reflect all of Japan.
  • Did not include patients without anticoagulant drugs.
  • Small enrollment of edoxaban users.
  • Follow-up data to explore the incidences of strokes and bleeding and the time in therapeutic range (TTR) for warfarin were not yet available.
  • Incorporated only selected institutions in a limited geographical area, so data may not reflect all of Japan
  • Did not include patients without anticoagulant drugs
  • Small enrollment of edoxaban users
  • Definition of inappropriate-low-dosing for dabigatran and edoxaban may not reflect the same meaning as for rivaroxaban or apixaban
  • Follow-up data for stroke/bleeding and time in therapeutic range (TTR) for warfarin were not yet available

Abstract

Abstract Background Large‐scale investigations on the use of oral anticoagulants including direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) have not included Japanese patients. Methods We established the multicenter SAKURA AF Registry to support prospective observational research on the status of anticoagulation treatment, especially with DOAC, for AF in Japan. We enrolled 3266 AF patients treated with warfarin ( n =1577) or any of 4 DOACs ( n =1689) from 63 institutions (2 cardiovascular centers, 13 affiliated hospitals or community hospitals, and 48 private clinics) in the Tokyo area. Results We conducted our first analysis of the registry data, and although we found equivalent mean age between the DOAC and warfarin users (71.8±9.5 vs. 72.3±9.4 years, p =0.2117), we found a slightly lower risk of stroke (CHADS 2 score of 0 or 1 46.9% vs. 39.4%, p <0.0001) and significantly better creatinine clearance in DOAC users (70.4±27 vs. 65.6±25.7 mL/min, p <0.0001). Importantly, we documented under‐dosing in 32% of warfarin users and inappropriate‐low‐dosing in 19.7–27.6% of DOAC users. Conclusions Our initial analysis of the SAKURA AF Registry data clarified the real‐world use of anticoagulants, which includes DOACs and warfarin in Japan. The DOAC users were at a lower risk for stroke than the warfarin users. In 20–30% of DOAC users, the dose was inappropriately reduced.

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Cite This Study

Okumura et al. (2017) conducted an observational in Atrial fibrillation (n=3,266). Direct oral anticoagulants (DOACs) vs. Warfarin was evaluated on CHADS2 score of 0 or 1 (lower risk of stroke) (p=<0.0001). Direct oral anticoagulant users had a lower baseline risk of stroke (CHADS2 score 0-1 in 46.9% vs 39.4%) compared to warfarin users, and inappropriate low dosing was observed in 19.7-27.6% of DOAC users.

synapsesocial.com/papers/6a26fc936b66951f6099214chttps://doi.org/10.1016/j.joa.2016.11.003
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