Circulation Journal
Online ISSN : 1347-4820
Print ISSN : 1346-9843
ISSN-L : 1346-9843
Target International Normalized Ratio Values for Preventing Thromboembolic and Hemorrhagic Events in Japanese Patients With Non-Valvular Atrial Fibrillation
– Results of the J-RHYTHM Registry –
Hiroshi InoueKen OkumuraHirotsugu AtarashiTakeshi YamashitaHideki OrigasaNaoko KumagaiMasayuki SakuraiYuichiro KawamuraIsao KubotaKazuo MatsumotoYoshiaki KanekoSatoshi OgawaYoshifusa AizawaMasaomi ChinushiItsuo KodamaEiichi WatanabeYukihiro KoretsuneYuji OkuyamaAkihiko ShimizuOsamu IgawaShigenobu BandoMasahiko FukataniTetsunori SaikawaAkiko Chishakion behalf of the J-RHYTHM Registry Investigators
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JOURNALS FREE ACCESS Advance online publication

Article ID: CJ-13-0290

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Abstract

Background: Target anticoagulation levels for warfarin in Japanese patients with non-valvular atrial fibrillation (NVAF) are unclear. Methods and Results: Of 7,527 patients with NVAF, 1,002 did not receive warfarin (non-warfarin group), and the remaining patients receiving warfarin were divided into 5 groups based on their baseline international normalized ratio (INR) of prothrombin time (≤1.59, 1.6–1.99, 2.0–2.59, 2.6–2.99, and ≥3.0). Patients were followed-up prospectively for 2 years. Primary endpoints were thromboembolic events (cerebral infarction, transient ischemic attack, and systemic embolism), and major hemorrhage requiring hospital admission. During the follow-up period, thromboembolic events occurred in 3.0% of non-warfarin group, but at lower frequencies in the warfarin groups (2.0, 1.3, 1.5, 0.6, and 1.8%/2 years for INR values of ≤1.59, 1.6–1.99, 2.0–2.59, 2.6–2.99, and ≥3.0, respectively; P=0.0059). Major hemorrhage occurred more frequently in warfarin groups (1.5, 1.8, 2.4, 3.3, and 4.1% for INR values ≤1.59, 1.6–1.99, 2.0–2.59, 2.6–2.99, and ≥3.0, respectively; P=0.0041) than in non-warfarin group (0.8%/2 years). These trends were maintained when the analyses were confined to patients aged ≥70 years. Conclusions: An INR of 1.6–2.6 is safe and effective at preventing thromboembolic events in patients with NVAF, particularly patients aged ≥70 years. An INR of 2.6–2.99 is also effective, but associated with a slightly increased risk in major hemorrhage. (UMIN Clinical Trials Registry UMIN000001569)

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© 2013 THE JAPANESE CIRCULATION SOCIETY
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