Oral Anticoagulants in Very Elderly Nonvalvular Atrial Fibrillation Patients With High Bleeding Risks: ANAFIE Registry

Ken Okumura, Takeshi Yamashita, Masaharu Akao, Hirotsugu Atarashi, Takanori Ikeda, Yukihiro Koretsune, Wataru Shimizu, Shinya Suzuki, Hiroyuki Tsutsui, Kazunori Toyoda, Atsushi Hirayama, Masahiro Yasaka, Takenori Yamaguchi, Satoshi Teramukai, Tetsuya Kimura, Yoshiyuki Morishima, Atsushi Takita, Hiroshi Inoue

Research output: Contribution to journalArticlepeer-review

7 Citations (Scopus)


Background: Data on the effectiveness and safety of oral anticoagulant (OAC) agents in very elderly nonvalvular atrial fibrillation patients with high bleeding risk are lacking. Objectives: This study examined 2-year outcomes and effects of OAC agents among these patients using the ANAFIE (All Nippon Atrial Fibrillation in the Elderly) registry (N = 32,275) data. Methods: Patients were classified into high-risk (age: ≥80 years; CHADS2 score: ≥2; and presence of ≥1 bleeding risk factor: creatinine clearance of 15-30 mL/minute, prior bleeding at critical sites, body weight of ≤45 kg, or continuous antiplatelet use) and reference groups. Results: In the high-risk (n = 7,104) and reference (n = 25,171) group patients, 89.0% and 93.4%, respectively, used OAC agents. Of these, respectively, 30.1% and 24.2% used warfarin, and 58.9% and 69.1% used direct-acting OAC (DOAC) agents. Compared with the reference group, the high-risk group had higher incidences of stroke/systemic embolism, major bleeding, intracranial hemorrhage, gastrointestinal bleeding, cardiovascular events, and all-cause death. In the high-risk group, DOAC agent use vs nonuse of OAC agents was associated with reduced incidences of stroke/systemic embolism (HR: 0.53; 95% CI: 0.36-0.79) and all-cause death (HR: 0.65; 95% CI: 0.52-0.81) but not with major bleeding (HR: 1.09; 95% CI: 0.63-1.89). DOAC agents were superior to warfarin in effectiveness and safety. For high-risk patients, history of major bleeding, severe liver dysfunction, and falls within 1 year were independent risk factors for major bleeding. Conclusions: High-risk elderly nonvalvular atrial fibrillation patients had higher event incidences. DOAC agents were associated with reduced risk of stroke/systemic embolism and all-cause death vs nonuse of OAC agents or warfarin.

Original languageEnglish
Pages (from-to)720-733
Number of pages14
JournalJACC: Asia
Issue number6
Publication statusPublished - Nov 2022

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine


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