Oral anticoagulant use and clinical outcomes in elderly Japanese patients: findings from the SAKURA AF Registry
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Direct-acting oral anticoagulants (DOACs) are widely used in aged Japanese patients with atrial fibrillation (AF), but outcome data for such patients are limited. We compared outcomes between 1895 (58.5%) patients aged < 75 years (non-elderly), 1078 (33.3%) 75–84 years (elderly) and 264 (8.2%) ≥ 85 years (very elderly) enrolled in a prospective multicenter registry. Kaplan–Meier analysis (median follow-up: 39.3 months) revealed a significantly high incidence of stroke/systemic embolism (SE) among the very elderly relative to that among the non-elderly or elderly (3.2 vs. 1.2 and 1.5 events per 100 patient-years, p < 0.001). Major bleeding in the non-elderly group was significantly infrequent relative to that among the elderly or very elderly group (1.1 vs. 1.6 vs. 1.8 events, p = 0.033). After multivariate adjustment, the stroke/SE incidence was comparable between DOAC and warfarin users, regardless of age, but major bleeding decreased significantly among very elderly DOAC users (adjusted HR 0.220, 95% CI 0.042–0.920). The greater increasing incidence of stroke/SE than major bleeding as patients age suggests that stroke prevention should outweigh the bleeding risk when anticoagulants are being considered for aged patients. Our data indicated that DOACs can be a therapeutic option for stroke prevention in very elderly patients.
KeywordsDirect oral anticoagulant Warfarin Atrial fibrillation Aged
The authors thank all centers involved in the study and all patients who consented to enroll in the registry. We also thank Mr. Seiji Udagawa for assistance with the statistical analysis, and we thank Ms. Wendy Alexander-Adams for encouragement and assistance with the reporting of our findings in English.
The study was supported financially by Bayer Yakuhin Ltd and conducted as an investigator-initiated research project based on a contract with Bayer Yakuhin Ltd. The study was also supported by scholarship funds from Daiichi-Sankyo, Astellas Pharma, Eisai, Sumitomo Dainippon Pharma, MSD, Nihon Medi-Physics, Bristol-Meyers Squibb, Boehringer Ingelheim, and Pfizer.
Compliance with ethical standards
Conflict of interest
Dr. Okumura has accepted remuneration from Daiichi-Sankyo; Dr. Hirayama has received research funding from Bayer Healthcare, Daiichi-Sankyo, Otsuka Pharmaceutical, Astellas Pharma, Eisai, Sumitomo Dainippon Pharma, MSD, Nihon Medi-Physics, Bristol-Meyers Squibb, Boehringer Ingelheim, Pfizer, Boston Scientific Corporation, Hokushin Medical, and has accepted remuneration from Bayer Healthcare, Daiichi-Sankyo, Eisai, Bristol-Meyers Squibb, Astellas Pharma, Sanofi, and Takeda Pharmaceutical; Dr Matsumoto has received research funding from Daiichi-Sankyo, Otsuka Pharmaceutical, and Sumitomo Dainippon Pharma, and has accepted remuneration from Nihon Medi-Physics, FUJIFILM RI Pharma, and Biosensors Interventional Technologies Japan.
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