Hiroshi Inoue1, Takeshi Yamashita2, Masaharu Akao3, Hirotsugu Atarashi4, Takanori Ikeda5, Ken Okumura6, Yukihiro Koretsune7, Wataru Shimizu8, Hiroyuki Tsutsui9, Kazunori Toyoda10, Atsushi Hirayama11, Masahiro Yasaka12, Takenori Yamaguchi13, Masahiro Akishita14, Naoyuki Hasebe15, Kazuomi Kario16, Yuji Mizokami17, Ken Nagata18, Masato Nakamura19, Yasuo Terauchi20, Takatsugu Yamamoto21, Satoshi Teramukai22, Tetsuya Kimura23, Jumpei Kaburagi23, Atsushi Takita24. 1. Saiseikai Toyama Hospital, Toyama, Japan. Electronic address: h-inoue@saiseikai-toyama.jp. 2. The Cardiovascular Institute, Tokyo, Japan. 3. Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan. 4. Nippon Medical School, Tokyo, Japan. 5. Department of Cardiovascular Medicine, Toho University Faculty of Medicine, Tokyo, Japan. 6. Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan. 7. Institute for Clinical Research, National Hospital Organization Osaka National Hospital, Osaka, Japan. 8. Division of Cardiology, Nippon Medical School Department of Medicine, Tokyo, Japan. 9. Department of Cardiovascular Medicine, Kyushu University Graduate School of Medical Science, Fukuoka, Japan. 10. Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan. 11. Department of Cardiology, Nihon University Itabashi Hospital, Tokyo, Japan. 12. Department of Cerebrovascular Medicine and Neurology, Cerebrovascular Center, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan. 13. National Cerebral and Cardiovascular Center, Osaka, Japan. 14. Department of Geriatric Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. 15. First Department of Internal Medicine, Asahikawa Medical College, Hokkaido, Japan. 16. Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan. 17. Division of Gastroenterology, University of Tsukuba Hospital, Ibaraki, Japan. 18. Clinical Research Institute, Yokohama General Hospital, Kanagawa, Japan. 19. Department of Cardiovascular Medicine, Ohashi Hospital Medical Center, Toho University, Tokyo, Japan. 20. Department of Endocrinology and Metabolism, Graduate School of Medicine, Yokohama City University, Kanagawa, Japan. 21. Department of Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan. 22. Department of Biostatistics, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan. 23. Medical Science Department, Daiichi Sankyo, Tokyo, Japan. 24. Safety and Risk Management Department, Daiichi Sankyo, Tokyo, Japan.
Abstract
BACKGROUND: Although anticoagulation effectively prevents stroke in patients with atrial fibrillation (AF), it has been underused in elderly AF patients for many reasons, mainly because of knowledge gaps regarding cardiovascular treatment of these populations with multiple comorbidities and poor prognosis. The objectives of the All Nippon AF In the Elderly (ANAFIE) Registry are to collect real-world information about the clinical status of patients with non-valvular AF (NVAF) aged ≥75 years, current status of anticoagulant therapy, and prognosis with/without anticoagulation to establish a database for this specific patient population that is increasing remarkably worldwide. METHODS AND DESIGN: The ANAFIE Registry is an observational, multicenter, prospective study of Japanese patients with NVAF aged ≥75 years that will include 30,000 patients and have the primary endpoint of composite of stroke and systemic embolism over a 2-year follow-up period. In parallel with the main study, seven sub-cohort studies will be conducted with assessments including coagulation-fibrinolysis markers, echocardiography, heart rate, hypertension, cognitive function, frailty, and medication adherence. Subgroup analyses will be performed, and stratified by renal function, HbA1c, and maximum number of drugs used. The study was started in October 2016, with a planned 2-year recruitment period. As of January 31, 2018, 33,213 patients were enrolled; the recruitment was therefore ended 8 months earlier than the original plan. CONCLUSIONS: The ANAFIE Registry will provide a valuable database for the clinical status, management, and outcomes of mortality, stroke, systemic embolism, and hemorrhagic events with/without anticoagulation in the increasing population of elderly NVAF patients, and will identify risk factors associated with these clinical events.
BACKGROUND: Although anticoagulation effectively prevents stroke in patients with atrial fibrillation (AF), it has been underused in elderly AF patients for many reasons, mainly because of knowledge gaps regarding cardiovascular treatment of these populations with multiple comorbidities and poor prognosis. The objectives of the All Nippon AF In the Elderly (ANAFIE) Registry are to collect real-world information about the clinical status of patients with non-valvular AF (NVAF) aged ≥75 years, current status of anticoagulant therapy, and prognosis with/without anticoagulation to establish a database for this specific patient population that is increasing remarkably worldwide. METHODS AND DESIGN: The ANAFIE Registry is an observational, multicenter, prospective study of Japanese patients with NVAF aged ≥75 years that will include 30,000 patients and have the primary endpoint of composite of stroke and systemic embolism over a 2-year follow-up period. In parallel with the main study, seven sub-cohort studies will be conducted with assessments including coagulation-fibrinolysis markers, echocardiography, heart rate, hypertension, cognitive function, frailty, and medication adherence. Subgroup analyses will be performed, and stratified by renal function, HbA1c, and maximum number of drugs used. The study was started in October 2016, with a planned 2-year recruitment period. As of January 31, 2018, 33,213 patients were enrolled; the recruitment was therefore ended 8 months earlier than the original plan. CONCLUSIONS: The ANAFIE Registry will provide a valuable database for the clinical status, management, and outcomes of mortality, stroke, systemic embolism, and hemorrhagic events with/without anticoagulation in the increasing population of elderly NVAF patients, and will identify risk factors associated with these clinical events.