Prospective observational study in elderly patients with non-valvular atrial fibrillation: Rationale and design of the All Nippon AF In the Elderly (ANAFIE) Registry

Hiroshi Inoue, Takeshi Yamashita, Masaharu Akao, Hirotsugu Atarashi, Takanori Ikeda, Ken Okumura, Yukihiro Koretsune, Wataru Shimizu, Hiroyuki Tsutsui, Kazunori Toyoda, Atsushi Hirayama, Masahiro Yasaka, Takenori Yamaguchi, Masahiro Akishita, Naoyuki Hasebe, Kazuomi Kario, Yuji Mizokami, Ken Nagata, Masato Nakamura, Yasuo TerauchiTakatsugu Yamamoto, Satoshi Teramukai, Tetsuya Kimura, Jumpei Kaburagi, Atsushi Takita

Research output: Contribution to journalArticle

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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.

Original languageEnglish
Pages (from-to)300-306
Number of pages7
JournalJournal of Cardiology
Volume72
Issue number4
DOIs
Publication statusPublished - Oct 1 2018

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Atrial Fibrillation
Observational Studies
Registries
Prospective Studies
Stroke
Embolism
Databases
Population
Medication Adherence
Fibrinolysis
Anticoagulants
Cognition
Multicenter Studies
Echocardiography
Comorbidity
Cohort Studies
Heart Rate
Hypertension
Kidney
Mortality

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

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Prospective observational study in elderly patients with non-valvular atrial fibrillation : Rationale and design of the All Nippon AF In the Elderly (ANAFIE) Registry. / Inoue, Hiroshi; Yamashita, Takeshi; Akao, Masaharu; Atarashi, Hirotsugu; Ikeda, Takanori; Okumura, Ken; Koretsune, Yukihiro; Shimizu, Wataru; Tsutsui, Hiroyuki; Toyoda, Kazunori; Hirayama, Atsushi; Yasaka, Masahiro; Yamaguchi, Takenori; Akishita, Masahiro; Hasebe, Naoyuki; Kario, Kazuomi; Mizokami, Yuji; Nagata, Ken; Nakamura, Masato; Terauchi, Yasuo; Yamamoto, Takatsugu; Teramukai, Satoshi; Kimura, Tetsuya; Kaburagi, Jumpei; Takita, Atsushi.

In: Journal of Cardiology, Vol. 72, No. 4, 01.10.2018, p. 300-306.

Research output: Contribution to journalArticle

Inoue, H, Yamashita, T, Akao, M, Atarashi, H, Ikeda, T, Okumura, K, Koretsune, Y, Shimizu, W, Tsutsui, H, Toyoda, K, Hirayama, A, Yasaka, M, Yamaguchi, T, Akishita, M, Hasebe, N, Kario, K, Mizokami, Y, Nagata, K, Nakamura, M, Terauchi, Y, Yamamoto, T, Teramukai, S, Kimura, T, Kaburagi, J & Takita, A 2018, 'Prospective observational study in elderly patients with non-valvular atrial fibrillation: Rationale and design of the All Nippon AF In the Elderly (ANAFIE) Registry', Journal of Cardiology, vol. 72, no. 4, pp. 300-306. https://doi.org/10.1016/j.jjcc.2018.02.018
Inoue, Hiroshi ; Yamashita, Takeshi ; Akao, Masaharu ; Atarashi, Hirotsugu ; Ikeda, Takanori ; Okumura, Ken ; Koretsune, Yukihiro ; Shimizu, Wataru ; Tsutsui, Hiroyuki ; Toyoda, Kazunori ; Hirayama, Atsushi ; Yasaka, Masahiro ; Yamaguchi, Takenori ; Akishita, Masahiro ; Hasebe, Naoyuki ; Kario, Kazuomi ; Mizokami, Yuji ; Nagata, Ken ; Nakamura, Masato ; Terauchi, Yasuo ; Yamamoto, Takatsugu ; Teramukai, Satoshi ; Kimura, Tetsuya ; Kaburagi, Jumpei ; Takita, Atsushi. / Prospective observational study in elderly patients with non-valvular atrial fibrillation : Rationale and design of the All Nippon AF In the Elderly (ANAFIE) Registry. In: Journal of Cardiology. 2018 ; Vol. 72, No. 4. pp. 300-306.
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T1 - Prospective observational study in elderly patients with non-valvular atrial fibrillation

T2 - Rationale and design of the All Nippon AF In the Elderly (ANAFIE) Registry

AU - Inoue, Hiroshi

AU - Yamashita, Takeshi

AU - Akao, Masaharu

AU - Atarashi, Hirotsugu

AU - Ikeda, Takanori

AU - Okumura, Ken

AU - Koretsune, Yukihiro

AU - Shimizu, Wataru

AU - Tsutsui, Hiroyuki

AU - Toyoda, Kazunori

AU - Hirayama, Atsushi

AU - Yasaka, Masahiro

AU - Yamaguchi, Takenori

AU - Akishita, Masahiro

AU - Hasebe, Naoyuki

AU - Kario, Kazuomi

AU - Mizokami, Yuji

AU - Nagata, Ken

AU - Nakamura, Masato

AU - Terauchi, Yasuo

AU - Yamamoto, Takatsugu

AU - Teramukai, Satoshi

AU - Kimura, Tetsuya

AU - Kaburagi, Jumpei

AU - Takita, Atsushi

PY - 2018/10/1

Y1 - 2018/10/1

N2 - 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.

AB - 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.

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