Satoshi Yasuda1, Koichi Kaikita2, Hisao Ogawa3, Masaharu Akao4, Junya Ako5, Tetsuya Matoba6, Masato Nakamura7, Katsumi Miyauchi8, Nobuhisa Hagiwara9, Kazuo Kimura10, Atsushi Hirayama11, Kunihiko Matsui12. 1. Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center Hospital, 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan. Electronic address: afire@jcvrf.jp. 2. Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, 1-1-1 Honjo, Chuo-ku, Kumamoto 860-8556, Japan. 3. National Cerebral and Cardiovascular Center, 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan. 4. Department of Cardiology, National Hospital Organization Kyoto Medical Center, 1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto 612-8555, Japan. 5. Department of Cardiovascular Medicine, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara 252-0373, Japan. 6. Department of Cardiovascular Medicine, Kyushu University Hospital, 3-1-1 Maidashi, Fukuoka 812-8582, Japan. 7. Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, 2-17-6, Ohashi, Meguro-ku, Tokyo 153-8515, Japan. 8. Department of Cardiology, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan. 9. Department of Cardiology, Tokyo Women's Medical University, 8-1, Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan. 10. Department of Cardiology, Yokohama City University Medical Center, 4-57, Urafune-cho, Minami-ku, Yokohama 232-0024, Japan. 11. Division of Cardiology, Nihon University School of Medicine, 30-1 Ohyaguchi Kamicho, Itabashi-ku, Tokyo 173-8610, Japan. 12. Department of Community, Family, and General Medicine, Kumamoto University Hospital, 1-1-1 Honjo, Chuo-ku, Kumamoto 860-8556, Japan.
Abstract
BACKGROUND: In atrial fibrillation (AF) patients with coronary artery disease (CAD), anticoagulants are commonly used in combination with antiplatelet drugs. However, dual therapy can increase the risk of bleeding, and the potential therapeutic benefits must be weighed against this. Therefore, it is recommended that dual therapy is only used for a limited time, and that monotherapy with anticoagulants should start from 1 year after percutaneous coronary intervention (PCI). However, there is a lack of evidence on the use of monotherapy, in particular with direct oral anticoagulants, in this group of patients. METHODS: The AFIRE Study is a multicenter, prospective, randomized, open-label, parallel group study conducted in patients aged ≥20 years with non-valvular AF (NVAF) and CAD. Patients who have undergone PCI or coronary artery bypass graft at least 1 year prior to enrollment, or those without significant coronary lesions requiring PCI (≥50% stenosis), will be included. Approximately 2200 participants will be randomized to receive either rivaroxaban monotherapy or rivaroxaban plus an antiplatelet drug (aspirin, clopidogrel, or prasugrel). The primary efficacy endpoints are the composite of cardiovascular events (stroke, non-central nervous system embolism, myocardial infarction, and unstable angina pectoris requiring revascularizations) and all-cause mortality. The primary safety endpoint is major bleeding as defined by the International Society on Thrombosis and Haemostasis criteria. CONCLUSIONS: This study will be the first to assess the efficacy and safety of rivaroxaban monotherapy in NVAF patients with stable CAD.
RCT Entities:
BACKGROUND: In atrial fibrillation (AF) patients with coronary artery disease (CAD), anticoagulants are commonly used in combination with antiplatelet drugs. However, dual therapy can increase the risk of bleeding, and the potential therapeutic benefits must be weighed against this. Therefore, it is recommended that dual therapy is only used for a limited time, and that monotherapy with anticoagulants should start from 1 year after percutaneous coronary intervention (PCI). However, there is a lack of evidence on the use of monotherapy, in particular with direct oral anticoagulants, in this group of patients. METHODS: The AFIRE Study is a multicenter, prospective, randomized, open-label, parallel group study conducted in patients aged ≥20 years with non-valvular AF (NVAF) and CAD. Patients who have undergone PCI or coronary artery bypass graft at least 1 year prior to enrollment, or those without significant coronary lesions requiring PCI (≥50% stenosis), will be included. Approximately 2200 participants will be randomized to receive either rivaroxaban monotherapy or rivaroxaban plus an antiplatelet drug (aspirin, clopidogrel, or prasugrel). The primary efficacy endpoints are the composite of cardiovascular events (stroke, non-central nervous system embolism, myocardial infarction, and unstable angina pectoris requiring revascularizations) and all-cause mortality. The primary safety endpoint is major bleeding as defined by the International Society on Thrombosis and Haemostasis criteria. CONCLUSIONS: This study will be the first to assess the efficacy and safety of rivaroxaban monotherapy in NVAF patients with stable CAD.
Authors: Samer Al Said; Samer Alabed; Klaus Kaier; Audrey R Tan; Christoph Bode; Joerg J Meerpohl; Daniel Duerschmied Journal: Cochrane Database Syst Rev Date: 2019-12-19