Rivaroxaban Monotherapy in Patients With Atrial Fibrillation After Coronary Stenting: Insights From the AFIRE Trial

Tetsuya Matoba; Satoshi Yasuda; Koichi Kaikita; Masaharu Akao; Junya Ako; Masato Nakamura; Katsumi Miyauchi; Nobuhisa Hagiwara; Kazuo Kimura; Atsushi Hirayama; Kunihiko Matsui; Hisao Ogawa; AFIRE Investigators

doi:10.1016/j.jcin.2021.07.045

Rivaroxaban Monotherapy in Patients With Atrial Fibrillation After Coronary Stenting: Insights From the AFIRE Trial

JACC Cardiovasc Interv. 2021 Nov 8;14(21):2330-2340. doi: 10.1016/j.jcin.2021.07.045.

Authors

Collaborators

AFIRE Investigators:
Satoshi Yasuda, Hisao Ogawa, Kazuo Kimura, Nobuhisa Hagiwara, Atsushi Hirayama, Masato Nakamura, Katsumi Miyauchi, Junya Ako, Masaharu Akao, Koichi Kaikita, Tetsuya Matoba, Yukihiro Koretsune, Takafumi Hiro, Tetsuya Sumiyoshi, Kazumi Kimura, Yoichiro Hashimoto, Teruyuki Hirano, Hiroyuki Daida, Yasushi Okada, Tsutomu Yamazaki, Kunihiko Matsui, Hisao Ogawa, Kazuo Kimura, Nobuhisa Hagiwara, Atsushi Hirayama, Masato Nakamura, Katsumi Miyauchi, Junya Ako, Masaharu Akao, Koichi Kaikita, Tetsuya Matoba, Kunihiko Matsui, A Nakamura, E Tamiya, T Yamamoto, S Suetake, T Noguchi, S Nakamura, A Matsumura, J Kojima, S Suwa, H Yamaguchi, K Kaikita, T Yasu, A Nakajima, T Yamada, H Arai, Y Hata, T Sakanashi, H Tateishi, T Nakayama, Y Nozaki, M Akao, Y Okumura, M Tokue, N Kuroki, Y Maruyama, T Matoba, N Hagiwara, H Suzuki, Y Nishida, M Ajioka, K Yumoto, S Shimizu, T Aoyama, H Shimomura, T Takeda, K Oshiro, N Sugishita, Y Shibata, T Otonari, H Kihara, H Ogawa, A Ohno, M Hazama, M Shimizu, K Tsukahara, S Haruta, T Wakeyama, T Haruna, M Ito, K Fujii, N Atsuchi, M Sata, K Kimura, N Hasebe, Y Kobayasi, K Ohsato, K Hironaga, Y Naganuma, K Anzaki, K Oiwa, S Okazaki, Y Nakagawa, K Tokuhiro, K Tanaka, T Momose, Y Fukushima, R Kametani, K Kawamitsu, Y Saito, S Akashi, K Kumagai, K Eshima, T Tobaru, T Seo, K Okuhara, K Kozuma, Y Ikari, T Takahashi, I Michishita, H Fujikura, S Momomura, Y Yamamoto, K Otomo, T Matsubara, H Tashiro, T Inoue, M Ishihara, I Shiojima, E Tachibana, J Ako, K Sumii, N Yamamoto, N Ohmura, T Nakamura, Y Morita, N Takahashi, K Watanabe, H Fujinaga, M Maruyama, T Oka, T Shirayama, T Amano, K Fukui, K Ando, S Oshima, S Kagiyama, H Teragawa, M Yuge, S Ono, T Koga, K Fujiu, M Kuwabara, Y Ohya, Y Yumoto, N Kuji, M Ikemura, K Kario, K Chatani, K Sato, H Miyagi, M Murakami, K Saito, M Hoshiga, S Sato, N Kubo, Y Sakamoto, K Ashida, H Sakamoto, S Murasaki, H Uehara, T Akasaka, Y Ooba, S Nakahara, Y Hanaoka, T Nishimiya, R Tsunoda, Y Onuma, S Higuchi, A Tani, A Wada, M Kato, H Obata, Y Higuchi, T Endo, R Katou, T Matsunaga, T Matsuoka, H Noguchi, M Usui, T Hayashi, Y Otsuji, T Osaki, H Zaizen, H Yoshihara, K Kadota, T Hirose, T Miyazawa, A Mori, M Takano, W Shimizu, M Wake, S Oriso, M Yoshiyama, S Kakinoki, T Nishioka, T Ozaki, K Nomoto, K Seki, K Kawai, Y Ozaki, S Miura, M Kawasaki, R Funada, K Dote, T Nagano, S Okamoto, T Kubo, Y Murozono, T Owada, T Doke, T Matsumura, M Horiuchi, A Takaishi, M Yamamoto, H Nakashima, M Munemasa, Y Sakata, N Inoue, T Ota, Y Hamano, N Abe, T Tsubokura, M Goto, I Kubota, M Yano, K Umetani, A Matsumura, T Date, H Morimoto, T Noda, S Goto, K Hibi, A Nakano, S Hiramitsu, Y Kihara, M Sugi, N Shiba, D Izumi, T Sato, S Tayama, T Matsui, A Suzuki, K Ajiki, M Oishi, M Kiryu, T Ko, H Ando, S Miyazaki, T Kinugawa, H Otake, H Kitaoka, Y Hirata, S Honda, M Manita, Y Ishii, H Oka, Y Nanba, M Nishino, T Sakamoto, T Saito, H Sakai, M Ichikawa, S Namiuchi, K Inoue, N Komiyama, Y Akashi, Y Nakamura, T Komaru, T Hosokawa, T Chikamori, H Tanaka, O Arasaki, K Aonuma, Y Wakasa, T Yoshizawa, T Sugano, N Yokota, A Kakutani, T Suzuki, Y Abe, T Kataoka, H Okayama, H Yokoi, K Chin, K Hasegawa, H Tomita, H Honzyo, H Kawai, K Yamamoto, Y Morino, S Tsujiyama, S Hamasaki, Y Niijima, T Aoyama, Y Mizuno, A Maki, K Tanabe, T Murohara, T Nakamura, S Naomi, M Arikawa, T Kato, N Matsumoto, T Minamino, H Sairenji, N Miyamoto, H Ito, Y Matsuura, S Hata, Y Nakatsu, T Onodera, M Yoshimura, H Amano, E Tokutake, M Kasao, M Moriguchi, K Yamamoto, M Tsuji, H Yamamoto, Y Yanbe, T Iwasawa, M Suzuki, H Mori

Affiliations

¹ Department of Cardiovascular Medicine, Faculty of Medical Sciences, Kyushu University, Fukuoka, Japan. Electronic address: [email protected].
² Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan; National Cerebral and Cardiovascular Center, Suita, Japan.
³ Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan; Division of Cardiovascular Medicine and Nephrology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Kiyotake, Japan.
⁴ Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.
⁵ Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara, Japan.
⁶ Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.
⁷ Department of Cardiovascular Medicine Juntendo Tokyo Koto Geriatric Medical Center, Tokyo, Japan.
⁸ Department of Cardiology, Tokyo Women's Medical University, Tokyo, Japan.
⁹ Cardiovascular Center, Yokohama City University Medical Center, Yokohama, Japan.
¹⁰ Department of Cardiology Osaka Police Hospital, Osaka, Japan.
¹¹ Department of General Medicine and Primary Care, Kumamoto University Hospital, Kumamoto, Japan.
¹² National Cerebral and Cardiovascular Center, Suita, Japan; Kumamoto University, Kumamoto, Japan.

PMID: 34736731
DOI: 10.1016/j.jcin.2021.07.045

Abstract

Objectives: The aim of this AFIRE (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease) trial subgroup analysis was to examine rivaroxaban monotherapy benefits and their relation to the time between stenting and enrollment among patients after coronary stenting.

Background: Of 2,215 patients with atrial fibrillation and stable coronary artery disease in the AFIRE trial, rivaroxaban monotherapy was noninferior to rivaroxaban plus antiplatelet therapy (combination therapy) in terms of efficacy and superior for safety endpoints. However, thrombotic risk after antiplatelet therapy cessation remained a concern among 1,444 patients who had undergone coronary stenting >1 year before enrollment.

Methods: The benefits of rivaroxaban monotherapy in coronary stenting subgroups were assessed for efficacy (a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death of any cause), safety (major bleeding defined according to International Society on Thrombosis and Haemostasis criteria), ischemic endpoints, net adverse clinical event, and time between stenting and enrollment.

Results: Efficacy and safety endpoints for monotherapy were superior to combination therapy, with HRs of 0.70 for efficacy (95% CI: 0.50-0.98; P = 0.036) and 0.55 for safety (95% CI: 0.33-0.92; P = 0.019). For ischemic endpoints, the HR was 0.82 (95% CI: 0.58-1.15; P = 0.240). The HR became smaller with longer time between stenting and enrollment (efficacy, P for interaction = 0.158; safety, P = 0.097).

Conclusions: In patients with atrial fibrillation after coronary stenting, the benefits of rivaroxaban monotherapy for efficacy and safety endpoints were consistent with those in the whole AFIRE trial population. The benefits became apparent with longer time between stenting and enrollment. (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease Study [AFIRE]; UMIN000016612, NCT02642419).

Keywords: direct oral anticoagulant; percutaneous coronary intervention; stable coronary disease; stents.

Publication types

Clinical Trial
Research Support, Non-U.S. Gov't

MeSH terms

Atrial Fibrillation* / drug therapy
Coronary Artery Disease / surgery
Factor Xa Inhibitors / adverse effects
Hemorrhage / chemically induced
Humans
Rivaroxaban* / adverse effects
Stents
Treatment Outcome

Substances

Factor Xa Inhibitors
Rivaroxaban

Associated data

ClinicalTrials.gov/NCT02642419
UMIN-CTR/UMIN000016612