Renal Function and Clinical Outcomes Among Elderly Patients With Nonvalvular Atrial Fibrillation From ANAFIE

Wataru Shimizu; Takeshi Yamashita; Masaharu Akao; Hirotsugu Atarashi; Takanori Ikeda; Yukihiro Koretsune; Ken Okumura; Shinya Suzuki; Hiroyuki Tsutsui; Kazunori Toyoda; Atsushi Hirayama; Masahiro Yasaka; Takenori Yamaguchi; Satoshi Teramukai; Tetsuya Kimura; Yoshiyuki Morishima; Atsushi Takita; Hiroshi Inoue

doi:10.1016/j.jacasi.2023.02.002

Renal Function and Clinical Outcomes Among Elderly Patients With Nonvalvular Atrial Fibrillation From ANAFIE

JACC Asia. 2023 Apr 11;3(3):475-487. doi: 10.1016/j.jacasi.2023.02.002. eCollection 2023 Jun.

Authors

Wataru Shimizu¹, Takeshi Yamashita², Masaharu Akao³, Hirotsugu Atarashi⁴, Takanori Ikeda⁵, Yukihiro Koretsune⁶, Ken Okumura⁷, Shinya Suzuki², Hiroyuki Tsutsui⁸, Kazunori Toyoda⁹, Atsushi Hirayama¹⁰, Masahiro Yasaka¹¹, Takenori Yamaguchi⁹, Satoshi Teramukai¹², Tetsuya Kimura¹³, Yoshiyuki Morishima¹³, Atsushi Takita¹⁴, Hiroshi Inoue¹⁵

Affiliations

¹ Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.
² Cardiovascular Institute, Tokyo, Japan.
³ Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.
⁴ AOI Hachioji Hospital, Tokyo, Japan.
⁵ Department of Cardiovascular Medicine, Toho University Faculty of Medicine, Tokyo, Japan.
⁶ National Hospital Organization Osaka National Hospital, Osaka, Japan.
⁷ Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.
⁸ Department of Cardiovascular Medicine, Faculty of Medical Sciences, Kyushu University, Fukuoka, Japan.
⁹ Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.
¹⁰ Osaka Police Hospital, Osaka, Japan.
¹¹ Department of Cerebrovascular Medicine and Neurology, Cerebrovascular Center, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
¹² Department of Biostatistics, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
¹³ Primary Medical Science Department, Daiichi Sankyo Co, Ltd, Tokyo, Japan.
¹⁴ Data Intelligence Department, Daiichi Sankyo Co, Ltd, Tokyo, Japan.
¹⁵ Saiseikai Toyama Hospital, Toyama, Japan.

Abstract

Background: Advancing age, decreasing renal function, and atrial fibrillation are strongly associated. Real-world evidence of direct oral anticoagulant (DOAC) use among elderly patients ≥75 years of age with nonvalvular atrial fibrillation and renal dysfunction is limited.

Objectives: This study sought to assess 2-year outcomes and anticoagulant treatment, stratified by renal function.

Methods: Enrolled patients were divided into 4 subgroups by creatinine clearance (CrCl) to determine the impact of renal dysfunction on clinical outcomes.

Results: Of 32,275 patients, 26,202 with CrCl data were analyzed (median follow-up 2.00 [IQR: 1.92-2.00] years); 1.3% of patients had CrCl <15 mL/min, 10.7% had CrCl 15 to <30 mL/min, 33.4% had CrCl 30 to <50 mL/min, 35.8% had CrCl ≥50 mL/min, and 18.9% had unknown CrCl. Cumulative incidences of stroke/systemic embolic events, major bleeding, major plus clinically relevant nonmajor bleeding, cardiovascular death, all-cause death, and net clinical outcomes increased with decreasing CrCl. In multivariable Cox regression analysis, lower CrCl emerged as an independent risk factor for these clinical outcomes, except for major bleeding, compared with CrCl ≥50 mL/min. The effectiveness and safety of DOACs over warfarin were similar or better across 3 CrCl subgroups with CrCl 15 mL/min or more. DOAC use was associated with a lower risk of stroke/systemic embolic events, major bleeding, cardiovascular death, all-cause death, and net clinical outcome compared with warfarin in patients with CrCl 30 to <50 mL/min.

Conclusions: Incidences of major clinical outcomes increased with decreasing renal function in elderly nonvalvular atrial fibrillation patients. DOACs were effective and safe even in patients with renal dysfunction (CrCl 15-<50 mL/min). (Prospective Observational Study in Late-Stage Elderly Patients with Non-Valvular Atrial Fibrillation: All Nippon AF In Elderly Registry [ANAFIE Registry]; UMIN000024006).

Keywords: anticoagulants; atrial fibrillation; elderly; renal function.