Clinical Outcomes of Anticoagulation Therapy With Direct Oral Anticoagulants or Warfarin in Patients With Atrial Fibrillation and Renal Impairment After Bioprosthetic Valve Replacement - Comparative Outcomes in a Japanese Nationwide Registry

Q: Which anticoagulants were compared in the study?

The study compared warfarin with direct oral anticoagulants (DOACs) in patients with atrial fibrillation after bioprosthetic valve replacement.

Q: How were patients grouped for renal function?

Patients were stratified by creatinine clearance into normal or mild impairment (≥50 mL/min), mild-to-moderate impairment (30–<50 mL/min), and moderate-to-severe impairment (15–<30 mL/min).

Q: What were the main outcome findings for stroke and cardiovascular events?

The composite outcome of stroke, systemic embolism, and cardiovascular events was numerically less frequent in the DOAC group across strata, but differences were not statistically significant.

Q: Can the study conclude that DOACs are better than warfarin?

No definitive comparative conclusion was drawn because of the small sample size, although both anticoagulants may be acceptable with individualized decision-making based on patient risk.

Sep 30, 2026

Uploaded by Ophelia

Atrial fibrillation after bioprosthetic valve replacement is common in older patients with multiple comorbidities and a high thromboembolism risk, yet renal impairment increases bleeding risk and complicates treatment choices. This registry subgroup analysis compared warfarin versus direct oral anticoagulants (DOACs) in 612 patients stratified by renal function. The composite of stroke, systemic embolism, and cardiovascular events and major bleeding were numerically less frequent with DOACs, but statistical significance was not reached. Small sample size limited definitive comparative conclusions.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages10

Reading Time25 min

AccessFree to download

Background

Methods and Results

Conclusions

Circulation Reports ORIGINAL ARTICLE Circ Rep 2026; 8: 58–67 doi:10.1253/circrep.CR-25-0156 Arrhythmia/Electrophysiology | Clinical Outcomes of Anticoagulation Therapy With Direct Oral Anticoagulants or Warfarin in Patients With Atrial Fibrillation and Renal Impairment After Bioprosthetic Valve Replacement | | | --- | --- | | Miwa Ito, MD, PhD; Misa Takegami, PhD, MPH; Yutaka Furukawa, MD, PhD; Makoto Miyake, MD, PhD; Tomoyuki Fujita, MD, PhD; Tadaaki Koyama, MD, PhD; Hidekazu Tanaka, MD, PhD; Kenji Ando, MD; Tatsuhiko Komiya, MD, PhD; Masaki Izumo, MD, PhD; Hiroya Kawai, MD, PhD; Kiyoyuki Eishi, MD, PhD; Kiyoshi Yoshida, MD, PhD; Takeshi Kimura, MD, PhD; Ryuzo Nawada, MD, PhD; Tomohiro Sakamoto, MD, PhD; Yoshisato Shibata, MD; Toshihiro Fukui, MD, PhD; Kenji Minatoya, MD, PhD; Yasushi Sakata, MD, PhD; Masayuki Fukuzawa, MS;
Kunihiro Nishimura, MD, PhD, MPH; Shozo Kaneko, MD, PhD;
Tadashi Hoshiyama, MD, PhD; Hisanori Kanazawa, MD, PhD;
Kenichi Tsujita, MD, PhD; Chisato Izumi, MD, PhD; for the BPV-AF Registry Group
Background: Atrial fibrillation (AF) after bioprosthetic valve (BPV) replacement is common in older patients with multiple comorbidities and is associated with a heightened risk of thromboembolism. Anticoagulation therapy is often indicated, but renal impairment and other comorbidities elevate bleeding risk, making clinical decisions complex. This study compared clinical outcomes between warfarin and direct oral anticoagulants (DOACs) in this high-risk population.
Methods and Results: This subgroup analysis of the BPV-AF Registry included 612 patients treated with oral anticoagulants after BPV replacement, stratified by renal function: normal or mild impairment (creatinine clearance [CCr] ≥50 mL/min), mild-to-moderate impairment (30mL/min ≤ CCr < 50mL/min), and moderate-to-severe impairment (15mL/min ≤ CCr < 30mL/min) . Baseline characteristics and outcomes were analyzed within each stratum. The composite outcome of stroke, systemic embolism, and cardiovascular events was numerically less frequent in the DOAC than warfarin group across all strata, although the differences were not statistically significant. Major bleeding also tended to be lower in the DOAC group.
Conclusions: In this study from a Japanese nationwide registry comparing outcomes of AF patients after BPV replacement with severe renal impairment between those treated with DOACs and those treated with warfarin, comparative conclusions between DOACs and warfarin cannot be drawn because of the small sample size. Nonetheless, both anticoagulants may be acceptable in clinical practice, highlighting the need for individualized decision-making based on patient risk.
Key Words: Anticoagulant therapy; Atrial fibrillation; Bioprosthetic valve replacement; Older patients; Renal impairment | | | M ost patients who undergo aortic valve replacement
with bioprosthetic valves (BPVs) are elderly,
with the number of patients with valvular heart
disease requiring BPV replacement increasing with the
aging society.1–3 Atrial fibrillation (AF) becomes more | prevalent with age and is a common comorbidity in the
elderly population. AF and valvular heart disease are both
influenced by aging and lifestyle-related risk factors, such
as hypertension, diabetes, and dyslipidemia, which can
lead to polypharmacy. AF in patients undergoing valve | Received August 12, 2025; revised manuscript received September 21, 2025; accepted September 22, 2025; J-STAGE Advance Publication released online November 20, 2025 Time for primary review: 1 day Department of Cardiovascular Medicine, Miyazaki Prefectural Nobeoka Hospital, Miyazaki (M. Ito); Department of Public Health and Health Policy, Graduate School of Medicine, The University of Tokyo, Tokyo (M.T.); Department of Preventive Medicine and Epidemiology (M.T., K.N.), Department of Cardiovascular Surgery (T. Fujita), Department of Heart Failure and Transplantation (C.I.), National Cerebra

FAQs

Which anticoagulants were compared in the study?

The study compared warfarin with direct oral anticoagulants (DOACs) in patients with atrial fibrillation after bioprosthetic valve replacement.

How were patients grouped for renal function?

Patients were stratified by creatinine clearance into normal or mild impairment (≥50 mL/min), mild-to-moderate impairment (30–<50 mL/min), and moderate-to-severe impairment (15–<30 mL/min).

What were the main outcome findings for stroke and cardiovascular events?

The composite outcome of stroke, systemic embolism, and cardiovascular events was numerically less frequent in the DOAC group across strata, but differences were not statistically significant.

Can the study conclude that DOACs are better than warfarin?

No definitive comparative conclusion was drawn because of the small sample size, although both anticoagulants may be acceptable with individualized decision-making based on patient risk.

Sep 30, 2026

Uploaded by Ophelia