Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2025 Mar 27;25(1):203.
doi: 10.1186/s12877-025-05838-4.

Efficacy, safety, and bleeding risk factor analysis of oral anticoagulants in AF patients ≥ 65 years of age: a multicenter retrospective cohort study

Yanxian Lan #  1   2 , Jiana Chen #  1 , Peiguang Niu #  1 , Xinhai Huang #  1 , Xiaomin Dong  3 , Cuifang You  4 , Shuzheng Jiang  5 , Jinhua Zhang  6
Affiliations
Observational Study

Efficacy, safety, and bleeding risk factor analysis of oral anticoagulants in AF patients ≥ 65 years of age: a multicenter retrospective cohort study

Yanxian Lan et al. BMC Geriatr. .

Abstract

Background: Stroke prevention in elderly patients with atrial fibrillation (AF) is challenging and requires a balance between thromboembolic prevention and bleeding. The comparison of novel oral anticoagulants (NOACs) and warfarin in clinical practice in elderly Asian patients has not been well studied. The purpose of this study was to evaluate the efficacy and safety of NOACs versus warfarin in elderly patients with AF in conjunction with data from real-world observational studies.

Methods: This was a retrospective multicenter cohort study conducted in 4 centers in China, where patient information and clinical events were collected through an average of 15 months of follow-up and case queries. Clinical outcomes included major bleeding, minor bleeding, total bleeding, thrombosis, and all-cause mortality.

Results: A total of 3450 elderly patients with AF were enrolled. 2656 patients were treated with at least 1 NOAC (dabigatran, rivaroxaban, apixaban, or edoxaban), and 794 patients were treated with warfarin. After correcting for confounders, NOACs significantly reduced the risk of minor bleeding [OR 0.70 (95% CL, 0.49-1.01),P = 0.049] and all-cause mortality [OR 0.57( 95% CI, 0.44-0.75),P < 0.001] compared with warfarin, however, major bleeding events [OR 1.51 (95% CL, 0.98-2.42),P = 0.075] and thrombotic events [OR 0.79 (95% CL, 0.57-1.13),P = 0.187] were not significantly different. There was no heterogeneity between clinical outcomes of NOACs and warfarin in subgroup analyses of age (65-74, 75-84, ≥ 85 years), sex (male, female), BMI (≥ 25, < 25), comorbidities (including hypertension, diabetes and no hypertension, no diabetes), except in female subgroup, where NOACs significantly reduced the risk of minor bleeding [OR 0.56 (95% CL, 0.34-0.91),P = 0.018] and increased the risk of major bleeding [OR 2.28 (95% CL, 1.12-5.14),P = 0.032] compared with warfarin.

Conclusion: Compared with warfarin, NOACs significantly reduced the risk of minor bleeding, all-cause mortality, and there were no statistically significant differences in major bleeding or thrombotic events. NOACs were not more effective than warfarin in thrombotic and bleeding events, regardless of the subgroup analyses on age, male, BMI and comorbid hypertension and diabetes.

Keywords: Atrial fibrillation; Bleeding; Effectiveness; Elderly patients; NOACs; Warfarin.

PubMed Disclaimer

Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study complied with the Declaration of Helsinki and was authorized by The Ethics Committee of Fujian Maternal and Child Health Hospital (registration number: ChiCTR2300067734). The review committee waived informed consent of patient because of the retrospective nature of this study. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
The flowchart of the study population selection
See this image and copyright information in PMC

References

    1. Heart Disease andStroke Statistics—2023 Update: A Report From the American Heart Association. Circulation. 2023;147:e00–e00. 10.1161/CIR.0000000000001123.
    1. Singer DE, Chang Y, Borowsky LH, et al. A new risk scheme to predict ischemic stroke and other thromboembolism in atrial fibrillation: the ATRIA study stroke risk Score[J]. J Am Heart Association Cardiovasc Cerebrovasc Disease. 2013;2(3):18–24. 10.1161/JAHA.113.000250 - PMC - PubMed
    1. Hindricks G, Potpara T, Dagres N et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC [J]. European Heart Journal: The Journal of the European Society of Cardiology, 2021;42(40):373. - PubMed
    1. Ferri N, Colombo E, Tenconi M, Baldessin L, Corsini A. Drug-Drug interactions of direct oral anticoagulants (DOACs): from Pharmacological to clinical practice. Pharmaceutics. 2022;14(6):1120. Published 2022 May 24. - PMC - PubMed
    1. Souza WK, S, B D. Original Investigation. The changing landscape for stroke prevention in AF. Findings from the GLORIA-AF registry phase 2[J]. J Am Coll Cardiol. 2017;69:777. - PubMed

Publication types

MeSH terms

LinkOut - more resources