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
. 2024 Dec 1:78:102974.
doi: 10.1016/j.eclinm.2024.102974. eCollection 2024 Dec.

Adverse events in clinically complex elderly patients with atrial fibrillation according to oral anticoagulation status

Affiliations

Adverse events in clinically complex elderly patients with atrial fibrillation according to oral anticoagulation status

Tommaso Bucci et al. EClinicalMedicine. .

Abstract

Background: Few data are available about the impact of oral anticoagulants (OAC) in patients with Atrial Fibrillation (AF) and clinical complexity (CC).

Methods: We conducted a retrospective study utilising data from the TriNetX network. Based on ICD-10-CM codes entered between 2020 and 2022, AF patients aged ≥75 years on long-term OAC with CC were categorised into two groups based on OAC use in the year before entering the study (maintained vs discontinued). CC was defined as BMI ≤23 kg/m2, and/or history of bleeding, and/or chronic kidney disease. The primary outcomes were the one-year risk of all-cause death, major cardiovascular events (MACE), and major bleeding. Cox regression analyses were used to calculate hazard ratios (HRs) and 95% CIs before and after 1:1 propensity score matching (PSM).

Findings: We identified 6554 AF CC patients who discontinued OAC (mean age 81.5 ± 6.0 years, 46.7% females) and 23,212 AF patients with CC who maintained OAC (81.3 ± 6.0 years, 49.4% females). Before PSM, AF CC patients who discontinued OAC had a higher prevalence of intracranial, gastrointestinal haemorrhages, and antiplatelet use, with no significant differences after PSM. OAC discontinuation was associated with a higher risk of all-cause death (HR 1.22, 95% CI 1.11-1.35) and MACE (HR 1.38, 95% CI 1.25-1.53). The one-year risk of major bleeding was similar in those who discontinued or maintained OAC (HR 1.05, 95% CI 0.94-1.18), although it was significantly higher during the early follow-up (HR 1.51, 95% CI 1.24-1.83). The risk of primary outcomes decreased over time, with the risk of bleeding becoming not significant.

Interpretation: AF CC patients who discontinued OAC have a high risk of adverse events. New antithrombotic and integrated care approaches to reduce thrombotic risk without increasing bleeding risk are needed in these patients.

Funding: This study received no funding.

Keywords: Anticoagulants; Atrial fibrillation; Bleeding; Clinical complexity; Thromboembolism.

PubMed Disclaimer

Conflict of interest statement

GFR reports consultancy for Boehringer Ingelheim and an educational grant from Anthos, outside the submitted work. No fees are directly received personally; MP is Italian national leader of the AFFIRMO project on multimorbidity in atrial fibrillation, which has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 899871; GYHL is a consultant and speaker for BMS/Pfizer, Boehringer Ingelheim, Daiichi-Sankyo, Anthos. No fees are received personally. GYHL is a National Institute for Health and Care Research (NIHR) Senior Investigator and co-principal investigator of the AFFIRMO project on multimorbidity in AF, which has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 89987. All other authors report no disclosures.

Figures

Fig. 1
Fig. 1
Flow chart of the study.
Fig. 2
Fig. 2
Aalen-Johansen curves for the cumulative incidence of primary outcomes in patients with atrial fibrillation and clinical complexity based on oral anticoagulant use at baseline. AF, Atrial Fibrillation; CC, Clinical Complexity; MACE, Major Adverse Cardiovascular Events; OAC, Oral Anticoagulants. The solid lines represent patients who discontinued oral anticoagulants, while the dashed lines represent patients who maintained oral anticoagulants. The colors in the graph are associated with different outcomes: red represents all-cause death, green represents major bleeding, and blue represents major adverse cardiovascular events.
Fig. 3
Fig. 3
Risk of primary outcomes in patients with atrial fibrillation and clinical complexity who discontinued oral anticoagulants in different time windows. CI, Confidence Intervals; HR, Hazard Ratio; MACE, Major Adverse Cardiovascular Events. A high χ2 suggests a greater deviation from the expected values, indicating a potential violation of the proportional hazard assumption. Conversely, a small χ2 value indicates that the observed residuals closely match the expected values.

References

    1. Chugh S.S., Havmoeller R., Narayanan K., et al. Worldwide epidemiology of atrial fibrillation: a global burden of disease 2010 study. Circulation. 2014;129(8):837–847. - PMC - PubMed
    1. Wu J., Nadarajah R., Nakao Y.M., et al. Temporal trends and patterns in atrial fibrillation incidence: a population-based study of 3.4 million individuals. Lancet Reg Health Eur. 2022;17 - PMC - PubMed
    1. Romiti G.F., Proietti M., Corica B., et al. Implications of clinical risk phenotypes on the management and natural history of atrial fibrillation: a report from the GLORIA-AF. J Am Heart Assoc. 2023;12(20) - PMC - PubMed
    1. Romiti G.F., Proietti M., Bonini N., et al. Clinical complexity domains, anticoagulation, and outcomes in patients with atrial fibrillation: a report from the GLORIA-AF registry phase II and III. Thromb Haemost. 2022;122(12):2030–2041. - PubMed
    1. Steinberg B.A., Ballew N.G., Greiner M.A., et al. Ischemic and bleeding outcomes in patients with atrial fibrillation and contraindications to oral anticoagulation. JACC Clin Electrophysiol. 2019;5(12):1384–1392. - PMC - PubMed

LinkOut - more resources