Risk factors of major bleeding associated with direct oral anticoagulant treatment in patients with venous thromboembolism: a systematic review and meta-analysis
- 1Department of Pharmacy, Fujian Maternity and Child Health Hospital College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University , ,
Abstract
Background
Direct oral anticoagulants (DOACs) are commonly prescribed for venous thromboembolism (VTE), but major bleeding (MB) remains an important complication of treatment. Despite their widespread use, systematic evaluations of prognostic factors associated with major bleeding during DOAC treatment remain scarce. To address this gap, we conducted a systematic review to identify prognostic factors associated with major bleeding during DOAC treatment in patients with VTE. This study seeks to enhance the safety and efficacy of anticoagulation therapy for VTE patients.Method and results
A systematic review and meta-analysis were conducted to search the PubMed and Web of Science databases for studies published before September 18, 2026. The review adhered to predefined inclusion and exclusion criteria to identify studies that investigated risk factors for major bleeding associated with DOAC treatment in patients diagnosed with VTE. Among the evaluated prognostic factors, quantitative pooling was possible only for age, which was reported in two studies; the remaining factors were summarized individually. Low-certainty evidence from a single study suggested a possible association between non-recommended dosing regimens and major bleeding. Evidence regarding declining adherence was also limited and of very low certainty. For age, very low-certainty evidence from the pooled analysis of two studies did not demonstrate a statistically significant association with major bleeding.Conclusion
The available evidence suggests possible associations between several prognostic factors and major bleeding in patients with VTE treated with DOACs; however, most findings are supported by low- or very low-certainty evidence and frequently by single studies. These findings should therefore be interpreted cautiously and require validation in larger, high-quality prospective studies.
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BibTeX
@article{zhan2026risk,
title = {{Risk factors of major bleeding associated with direct oral anticoagulant treatment in patients with venous thromboembolism: a systematic review and meta-analysis}},
author = {Hairong Zhan and Fuxin Ma and Jintuo Zhou and Jinhua Zhang},
journal = {Frontiers in medicine},
year = {2026},
month = oct,
doi = {10.3389/fmed.2026.1869818},
url = {https://europepmc.org/article/PMC/PMC13716557},
note = {CC BY},
}
RIS
TY - JOUR
TI - Risk factors of major bleeding associated with direct oral anticoagulant treatment in patients with venous thromboembolism: a systematic review and meta-analysis
AU - Hairong Zhan
AU - Fuxin Ma
AU - Jintuo Zhou
AU - Jinhua Zhang
PY - 2026
DA - 2026/10/15
JO - Frontiers in medicine
DO - 10.3389/fmed.2026.1869818
UR - https://europepmc.org/article/PMC/PMC13716557
AB - Background Direct oral anticoagulants (DOACs) are commonly prescribed for venous thromboembolism (VTE), but major bleeding (MB) remains an important complication of treatment. Despite their widespread use, systematic evaluations of prognostic factors associated with major bleeding during DOAC treatment remain scarce. To address this gap, we conducted a systematic review to identify prognostic factors associated with major bleeding during DOAC treatment in patients with VTE. This study seeks to enhance the safety and efficacy of anticoagulation therapy for VTE patients.Method and results A systematic review and meta-analysis were conducted to search the PubMed and Web of Science databases for studies published before September 18, 2026. The review adhered to predefined inclusion and exclusion criteria to identify studies that investigated risk factors for major bleeding associated with DOAC treatment in patients diagnosed with VTE. Among the evaluated prognostic factors, quantitative pooling was possible only for age, which was reported in two studies; the remaining factors were summarized individually. Low-certainty evidence from a single study suggested a possible association between non-recommended dosing regimens and major bleeding. Evidence regarding declining adherence was also limited and of very low certainty. For age, very low-certainty evidence from the pooled analysis of two studies did not demonstrate a statistically significant association with major bleeding.Conclusion The available evidence suggests possible associations between several prognostic factors and major bleeding in patients with VTE treated with DOACs; however, most findings are supported by low- or very low-certainty evidence and frequently by single studies. These findings should therefore be interpreted cautiously and require validation in larger, high-quality prospective studies.
SN - 2296-858X
ER -