Risk factors of major bleeding associated with direct oral anticoagulant treatment in patients with venous thromboembolism: a systematic review and meta-analysis
Year: 2026
Type: review
Study design: Systematic Review
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.
Source: Frontiers in Medicine
Authors: Hairong Zhan, Fuxin Ma, Jintuo Zhou, Jinhua Zhang
Institution: Fujian Medical University
Language: English
Subfield: Internal Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,801
OpenAlex ID: W7221954953
