Article Impact Level: HIGH Data Quality: STRONG Summary of Journal of Internal Medicine, joim.20067. https://doi.org/10.1111/joim.20067 Dr. Katarina Glise Sandblad et al.
Points
- The study aimed to analyze the risk of excess bleeding in patients with venous thromboembolism (VTE) who were treated with direct oral anticoagulants (DOACs). This was compared to matched controls not receiving anticoagulant therapy, utilizing Swedish nationwide registers from 2014 to 2020.
- The Initial Treatment Phase (0–6 months) observed that 1.07% of VTE patients and 0.29% of controls experienced major bleeding, resulting in an incidence rate difference (IRD) of 2.19 per 100 person-years. Female and older patients exhibited a greater risk of excess bleeding compared to males.
- The Extended Treatment Phase (6 months–5 years) observed that 0.70% of VTE patients and 1.08% of controls experienced major bleeding, resulting in an incidence rate difference (IRD) of 0.70 per 100 person-years. The bleeding risk was consistent across genders and age demographics in this phase.
- The greatest bleeding risk was observed during the initial treatment phase, especially among female and elderly patients, with a notable reduction in risk during prolonged anticoagulation.
- The findings highlight the necessity of personalized treatment strategies in managing VTE, taking into account treatment duration, patient characteristics, and bleeding risks.
Summary
This study evaluated the excess bleeding risk in patients with venous thromboembolism (VTE) who received direct oral anticoagulants (DOACs), comparing this risk to matched population controls not on anticoagulants. Data from nationwide Swedish registers were utilized to match 36,115 cases of VTE treated with DOACs from 2014 to 2020 with 36,115 controls. The assessment of major bleeding risk occurred during two treatment phases: the initial phase (0 to 6 months) and the extended phase (6 months to 5 years). The incidence rate difference (IRD) was calculated to compare the bleeding rate in VTE patients with that of controls for both periods.
During the initial treatment phase, 388 patients with VTE (1.07%) and 103 controls (0.29%) experienced major bleeding, yielding an incidence rate difference (IRD) of 2.19 (95% CI 1.89–2.49) per 100 person-years. In this phase, females demonstrated a greater risk of excess bleeding compared to males, with an incidence rate difference (IRD) of 2.69 (95% CI 2.23–3.15) for females and 1.73 (95% CI 1.34–2.12) for males. The risk of excessive bleeding was significantly elevated in the older population. During the extended treatment phase (6 months to 5 years), there were 139 cases of VTE (0.70%) and 214 controls (1.08%) that experienced bleeding, resulting in an IRD of 0.70 (95% CI 0.52–0.89). During this phase, the bleeding risk showed no significant variation by sex, with incidence rate differences (IRDs) of 0.60 (95% CI 0.35–0.85) for males and 0.81 (95% CI 0.54–1.08) for females.
The research found that the risk of excessive bleeding linked to anticoagulant therapy was greatest in the early stages, especially among female and elderly patients. The risk diminished during the extended treatment phase, showing no significant differences between sexes or across age groups. The findings underscore the necessity of evaluating both treatment duration and patient characteristics in the assessment of bleeding risk in VTE management.
Link to the article: https://onlinelibrary.wiley.com/doi/10.1111/joim.20067
References Glise Sandblad, K., Rosengren, A., Schulman, S., Roupe, M., Sandström, T. Z., Philipson, J., Svennerholm, K., & Tavoly, M. (2025). Excess risk of bleeding in patients with venous thromboembolism on direct oral anticoagulants during initial and extended treatment versus population controls. Journal of Internal Medicine, joim.20067. https://doi.org/10.1111/joim.20067
