Key result
DOACs in VTE linked to ~2.2 excess major bleeds per 100 person-years during initial treatment.
Why the study?
Anticoagulant-related major bleeding risk is influenced by both treatment and baseline risk, which is often disregarded, prompting evaluation of excess bleeding risk versus matched population controls.
Does direct oral anticoagulant treatment increase the excess risk of major bleeding in cancer-free patients with venous thromboembolism compared to matched population controls during initial and extended treatment?
Cohort (n=72,230)
Yes
Does direct oral anticoagulant treatment increase the excess risk of major bleeding in cancer-free patients with venous thromboembolism compared to matched population controls during initial and extended treatment?
Effect estimate: IRD 2.19 per 100 person-years (95% CI 1.89-2.49)
Absolute Event Rate: 1.07% vs 0.29%
Direct oral anticoagulants for VTE are associated with a high excess risk of major bleeding during the first 6 months, especially in females and older patients, but this excess risk decreases significantly and is not influenced by sex or age during extended treatment.
May warrant closer monitoring during initial direct oral anticoagulant therapy for VTE; leaves open whether extended-treatment risk normalizes in broader populations.
BACKGROUND: The risk of major bleeding from anticoagulant treatment is influenced by both the treatment and the patient's baseline risk, which is often disregarded. OBJECTIVES: To determine the excess bleeding risk in venous thromboembolism (VTE) cases during initial (0 to 6 months) and extended (6 months to 5 years) treatment compared to matched population controls without VTE or anticoagulant treatment, overall, and stratified by sex and age. METHODS: Cancer-free patients with VTE treated with direct oral anticoagulants from 2014 to 2020, along with propensity score-matched controls, were identified from nationwide Swedish registers. Excess risk of major bleeding was assessed using the incidence rate difference (IRD) calculated by subtracting the control bleeding rate from the case bleeding rate. RESULTS: The matched cohort comprised 36,115 VTE cases and 36,115 controls. During initial treatment, 388 VTE cases (1.07%) and 103 controls (0.29%) experienced bleeding, IRD: 2.19 (95% confidence interval 1.89-2.49) per 100 person-years. Following rematching at 6 months, 139 cases (0.70%) and 214 controls (1.08%) experienced bleeding, IRD: 0.70 (0.52-0.89). During initial treatment, females had a higher excess bleeding risk than males, with male IRD: 1.73 (1.34-2.12) and female IRD: 2.69 (2.23-3.15). Excess bleeding risk was highest in the oldest patient population. In extended treatment, excess bleeding was not dependent on sex-male IRD: 0.60 (0.35-0.85), female IRD: 0.81 (0.54-1.08)-and did not increase with age. CONCLUSION: The excess bleeding risk from anticoagulant treatment was high during initial treatment, particularly among females and the elderly, but lower and not influenced by sex or age during extended treatment.
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Sandblad et al. (2025) conducted a cohort in Venous thromboembolism (VTE) (n=72,230). Direct oral anticoagulants vs. Matched population controls without VTE or anticoagulant treatment was evaluated on Major bleeding during initial treatment (0 to 6 months) (IRD 2.19 per 100 person-years, 95% CI 1.89-2.49). Direct oral anticoagulants in VTE patients were associated with an excess major bleeding risk of 2.19 per 100 person-years (95% CI 1.89-2.49) during initial treatment compared to matched controls.
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