Identification of patients at risk of major
bleeding is pivotal for optimal management of
anticoagulant therapy in
venous thromboembolism (VTE). Studies have suggested that
D-dimer may predict major
bleeding during anticoagulation; however, this is scarcely investigated in VTE patients. We aimed to investigate the role of
D-dimer, measured at VTE diagnosis, as a predictive
biomarker of major
bleeding. The study population comprised 555 patients with a first community-acquired VTE (1994-2016), who were identified among participants from the Tromsø study. Major
bleeding events were recorded during the first year after VTE and defined according to the criteria of the International Society on
Thrombosis and Haemostasis. Cox-regression was used to calculate hazard ratios (HRs) with 95% confidence intervals (CIs) adjusted for age, sex, and duration of
anticoagulant therapy. In total, 29 patients experienced major
bleeding (incidence rate: 5.7/100 person-years, 95% CI: 4.0-8.2). The major
bleeding risk was highest during the first 3 months, especially in patients with
D-dimer ≥8.3 µg/mL (upper 20th percentile), with 28.8 major bleedings/100 person-years (95% CI: 13.7-60.4). Patients with
D-dimer ≥8.3 µg/mL had a 2.6-fold (95% CI: 1.1-6.6) higher risk of major
bleeding than patients with
D-dimer ≤2.3 µg/mL (lower 40th percentile). Major
bleeding risk according to
D-dimer ≥8.3 versus ≤2.3 µg/mL was particularly pronounced among those with
deep vein thrombosis (HR: 4.6, 95% CI: 1.3-16.2) and provoked events (HR: 4.2, 95% CI: 1.0-16.8). In conclusion, our results suggest that
D-dimer measured at diagnosis may serve as a predictive
biomarker of major
bleeding after VTE, especially within the initial 3 months.