Incidence and clinical impact of bleeding events in older patients with acute venous thromboembolism.

Elderly patients anticoagulated for venous thromboembolism (VTE) have an increased risk of bleeding compared to younger patients. Little is known about the clinical impact of anticoagulation-related bleeding in this growing patient group. To prospectively assess the incidence, clinical impact, and predictors of bleeding in elderly patients anticoagulated for VTE. We analyzed 981 patients aged ≥65 years with acute VTE in a prospective multicenter cohort. 88% were anticoagulated with vitamin K antagonists. Outcomes were the occurrence of a major (MB) or clinically relevant non-major bleeding (CRNMB) during the initial anticoagulation period up to 36 months. We described the incidence and clinical impact of bleeding and examined the association between risk factors and time to a first bleeding using competing risk regression. 100 MB and 125 CRNMB occurred during follow-up. The incidence of MB and CRNMB was 8.5 (95%CI 7.0-10.4) and 13.4 events (95%CI 11.4-15.7) per 100 patient-years, respectively. In patients with MB, 79% required hospitalization, 18% a surgical intervention, and 19% a permanent discontinuation of anticoagulation. 15% of MB were intracranial and 6% fatal. After adjustment, active cancer (sub-hazard ratio [SHR] 1.81, 95%CI 1.12-2.93) and low physical activity (SHR 1.88, 95%CI 1.19-2.98) were associated with MB, and high risk of falls with CRNMB (SHR 2.04, 95%CI 1.39-3.00). Older patients anticoagulated for VTE had a high incidence of MB and CRNMB, and these bleeding episodes caused a great burden of disease. Physicians should carefully weigh the risks/benefits of extended anticoagulation in the older population with VTE.