Major bleeding episodes occur in people receiving anticoagulant therapy for venous thromboembolism

Question

What is the clinical impact of bleeding in people taking anticoagulants for venous thromboembolism?

Study design

Systematic review with meta-analysis.

Main results

Thirty-three studies met inclusion criteria (29 randomised controlled trials, 4 prospective cohort studies; 10,757 people). Major bleeding occurred in $\text{276}\text{10,757}$ (2.6%) of people receiving anticoagulant therapy for venous thromboembolism (see Table 1). Intracranial bleeding accounted for $\text{24}\text{276}$ (8.7%) of all major bleeding episodes with fatalities occurring in $\text{11}\text{24}$ (45.8%) of these episodes.

Table 1 Clinical impact of bleeding in people receiving anticoagulant therapy for venous thromboembolism.
	Absolute risk (%)	Absolute risk for fatal episodes (%)	Rate of bleeding per 100 patient-years (95% CI)
Entire anticoagulation period
Major bleeding episodes	276/10,757 (2.6%)	37/276 (13.4%)	7.22 (7.19 to 7.24)
Intracranial bleeding episodes	24/8717 (0.3%)	11/24 (45.8%)	1.15 (1.14 to 1.16)

Authors’ conclusions

Major bleeding associated with anticoagulant therapy has considerable clinical consequences that will need to be weighed against therapeutic benefits in people with venous thromboembolism.