Effectiveness and Safety of Apixaban for Treatment of Venous Thromboembolism in Daily Practice
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Key result
In a daily practice cohort of patients with VTE, apixaban treatment for 3 months resulted in a 0.3% incidence of recurrent VTE and a 1.8% incidence of major bleeding.
Why the study?
With DOACs being increasingly used in clinical practice, evaluation of apixaban under daily practice-based conditions was needed to confirm its safety and effectiveness in acute VTE patients.
Population
671 consecutive VTE patients treated with apixaban in two Dutch hospitals
Design
Retrospective cohort study
Follow-up
3 months
Authors
Discussion
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Implication
Apixaban for VTE in routine care yields low recurrence comparable to trials but higher bleeding; leaves open optimal patient selection and monitoring.
Study Design
Type
Cohort (n=671)
Multicenter
Yes
Structured PICO
P
Population
671 consecutive patients with venous thromboembolism treated with apixaban, followed for 3 months.
E
Exposure
Apixaban (either 10 mg twice daily for 1 week followed by 5 mg twice daily, or 5 mg twice daily after approximately 1 week of therapeutic low-molecular-weight heparin) for at least 3 months.
O
Outcome
Recurrent VTE and all-cause mortality (primary efficacy) and incidence of major bleeding (primary safety) during a 3-month follow-up period.hard clinical
In daily clinical practice, apixaban for VTE treatment demonstrated a low rate of recurrence comparable to phase 3 trials, but a higher incidence of major bleeding, underscoring the differences between trial populations and real-world patients.
Limitations
- Selection bias, as it is unknown in how many patients (and why) another anticoagulant strategy than apixaban was chosen
- Two of the major bleedings occurred on LMWH treatment in the first week, which may have led to an overestimation of the apixaban-associated rate of major bleeding
Cite This Study
Hendriks et al. (2020) conducted a cohort in venous thromboembolism (n=671). Apixaban was evaluated on recurrent VTE (95% CI 0.08-1.1). In a daily practice cohort of patients with VTE, apixaban treatment for 3 months resulted in a 0.3% incidence of recurrent VTE and a 1.8% incidence of major bleeding.
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