Can apixaban (apixaban) 2.5mg twice daily (bid) be used for up to 12 months in patients with provoked pulmonary embolism (PE)?

Use of Apixaban 2.5mg BID for Provoked PE Up to 12 Months

For patients with provoked pulmonary embolism (PE), apixaban 2.5mg twice daily can be used for extended treatment up to 12 months after completing the initial 3-month treatment period, especially in those with enduring risk factors. 1

Initial Treatment Recommendations

• All patients with PE should receive therapeutic anticoagulation for at least 3 months 2
• For patients with PE who are eligible for a NOAC (non-vitamin K antagonist oral anticoagulant), NOACs such as apixaban are preferred over vitamin K antagonists (VKAs) 2
• The standard initial treatment dose for apixaban in PE is 10mg twice daily for 7 days, followed by 5mg twice daily 3

Duration of Treatment for Provoked PE

• For patients with PE provoked by surgery or a transient risk factor, guidelines recommend anticoagulation for 3 months and then discontinuation 2
• After completing the initial 3-month treatment period, the decision to extend therapy should be based on:
  • The risk of recurrence after treatment discontinuation 2
  • The risk of bleeding complications while on treatment 2
  • The presence of enduring risk factors 1

Extended Treatment with Reduced-Dose Apixaban

• The AMPLIFY-EXT trial demonstrated that apixaban 2.5mg twice daily for 12 months after completing initial treatment was superior to placebo in preventing recurrent VTE (3.8% vs 11.6%, relative risk 0.33) with a low risk of major bleeding 3
• Recent evidence from the HI-PRO trial specifically showed that in patients with provoked VTE who have enduring risk factors, apixaban 2.5mg twice daily for 12 months resulted in significantly lower risk of recurrent VTE compared to placebo (1.3% vs 10.0%) 1
• The 2019 ESC guidelines suggest that a reduced dose of apixaban (2.5mg twice daily) should be considered after the first 6 months of treatment for extended anticoagulation 2

Patient Monitoring and Considerations

• For patients receiving extended anticoagulation, regular reassessment of drug tolerance, adherence, hepatic and renal function, and bleeding risk is recommended 2
• Do not use NOACs including apixaban in patients with severe renal impairment or in those with antiphospholipid antibody syndrome 2
• Patients should be informed about the risk of bleeding and instructed to report any unusual bleeding to their physician 3

Special Considerations

• For patients with cancer-associated PE, extended anticoagulation is generally recommended, with recent evidence supporting that reduced-dose apixaban (2.5mg twice daily) is non-inferior to full-dose apixaban with lower bleeding risk 4
• For patients with unprovoked PE, extended anticoagulation is often preferred if bleeding risk is low or moderate 2

Conclusion

For patients with provoked PE who have completed the initial 3-month treatment period, apixaban 2.5mg twice daily is an effective and safe option for extended treatment up to 12 months, particularly in those with enduring risk factors that may increase recurrence risk 1. This approach provides continued protection against recurrent VTE while minimizing bleeding risk compared to full-dose anticoagulation.