How long should a patient with bilateral extensive pulmonary embolism (PE) and right heart strain after prostatectomy be on Eliquis (apixaban)?

From the Guidelines

The patient should be on Eliquis for at least 3 months, but considering the extensive nature of the PE with right heart strain and the provoked nature of the event, a 6-month course is recommended, followed by reassessment for extended therapy. The patient's current situation, having developed bilateral extensive PE with right heart strain after prostatectomy, suggests a significant risk factor that may influence the decision for the duration of anticoagulation therapy 1. According to the 2019 ESC guidelines for the diagnosis and management of acute pulmonary embolism, therapeutic anticoagulation for more than 3 months is recommended for all patients with PE, and for patients with a first PE secondary to a major transient/reversible risk factor, discontinuation of therapeutic oral anticoagulation is recommended after 3 months 1.

Given the patient's condition, the following points are crucial:

• The standard dosing for Eliquis in this setting is typically 10 mg twice daily for the first 7 days, followed by 5 mg twice daily for the remainder of the treatment period.
• After completing the initial treatment period, the patient should be reassessed for the risk of recurrence, and if risk factors persist or if this is a recurrent event, extended therapy beyond 6 months may be warranted 1.
• The decision for extended therapy should balance the risk of recurrent thrombosis against bleeding risk, and Eliquis is generally well-tolerated compared to warfarin, with a lower bleeding risk, which may factor into decisions about extended therapy 1.
• If extended oral anticoagulation is decided after PE in a patient without cancer, a reduced dose of the NOACs apixaban (2.5 mg b.i.d.) or rivaroxaban (10 mg o.d.) should be considered after 6 months of therapeutic anticoagulation 1.

Key considerations in the management of this patient include:

• Regular follow-up appointments to monitor for signs of recurrent PE, bleeding complications, and to reassess the need for continued anticoagulation.
• Assessment of the patient's bleeding risk to identify and treat modifiable bleeding risk factors, which may influence decision-making on the duration and regimen/dose of anticoagulant treatment 1.

From the FDA Drug Label

Both studies were randomized, parallel-group, double-blind trials in patients with symptomatic proximal DVT and/or symptomatic PE. Patients with an objectively confirmed symptomatic DVT and/or PE were randomized to treatment with apixaban 10 mg twice daily orally for 7 days followed by apixaban 5 mg twice daily orally for 6 months, In the AMPLIFY-EXT study, both doses of apixaban were superior to placebo in the primary endpoint of symptomatic, recurrent VTE (nonfatal DVT or nonfatal PE), or all-cause death

The patient should be on Eliquis (apixaban) for at least 6 months as per the AMPLIFY study.

• The decision to extend anticoagulation should be based on the risk of recurrent VTE and the risk of anticoagulant-related bleeding.
• The AMPLIFY-EXT study suggests that extended anticoagulation with apixaban can reduce the risk of recurrent VTE, but the optimal duration of treatment is not clearly defined 2.

From the Research

Duration of Anticoagulant Therapy

The patient developed bilateral extensive pulmonary embolism (PE) with right heart strain after prostatectomy and has been on Eliquis (apixaban). The duration of anticoagulant therapy for venous thromboembolism (VTE), which includes PE, is generally 3 months or indefinitely, depending on the risk of recurrence and bleeding 3.

Factors Influencing Treatment Duration

The decision to stop anticoagulants at 3 months or to treat indefinitely is dominated by the long-term risk of recurrence, and secondarily influenced by the risk of bleeding and by patient preference 3. In this case, the patient had a provoked PE (after prostatectomy), which may have a lower risk of recurrence compared to unprovoked PE.

Treatment Options

Apixaban is an oral, direct factor Xa inhibitor that is approved for the acute treatment of deep-vein thrombosis (DVT) and PE, as well as for the reduction in the risk of recurrent DVT and PE following initial therapy 4. Studies have shown that apixaban is effective and safe for the treatment of VTE, including PE, and may be a preferable treatment option for cancer-associated VTE due to its lower risk of severe bleeding and reduced PE recurrence 5, 6, 7.

Recommended Treatment Duration

Based on the available evidence, the recommended treatment duration for the patient is at least 3 months, as this is the minimum duration required to complete "active treatment" of VTE 3. However, the decision to extend treatment beyond 3 months should be based on the individual patient's risk of recurrence and bleeding, as well as their preference.

• Factors to consider when deciding on treatment duration:
  • Risk of recurrence: patients with a high risk of recurrence may benefit from extended treatment
  • Risk of bleeding: patients with a high risk of bleeding may require closer monitoring and consideration of alternative treatment options
  • Patient preference: patient preferences and values should be taken into account when making decisions about treatment duration
• Potential benefits of extended treatment:
  • Reduced risk of recurrence
  • Improved patient outcomes
• Potential risks of extended treatment:
  • Increased risk of bleeding
  • Increased burden on the patient due to ongoing treatment requirements