From the Guidelines
Patients with large volume bilateral unprovoked pulmonary embolisms (PEs) on Apixaban should be advised to attend regular follow-up examinations, at least yearly, to monitor for signs of VTE recurrence, cancer, or bleeding complications, and to assess for persisting or new-onset dyspnoea or functional limitation.
Safety Netting Advice
- The patient should be informed about the lifelong risk of VTE recurrence after a first episode of PE, and the importance of regular follow-up examinations to monitor for signs of recurrence, cancer, or bleeding complications 1.
- The patient should be advised to seek medical attention immediately if they experience any symptoms of VTE recurrence, such as dyspnoea, chest pain, or leg swelling.
- The patient should be re-assessed at regular intervals to weigh the benefits vs. risks of continuing anticoagulant therapy, and to consider the patient's preference 1.
- Follow-up imaging is not routinely recommended in asymptomatic patients, but it may be considered in patients with risk factors for development of CTEPH 1.
- The patient should be informed about the importance of adherence to anticoagulant therapy, and the need to monitor for signs of bleeding complications, such as bruising, bleeding gums, or heavy menstrual bleeding.
Anticoagulant Therapy
- Apixaban is a suitable option for long-term anticoagulation in patients with unprovoked PE, and reduced-dose apixaban (2.5 mg b.i.d.) may be considered after 6 months of therapeutic anticoagulation 1.
- The patient's bleeding risk should be assessed regularly, and the dose of anticoagulant therapy should be adjusted accordingly 1.
- The patient should be informed about the importance of regular monitoring of hepatic and renal function, as well as drug tolerance and adherence 1.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Safety Netting Advice for Patients with Large Volume Bilateral Unprovoked Pulmonary Embolisms (PEs) on Apixaban
- The studies 2, 3, 4, 5, 6 provide information on the treatment of venous thromboembolism (VTE) with apixaban, but do not specifically address safety netting advice for patients with large volume bilateral unprovoked PEs.
- However, the study 6 mentions that patients with PE should be evaluated using a structured score or clinical gestalt to assess the clinical probability of PE, and that direct oral anticoagulants such as apixaban are noninferior for treating PE and have a lower rate of bleeding compared to heparin combined with a vitamin K antagonist.
- The study 2 reports that apixaban yielded a low incidence of recurrent VTE and a higher incidence of major bleeding in a daily practice-based cohort, highlighting the importance of monitoring patients on apixaban.
- The study 4 found that prescribing patterns of apixaban lead-in therapy duration are variable in patients receiving initial parenteral anticoagulation, and that a reduced lead-in duration may be associated with a higher risk of bleeding.
- The study 5 provides information on the pharmacokinetics and pharmacodynamics of apixaban, which may be useful in guiding dosing and monitoring decisions.
Key Considerations
- Patients with large volume bilateral unprovoked PEs on apixaban should be closely monitored for signs and symptoms of recurrent VTE and bleeding.
- The clinical probability of PE should be assessed using a structured score or clinical gestalt, and patients with a high probability of PE should undergo chest imaging.
- Direct oral anticoagulants such as apixaban are noninferior for treating PE and have a lower rate of bleeding compared to heparin combined with a vitamin K antagonist.
- Prescribing patterns of apixaban lead-in therapy duration should be individualized based on patient factors, such as age and comorbidities.