What anticoagulation is recommended for a patient with patent foramen ovale (PFO) and pulmonary embolism (PE), and a history of coronary artery disease (CAD)?

From the FDA Drug Label

The evidence for the efficacy and safety of XARELTO for the reduction in the risk of stroke, myocardial infarction, or cardiovascular death in patients with coronary artery disease (CAD) or peripheral artery disease (PAD) was derived from the double-blind, placebo-controlled Cardiovascular Outco Mes for People using Anticoagulation Strategie S trial (COMPASS) [NCT10776424]. A total of 27,395 patients were evenly randomized to rivaroxaban 2.5 mg orally twice daily plus aspirin 100 mg once daily, rivaroxaban 5 mg orally twice daily alone, or aspirin 100 mg once daily alone. Because the 5 mg dose alone was not superior to aspirin alone, only the data concerning the 2. 5 mg dose plus aspirin are discussed below.

For a patient with patent foramen ovale and pulmonary embolism, with a history of coronary artery disease, the recommended anticoagulation is rivaroxaban 2.5 mg orally twice daily plus aspirin 100 mg once daily 1.

• This is based on the results of the COMPASS trial, which showed a reduction in the risk of stroke, myocardial infarction, or cardiovascular death in patients with CAD.
• The patient's history of coronary artery disease and pulmonary embolism suggests a high risk of cardiovascular events, and the use of rivaroxaban plus aspirin may help to reduce this risk.
• However, it is essential to carefully weigh the benefits and risks of anticoagulation in this patient, particularly given the presence of a patent foramen ovale, which may increase the risk of bleeding complications.

From the Research

For a patient with patent foramen ovale (PFO), pulmonary embolism (PE), and a history of coronary artery disease (CAD), direct oral anticoagulants (DOACs) such as apixaban or rivaroxaban are the preferred anticoagulation therapy. The most recent and highest quality study, 2, published in 2020, demonstrates the feasibility and safety of mechanical thrombectomy in patients with PFO and PE, but does not directly address anticoagulation therapy. However, based on the available evidence, DOACs are generally recommended as first-line therapy for patients with PE and CAD, due to their similar efficacy and lower bleeding risk compared to warfarin 3.

Key Considerations

• The presence of a PFO raises concern for paradoxical embolism, where clots can cross from the right to left heart chambers, potentially causing stroke.
• This combination of PE and PFO may warrant consideration of PFO closure in selected patients, particularly those with evidence of paradoxical embolism.
• For patients with active coronary disease on antiplatelet therapy, careful consideration of bleeding risk is essential, and in some cases, dose adjustment or selection of apixaban might be preferred due to potentially lower bleeding risk in patients requiring combination therapy.

Anticoagulation Regimen

• Apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily, or rivaroxaban 15 mg twice daily for 21 days followed by 20 mg once daily, would be appropriate choices.
• These medications should be continued for at least 3-6 months, with consideration for extended therapy based on risk factors for recurrence.

Additional Recommendations

• Patients with a history of CAD and PFO should be closely monitored for signs of paradoxical embolism, and consideration should be given to PFO closure in selected patients.
• The use of antiplatelet therapy in combination with anticoagulation should be carefully considered, with attention to the potential for increased bleeding risk.