What is the gold standard treatment of Pulmonary Embolism (PE)?

From the Guidelines

The gold standard treatment for pulmonary embolism (PE) is anticoagulation therapy, with the most recent guidelines recommending initiation of anticoagulation without delay in patients with high or intermediate clinical probability of PE. According to the 2019 ESC guidelines for the diagnosis and management of acute pulmonary embolism 1, initial treatment typically involves parenteral anticoagulation with either low molecular weight heparin (LMWH) such as enoxaparin 1 mg/kg twice daily, unfractionated heparin (UFH) as a continuous infusion with target aPTT of 1.5-2.5 times normal, or fondaparinux 5-10 mg daily based on weight. This is followed by oral anticoagulants, with direct oral anticoagulants (DOACs) like rivaroxaban (15 mg twice daily for 21 days, then 20 mg daily), apixaban (10 mg twice daily for 7 days, then 5 mg twice daily), or edoxaban and dabigatran (after initial parenteral anticoagulation) being preferred over vitamin K antagonists like warfarin (target INR 2-3) 1.

Some key points to consider in the treatment of PE include:

• The use of systemic thrombolytic therapy is recommended for high-risk PE 1
• Surgical pulmonary embolectomy is recommended for patients with high-risk PE, in whom thrombolysis is contraindicated or has failed 1
• Percutaneous catheter-directed treatment should be considered for patients with high-risk PE, in whom thrombolysis is contraindicated or has failed 1
• The treatment duration is typically 3-6 months for provoked PE and at least 6-12 months or indefinitely for unprovoked PE 1

It's worth noting that the American College of Chest Physicians evidence-based clinical practice guidelines also recommend initial parenteral anticoagulant therapy for acute DVT or pulmonary embolism (PE) 1. However, the most recent guidelines from the European Society of Cardiology provide more specific recommendations for the treatment of PE, including the use of DOACs and the management of high-risk PE 1.

In terms of specific medications and dosages, the guidelines recommend:

• Rivaroxaban 15 mg twice daily for 21 days, then 20 mg daily 1
• Apixaban 10 mg twice daily for 7 days, then 5 mg twice daily 1
• Edoxaban and dabigatran after initial parenteral anticoagulation 1
• Warfarin with a target INR of 2-3 1

Overall, the treatment of PE should be individualized based on the patient's specific clinical presentation and risk factors, with a focus on reducing the risk of morbidity, mortality, and improving quality of life.

From the FDA Drug Label

1.3 Treatment of Pulmonary Embolism XARELTO is indicated for the treatment of pulmonary embolism (PE). The gold standard treatment of Pulmonary Embolism (PE) is not explicitly stated in the provided drug label.

• The label only mentions that XARELTO is indicated for the treatment of PE 2.
• However, it does not provide information on whether XARELTO is the gold standard treatment or if other treatments are considered gold standard.

From the Research

Gold Standard Treatment of Pulmonary Embolism (PE)

The gold standard treatment of PE involves anticoagulation therapy to prevent further clot formation and reduce the risk of recurrence.

• Anticoagulation is performed with unfractionated heparin (UFH) in hemodynamically unstable patients and with low molecular weight heparins (LMWH) or fondaparinux in normotensive patients 3.
• The current guidelines recommend that all eligible patients should be treated with a non-vitamin K antagonist oral anticoagulant (NOAC) in preference to a vitamin K antagonist (VKA) 3.
• LMWH and fondaparinux are preferred over UFH in the initial anticoagulation of PE since they are associated with a lower risk of bleeding 3, 4, 5.

Duration of Anticoagulation

• All patients with PE require therapeutic anticoagulation for at least three months 3.
• The decision on the duration of anticoagulation should consider both, the individual risk of PE recurrence and the individual risk of bleeding 3.
• Patients with a strong transient risk factor have a low risk of recurrence and anticoagulation can be discontinued after three months, while patients with strong persistent risk factor (such as active cancer) have a high risk of recurrence and thus should receive anticoagulant treatment of indefinite duration 3.

Treatment Options

• Low-molecular-weight heparin (LMWH) is at least as effective as unfractionated heparin (UFH) in the treatment of PE, with a similar risk of bleeding 4, 6, 5.
• Outpatient treatment with LMWH has been shown to be feasible in many patients, and offers the potential for cost-savings and improvements in health-related quality of life 4.
• NOACs, such as Apixaban, Edoxaban, and Rivaroxaban, are effective alternatives to treatment with LMWH, especially in patients with active cancer 3.