What is the recommended duration of treatment with Xarelto (rivaroxaban) for a 60-year-old patient with unprovoked pulmonary embolism and a history of ulcerative colitis in histologic remission, with normal kidney function and a glomerular filtration rate (GFR) of 88?

From the Guidelines

For a 60-year-old patient with unprovoked pulmonary embolism on Xarelto and ulcerative colitis in histologic remission, indefinite anticoagulation therapy is recommended. The patient should continue Xarelto at 20 mg once daily with food, as this is the standard maintenance dose after the initial 15 mg twice daily for 21 days. Given the unprovoked nature of the PE and the patient's age, the risk of recurrence is high if anticoagulation is discontinued, as suggested by the European Society of Cardiology guidelines 1. The normal kidney function (GFR of 88) supports the standard Xarelto dosing without adjustment.

Key Considerations

• The patient's history of ulcerative colitis in histologic remission is important, as active inflammation can increase thrombotic risk, but the current remission status does not directly influence the anticoagulation strategy.
• Additional testing should include a comprehensive thrombophilia panel (including Factor V Leiden, Prothrombin gene mutation, Protein C and S levels, Antithrombin III, and antiphospholipid antibodies), D-dimer levels, complete blood count, comprehensive metabolic panel, and an echocardiogram to assess for right ventricular dysfunction and pulmonary hypertension, as recommended for patients with unprovoked PE 1.
• Regular monitoring of inflammatory markers like CRP and fecal calprotectin would be prudent given the ulcerative colitis history.
• The patient should also undergo cancer screening appropriate for their age and risk factors, as occult malignancy can present with unprovoked thrombosis.
• Periodic reassessment of bleeding risk is essential, particularly given the history of ulcerative colitis which may increase bleeding risk if it flares, but the current guidelines suggest that the benefits of anticoagulation outweigh the risks in patients with unprovoked PE and low bleeding risk 1.

Treatment Duration

The decision to extend anticoagulation is based on the balance between the risk of recurrent venous thromboembolism (VTE) and the risk of anticoagulant-related bleeding. For patients with unprovoked PE, the risk of recurrence is significant, and indefinite anticoagulation is recommended for those with a low risk of bleeding, as stated in the guidelines 1. The choice of anticoagulant can be based on patient preference, bleeding risk, and other factors, but rivaroxaban is a suitable option for long-term anticoagulation in this context, given its efficacy and safety profile compared to vitamin K antagonists 1.

From the Research

Treatment Duration for Unprovoked Pulmonary Embolism

The recommended duration of treatment with Xarelto (rivaroxaban) for a 60-year-old patient with unprovoked pulmonary embolism and a history of ulcerative colitis in histologic remission, with normal kidney function and a glomerular filtration rate (GFR) of 88, can be determined based on the following factors:

• The risk of recurrence of venous thromboembolism (VTE) without anticoagulation 2, 3, 4
• The risk of bleeding while on anticoagulant therapy 2, 3, 4
• The presence of a reversible risk factor or a first unprovoked isolated distal deep vein thrombosis (DVT) 2
• The presence of active cancer or a second unprovoked VTE 2

Considerations for Treatment Duration

Key considerations for determining the treatment duration include:

• The minimal duration of anticoagulation for pulmonary embolism is 3 months 4
• After pulmonary embolism that was provoked by a major transient risk factor, the risk of recurrence is low and does not justify prolonging anticoagulation beyond 6 months 4
• In patients with an unprovoked pulmonary embolism, the prolongation of anticoagulation up to 1 or 2 years as compared to 3 or 6 months is not associated with a long-term reduction in the risk of recurrence, and these patients should be treated either for 3 to 6 months or indefinitely 4
• The use of novel oral anticoagulants, such as rivaroxaban, may be considered for the treatment of pulmonary thromboembolism in patients with ulcerative colitis 5

Patient-Specific Factors

In this patient's case, the following factors should be considered:

• The patient has a history of ulcerative colitis in histologic remission, which may increase the risk of thromboembolic complications 6, 5
• The patient has normal kidney function and a GFR of 88, which is important for determining the safety and efficacy of anticoagulant therapy 2, 3
• The patient is 60 years old, which may affect the risk of bleeding and recurrence of VTE 2, 3