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 for long-term PE treatment, as suggested by the guidelines for antithrombotic therapy for VTE disease 1. Given that this is an unprovoked PE in a patient over 60, the risk of recurrence is high enough to warrant extended treatment beyond the typical 3-6 months. This approach is supported by the European Society of Cardiology guidelines, which recommend indefinite anticoagulant therapy for patients with a first unprovoked proximal DVT or PE and a low risk of bleeding 1.

Key Considerations

• The patient's normal kidney function (GFR 88) supports the standard Xarelto dosing without adjustment.
• Regular monitoring for gastrointestinal bleeding is particularly important given the history of ulcerative colitis, even though it's currently in remission.
• Additional testing should include a D-dimer test to establish a baseline, complete blood count to monitor for bleeding risk, comprehensive metabolic panel to assess liver function, and a thrombophilia workup if not previously done.
• An echocardiogram should be performed to evaluate for right ventricular dysfunction and pulmonary hypertension, which may influence prognosis.

Follow-Up and Monitoring

• The patient should have follow-up appointments every 3-6 months to reassess the benefit-risk ratio of continued anticoagulation, with special attention to any UC flares that might increase bleeding risk.
• The indefinite anticoagulation recommendation is based on the unprovoked nature of the PE, which carries a higher recurrence risk than provoked events, particularly in older patients, as noted in the guidelines 1.

From the Research

Recommended Duration of Treatment with Xarelto (Rivaroxaban)

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, is based on individual assessment of the risk of recurrence and bleeding complications.

• The optimal duration of anticoagulation after a first episode of pulmonary embolism remains controversial and should be made on an individual basis, balancing the estimated risk for recurrence without anticoagulant treatment against bleeding risk under anticoagulation 2.
• For patients with a first unprovoked event and an estimated low risk for bleeding complications, anticoagulant therapy should be evaluated for indefinite treatment on an individualized basis after 3 to 6 months of anticoagulant treatment 2, 3.
• The minimal duration of anticoagulation for pulmonary embolism is 3 months, and 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 3.
• 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 during 3 to 6 months or indefinitely 3.

Considerations for Patients with Ulcerative Colitis

• Patients with ulcerative colitis are prone to form venous thromboembolism (VTE), and the use of corticosteroids during treatment increases the risk of thrombus 4.
• The inflammatory and thrombotic processes are connected, creating a vicious circle, and inflammatory bowel disease predisposes to thromboembolic episodes, while thrombosis, if not the initial cause, is at least implicated in maintaining the inflammatory process in ulcerative colitis and Crohn's disease 5.

Anticoagulant Therapy Options

• Rivaroxaban is one of the currently approved drugs for treatment of venous thromboembolism, and the advent of newer oral anticoagulants such as rivaroxaban, dabigatran, and apixaban has provided alternative therapeutic options for long-term anticoagulation 6.