Under what circumstances should a patient take Xarelto (rivaroxaban) for 3 years?

Extended Anticoagulation with Xarelto (Rivaroxaban) for 3 Years

Patients should receive Xarelto for extended duration (up to 3 years or longer) when they have unprovoked VTE or VTE with persistent risk factors, provided they have low to moderate bleeding risk and the benefits of preventing recurrent thromboembolism outweigh bleeding risks. 1, 2

Clinical Scenarios Warranting Extended Anticoagulation

Unprovoked VTE

• Patients with unprovoked proximal DVT or PE should receive extended anticoagulation with no scheduled stop date after completing the initial 3 months of treatment 1
• The EINSTEIN Extension trial demonstrated that rivaroxaban 20 mg once daily was superior to placebo in preventing recurrent VTE when continued for an additional 6-12 months after initial treatment 1
• Studies have followed patients on rivaroxaban for up to 40 months, establishing safety and efficacy for this extended duration 1

VTE with Persistent Risk Factors

• Patients with enduring risk factors such as heart failure, active cancer, or other persistent thrombotic conditions should receive extended anticoagulation 2
• The American College of Chest Physicians specifically recommends extended anticoagulation for VTE associated with persistent risk factors 2
• These patients face ongoing elevated risk of recurrent VTE that persists beyond the initial 3-month treatment period 2

Recurrent VTE

• Any patient with recurrent VTE not related to a major transient risk factor requires indefinite anticoagulation 3
• This applies regardless of whether the recurrence occurred on or off anticoagulation 3

Dosing for Extended Treatment

• After the initial 3 weeks of rivaroxaban 15 mg twice daily, continue with 20 mg once daily for extended treatment 1, 4
• Dose reduction to 15 mg once daily is required if creatinine clearance is 30-49 mL/min 1
• The same dose used for initial treatment (20 mg daily) continues for extended therapy without need to change anticoagulant choice 1

Bleeding Risk Assessment

Extended anticoagulation is recommended when bleeding risk is low to moderate 1:

• For low or moderate bleeding risk: extended therapy is suggested over stopping at 3 months 1
• For high bleeding risk: stopping at 3 months is recommended over extended therapy 1
• The EINSTEIN studies showed rivaroxaban had significantly lower major bleeding rates (1.0-1.1%) compared to standard therapy (1.7-2.2%) 4, 5

Contraindications to Extended Rivaroxaban

Do not use rivaroxaban for extended treatment in 1:

• Severe renal failure with creatinine clearance <15 mL/min
• Hepatic disease associated with coagulopathy
• Concomitant systemic azole-antimycotics or HIV protease inhibitors
• Pregnancy or breastfeeding
• Children or adolescents <18 years of age

Monitoring and Reassessment

• Patients on extended anticoagulation must be reassessed at least annually to evaluate continued need, bleeding risk, treatment burden, and patient preferences 1, 2
• Reassessment should also occur at times of significant health status changes 2
• Extended-phase anticoagulation has no predefined stop date, though most studies followed patients for 2-4 years 2
• No routine coagulation monitoring is required for rivaroxaban 6, 7

Clinical Scenarios Where Extended Treatment is NOT Indicated

Stop anticoagulation at 3 months for 1:

• VTE provoked by surgery (strong recommendation)
• VTE provoked by nonsurgical transient risk factors with low/moderate bleeding risk (conditional recommendation)
• VTE provoked by nonsurgical transient risk factors with high bleeding risk (strong recommendation)

Important Caveats

• The net clinical benefit (combining efficacy and safety) of rivaroxaban was significantly greater than comparators in extended treatment trials 7
• Rivaroxaban showed a nonsignificant increase in clinically relevant nonmajor bleeding compared to placebo in extended treatment, but major bleeding increase was also nonsignificant 1
• The single-drug approach with rivaroxaban eliminates the need for initial parenteral anticoagulation and laboratory monitoring, potentially improving adherence for long-term treatment 7, 5