Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism

Exclusion Criteria

• •1. Presence of leg deep vein thrombosis (DVT) or upper extremity DVT (subclavian vein or above)
• •2. Active cancer, defined as cancer treated with surgery, chemotherapy, radiotherapy, or palliative care during the last 6 months
• •3. ≥1 prior episode of unprovoked VTE (absence of a transient or permanent risk factor)
• •4. Clinical instability (systolic blood pressure \<100 mm Hg or arterial Oxygen saturation \<92% at ambient air) at the time of presentation
• •5. Active bleeding or at high risk of bleeding
• •6. Severe renal failure (creatinine clearance \<30ml/min)
• •7. Severe liver insufficiency (Child-Pugh B or C)
• •8. Concomitant use of strong CYP3A4 inhibitors or strong CYP3A4 inducers
• •9. Known hypersensitivity to rivaroxaban
• •10. Need for therapeutic anticoagulation for another reason
• •11. Therapeutic anticoagulation for \>72 hours for any reason at the time of screening
• •12. Hospitalized for \>72 hours prior to the diagnosis of isolated SSP (hospital-acquired VTE)
• •13. Known pregnancy or breast feeding (pregnancy test to be performed for women of childbearing potential)
• •14. Lack of safe contraception in women of childbearing potential
• •15. Refusal or inability to provide informed consent
• •16. Prior enrolment in this trial