From the Guidelines
Patients with a chronic risk factor, such as inflammatory bowel disease or an autoimmune disorder, who sustain a VTE are considered to be at higher risk for recurrence if anticoagulation is discontinued after completion of the primary treatment phase. The criteria for sustained Venous Thromboembolism (VTE) include the presence of chronic risk factors, such as inflammatory bowel disease or an autoimmune disorder, which increase the risk of recurrence if anticoagulation is discontinued after completion of the primary treatment phase 1. Key factors to consider in the evaluation of sustained VTE include:
- The presence of chronic risk factors, such as inflammatory bowel disease or an autoimmune disorder
- The presence of transient risk factors, such as surgery or hospitalization for an acute illness
- The patient's risk for bleeding complications, which includes factors such as older age, history of prior bleeding, cancer, hepatic and/or renal insufficiency, hypertension, thrombocytopenia, prior stroke, need for antiplatelet therapy, anemia, alcohol abuse, and frequent falls 1
- The severity of the risk factor, the number of risk factors present, and the presence of additional comorbid conditions 1 The American Society of Hematology guideline panel recommends continuing antithrombotic therapy indefinitely after completion of primary treatment for patients with chronic risk factors, with regular reevaluation at least annually to review their clinical course and reassess the clinical indication for continued indefinite therapy and bleeding risk factors 1.
From the FDA Drug Label
9 Treatment of Venous Thromboembolism and Reduction in Risk of Recurrent Venous Thromboembolism in Pediatric Patients XARELTO is indicated for the treatment of venous thromboembolism (VTE) and the reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years after at least 5 days of initial parenteral anticoagulant treatment.
The criteria for sustained Venous Thromboembolism (VTE) are not explicitly stated in the provided drug label. However, the label does mention the treatment of VTE and reduction in risk of recurrent VTE in pediatric patients, indicating that the drug is used for patients who have already developed VTE.
- The label states that XARELTO is indicated for the treatment of VTE in pediatric patients from birth to less than 18 years after at least 5 days of initial parenteral anticoagulant treatment.
- It also mentions that therapy with XARELTO should be continued for at least 3 months in children with thrombosis, and treatment can be extended up to 12 months when clinically necessary. However, the label does not provide specific criteria for determining when a VTE is considered sustained. 2
From the Research
Criteria for Sustained Venous Thromboembolism (VTE)
The criteria for sustained VTE are not explicitly stated in the provided studies. However, the following factors are associated with an increased risk of recurrent VTE:
- History of VTE 3, 4, 5, 6
- Thrombophilia 4, 5
- Chronic liver disease 4
- Immune-mediated disorders 4
- Thrombocytopenia 4
- History of bleed 4
Diagnosis and Treatment of VTE
The diagnosis and treatment of VTE have advanced in recent years, with the introduction of direct oral anticoagulants (DOACs) such as apixaban 3, 4, 5, 7, 6. The management of VTE requires immediate anticoagulation therapy based on a risk assessment for bleeding 6. The following are key points in the diagnosis and treatment of VTE:
- The application of an age-adjusted D-dimer threshold in patients with suspected PE can increase the number of patients in whom imaging can be withheld 5
- The Pulmonary Embolism Rule-Out Criteria can safely exclude PE when the pretest probability is low 5
- DOACs have allowed for a simplified treatment of VTE with a lower risk of bleeding regardless of etiology or extent of the VTE (except for massive PE) 5
- Thrombolysis is best reserved for patients with massive PE or those with DVT and threatened limb loss 5
- Insertion of inferior vena cava filters should be avoided unless anticoagulation is absolutely contraindicated in patients with recent acute VTE 5
- Graduated compression stockings are no longer recommended to treat DVT but may be used when acute or chronic symptoms are present 5
- Anticoagulation may no longer be indicated for patients with isolated distal DVT at low risk of recurrence 5