1. In a cohort of patients who had symptomatic isolated distal deep vein thrombosis, an additional 6 weeks of rivaroxaban therapy in addition to standard therapy reduced the risk of recurrent venous thromboembolism
2. Additional treatment with rivaroxaban was not associated with increased incidence of hemorrhage
Evidence Rating Level: 1 (Excellent)
Isolated distal deep vein thrombosis (DVT) is generally perceived as more benign than proximal DVT, but can still lead to pulmonary embolism in up to 22% of untreated patients. Guidelines for isolated DVT currently suggest anticoagulant therapy for patients with symptoms or those with risk factors, whereas others are treated with repeated imaging of deep veins. This randomized control trial involved 403 patients who had symptomatic isolated distal DVT, thus qualifying for anticoagulant therapy. Patients were given standard doses of rivaroxaban for 6 weeks, then were randomly assigned to receive 20 mg of rivaroxaban or a placebo for 6 additional weeks, and then followed for 2 years. Five follow-up visits were scheduled including a baseline visit that collected lab tests including: complete blood count, D-dimer, prothrombin, activated partial thromboplastin time, liver and renal function. Following the baseline visit, compression ultrasonography and lab tests were completed at six weeks, 3 months and as needed if there were any future symptoms of DVT. 11% of rivaroxaban patients and 19% of placebo patients had recurrent venous thromboembolism (relative risk 0.59, 95% confidence interval 0.36 to 0.95; P=0.03). Recurrent isolated DVT occurred in 8% of rivaroxaban patients and 15% of placebo patients (P=0.02). No significant differences were seen in rates of proximal DVT or pulmonary embolism (P=0.8), and no major bleeding events occurred in either group. Strengths of this study included the population size and the study design of randomized controlled trial, however it does not help address whether patients with isolated DVT should receive treatment and these guidelines remain unclear. Overall, this study showed that 6 additional weeks of treatment with rivaroxaban reduced the risk of recurrent venous thromboembolism over a two year time period, without increasing the risk of bleeding.
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