Clinical outcomes of prolonged anticoagulation with rivaroxaban after unprovoked venous thromboembolism.
Berger JS, Seheult R, Laliberte F, Crivera C, Lejeune D, Xiao Y, Schein J, Lefebvre P, and Kaatz S. Clinical outcomes of prolonged anticoagulation with rivaroxaban after unprovoked venous thromboembolism Res Pract Thromb Haemost 2018; 2(1):58-68
Res Pract Thromb Haemost
Background: Randomized trial data demonstrate the gain of extended duration anticoagulation in patients with venous thromboembolic events (VTE); however, real-world data are limited.
Objectives: Assess the risk of recurrent VTE and major bleeding in a real-world setting of patients who experienced unprovoked VTE and received extended treatment with rivaroxaban.
Methods: US claims databases (February 2011-April 2015) were used in this retrospective study. The study population included adult patients initiated on rivaroxaban within 7 days after their first unprovoked VTE (ie, deep vein thrombosis, pulmonary embolism) and received ≥3 months continuous rivaroxaban treatment (index date: end of 3-month treatment). Patients who were treated beyond 3 months formed the continued cohort and the remainder formed the discontinued cohort (ie, discontinued at 3 months). Adjusted Kaplan-Meier rates for recurrent VTE and major bleeding events were compared between cohorts with confounders being controlled through a propensity score weighting approach.
Results: Patients in the continued cohort (N = 3763) had significantly lower rates of recurrent VTE than those who discontinued (N = 1051): 0.57% vs 1.19% (
Conclusions: Continued rivaroxaban treatment beyond an initial 3- or 6-month treatment period significantly lowered the risk of recurrent VTE without a significant increase of major bleeding, compared to treatment discontinued at 3 or 6 months.